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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2004

 

The detailed view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. 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

Arixtra (fondaparinux sodium) Injection

(click product name to read prescribing information)

CONTRAINDICATIONS

WARNINGS

  • Renal Impairment
  • Laboratory Testing
  • Thrombocytopenia

PRECAUTIONS

  • General
  • Geriatric Use

ADVERSE REACTIONS

  • Second Paragraph
  • Hemorrhage
  • Prophylaxis
  • Treatment of DVT and PE
    • Table 9
  • Elevations of Serum Aminotransferases
  • Other
  • Table 11

CONTRAINDICATIONS

Arixtra prophylactic therapy is contraindicated in patients with body weight <50 kg undergoing hip fracture, hip replacement or knee replacement surgery.

WARNINGS

Occurrences of major bleeding in patients receiving therapeutic regimen in treatment of DVT and PE with normal renal function, mild renal impairment, moderate renal impairment, and severe renal impairment have been found to be 0.4% (4/1132), 1.6% (12/733), 2.2% (7/318), and 7.3% (4/55), respectively.

Moderate thrombocytopenia occurred at a rate of 0.5% in patients given the ARIXTRA treatment regimen in the DVT and PE treatment clinical trials. Severe thrombocytopenia occurred at a rate of 0.04% in patients given the Arixtra treatment regimen in the DVT and PE treatment clinical trials.

Cordarone (amiodarone HCl) Tablets

(click product name to read prescribing information)

CONTRAINDICATIONS

WARNINGS

  • Worsened Arrhythmia

PRECAUTIONS

  • Thyroid Abnormalities
  • Drug Interactions
  • Electrolyte Disturbances
  • Nursing Mothers

ADVERSE REACTIONS

  • Postmarketing Reports
    • Muscle Weakness
    • Pruritus

CONTRAINDICATIONS

Cordarone is contraindicated in severe sinus-node dysfunction, causing marked sinus bradycardia; second- or third-degree atrioventricular block; and when episodes of bradycardia have caused syncope (except when used in conjunction with a pacemaker).

Cordarone is contraindicated in patients with a known hypersensitivity to the drug or to any of its components, including iodine.

WARNINGS

The need to co-administer amiodarone with any other drug known to prolong the QTc interval must be based on a careful assessment of the potential risks and benefits of doing so for each patient.

A careful assessment of the potential risks and benefits of administering Cordarone must be made in patients with thyroid dysfunction due to the possibility of arrhythmia breakthrough or exacerbation of arrhythmia in these patients.

Robaxin Injectable (methacarbamol injection, USP)

Please contact Baxter Healthcare Corporation at 1-800-422-9837 for prescribing information.

CONTRAINDICATIONS

ADVERSE REACTIONS

  • Body as a Whole
  • Angioneurotic edema

Polyethylene glycol 300 is known to have increased pre-existing acidosis and urea retention in patients with renal impairment.

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Brand (Generic) Name

Sections Modified

Summary of Changes to Contraindications and Warnings

Viramune (nevirapine) Tablets and Oral Suspension

(click product name to read prescribing information)

BOXED WARNING

WARNINGS

  • Hepatic Events

PRECAUTIONS

  • Information for Patients
  • Pregnancy

ADVERSE REACTIONS

  • Adults

PATIENT PACKAGE INSERT

BOXED WARNING

Hepatic events are often associated with rash. Women, and patients with higher CD4 counts, are at increased risk of these hepatic events. Women with CD4 counts >250 cells/mm3, including pregnant 11 women receiving chronic treatment for HIV infection, are at considerably higher risk of these events. Patients with signs or symptoms of hepatitis must discontinue Viramune and seek medical evaluation immediately.

In some cases, hepatic injury has progressed despite discontinuation of treatment.

WARNINGS

In general, women have a three fold higher risk than men for symptomatic, often rash associated, hepatic events (5.8% versus 2.2%), and patients with higher CD4 counts at initiation of Viramune therapy are at higher risk for symptomatic hepatic events with Viramune.

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Brand (Generic) Name

Sections Modified

Summary of Changes to Contraindications and Warnings

Angiomax (bivalirudin) for Injection

(click product name to read prescribing information)

WARNINGS

PRECAUTIONS

  • General

ADVERSE REACTIONS

  • Postmarketing Events

An increased risk of thrombus formation has been associated with the use of Angiomax in gamma brachytherapy, including fatal outcomes.

