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.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Patients with known hypersensitivity to benzyl alcohol should not be treated using the multi-dose formulation of Lovenox.

(click product name to read prescribing information)

WARNINGS

PRECAUTIONS

• Laboratory Tests

• Drug/Laboratory Test Interactions

• Carcinogenesis, Mutagenesis, Impairment of Fertility
• Pregnancy, Teratogenic Effects
• Nursing Mothers

ADVERSE REACTIONS

• Changes in Bone Density

PATIENT PACKAGE INSERT

Periodic monitoring of serum testosterone and PSA levels is recommended, especially if the anticipated clinical or biochemical response to treatment has not been achieved. It should be noted that results of testosterone determinations are dependent on assay methodology. It is advisable to be aware of the type and precision of the assay methodology to make appropriate clinical and therapeutic decisions.

(click product name to read prescribing information)

WARNINGS

There have been reports of fatalities after initiating therapy with growth hormone in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females..... (See prescribing information.)

(click product name to read prescribing information)

WARNINGS

• Neuropsychiatric Disorders
• Cardiovascular Disorders
• Hypersensitivity
• Hepatic Disorders
• Gastrointestinal Disorders
• Bone Marrow Toxicity
• Endocrine Disorders
• Pulmonary Disorders

PRECAUTIONS

• General
• Renal Impairment
• Autoimmune Disease
• Information for Patients
• Laboratory Tests
• Drug Interactions

ADVERSE REACTIONS

• In Other Investigational Studies of Roferon-A
• Postmarketing

MEDICATION GUIDE

Roferon-A is contraindicated in patients with:

·        Hypersensitivity to Roferon-A or any of its components

·        Autoimmune hepatitis

·        Hepatic decompensation (Child-Pugh class B and C) before or during treatment

Roferon-A is contraindicated in neonates and infants because it contains benzyl alcohol.  Benzyl alcohol is associated with an increased incidence of neurologic and other complications in neonates and infants, which are sometimes fatal.

WARNINGS

Roferon-A should be used with extreme caution in patients who report a history of depression.

Cases of cardiomyopathy have been observed on rare occasions in patients treated with alpha interferons.

(See prescribing information for additional warnings.)

Tikosyn (dofetilide) Capsules

(click product name to read prescribing information)

WARNINGS

• Hypokalemia and Potassium-Depleting Diuretics

• Use with Drugs that Prolong QT Interval and Antiarrhythmic Agents

PRECAUTIONS

• Information for Patients

  • Medications and Supplements

• Drug-Drug Interactions

• Hydrochlorothiazide (HCTZ) Alone or in Combination with Triamterene

PATIENT PACKAGE INSERT

CONTRAINDICATIONS

The concomitant use of hydrochlorothiazide (alone or in combinations such as with triamterene) with Tikosyn is contraindicated because this has been shown to significantly increase dofetilide plasma concentrations and QT interval prolongation.

WARNINGS

Hypokalemia or hypomagnesemia may occur with administration of potassium-depleting diuretics, increasing the potential for torsade de pointes. Potassium levels should be within the normal range prior to administration of Tikosyn and maintained in the normal range during administration of Tikosyn. 

The use of Tikosyn in conjunction with other drugs that prolong the QT interval has not been studied and is not recommended. Such drugs include phenothiazines, cisapride, bepridil, tricyclic antidepressants, certain oral macrolides, and certain fluoroquinolones.

(click product name to read prescribing information)

BOXED WARNING

• Experienced Physician and Institution
• Retinoic Acid-APL Syndrome

WARNINGS

• Pseudotumor Cerebi

PRECAUTIONS

• General
• Drug Interactions
  • Drugs Metabolized By the Hepatic P450 System
  • Agents Known to Cause Pseudotumor Cerebri/Intracranial Hypertension (Such as Tetracyclines)
  • Vitamin A
  • Antifibrinolytic Agents (Such as Tranexamic Acid, Aminocaproic Acid,or Aprotinin)

ADVERSE REACTIONS

• RA-APL Syndrome
• Additional Adverse Reactions Reported With Vesanoid
  • Cardiovascular
  • Hematologic
• Skin
• Miscellaneous Adverse Event

CONTRAINDICATIONS

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

(click product name to read prescribing information)

• Myocardial Damage

• Cardiac Toxicity
• Myelosuppression
• Infusion Reactions
• Hand-Foot Syndrome (HFS)

• Information for the Patient

  BOXED WARNING

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Altace (ramipril) Capsules

(click product name to read prescribing information)

• Intestinal Angioedema

• Pediatric Use

• Renal
  • Acute Renal Failure

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.

