MedWatch - June 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) -- June 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.

Summary View

Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Dilaudid-HP (hydromorphone hydrochloride) Injection (click product name to read prescribing information)	BOXED WARNING WARNINGS Dilaudid-HP contains hydromorphone..... Misuse, Abuse, and Diversion of Opioids Interactions with Alcohol and Drugs of Abuse Head Injury and Increased Intracranial Pressure PRECAUTIONS Special Risk Patients Use in Drug and Alcohol Dependent Patients Drug Interactions Interactions with Mixed Agonist/Antagonist Opioid Analgesics Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy - Pregnancy Category C	BOXED WARNING Dilaudid-HP (High Potency) is a highly concentrated solution of hydromorphone, a potent Schedule II controlled opioid agonist..... Schedule II opioid agonists, including morphine, oxymorphone, oxycodone, fentanyl and methadone, have the highest potential for abuse and risk of producing respiratory depression. Alcohol, other opioids and central nervous system depressants (sedative-hypnotics) potentiate the respiratory depressant effects of hydromorphone, increasing the risk of respiratory depression that might result in death. WARNINGS Dilaudid-HP contains hydromorphone, which is a potent Schedule II, controlled opioid agonist. Schedule II opioid agonists, including morphine, oxycodone, oxymorphone, fentanyl and methadone, have the highest potential for abuse and risk of fatal respiratory depression..... Misuse, Abuse, and Diversion of Opioids Hydromorphone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion..... Interactions with Alcohol and Drugs of Abuse Hydromorphone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Head Injury and Increased Intracranial Pressure .....Opioid analgesics including Dilaudid-HP may produce effects on pupillary response and consciousness which can obscure the clinical course and neurologic signs of further increase in pressure in patients with head injuries.

Dilaudid (hydromorphone hydrochloride) Oral Liquid and 8 mg Tablets (click product name to read prescribing information)	BOXED WARNING WARNINGS Respiratory Depression Dilaudid Oral Liquid and Dilaudid 8 mg Tablets..... Misuse, Abuse, and Diversion of Opioids Interactions with Alcohol and Drugs of Abuse Head Injury and Increased Intracranial Pressure Sulfites PRECAUTIONS Special Risk Patients Use in Drug and Alcohol Dependent Patients Tolerance and Physical Dependence Information for Patient/Caregivers Drug Interactions Drug Interactions with Other CNS Depressants Dilaudid should not be taken with alcohol..... Interactions with Mixed Agonist/Antagonist Opioid Analgesics Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy - Pregnancy Category C	BOXED WARNING & WARNING Dilaudid Oral Liquid and Dilaudid 8 mg Tablets contain hydromorphone, which is a potent Schedule II controlled opioid agonist. Schedule II opioid agonists, including morphine, oxymorphone, oxycodone, fentanyl, and Methadone, have the highest potential for abuse and risk of producing respiratory depression. Alcohol, other opioids and central nervous system depressants (sedative-hypnotics) potentiate the respiratory depression effects of hydromorphone, increasing the risk of respiratory depression that might result in death. WARNINGS Respiratory Depression .....Respiratory depression is more likely to occur in the elderly, in the debilitated, and in those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation. Misuse, Abuse, and Diversion of Opioids Hydromorphone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion..... Interactions with Alcohol and Drugs of Abuse Hydromorphone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Head Injury and Increased Intracranial Pressure .....Opioid analgesics including Dilaudid Oral Liquid and Dilaudid 8 mg Tablets (hydromorphone hydrochloride) may produce effects on pupillary response and consciousness which can obscure the clinical course and neurologic signs of further increase in intracranial pressure in patients with head injuries. Sulfites Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.....