Avandamet (rosiglitazone maleate and metformin HCl) Tablets

(click product name to read prescribing information)

WARNINGS

  • Rosiglitazone Maleate
    • Cardiac Failure and Other Cardiac Effects

PRECAUTIONS

  • Hepatic Effects

PATIENT PACKAGE INSERT

Rosiglitazone, like other thiazolidinediones, alone or in combination with other antidiabetic agents, can cause fluid retention, which may exacerbate or lead to heart failure.

In combination with insulin, thiazolidinediones may increase the risk of other cardiovascular adverse events... (see prescribing information)

In a double-blind study in type 2 diabetes patients with chronic renal failure (112 received 4 mg or 8 mg of rosiglitazone plus insulin and 108 received insulin alone), there was no difference in cardiovascular adverse events with rosiglitazone in combination with insulin compared to insulin alone.

Patients treated with combination Avandamet and insulin should be monitored for cardiovascular adverse events. The combination therapy should be discontinued in patients who do not respond as manifested by a reduction in HbA1c or insulin dose after 4 to 5 months of therapy or who develop any significant adverse events.

Campath (alemtuzumab)

(click product name to read prescribing information)

WARNINGS

  • Infusion-Related Events

Carnpath has been associated with infusion-related events including hypotension, rigors, fever shortness of breath, bronchospasm, chills, and/or rash. In post-marketing reports, the following serious infusion-related events were reported: syncope, pulmonary infiltrates, ARDS, respiratory arrest, cardiac arrhythmias , myocardial infarction and cardiac arrest.

Capoten (captopril) Tablets

(click product name to read prescribing information)

WARNINGS

  • Head and Neck Angioedema
  • Intestinal Angioedema

Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

Celexa (citalopram hydrobromide) and Oral Solution

(click product name to read prescribing information)

WARNINGS

  • Clinical Worsening and Suicide Risk

PRECAUTIONS

  • Information for Patients

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases... (See prescribing information)

Crixivan (indinavir sulfate) Capsules

(click product name to read prescribing information)

WARNINGS

  • Drug Interactions

PRECAUTIONS

  • Information for Patients
  • Table 8
  • Table 9

PATIENT PACKAGE INSERT

Particular caution should be used when prescribing sildenafil, tadalafil, or vardenafil in patients receiving indinavir. Coadministration of Crixivan with these medications is expected to substantially increase plasma concentrations of sildenafil, tadalafil, and vardenafil and may result in an increase in adverse events, including hypotension, visual changes, and priapism, which have been associated with sildenafil, tadalafil, and vardenafil.

Decadron (dexamethasone tablets, USP)

(click product name to read prescribing information)

WARNINGS

  • General
  • Endocrine

PRECAUTIONS

  • General
  • Cardio-renal
  • Gastrointestinal
  • Information for Patients
  • Drug Interactions
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use

ADVERSE REACTIONS

Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy.

Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment.

Duramorph (morphine sulfate injection) 

Please contact Baxter Healthcare Corporation at 1-800-422-9837 for prescribing information.

WARNINGS

ADVERSE REACTIONS

  • Inflammatory Masses

Inflammatory masses such as granulomas, some of which have resulted in serious neurologic impairment including paralysis, have been reported to occur in patients receiving continuous infusion of opiod analgesics including Infumorph via indwelling intrathectal catheter. Patients receiving continuous infusion of infumorph via indwelling intrathecal catheter should be monitored for new neurologic signs or symptoms, further assessment or intervention should be based on the clinical condition of the individual patient.

Effexor (venlafaxine hydrochloride) Tablets

(click product name to read prescribing information)

WARNINGS

  • Clinical Worsening and Suicide Risk

PRECAUTIONS

  • Information for Patients

PATIENT PACKAGE INSERT

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases... (See prescribing information)

Effexor XR (venlafaxine hydrochloride) Extended Release Capsules

(click product name to read prescribing information)

WARNINGS

Clinical Worsening and Suicide Risk

PRECAUTIONS

  • Information for Patients

PATIENT PACKAGE INSERT

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases... (See prescribing information)

8.5% FreAmine III (amino acid injection)

(click product name to read prescribing information)

WARNINGS

PRECAUTIONS

  • General
  • Laboratory Tests
  • Drug Interactions
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Labor and Delivery
  • Pediatric Use
  • Geriatric Use

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphorous solutions, which contain aluminum.

