Drugs
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2010 Drug Safety Communications
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- Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death
12/22/2010 - Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate)
12/17/2010 - Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of
age
12/14/2010 - FDA recommends against the continued use of propoxyphene
11/19/2010 - Invirase (saquinavir) labels now contain updated risk information on abnormal heart rhythms
10/21/2010 - Update to Ongoing Safety Review of GnRH Agonists and Notification to Manufacturers of GnRH Agonists to Add New
Safety Information to Labeling Regarding Increased Risk of Diabetes and Certain Cardiovascular Diseases
10/20/2010 - Oral Bisphosphonates - Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures
10/13/2010 - Meridia (sibutramine) - FDA Recommends Against the Continued Use of Meridia (sibutramine)
10/8/2010 - Actos (pioglitazone) - Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure
9/17/2010 - Valcyte (valganciclovir) - New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in
pediatric transplant patients
9/15/2010 - GBCA - New recommendations for using gadolinium-based contrast agents in patients with kidney dysfunction
9/9/2010; updated 12/23/2010 - Tygacil - Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections
9/102010 - Stalevo - Ongoing Safety Review of Stalevo and possible increased cardiovascular risk
8/20/2010 - Lamictal (lamotrigine) - Aseptic meningitis associated with use of Lamictal (lamotrigine)
8/12/2010 FDA Drug Safety Communication: Serious medication errors from intravenous administration of nimodipine oral capsules FDA Drug Safety Communication: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen FDA Drug Safety Communication: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin) FDA Drug Safety Communication: Ongoing safety review of the angiotensin receptor blockers and cancer FDA Drug Safety Communication: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide) FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate) FDA Drug Safety Communication: Ongoing safety review of Benicar(olmesartan) and cardiovascular events FDA Drug Safety Communication: Drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs) FDA Drug Safety Communication: Completed safety review of Xenical/Alli (orlistat) and severe liver injury FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors FDA Drug Safety Communication: Medication errors from swallowing topical Benadryl Extra Strength Itch Stopping Gel FDA Drug Safety Communication: Ongoing Safety Review of GnRH Agonists and possible increased risk of diabetes and certain cardiovascular diseases FDA Drug Safety Communication: New Boxed Warning on severe liver injury with propylthiouracil FDA Drug Safety Communication: Update: Follow up to the Public Health Alert about Changes to the Heparin Sodium USP Monograph FDA Drug Safety Communication: Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development of Prostate Cancer FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible association with abnormal heart rhythms FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety FDA Drug Safety Communication: New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs) FDA Drug Safety Communication: Product Confusion with Maalox Total Relief and Maalox Liquid Products FDA Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of Tysabri (natalizumab) FDA Drug Safety Communication: Serious liver disorder associated with the use of Videx/Videx EC (didanosine)
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