Foradil Aerolizer (formoterol fumarate inhalation powder) for Oral Inhalation only (click product name to read prescribing information)	BOXED WARNING WARNINGS Initial Section Deterioration of Asthma Use of Anti-inflammatory Agents Do Not Exceed Recommended Dose PRECAUTIONS Information for Patients ADVERSE REACTIONS Initial Paragraph Experience in Pediatric, Adolescent and Adult Patients with Asthma In two 12-week controlled trials with combined enrollment of 1095 patients 12 years of age and older..... Table: Number and Frequency of Serious Asthma Exacerbations..... In a 16-week, randomized, multi-center, double-blind, parallel-group trial, patients who received either 24 mcg twice daily or 12 mcg twice daily..... Table: Number and Frequency of Serious Asthma Exacerbations..... Experience in Children with Asthma Table: Number and Frequency of Serious Asthma Exacerbations..... Experience in Adult Patients with COPD Other adverse reactions to Foradil Aerolizer are similar in nature to other selective beta₂-adrenoceptor agonists..... Post-marketing Experience MEDICATION GUIDE	BOXED WARNING Long-acting beta₂-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, Foradil Aerolizer should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies, including Foradil Aerolizer..... WARNINGS Initial Section Long-acting beta₂-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, Foradil Aerolizer should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies, including Foradil Aerolizer..... ...... No studies have been conducted that were adequate to determine whether the rate of death in patients with COPD is increased by long-acting beta₂-adrenergic agonists. Foradil Aerolizer should not be initiated in patients with significantly worsening or acutely deteriorating asthma, which may be a life-threatening condition..... Foradil Aerolizer should not be used in conjunction with an inhaled, long-acting beta₂-agonist..... Foradil Aerolizer is not a substitute for inhaled or oral corticosteroids..... When beginning treatment with Foradil Aerolizer, patients who have been taking inhaled, short-acting beta₂-agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute asthma symptoms. Deterioration of Asthma .....It is important to watch for signs of worsening asthma, such as increasing use of inhaled, short-acting beta₂-adrenergic agonists or a significant decrease in peak expiratory flow (PEF) or lung function..... Use of Anti-inflammatory Agents For the treatment of asthma, Foradil Aerolizer should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies, including Foradil Aerolizer..... Do Not Exceed Recommended Dose .....In addition, data from clinical trials with Foradil Aerolizer suggest that the use of doses higher than recommended is associated with an increased risk of serious asthma exacerbations..... For additional details, see MedWatch 11/18/2005 Safety Alert.

Revlimid (lenalidomide) Capsules (click product name to read prescribing information)	BOXED WARNING Special Prescribing Requirement Revassist Program Description Female Patients Male Patients WARNINGS Pregnancy Category X PRECAUTIONS Laboratory Tests The multiple myeloma studies.... Drug Interactions Digoxin Geriatric Use Revlimid (lenalidomide) has been used in multiple myeloma (MM) clinical trials in patients up to 86 years of age. Of the 692 MM patients enrolled in Studies 1 and 2, 45% were age 65 or over while 12% of patients were age 75 and over..... ADVERSE REACTIONS Multiple Myeloma Table 6: Number of Patients with Adverse Events..... Table 7: Adverse Events with NCI CTC Grades 3 and 4.... Thrombotic Events In these and other clinical studies of Revlimid (lenalidomide) in patients with multiple myeloma, the following serious adverse events..... MEDICATION GUIDE	BOXED WARNING Special Prescribing Requirement .....Under this program, only prescribers and pharmacists registered with the program can prescribe and dispense the product. In addition, Revlimid must only be dispensed to patients who are registered and meet all the conditions of the Revassist Program. Revassist Program Description See prescribing information for revised information. WARNINGS Pregnancy Category X .....Because of this potential toxicity and to avoid fetal exposure to Revlimid (lenalidomide), Revlimid (lenalidomide) is only available under a special restricted distribution program. This program is called "RevAssist".....

