MedWatch - January 2006 Safety-Related Drug Labeling Changes

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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2006

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. Deletions or editorial revisions made to these sections are not included in this summary. The prescribing information may be accessed by clicking on the drug name.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Anaprox /Anaprox DS (naproxen sodium tablets) (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Ansaid (flurbiprofen tablets, USP) (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Arthrotec (diclofenac sodium/misoprostol) Tablets (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Cataflam (diclofenac potassium immediate-release tablets) (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Clinoril (sulindac) Tablets (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Daypro (oxaprozin) Caplets (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Daypro Alta (oxaprozin potassium) Tablets (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Depacon (valproate sodium injection) (click product name to read prescribing information)	BOXED WARNING Teratogenicity PRECAUTIONS Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use General Multi-organ Hypersensitivity Reaction Information for Patients Drug Interactions Drugs for Which a Potentially Important Valproate Interaction Has Been Observed Topiramate	BOXED WARNING .....This is especially important when the treatment of a spontaneously reversible condition not ordinarily associated with permanent injury or risk of death (e.g., migraine) is contemplated. See WARNINGS, Information for Patients.

Depakene (valproic acid capsules and syrup) (click product name to read prescribing information)	BOXED WARNING Teratogenicity PRECAUTIONS Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use General Multi-organ Hypersensitivity Reaction Information for Patients Drug Interactions Drugs for Which a Potentially Important Valproate Interaction Has Been Observed Topiramate PATIENT PACKAGE INSERT	BOXED WARNING .....This is especially important when the treatment of a spontaneously reversible condition not ordinarily associated with permanent injury or risk of death (e.g., migraine) is contemplated. See WARNINGS, Information for Patients. An Information Sheet describes the teratogenic potential of Valproate is available for patients.

Depakote (divalproex sodium coated particles in capsules) Sprinkle Capsules (click product name to read prescribing information)	BOXED WARNING Teratogenicity PRECAUTIONS Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use General Multi-organ Hypersensitivity Reaction Information for Patients Drug Interactions Drugs for Which a Potentially Important Valproate Interaction Has Been Observed Topiramate PATIENT PACKAGE INSERT	BOXED WARNING .....This is especially important when the treatment of a spontaneously reversible condition not ordinarily associated with permanent injury or risk of death (e.g., migraine) is contemplated. See WARNINGS, Information for Patients. An Information Sheet describes the teratogenic potential of Valproate is available for patients.

Dolobid (diflunisal) Tablets (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Elidel (pimecrolimus) Cream 1% (click product name to read prescribing information)	BOXED WARNING (located in the WARNINGS section) Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established WARNINGS MEDICATION GUIDE	BOXED WARNING Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Elidel Cream. Therefore: • Continuous long-term use of topical calcineurin inhibitors, including Elidel Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. • Elidel Cream is not indicated for use in children less than 2 years of age. WARNINGS Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression..... For additional details, see MedWatch 1/20/06 Safety Alert.

Feldene (piroxicam) Capsules (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertitlity Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Indocin (indomethacin) Capsules, Oral Suspension, and Suppositories (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Lodine (etodolac capsules and tablets) (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertitlity Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Lodine XL (etodolac extended-release tablets) (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertitlity Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Motrin (ibuprofen) Suspension 100 mg/5 mL (click product name to read prescribing information)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Pregnancy Teratogenic Effects - Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached prescribing information. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. For additional details, see MedWatch 6/15/05 Safety Alert.

Motrin (ibuprofen tablets, USP) (click product name to read prescribing information)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin-type Anticoagulants Pregnancy Teratogenic Effects: Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached prescribing information. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. For additional details, see MedWatch 6/15/05 Safety Alert.

Nalfon (fenoprofen calcium capsules, USP) (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Naprelan (naproxen sodium) Controlled-Release Tablets (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Naprosyn (naproxen tablets) Naprosyn (naproxen suspension) EC-Naprosyn (naproxen delayed-release tablets) (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Nimotop (nimodipine) Capsules For Oral Use (click product name to read prescribing information)	BOXED WARNING WARNINGS Death due to inadvertent intravenous administration PRECAUTIONS General: Blood Pressure Death Bradycardia	BOXED WARNING Do not administer Nimotop intravenously or by other parenteral routes. Deaths and serious, life threatening adverse events have occurred when the contents of Nimotop Capsules have been injected parenterally. WARNINGS Do not administer Nimotop intravenously or by other parenteral routes. Deaths and serious, life threatening adverse events, including cardiac arrest, cardiovascular collapse, hypotension, and bradycardia, have occurred when the contents of Nimotop Capsules have been injected parenterally. For additional details, see MedWatch 2/15/06 Safety Alert.

Orudis (ketoprofen) Capsules Oruvail (ketoprofen) Extended-Release Capsules) (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Ponstel (mefenamic acid capsules, USP) (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Protopic (tacrolimus) Ointment, 0.03% and 0.1% (click product name to read prescribing information)	BOXED WARNING (located in the WARNINGS section) Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established WARNINGS MEDICATION GUIDE	BOXED WARNING Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Protopic Cream. Therefore: • Continuous long-term use of topical calcineurin inhibitors, including Protopic Ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. • Protopic Ointment is not indicated for use in children less than 2 years of age. Only 0.03% Protopic Ointment is indicated for use in children 2-15 years of age. WARNINGS Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression..... For additional details, see MedWatch 1/20/06 Safety Alert.

