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

(click product name to read prescribing information)

CONTRAINDICATIONS

PRECAUTIONS

• Adrenal Crisis

ADVERSE REACTIONS

• Observed During Clinical Practice
  • Non-Site Specific
    • Anaphylactic Reaction

WARNINGS

Growth hormone is contraindicated in patients with Prader- Willi syndrome who are severely obese or have severe respiratory impairment.

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. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with growth hormone. If during treatment with growth hormone, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome treated with growth hormone should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively.

Please contact Teva Pharmaceuticals USA at 1-215-591-3000 for prescribing information.

PRECAUTIONS

• Drug Interactions
  • Sertaline

The use of sertaline with Orap is contraindicated.

(click product name to read prescribing information)

• Pregnancy: Category X

WARNINGS

• Birth Defects
• Thrombotic Events

PRECAUTIONS

• General
• Bradycardia
• Information for Patients
• Laboratory Tests
• Important Non-Thalidomide Drug Interactions
  • Drugs that Interfere with Hormonal Contraceptives
• Pregnancy: Pregnancy Category X

ADVERSE REACTIONS

• Other Adverse Event
• Other Adverse Events Observed in ENL Patients
  • Metabolic and Endocrine
• Other Adverse Events Observed in HIV-seropositive Patients
  • Body As a Whole
• Other Adverse Events Observed in Postmarketing Use

The risk to the fetus from the semen of male patients taking thalidomide is unknown.

WARNINGS

Birth Defects

The risk to the fetus from the semen of male patients taking thalidomide is unknown.

Thrombotic Events 

Thrombotic events have been reported in patients treated with Thalomid (thalidomide). Patients with neoplastic and various inflammatory conditions being treated with Thalomid (thalidomide) may have an increased incidence of pulmonary embolism, deep vein thrombophlebitis, thrombophlebitis, or thrombosis. It is not known if concomitant therapy with other medications including anticancer agents, are a contributing factor.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Accupril (quinapril hydrochloride) Tablets 

(click product name to read prescribing information)

• Head and Neck Angioedema
• Intestinal Angioedema

ADVERSE REACTIONS

• General
  • Anaphylactoid reaction
• Gastrointestinal
  • Dyspepsia

Angioedema subsection re-titled "Head and Neck 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. 

(click product name to read prescribing information)

• Head and Neck Angioedema
• Intestinal Angioedema

ADVERSE REACTIONS

• Postmarketing Experiences
  • Body as a Whole
    • Anaphylactoid Reaction

Angioedema subsection re-titled "Head and Neck 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. 

Aceon (perindopril erbumine) Tablets

(click product name to read prescribing information)

• Head and Neck Angioedema
• Intestinal Angioedema

Angioedema subsection re-titled "Head and Neck 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. 

(click product name to read prescribing information)

• Stomach Bleeding

ASK YOUR DOCTOR BEFORE USE IF YOU HAVE:

• Kidney Disease
• Ulcers
• Bleeding Problems
• Stomach Problems that last or come back, such as heartburn, upset stomach, or pain
• Had problems or serious side effects from taking pain relievers or fever reducers

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE:

• Under a doctor's care for any continuing medical condition
• Over 65 years of age
• Taking any other product that contains ibuprofen or any other pain reliever/fever reducer
• Taking any other product that contains pseudoephedrine or any other nasal decongestant
• Taking a prescription drug for anticoagulation (blood thinner) or a diuretic
• Taking any other drug

STOP USE AND ASK A DOCTOR IF

• Any new symptoms appear

(click product name to read prescribing information)

• Other Vasospasm-Related Events

Both peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea have been reported with naratriptan.

(click product name to read prescribing information)

PRECAUTIONS

• Drug Interactions
  • Atenolol

ADVERSE REACTIONS

• Hemic and Lymphatic
  • Prothrombin Time Prolonged/International Normalized Ratio (INR) increased
• Postmarketing Adverse Event Reports

Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia. The magnitude of QT prolongation may increase with increasing concentrations of the drug or increasing rates of infusion of the intravenous formulation. Therefore the recommended dose or infusion rate should not be exceeded. QT prolongation may lead to an increased risk for ventricular arrhythmias including torsade de pointes. 