Taxotere (docetaxel) Injection Concentrate (click product name to read prescribing information)	BOXED WARNING Fatal Anaphylaxis WARNINGS Hypersensitivity Reactions ADVERSE REACTIONS Post-marketing Experiences Cutaneous Cutaneous Lupus Erythematosus Hypersensitivity Rare cases of anaphylactic shock..... Hearing Rare cases of ototoxicity Hearing Disorders and/or Hearing Loss..... Respiratory Rare cases of radiation pneumonitis.....	BOXED WARNING Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received the recommended 3-day dexamethasone pre-medication..... WARNINGS Patients should be observed closely for hypersensitivity reactions, especially during the first and second infusions. Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients pre-medicated with 3 days of corticosteroids. Hypersensitivity reactions require immediate discontinuation of the Taxotere infusion. Patients with a history of severe hypersensitivity reactions should not be rechallenged with Taxotere.
Tysabri (natalizumab) (click product name to read prescribing information)	BOXED WARNING CONTRAINDICATIONS WARNINGS Progressive Multifocal Leukoencephalopathy (PML) Prescribing, Distribution, and Administration Program for Tysabri Information for Patients Immunosuppression PRECAUTIONS Laboratory Tests Carcinogenesis, Mutagenesis, and Impairment of Fertility Pregnancy (Category C) Nursing Mothers ADVERSE REACTIONS General Table 3: Adverse Reactions in Study 1 (Monotherapy Study) Infections Infusion-related Reactions Immunogenicity MEDICATION GUIDE TYSABRI RISK MINIMIZATION ACTION PLAN: SUMMARY OF TOUCH	BOXED WARNING (new) Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Although the cases of PML were limited to patients with recent or concomitant exposure to immunomodulators or immunosuppressants, there were too few cases to rule out the possibility that PML may occur with Tysabri monotherapy. Because of the risk of PML, Tysabri is available only through a special restricted distribution program called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, only prescribers, infusion centers, and pharmacies associated with infusion centers registered with the program are able to prescribe, distribute, or infuse the product..... Healthcare professionals should monitor patients on Tysabri for any new sign or symptom that may be suggestive of PML. Tysabri dosing should be withheld immediately at the first sign or symptom suggestive of PML..... CONTRAINDICATIONS .....Tysabri is contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML). WARNINGS See prescribing information for revised text. For additional details, see MedWatch 6/05/2006 Safety Alert.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Ketek (telithromycin) Tablets (click product name to read prescribing information)	CONTRAINDICATIONS WARNINGS Hepatotoxicity Exacerbation of Myasthenia Gravis PRECAUTIONS General .....These events were generally reversible, though acute hepatic failure and severe liver injury, in some cases fatal, have been reported. Information for Patients Patients should also be advised of the possibility of liver injury, associated with Ketek..... Patients with myasthenia gravis should not take Ketek, unless there are no other therapeutic alternatives..... ADVERSE REACTIONS Post-marketing Adverse Events Reports Liver and Biliary System .....These hepatic reactions were observed during or immediately after treatment. In some of these cases, liver injury progressed rapidly and occurred after administration of only a few doses of Ketek. PATIENT PACKAGE INSERT	CONTRAINDICATIONS Ketek is contraindicated in patients with previous history of hepatitis and/or jaundice associated with the use of Ketek tablets, or any macrolide antibiotic. WARNINGS Hepatotoxicity Acute hepatic failure and severe liver injury, in some cases fatal, have been reported in patients treated with Ketek. These hepatic reactions included fulminant hepatitis and hepatic necrosis leading to liver transplant, and were observed during or immediately after treatment. In some of these cases, liver injury progressed rapidly and occurred after administration of a few doses of Ketek...... .....Ketek must not be re-administered to patients with a previous history of hepatitis and/or jaundice associated with the use of Ketek tablets, or any macrolide antibiotic. Exacerbation of Myasthenia Gravis Telithromycin should not be used in patients with myasthenia gravis unless no other therapeutic alternatives are available. Exacerbations of myasthenia gravis have been reported in patients with myasthenia gravis treated with telithromycin. This has sometimes occurred within a few hours after intake of the first dose of telithromycin. Reports have included death and life-threatening acute respiratory failure with a rapid onset in patients with myasthenia gravis treated for respiratory tract infections with telithromycin. For additional details, see MedWatch 6/29/2006 Safety Alert.