Over-the-Counter Drug

Please contact Wyeth Consumer Healthcare at 1-800-322-3129 for prescribing information.

(click product name to read prescribing information)

• Long-Term Suppression of Growth
• Hypertension and Other Cardiovascular Conditions

• Initial Paragraph
• Adverse Findings in Clinical Trials with Concerta
  • Treatment-Emergent Adverse Events Among Concerta-Treated Patients
    • Table 4
    • Table 5

Data are inadequate to determine whether chronic use of stimulants in children, including amphetamine, may cause suppression of growth. Therefore, growth should be monitored during treatment, and patients who are not growing or gaining weight as expected should have their treatment interrupted.

Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, eg, those with preexisting hypertension, heart failure, recent myocardial infarction, or hyperthyroidism. Blood pressure should be monitored at appropriate intervals in patients taking Concerta, especially patients with hypertension.

• Pregnancy Category D

• Carcinogenesis, Mutagenesis, Impairment of Fertility
• Geriatric Use

Penicillamine can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

(click product name to read prescribing information)

• Infections
• Malignancies

• Adverse Reactions in Adult Patients with RA, Psoriatic Arthritis, Ankylosing Spondylitis, or Plaque Psoriasis
• Malignancies

During the controlled portions of Enbrel trials, 3 lymphomas were observed among 4509 Enbrel -treated patients versus 0 among 2040 control patients (duration of controlled treatment ranged from 3 to 24 months). In the controlled and open-label portions of clinical trials of Enbrel, 9 lymphomas were observed in 5723 patients over approximately 11201 patient-years of therapy. This is 3-fold higher than that expected in the general population.

Fuzeon (enfuvirtide) for Injection

(click product name to read prescribing information)

• Local Injection Site Reactions
• Hypersensitivity Reactions

• Information for Patients
• Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Carcinogenesis
• Pediatric Use

• Initial Paragraph
• Local Injection Site Reactions
  • Table 4
• Other Adverse Events
  • Table 5
• Less Common Events
  • Renal and Urinary Disorders
    • Tubular Necrosis
    • Renal Insufficiency
  • Blood and Lymphatic Disorders
    • Lymphadenopathy
  • Infections
  • Nervous System Disorder
    • Taste Disturbance
    • Peripheral Neuropathy
  • Cardiac Disorders
  • Gastrointestinal Disorders
  • General
  • Hepatobiliary Disorders
  • Investigations
  • Psychiatric Disorders
  • Respiratory, Thoracic and Mediastinal Disorders
  • Skin and Subcutaneous Tissue Disorders
• Laboratory Abnormalities
  • Table 6
• Adverse Events in Pediatric Patients

The majority of patients (98%) receiving Fuzeon in the Phase 3 clinical trials had at least one local injection site reaction; ISRs occurred throughout treatment with Fuzeon.

Systemic hypersensitivity reactions have been associated with Fuzeon therapy and may recur on re-challenge. Hypersensitivity reactions have occurred in <1% of patients studied and have included combinations of: rash, fever, nausea and vomiting, chills, rigors, hypotension, and/or elevated serum liver transaminases.

• Drug Interactions

• Immune Reconstitution Syndrome
• Information for Patients
• Drug Interactions
  • Table 9
    • Nucleoside Reverse Transcriptase Inhibitor:  Tenofovir
    • HIV-Protease Inhibitors:  Fosamprenavir
    • Antigungals:  Ketoconazole, Itraconazole, Voriconazole
    • PDE5 Inhibitors: Sildenafil, Tadalafil, Vardenafil
    • Oral Contraceptive:  Ethinyl Estradiol
• Carcinogenesis, Mutagenesis and Impairment of Fertility
• Pregnancy