Relafen (nabumetone) Tablets (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Voltaren (diclofenac sodium enteric-coated tablets) (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Voltaren-XR (diclofenac sodium extended-release tablets) (click product name to read labeling template)	BOXED WARNING Cardiovascular Risk Gastrointestinal Risk CONTRAINDICATIONS WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects Advanced Renal Disease Anaphylactoid Reactions Skin Reactions Pregnancy PRECAUTIONS General Hepatic Effects Hematological Effects Preexisting Asthma Information for Patients Laboratory Tests Drug Interactions ACE-inhibitors Aspirin Diuretics Lithium Methotrexate Warfarin Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects. Pregnancy Category C Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use MEDICATION GUIDE	Please see attached labeling template. This labeling supplement is in response to the Agency’s June 15, 2005 letter to all sponsors of nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the labeling of all NSAIDs to provide more specific information for practitioners, patients, family members and caregivers about potential risks of CV (cardiovascular) and GI (gastrointestinal) adverse effects for patients taking NSAIDs. Additionally, the label was revised to include a description of early symptoms associated with Stevens-Johnson Syndrome. The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

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Brand (Generic) Name

Sections Modified

Summary of Changes to Contraindications and Warnings

Parnate (tranylcypromine sulfate tablets)

(click product name to read prescribing information)

CONTRAINDICATIONS

Warnings to Physicians
- Clinical Worsening and Suicide Risk

MEDICATION GUIDE

.....In addition, patients with a history of suicidal behavior or thoughts, those patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at an increased risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

For additional details, see 7/1/2005 MedWatch Safety Alert.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Aleve (220 mg naproxen sodium) Tablets Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF YOU HAVE...... ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF..... IF PREGNANT OR BREAST-FEEDING.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Aleve Cold& Sinus (220 mg naproxen sodium and 120 mg pseudoephedrine HCl) Extended Release Tablets Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF YOU HAVE...... ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF..... IF PREGNANT OR BREAST-FEEDING.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Aleve Sinus& Headache (220 mg naproxen sodium and 120 mg pseudoephedrine HCl) Extended Release Tablets Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF YOU HAVE...... ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF..... IF PREGNANT OR BREAST-FEEDING.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Carbatrol (carbamazepine) Extended-Release Capsules (click product name to read prescribing information)	WARNINGS General PRECAUTIONS Information for Patients Carbatrol may interact with some drugs..... Laboratory Tests Increases in total cholesterol, LDL and HDL..... Drug Interactions Agents Highly Bound to Plasma Protein Agents that Inhibits Cytochrome P450 Isoenzymes and/or Epoxide Hydrolase Agents that Induce Cytochrome P450 Isoenzymes Agents with Decreased Levels in the Presence of Carbamazepine due to Induction of Cytochrome P450 Enzymes Agents with Increased Levels in the Presence of Carbamazepine Pharmacological/Pharmacodynamic Interactions with Carbamazepine	In patients with seizure disorder, carbamazepine should not be discontinued abruptly because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. Co-administration of carbamazepine and delavirdine may lead to loss of virologic response and possible resistance to Rescriptor or to the class of non-nucleoside reverse transcriptase inhibitors

Children's ElixSure IB (100 mg/5 mL ibuprofen) Suspension Over-the-Counter (OTC) Medication (click product name to read prescribing information)	WARNINGS Allergy Alert Stomach Bleeding Warning Sore Throat Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF THE CHILD HAS..... ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF.....	Please see prescribing information. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". For additional details, see MedWatch 6/15/05 Safety Alert.

Junior Strength Advil (100 mg ibuprofen) Tablets Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning Sore Throat Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF THE CHILD HAS..... ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

Effexor (venlafaxine hydrochloride) Tablets (click product name to read prescribing information)	WARNINGS Sustained Hypertension	.....Cases of elevated blood pressure requiring immediate treatment have been reported in post marketing experience. Pre-existing hypertension should be controlled before treatment with venlafaxine.

Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules (click product name to read prescribing information)	WARNINGS Sustained Hypertension	.....Cases of elevated blood pressure requiring immediate treatment have been reported in post marketing experience. Pre-existing hypertension should be controlled before treatment with venlafaxine.

Midol Extended Relief (220 mg naproxen sodium) Tablets Over-the-Counter (OTC) Medication (click product name to read labeling template)	WARNINGS Allergy Alert Stomach Bleeding Warning DO NOT USE..... ASK A DOCTOR BEFORE USE IF YOU HAVE...... ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE..... WHEN USING THIS PRODUCT..... STOP USE AND ASK A DOCTOR IF..... IF PREGNANT OR BREAST-FEEDING.....	Please see attached labeling template. Revisions to the Drug Facts label and Principal Display Panel include more specific information for consumers, family members, and caregivers about potential risks of cardiovascular and gastrointestinal adverse effects associated with the use of non-prescription NSAIDS (excluding aspirin). In addition, the "Allergy Alert" has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS). The "Alcohol Warning" has been relocated to appear as part of the new "Stomach Bleeding Warning". The labeling template includes the recommended general changes and not the specific approved product labeling. For additional details, see MedWatch 6/15/05 Safety Alert.