Marinol (dronabinol) Capsules (click product name to read prescribing information)	CONTRAINDICATIONS PRECAUTIONS General Seizure and seizure-like activity have been reported in patients receiving Marinol Capsules during marketed use of the drug and in clinical trials..... ADVERSE REACTIONS Post-marketing Experience Seizure and seizure-like activity have been reported in patients..... Reports of fatigue have also been received.....	Marinol Capsules is contraindicated in any patient who has a known sensitivity to Marinol Capsules or any of its ingredients. It contains cannabinoid and sesame oil and should never be used by patients allergic to these substances.

Soma (carisoprodol) Tablets, USP (click product name to read prescribing information)	CONTRAINDICATIONS WARNINGS Potentially Hazardous Tasks Drug Dependence, Withdrawal and Abuse Allergic Reactions PRECAUTIONS Seizure Disorder	CONTRAINDICATIONS Soma is contraindicated in patients with acute intermittent porphyria, and in patients who are allergic to or who have idiosyncratic reactions to carisoprodol or meprobamate related compounds. WARNINGS Potentially Hazardous Tasks Patients should be warned that carisoprodol may have sedative properties and may impair the mental and/or physical abilities required..... Drug Dependence, Withdrawal and Abuse In post-marketing experience, cases of drug abuse, dependence and withdrawal have been reported..... Allergic Reactions Section moved from ADVERSE REACTIONS to WARNINGS section.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Avandaryl (rosiglitazone maleate and glimepiride) Tablets (click product name to read prescribing information)	WARNINGS Rosiglitazone Cardiac Failure and Other Cardiac Effects PRECAUTIONS Macular Edema ADVERSE REACTIONS Rosiglitazone Post-marketing reports of new onset or worsening diabetic macular edema with decreased visual acuity have also been received. PATIENT PACKAGE INSERT	Patients with congestive heart failure (CHF) New York Heart Association (NYHA) Class 1 and 2 treated with rosiglitazone have an increased risk of cardiovascular events. A 52-week, double-blind, placebo-controlled echocardiographic study was conducted in 224 patients with type 2 diabetes mellitus and NYHA Class 1 or 2 CHF (ejection fraction <45%) on background antidiabetic and CHF therapy..... For additional details, see MedWatch 1/5/2006 Safety Alert.

Combivir (lamivudine/zidovudine) Tablets (click product name to read prescribing information)	WARNINGS Initial Paragraph Use With Interferon- and Ribavirin-Based Regimens PRECAUTIONS Patients With Impaired Hepatic Function Immune Reconstitution Syndrome Information for Patients Patients should be advised of the importance of taking Combivir exactly as it is prescribed. Zidovudine Drug Interactions Zidovudine	Initial Paragraph Combivir is a fixed-dose combination of lamivudine and zidovudine. Ordinarily, Combivir should not be administered concomitantly with lamivudine, zidovudine, or Epzicom, a fixed-dose combination of abacavir and lamivudine, or Trizivir, a fixed-dose combination of abacavir, lamivudine, and zidovudine. Use With Interferon- and Ribavirin-Based Regimens In vitro studies have shown ribavirin can reduce the phosphorylation of pyrimidine nucleoside analogues such as lamivudine and zidovudine. Although no evidence of a pharmacokinetic or pharmacodynamic interaction (e.g., loss of HIV/HCV virologic suppression) was seen when ribavirin was coadministered with lamivudine or zidovudine in HIV/HCV co-infected patients, hepatic decompensation (some fatal) has occurred in HIV/HCV co-infected patients receiving combination antiretroviral therapy for HIV and interferon alfa with or without ribavirin. Patients receiving interferon alfa with or without ribavirin and Combivir should be closely monitored for treatment-associated toxicities, especially hepatic decompensation, neutropenia, and anemia. Discontinuation of Combivir should be considered as medically appropriate.....