Please contact SkyePharma Inc. at 1-858-625-2424 or 1-212-753-5780 for prescribing information.

Infectious meningitis may be associated with intrathecal drug administration. Hydrocephalus has also been reported, possibly precipitated by arachnoiditis.

In the controlled lymphoma study, the patient incidence of seizures was higher in the DepoCyt group (4/17, 23.5%) than in the cytarabine group (1/16, 6.3%).

Following intrathecal administration of DepoCyt, central nervous system toxicity, including persistent extreme somnolence, hemiplegia, visual disturbances including blindness, deafness and cranial nerve palsies have been reported. Symptoms and signs of peripheral neuropathy, such as pain, numbness, paresthesia, weakness, and impaired bowel and bladder control have also been observed.

Enbrel (etanercept)

(click product name to read prescribing information)

• Malignancies

ADVERSE REACTIONS

• Malignancies

In the controlled portions of clinical trials of all the TNF-blocking agents, more cases of lymphoma have been observed among patients receiving the TNF blocker compared to control patients.  (See prescribing information for details of clinical trials.)

(click product name to read prescribing information)

• Exacerbation of Chemotherapy-Induced Neutropenia

ADVERSE REACTIONS

• Neutropenia
• Elevated Blood Pressure

Lotensin (benazepril HCl) Tablets

(click product name to read prescribing information)

• Head and Neck Angioedema
• Intestinal Angioedema

Angioedema subsection re-titled "Head and Neck 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. 

(click product name to read prescribing information)

• Head and Neck Angioedema
• Intestinal Angioedema

Angioedema subsection re-titled "Head and Neck 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. 

(click product name to read prescribing information)

• Fetal/Neonatal Morbidity and Mortality

PRECAUTIONS

• Drug Interactions
  • Other Drugs
    • Simvastatin

ADVERSE REACTIONS

• Postmarketing Experience
  • Angioedema & Urticaria

In rabbits, embryolethality associated with maternal toxicity (reduced body weight gain and food consumption) was observed at 45 mg/kg/day [about 12 times the maximum recommended human dose (MRHD) of 80 mg on a mg/m2 basis].

Monopril (fosinopril sodium) Tablets 

(click product name to read prescribing information)

• 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. 

Monopril-HCT (fosinopril sodium/hydrochlorothiazide) Tablets 

(click product name to read prescribing information)

• 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. 

(click product name to read prescribing information)

See Dear Healthcare Provider letter, December 2003

• Falling Asleep During Activities of Daily Living
• Serous Inflammation and Fibrosis
  • Cardiac Valvulopathy

PRECAUTIONS

• Information for Patients
• Geriatric Use

Patients treated with Permax have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Although many of these patients reported somnolence while on Permax, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events had been reported as late as one year after the initiation of treatment.

There have been rare reports of pleuritis, pleural effusion, cardiac valvulopathy involving one or more valves, or retroperitoneal fibrosis in patients taking pergolide. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide.

(click product name to read prescribing information)

ADVERSE REACTIONS

• Cardiovascular System
  • Venous thromboembolism
• Other Clinical Experience

(click product name to read prescribing information)

PRECAUTIONS

• Pediatric Use

ADVERSE REACTIONS

• Pediatric Patients
• Table 7
• Rebetol/Peg-Intron Combination Therapy

There are significant adverse events caused by Rebetol/Intron A or Peg- Intron therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes. Suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% versus 1%) during treatment and off-therapy follow-up. 

Please contact Akorn, Inc at 1-800-535-7155 for prescribing information.

PRECAUTIONS

• General

ADVERSE REACTIONS

(click product name to read prescribing information)

• Pregnancy and Fetal Injury

PRECAUTIONS

• Drug Interactions

  • Lithium Preparations

• Nursing Mothers

Neonates born to mothers who are receiving atenolol at parturition or breast-feeding may be at risk for hypoglycemia. Caution should be exercised when Tenoretic is administered during pregnancy or to a woman who is breast-feeding.

Uniretic (moexipril hydrochloride/hydrochlorothiazide)  Tablets

(click product name to read prescribing information)

• 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. 