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Brand (Generic) Name	Sections Modified
Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Coly-Mycin M Parenteral (colistimethate for injection, USP) (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Crixivan (indinavir sulfate) Capsules (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Table 9: Established and Other Potentially Significant Drug Interactions..... Venlafaxine

Depakote (divalproex sodium delayed release tablets) Tablets (click product name to read prescribing information)	PRECAUTIONS Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use General Multi-organ Hypersensitivity Reaction Information for Patients Drug Interactions Drugs for Which a Potentially Important Valproate Interaction Has Been Observed Topiramate PATIENT PACKAGE INSERT

Depakote ER (divalproex sodium extended-release tablets) (click product name to read prescribing information)	PRECAUTIONS Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use General Multi-organ Hypersensitivity Reaction Information for Patients Drug Interactions Drugs for Which a Potentially Important Valproate Interaction Has Been Observed Topiramate PATIENT PACKAGE INSERT

Didronel (etidronate disodium) Tablets (click product name to read prescribing information)	PRECAUTIONS General Osteonecrosis, primarily in the jaw..... Musculoskeletal Pain Pregnancy: Teratogenic Effects: Pregnancy Category C Bisphosphonates are incorporated into the bone matrix.....

Eryc (erythromycin delayed-release capsules, USP) (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Floxin (ofloxacin tablets) Tablets (click product name to read prescribing information)	PRECAUTIONS Interaction with Laboratory or Diagnostic Testing

Keppra (levetiracetam) Tablets and Oral Solution Please contact UCB Pharma Inc. at 1-800-477-7877 for prescribing information.	PRECAUTIONS Drug Interactions Initial Section "Levetiracetam circulates largely unbound (<10% bound) to plasma proteins; clinically significant interactions with other drugs through competition for protein binding sites are therefore unlikely."

Levaquin (levofloxacin) Tablets, Oral Solution, and Injection Levaquin (levofloxacin in 5% dextrose) Injection (click product name to read prescribing information)	PRECAUTIONS Interaction with Laboratory or Diagnostic Testing PATIENT PACKAGE INSERT

Miacalcin (calcitonin-salmon) Nasal Spray (click product name to read prescribing information)	PRECAUTIONS Geriatric Use

Prilosec (omeprazole) Delayed-Release Capsules (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Atazanavir

Proloprim (trimethoprim) Tablets (click product name to read prescribing information)	SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria. PRECAUTIONS General Information for Patients

Reyataz (atazanavir sulfate) Capsules (click product name to read prescribing information)	PRECAUTIONS Drug Interactions CYP2C8 Reduced plasma concentrations and proton-pump inhibitors Table 10: Drugs That Should Not Be Administered with Reyataz Antimycobacterials: Rifampin Proton-Pump Inhibitors Table 11: Established and Other Potentially Significant Drug Interactions..... NRTIs: didanosine buffered formulations enteric-coated capsules Other Agents Antifungals: voriconazole H₂-Receptor Antagonists

Stromectol (ivermectin) Tablets (click product name to read prescribing information)	PRECAUTIONS General Seizures ADVERSE REACTIONS Post-Marketing Experience for All Indications Seizures Elevation of Liver Enzymes Elevation of Bilirubin

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Brand (Generic) Name	Sections Modified
Actonel (risedronate sodium tablets) (click product name to read prescribing information)	ADVERSE REACTIONS Osteoporosis Prevention

Actonel with Calcium (risedronate sodium tablets with calcium carbonate tablets, USP) (click product name to read prescribing information)	ADVERSE REACTIONS Osteoporosis Prevention

Aristopan (triamcinolone hexacetonide injectabale suspension, USP) 5 mg/mL, Parenteral (click product name to read prescribing information)	ADVERSE REACTIONS Musculoskeletal Calcinosis (following intra-articular or intra-lesional use)

Aristopan (triamcinolone hexacetonide injectabale suspension, USP) 20 mg/mL, Parenteral (click product name to read prescribing information)	ADVERSE REACTIONS Musculoskeletal Calcinosis (following intra-articular or intra-lesional use)

Mylotarg (gemtuzumab ozogamicin for injection) (click product name to read prescribing information)	ADVERSE REACTIONS Other Clinical Experience Observational Study

Nexium I.V. (esomeprazole sodium) for Injection (click product name to read prescribing information)	ADVERSE REACTIONS Postmarketing Reports Myalgia Rarely, hepatitis with or without jaundice...

Zetia (ezetimibe) Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Post-marketing Experience Hypersensitivity Reactions Urticaria Arthralgia PATIENT PACKAGE INSERT

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