Epivir (lamivudine) Tablets and Oral Solution (click product name to read prescribing information)	WARNINGS Important Differences Among Lamivudine-Containing Products Use With Interferon- and Ribavirin-Based Regimens PRECAUTIONS Immune Reconstitution Syndrome Drug Interactions TMP 160 mg/SMX 800 mg once daily has been shown to increase lamivudine exposure (AUC) by 43%.....	Important Differences Among Lamivudine-Containing Products These statements have been updated to include Epzicom (abacavir sulfate and lamivudine) Tablets. Use With Interferon- and Ribavirin-Based Regimens In vitro studies have shown ribavirin can reduce the phosphorylation of pyrimidine nucleoside analogues such as lamivudine. Although no evidence of a pharmacokinetic or pharmacodynamic interaction (e.g., loss of HIV/HCV virologic suppression) was seen when ribavirin was coadministered with lamivudine in HIV/HCV co-infected patients, hepatic decompensation (some fatal) has occurred in HIV/HCV co-infected patients receiving combination antiretroviral therapy for HIV and interferon alfa with or without ribavirin. Patients receiving interferon alfa with or without ribavirin and Epivir should be closely monitored for treatment-associated toxicities, especially hepatic decompensation. Discontinuation of Epivir should be considered as medically appropriate.....

Hycamtin (topotecan hydrochloride) for Injection for Intravenous Use (click product name to read prescribing information)	WARNINGS Bone Marrow Suppression Neutropenia Cervical Cancer Thrombocytopenia Cervical Cancer Anemia Cervical Center PRECAUTIONS Drug Interactions Myelosuppression was more severe..... Geriatric Use ADVERSE REACTIONS Cervical Cancer Table 9: Hematologic Adverse Events in Cervical Cancer Patients..... Table 10: Non-hematologic Adverse Events.....	Bone Marrow Suppression Bone marrow suppression (primarily neutropenia) is the dose-limiting toxicity of Hycamtin. Neutropenia is not cumulative over time. The following data on myelosuppression is based on: the experience of 140 patients with cervical cancer randomized to receive Hycamtin 0.75 mg/m²/day on days 1, 2, and 3 plus cisplatin 50 mg/m²on day 1. Neutropenia Cervical cancer experience: Grade 3 and grade 4 neutropenia affected 26% and 48% of patients, respectively. Thrombocytopenia Cervical cancer experience: Grade 3 and grade 4 thrombocytopenia affected 26% and 7% of patients, respectively. Anemia Cervical cancer experience: Grade 3 and grade 4 anemia affected 34% and 6% of patients, respectively.

Ultane (sevoflurane) Volatile Liquid for Inhalation (click product name to read prescribing information)	WARNINGS Initial Section Perioperative Hyperkalemia ADVERSE REACTIONS Adverse Events During Post-Marketing Experience In addition, there have been rare post-marketing reports of hepatic failure and hepatic necrosis associated with the use of potent volatile anesthetic agents....	Initial Section Sevoflurane may present an increased risk in patients with known sensitivity to volatile halogenated anesthetic agents. KOH containing CO2 absorbents are not recommended for use with sevoflurane. Perioperative Hyperkalemia Use of inhaled anesthetic agents has been associated with rare increases in serum potassium levels that have resulted in cardiac arrhythmias and death in pediatric patients during the postoperative period. Patients with latent as well as overt neuromuscular disease, particularly Duchenne muscular dystrophy, appear to be most vulnerable.....

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Brand (Generic) Name	Sections Modified
Avandia (rosiglitazone maleate) Tablets (click product name to read prescribing information)	PRECAUTIONS Macular Edema ADVERSE REACTIONS Postmarketing reports of new onset or worsening diabetic macular edema with decreased visual acuity have also been received. PATIENT PACKAGE INSERT For additional details, see MedWatch 1/5/2006 Safety Alert.