Safe and effective use of central venous nutrition requires knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring of central venous nutrition.

10% FreAmine III (amino acid injections)

(click product name to read prescribing information)

WARNINGS

PRECAUTIONS

  • General
  • Laboratory Tests
  • Drug Interactions
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Labor and Delivery
  • Pediatric Use
  • Geriatric Use

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphorous solutions, which contain aluminum.

Safe and effective use of central venous nutrition requires knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring of central venous nutrition.

3% FreAmine III (amino acid injection) with Electrolytes

(click product name to read prescribing information)

WARNINGS

PRECAUTIONS

  • General
  • Laboratory Tests
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Labor and Delivery
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphorous solutions, which contain aluminum.

Safe and effective use of central venous nutrition requires knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring of central venous nutrition.

8.5% FreAmine III (amino acid injection) with Electrolytes

(click product name to read prescribing information)

WARNINGS

PRECAUTIONS

  • General
  • Laboratory Tests
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Labor and Delivery
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphorous solutions, which contain aluminum.

Safe and effective use of central venous nutrition requires knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring of central venous nutrition.

6.9% FreAmine HBC (amino acid injection)

(click product name to read prescribing information)

WARNINGS

PRECAUTIONS

  • General
  • Laboratory Tests
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Labor and Delivery
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphorous solutions, which contain aluminum.

Safe and effective use of central venous nutrition requires knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring of central venous nutrition.

Infumorph (preservative-free morphine sulfate sterile solution)

Please contact Baxter Healthcare Corporation at 1-800-422-9837 for prescribing information.

WARNINGS

ADVERSE REACTIONS

  • Inflammatory Masses

Inflammatory masses such as granulomas, some of which have resulted in serious neurologic impairment including paralysis, have been reported to occur in patients receiving continuous infusion of opiod analgesics including Infumorph via indwelling intrathecal catheter. Patients receiving continuous infusion of infumorph via indwelling intrathecal catheter should be monitored for new neurologic signs or symptoms, further assessment or intervention should be based on the clinical condition of the individual patient.

Lexapro (escitalopram oxalate) Tablets and  Oral Solution

(click product name to read prescribing information)

WARNINGS

  • Clinical Worsening and Suicide Risk

PRECAUTIONS

  • Information for Patients

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases...  (See prescribing information)

5.4% NephrAmine (essential amino acid injection)

(click product name to read prescribing information)

WARNINGS

PRECAUTIONS

  • General
  • Laboratory Tests
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Labor and Delivery
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Safe and effective use of central venous nutrition requires knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring of central venous nutrition. Laboratory tests should include measurement of blood sugar, electrolyte, and serum protein concentrations; kidney and liver function tests; and evaluation of acid-base balance and fluid balance.

Neumega (oprelvekin)

(click product name to read prescribing information)

WARNINGS

  • Increased Toxicity Following Myeloablative Therapy
  • Fluid Retention

ADVERSE REACTIONS

  • Postmarketing Reports

Neumega is not indicated following myeloablative chemotherapy. In a randomized, placebo controlled Phase 2 study, the effectiveness of Neumega was not demonstrated. In this study, a statistically significant increased incidence in edema, conjunctival bleeding, hypotension, and tachycardia was observed in patients receiving Neumega as compared to placebo.

Neumega is known to cause serious fluid retention that can result in peripheral edema, dyspnea on exertion, pulmonary edema, capillary leak syndrome, atrial arrhythmias, and exacerbation of pre-existing pleura) effusions. Severe fluid retention, some cases resulting in death, was reported following recent bone marrow transplantation in patients who have received Neumega.