(click product name to read prescribing information)

• Head and Neck Angioedema
• Intestinal Angioedema

Angioedema subsection re-titled "Head and Neck 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. 

Accolate (zafirlukast) Tablets

(click product name to read prescribing information)

• Pediatric Use

(click product name to read prescribing information)

• Information for Patients
• Pediatric Use

ADVERSE REACTIONS

• Postmarketing Experience
  • General
  • Skin

(click product name to read prescribing information)

• General
  • Hypocalcemia

(click product name to read prescribing information)

PRECAUTIONS

• Adrenal Crisis

ADVERSE REACTIONS

• Observed During Clinical Practice
  • Non-Site Specific
    • Anaphylactic Reactions

Ionamin (phentermine resin) Capsules

Please contact Celltech Pharmaceutical Company at
1-800-234-5535 for prescribing information.

• Geriatric Use

Lopressor HCT (metoprolol tartrate and hydrochlorothiazide) Tablets

(click product name to read prescribing information)

• Geriatric Use

• Geriatric Use

(click product name to read prescribing information)

PRECAUTIONS

• Information for Patients
• General
• Geriatric Use

Methergine (methylergonovine maleate) Tablets and Injection

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• Drug Interaction
  • Warfarin

ADVERSE REACTIONS

• Blurred Vision
• Eye Irritation

(click product name to read prescribing information)

• Fat Redistribution
• Information for Patients
  • Fat Redistribution

ADVERSE REACTIONS

• Observed During Clinical Practice
  • Body as a Whole
    • Fat redistribution/accumulation of body fat

(click product name to read prescribing information)

• Drug Interactions
  • Folate Supplementation
• Geriatric Use
• Organ System Toxicity
  • Renal

ADVERSE REACTIONS

• Blood and Lymphatic System Disorders
• Hepatobiliary Disorders
• Infection

PATIENT PACKAGE INSERT

Risperdal (risperidone) Tablets and Oral Solution

Risperdal M-TAB (risperidone) Orally Disintegrating Tablets

(click product name to read prescribing information)

PRECAUTIONS

• Use in Patients with Concomitant Illness 

ADVERSE REACTIONS

• ECG Changes

(click product name to read prescribing information)

• Fluid Retention
• Drug Interactions
  • Tacrolimus

ADVERSE REACTIONS

• Adverse Events
• Long-term Treatment

MEDICATION GUIDE

• Who should not take Tracleer?
  • Tacrolimus
• What should I avoid while taking Tracleer?

(click product name to read prescribing information)

• Drug Interactions
  • Fenofibrate

Please contact Bristol-Meyers Squibb Medical Imaging Inc. at 1-800-225-1572 for prescribing information.

• Geriatric Use

Floxin Otic (ofloxacin otic solution)

(click product name to read prescribing information)

• Postmarketing Adverse Events
  • Transient Neuropsychiatric Disturbances

Gleevec (imatinib mesylate) Capsules

(click product name to read prescribing information)

• Postmarketing Experiences

(click product name to read prescribing information)

• Postmarketing Experience
  • paresthesia/hypoesthesia

PATIENT PACKAGE INSERT

• What are the possible side effects of Singulair?
  • pin and needles/numbness

Teveten (eprosartan mesylate) Tablets

Please contact Biovail Technologies Ltd. at 1-703-480-6000 for prescribing information.

• Rhabdomyolysis
• Cardiovascular
  • Orthostatic Hypotension

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

Cardiovascular: angina pectoris, bradycardia, abnormal ECG, specific abnormal ECG, extrasystoles, atrial fibrillation, hypotension (including orthostatic hypotension), tachycardia, palpitations.

Teveten HCT (eprosartan mesylate/hydrochlorothiazide) Tablets

Please contact Biovail Technologies Ltd. at 1-703-480-6000 for prescribing information.

• Eprosartan Mesylate
  • Cardiovascular
    • Orthostatic Hypotension

Cardiovascular: angina pectoris, bradycardia, abnormal ECG, specific abnormal ECG, extrasystoles, atrial fibrillation, hypotension (including orthostatic hypotension), tachycardia, palpitations.

FDA/CDER/OCD/Safety Policy and Communication Staff
Web page last revised by jlw Jan 06, 2004