Carbatrol (carbamazepine) Extended-Release Capsules (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Agents with Decreased Levels in the Presence of Carbamazepine due to Induction of Cytochrome P450 Enzymes Trazodone

Cymbalta (duloxetine hydrochloride) Delayed-release Capsules (click product name to read prescribing information)	PRECAUTIONS General Hepatotoxicity For additional details, see MedWatch 10/17/2005 Safety Alert.

Emend (aprepitant) Capsules, 40 mg (click product name to read prescribing information) This supplemental new drug application provides for the use of Emend (aprepitant) Capsules for the prevention of post-operative nausea and vomiting (PONV) utilizing a new 40 mg strength.	PRECAUTIONS General Information for Patients Drug Interactions Effect of Aprepitant on the Pharmokinetics of Other Agents Corticosteroids Dexamethasone Methylprednisolone Warfarin Tolbutamide Oral Contraceptives While studies have not been done with the 40 mg single PONV dose..... Midazolam ADVERSE REACTIONS Postoperative Nausea and Vomiting Laboratory Adverse Experiences PATIENT PACKAGE INSERT

Emend (aprepitant) Capsules, 80 mg and 125 mg (click product name to read prescribing information)	PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility

Epogen (epoetin alfa) for Injection (click product name to read prescribing information)	PRECAUTIONS Information for Patients PATIENT PACKAGE INSERT

Exelon (rivastigmine tartrate) Capsules and Oral Solution (click product name to read prescribing information)	PRECAUTIONS Information for Patients and Caregivers Caregivers and patients should be advised that, like other cholinomimetics, Exelon may exacerbate or induce extrapyramidal symptoms..... ADVERSE REACTIONS Dementia Associated with Parkinson's Disease Adverse Events Leading to Discontinuation Most Frequent Adverse Clinical Events Seen in Association with the Use of Exelon Adverse Events Reported in Controlled Trials Table 3: Adverse Events Reported in the Single Controlled Clinical Trial in at Least 2% of Patients..... Other Adverse Events Observed During Clinical Trials Dementia Associated with Parkinson's Disease

Loprox (ciclopirox) Shampoo, 1% (click product name to read prescribing information)	PRECAUTIONS General In patients with lighter hair color, hair discoloration has been rarely reported.

Lumigan (bimatoprost ophthalmic solution) 0.03% (click product name to read prescribing information)	PRECAUTIONS Information for Patients Carcinogenesis, Mutagenesis, Impairment of Fertility

Prandin (repaglinide) Tablets (click product name to read prescribing information)	PRECAUTIONS Hypoglycemia Drug-Drug Interactions In vitro data indicate that Prandin is metabolized by cytochrome P450 enzymes 2C8 and 3A4..... .....In addition, an increase in repaglinide plasma levels was observed in a study that evaluated the co-administration of Prandin with trimethoprim, a cytochrome P-450 enzyme 2C8 inhibitor..... ADVERSE REACTIONS Infrequent Adverse Events (<1% of Patients) Jaundice Hepatitis

Prinivil (lisinopril) Tablets (click product name to read prescribing information)	PRECAUTIONS Hyperkalemia .....Hyperkalemia can cause serious, sometimes fatal, arrhythmias. Prinivil should be used cautiously, if at all, with these agents and with frequent monitoring of serum potassium. Hypoglycemia Drug Interactions Antidiabetics Agents Increasing Serum Potassium Eplerenone ADVERSE REACTIONS Metabolic Cases of hypoglycemia in diabetic patients on oral antidiabetic agents or insulin have been reported.