Paxil (paroxetine hydrochloride)  Tablets and Oral Suspension

(click product name to read prescribing information)

WARNINGS

  • Clinical Worsening and Suicide Risk

PRECAUTIONS

  •  Information for Patients

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal  ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

Paxil (paroxetine hydrochloride) Controlled Release Tablets

(click product name to read prescribing information)

WARNINGS

  • Clinical Worsening and Suicide Risk

PRECAUTIONS

  • Information for Patients

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases... (See prescribing information)

Serzone (nefazodone hydrochloride) Tablets

(click product name to read prescribing information)

WARNINGS

  • Clinical Worsening and Suicide Risk

PRECAUTIONS

  • Information for Patients

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases... (See prescribing information)

Taxotere (docetaxel) for Injection Concentrate

(click product name to read prescribing information)

WARNINGS

  • Premedication Regimen

PRECAUTIONS

  • Geriatric Use

ADVERSE REACTIONS

  • Combination Therapy with Taxotere in Patients with Prostate Cancer

The pretreatment regimen for hormone-refractory metastatic prostate cancer is oral dexamethasone 8 mg, at 12 hours, 3 hours and 1 hour before the Taxotere infusion.

Twinject (epinephrine) Auto-Injector

Please contact Hollister-Stier Laboratories, LLC at 1-800-992-1120 for prescribing information.

WARNINGS

PRECAUTIONS

  • General

PATIENT PACKAGE INSERT

Epinephrine is the preferred treatment for anaphylaxis even though the product contains sodium bisulfite, which in other products may cause allergic-type reactions including anaphylactic symptoms or life-threatening asthma in certain susceptible persons.

The alternatives to using epinephrine in anaphylaxis may not be satisfactory. The presence of sulfite in this product should not deter administration of the drug for treatment of anaphylaxis, even if the patient is sulfite-sensitive.

Wellbutrin (bupropion hydrochloride) Tablets

(click product name to read prescribing information)

WARNINGS

  • Clinical Worsening and Suicide Risk

PRECAUTIONS

  • Information for Patients

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases... (See prescribing information)

Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets

(click product name to read prescribing information)

WARNINGS

  • Clinical Worsening and Suicide Risk

PRECAUTIONS

  • Information for Patients

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases... (See prescribing information)

Wellbutrin XL (bupropion hydrochloride extended-release tablets)

(click product name to read prescribing information)

WARNINGS

  • Clinical Worsening and Suicide Risk

PRECAUTIONS

  • Information for Patients

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases... (See prescribing information)

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Brand (Generic) Name

Sections Modified

Aricept (donepezil hydrochloride tablets)

(click product name to read prescribing information)

PRECAUTIONS

  • Drug-Drug Interactions
    • Effect of Aricept on the Metabolism of Other Drugs
    • Effect of Other Drugs on the Metabolism of Aricept
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Geriatric Use

Avandia (rosiglitazone maleate) Tablets

(click product name to read prescribing information)

PRECAUTIONS

  • Hepatic Effects

Brevital Sodium (methohexital sodium for injection)

(click product name to read prescribing information)

PRECAUTIONS

  • Geriatric Use

Cantil (mepenzolate bromide USP) Tablets

(click product name to read prescribing information)

PRECAUTIONS

  • Geriatric Use

Combivir (lamivudine/zidovudine) Tablets

(click product name to read prescribing information)

PRECAUTIONS

  • Nursing Mothers

ADVERSE REACTIONS

  • Observed During Clinical Practice

Copegus (ribavirin, USP) Tablets

(click product name to read prescribing information)

PRECAUTIONS

  • Pregnancy
    • Ribavirin Pregnancy Registry

Estraderm (estradiol transdermal system)

(click product name to read prescribing information)

PRECAUTIONS

  • Geriatric Use

Fortaz (ceftazidime for injection)

Fortaz (ceftazidime injection)

(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

Invanz (ertapenem for injection)

(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

Iressa (gefitinib tablets)

(click product name to read prescribing information)

PRECAUTIONS

  • Pediatric Use
    • CNS Hemorrhage

Klor-Con (potassium chloride) Extended-Release 8 & 10 mEq Tablets

Please contact Upsher-Smith Laboratories, Inc. at 1-800-654-2299 for prescribing information.