• Adults
  • Table 10
    • Cardiovascular System
      • Cerebral Infarct
      • Deep Thrombophlebitis
      • Postural Hypotension
    • Digestive System
      • Periodontitis
    • Musculoskeletal System
      • Bone Necrosis
    • Nervous System
      • Hypertonianervousness
      • Vertigo
    • Urogenital System
      • Breast Enlargement
  • Post-Marketing Experience
    • Skin and Appendages
      • Stevens Johnson Syndrome
      • Erythema Multiforme
  • Table 11

Particular caution should be used when prescribing sildenafil, tadalafil, or vardenafil in patients receiving Kaletra. Co-administration of Kaletra with these drugs is expected to substantially increase their concentrations and may result in an increase in associated adverse events including hypotension, syncope, visual changes and prolonged erection.

Levaquin (levofloxacin in 5% dextrose) Injection

(click product name to read prescribing information)

• Information for Patients

In immature rats and dogs, the oral and intravenous administration of levofloxacin resulted in increased osteochondrosis. Histopathological examination of the weightbearing joints of immature dogs dosed with levofloxacin revealed persistent lesions of the cartilage. Other fluoroquinolones also produce similar erosions in the weight bearing joints and other signs of arthropathy in immature animals of various species. The relevance of these findings to the clinical use of levofloxacin is unknown.

Over-the-Counter Drug

(click product name to read prescribing information)

DO NOT USE:

• If you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
• With other acid reducers

Over-the-Counter Drug

(click product name to read prescribing information)

DO NOT USE:

• If you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
• With other acid reducers

Over-the-Counter Drug

(click product name to read prescribing information)

DO NOT USE:

• If you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
• With other acid reducers

Over-the-Counter Drug
 

(click product name to read prescribing information)

DO NOT USE:

• If you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
• With other acid reducers

Over-the-Counter Drug

(click product name to read prescribing information)

• If you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
• If you have kidney disease, except under the advice and supervision of a doctor
• With other acid reducers

Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets

(click product name to read prescribing information)

• Initial Paragraph

As Wellbutrin XL is bioequivalent to both the immediate-release formulation of bupropion and to the sustained-release formulation of bupropion, the seizure incidence with Wellbutrin XL, while not formally evaluated in clinical trials, may be similar to that presented below for the immediate-release and sustained-release formulations of bupropion......  (See prescribing information.)

Diflucan (fluconazole) Tablets, Injection and Powder for Oral Suspension

(click product name to read prescribing information)

(click product name to read prescribing information)

ADVERSE REACTIONS

(click product name to read prescribing information)

• Information for Patients
• Carcinogenesis, Mutagenesis, Impairment of Fertility
• Pregnancy
  • Teratogenic Effects: Pregnancy Category X

ADVERSE REACTIONS

• Clinical Studies for Propecia (finasteride 1 mg) in the Treatment of Male Pattern Hair Loss

• Controlled Clinical Trials and Long-Term Open Extension Studies for Proscar (finasteride 5 mg) in the Treatment of Benign Prostatic Hyperplasia

PATIENT PACKAGE INSERT

(click product name to read prescribing information)

• Carcinogenesis, Mutagenesis, and Impairment of Fertility

Sustiva (efavirenz) Tablets and Capsules

(click product name to read prescribing information)

Femara (letrozole tablets)

(click product name to read prescribing information)

• Initial Paragraph
• Extended Adjuvant Treatment of Early Breast Cancer in Postmenopausal Women who have Received 5 Years of Adjuvant Tamoxifen Therapy

• Adverse Findings Observed in Short-Term, Placebo-Controlled Trials with Oral Ziprasidone
• Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials of Oral Ziprasidone
  • Bipolar Mania
• Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials
  • Table 2
• Adverse Events Occurring at an Incidence of 2% or More Among Ziprasidone-Treated Patients in Short-Term, Oral, Placebo-Controlled Trials
  • Table 4

Keppra (levetiracetam) Tablets and Oral Solution

(click product name to read prescribing information)

• Postmarketing Experience

Kineret (anakinra)

(click product name to read prescribing information)

• Infections
• Malignancies
• Immunogenicity

Xenical (orlistat) Capsules

(click product name to read prescribing information)

• Incidence in Controlled Clinical Trials

FDA/CDER/OCD/Safety Policy and Communication Staff
Web page last revised by jlw December 17, 2004