Prinzide (lisinopril-hydrochlorothiazide) Tablets (click product name to read prescribing information)	PRECAUTIONS Hyperkalemia .....Hyperkalemia can cause serious, sometimes fatal, arrhythmias. Prinzide should be used cautiously, if at all, with these agents and with frequent monitoring of serum potassium. Drug Interactions Lisinopril Agents Increasing Serum Potassium Eplerenone

Rapamune (sirolimus) Oral Solution and Tablets (click product name to read prescribing information)	PRECAUTIONS Lipids ADVERSE REACTIONS Rapamune following Cyclosporine Withdrawal .....Conclusions regarding these differences in the incidence of malignancy could not be made because Study 4 was not designed to consider malignancy risk factors or systematically screen subjects for malignancy. In addition, more patients in the Rapamune with cyclosporine group had a pretransplantation history of skin carcinoma. Table: Incidence (%) of Malignancies in Study 4....

Timoptic (timolol maleate ophthalmic solution) in Ocudose (Dispenser) (click product name to read prescribing information)	PRECAUTIONS Drug Interactions CYP2D6 Inhibitors SSRIs

Viagra (sildenafil citrate) Tablets (click product name to read prescribing information)	PRECAUTIONS General Caution is advised when Phosphodiesterase Type 5 (PDE5) inhibitors are co-administered with alpha-blockers..... Information for Patients Physicians should advise patients of the potential for Viagra to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of Viagra and an alpha-blocker may lead to symptomatic hypotension in some patients. Drug Interactions Effects of Viagra on Other Drugs In Vivo Studies Doxazosin

Wellbutrin XL (bupropion hydrochloride extended-release tablets) (click product name to read prescribing information)	PRECAUTIONS Pregnancy: Teratogenic Effects: Pregnancy Category C. ADVERSE REACTIONS Seasonal Affective Disorder Adverse Events Leading to Discontinuation of Treatment with Wellbutrin XL Adverse Events Occurring at an Incidence of 2% or More Among Patients Being Treated with Wellbutrin XL Table 7: Treatment-Emergent Adverse Events....

Zestoretic (lisinopril/hydrochlorothiazide) Tablets (click product name to read prescribing information)	PRECAUTIONS Hyperkalemia .....Hyperkalemia can cause serious, sometimes fatal, arrhythmias. Zestoretic should be used cautiously, if at all, with these agents and with frequent monitoring of serum potassium. Drug Interactions Lisinopril Agents Increasing Serum Potassium Eplerenone

Zestril (lisinopril) Tablets (click product name to read prescribing information)	PRECAUTIONS Hyperkalemia .....Hyperkalemia can cause serious, sometimes fatal, arrhythmias. Zestril should be used cautiously, if at all, with these agents and with frequent monitoring of serum potassium. Hypoglycemia Drug Interactons Antidiabetics Agents Increasing Serum Potassium Eplerenone ADVERSE REACTIONS Metabolic .....Cases of hypoglycemia in diabetic patients on oral antidiabetic agents or insulin have been reported in post-marketing experience.

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Brand (Generic) Name	Sections Modified
Adderall XR (mixed salts of single-entity amphetamine products) Capsules (click product name to read prescribing information)	ADVERSE REACTIONS Allergic Rash Hypersensivity reactions including angioedema and anaphylaxis

Avastin (bevacizumab) for Intravenous Use (click product name to read prescribing information)	ADVERSE REACTIONS Adverse Reactions in Clinical Trials Hemorrhage Hypertension Second-Line Treatment of Metastatic Carcinoma of the Colon and Rectum Table 7: NCI-CTC Grade 3-5 Non-Hematologic and Grade 4-5 Hematologic Adverse Events.....

Edex (alprostadil for injection) for Intracavernous Use only (click product name to read prescribing information)	ADVERSE REACTIONS Post-Marketing Adverse Experiences Needle Breakage PATIENT PACKAGE INSERT

Leustatin (cladrabine) for Injection for Intravenous Infusion only (click product name to read prescribing information)	ADVERSE REACTIONS Hematologic Rare cases of myelodysplastic syndrome have been reported.

Trecator (ethionamide tablets, USP) (click product name to read prescribing information)	ADVERSE REACTIONS Other Hypothyroidism

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