PRECAUTIONS

  • Geriatric Use

Metopirone (metyrapone USP) Capsules

(click product name to read prescribing information)

PRECAUTIONS

  • Geriatric Use

Minocin (minocycline for injection) Intravenous

(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

ADVERSE REACTIONS

  • Hepatic Toxicity
    • Autoimmune Hepatitis
  • Other
    • Oral Cavity Discoloration

Minocin (minocycline hydrochloride) Oral Suspension

Please contact Wyeth at 1-800-395-9938 for prescribing information.

SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria

PRECAUTIONS

  • General
  • Information for Patients

ADVERSE REACTIONS

  • Hepatic Toxicity
    • Autoimmune Hepatitis
  • Other
    • Oral Cavity Discoloration

Minocin (minocycline hydrochloride) Pellet-filled Capsules

(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

ADVERSE REACTIONS

  • Hepatic Toxicity
    • Autoimmune Hepatitis
  • Other
    • Oral Cavity Discoloration

Primaxin I.M. Injectable (imipenem and cilastatin for injectable suspension)

(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

Primaxin I.V. (imipenem and cilastatin for injection)

(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

Prinivil (lisinopril) Tablets

(click product name to read prescribing information)

PRECAUTIONS

  • Geriatric Use

Protonix (pantoprazole sodium) Delayed-Release Tablets

(click product name to read prescribing information)

PRECAUTIONS

  • Drug Interaction
    • Warfarin

Protonix I.V. (pantoprazole sodium) for Injection

(click product name to read prescribing information)

PRECAUTIONS

  • Drug Interaction
    • Warfarin

Relpax (eletriptan) Tablets

Please contact Pfizer Inc. at 1-800-879-3477 for prescribing information.

PRECAUTIONS

  • Drug Interactions
     

Ritalin (methylphenidate HCl tablets)

Ritalin SR (methylphenidate HCl sustained- release tablets)

(click product name to read prescribing information)

PRECAUTIONS

  • Carcinogenesis/Mutagenesis/Impairment of Fertility
  • Pregnancy
  • Nursing Mothers
  • Pediatric Use

Vancocin (vancomycin hydrochloride capsules, USP) Pulvules

(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

Velcade (bortezomib) for Injection

(click product name to read prescribing information)

PRECAUTIONS

  • Heart Failure
  • Laboratory Tests
  • Thrombocytopenia
    • Table 3
  • Tumor Lysis Syndrome

ADVERSE REACTIONS

  • Thrombocytopenia

Verelan PM capsules (verapamil hydrochloride) Extended-Release Capsules Controlled-Onset

(click product name to read prescribing information)

PRECAUTIONS

  • Initial Paragraph
  • General
    • Use in patients with impaired renal function
  • Information for Patients

Zinacef (cefuroxime for injection)

Zinacef (cefuroxime injection)

(click product name to read prescribing information)

PRECAUTIONS

  • General
  • Information for Patients

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Brand (Generic) Name

Sections Modified

Augmentin (amoxicillin/clavulanate potassium) Tablets

(click product name to read prescribing information)

ADVERSE REACTIONS

  • Renal
  • Miscellaneous

Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets

(click product name to read prescribing information)

ADVERSE REACTIONS

  • Renal

Enbrel (etanercept)

(click product name to read prescribing information)

ADVERSE REACTIONS

  • Initial Paragraph
  • Injection Site Reactions
  • Infections
  • Malignancies
  • Immunogenicity
  • Other Adverse Reactions

Gemzar (gemcitabine HCl) for Injection

Please contact Eli Lilly and Company at 1-800-545-5979 for prescribing information.

ADVERSE REACTIONS

  • Combination Use in Breast Cancer
  • Table 9

Lactated Ringer’s and 5% Dextrose Injection, USP

(click product name to read prescribing information)

ADVERSE REACTIONS

Lovenox (enoxaparin sodium injection)

(click product name to read prescribing information)

ADVERSE REACTIONS

  • Other Ongoing Safety Surveillance Reports
    • Hypersensitivity Cutaneous Vasculitis

Zovirax (acyclovir sodium)  Capsules, Tablets, and Suspension

(click product name to read prescribing information)

ADVERSE REACTIONS

  • Observed During Clinical Practice

Zovirax (acyclovir) for Injection

(click product name to read prescribing information)

ADVERSE REACTIONS 

  • Observed During Clinical Practice

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