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Drug Safety and Availability

Drug Safety Communications - Volume 1, Number 2, Winter 2008

Drug Safety Communications posted by FDA from June 1, 2007 to December 31, 2007 (advisories are available at www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm)

Date Product(s) Safety Issue and Web Address
December 21, 2007 Fentanyl transdermal system (Duragesic and generics) Update highlighting information on appropriate prescribing and use in light of continued reports of death and life-threatening adverse events related to fentanyl overdose.
December 12, 2007 Carbamazepine (Carbatrol, Equetro, Tegretol, and generics) Increased risk of serious skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) in patients with a particular human leukocyte antigen allele, HLA-B*1502.
December 10, 2007 Omeprazole (Prilosec) and Esomeprazole (Nexium) Update of safety review finding that long-term use is not likely associated with an increased risk of heart problems.
December 4, 2007 Desmopressin acetate (DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) Reports of severe hyponatremia and seizures in children and removal of primary nocturnal enuresis indication for intranasal formulations.
November 20. 2007 Varenicline (Chantix)1 Ongoing safety review of reports of suicidal thoughts and aggressive and erratic behavior.
November 19, 2007 Rosiglitazone maleate (Avandia, Avandamet, and Avandaryl) Update highlighting new labeled warning about the potential increased risk of myocardial ischemia.
November 14, 2007 Phosphodiesterase type 5 (PDE5) inhibitors [sildenafil (Viagra and Revatio) vardenafil (Levitra),and tadalafil (Cialis)] Potential risk of sudden hearing loss.
November 14, 2007 Cefepime (Maxipime)1 Ongoing safety review to further evaluate the risk of death in patients treated with cefepime.
November 8, 2007 Erythropoiesis Stimulating Agents (ESAs) [darbepoetin alfa (Aranesp), (epoetin alfa (Epogen, (Procrit)] Update: New revisions to the product labeling to clarify the evidence for safety and effectiveness in cancer and chronic kidney failure patients.
October 25, 2007 Aprotinin (Trasylol)1,2 Ongoing safety review re-evaluating the overall risks and benefits in light of preliminary findings of a randomized trial in a cardiac surgery population (BART study).
October 16, 2007 Exenatide (Byetta) Reports of acute pancreatitis.
October 12, 2007 Perflutren Micro-bubble Contrast Agents (Definity and Optison) Reports of deaths and serious cardiopulmonary reactions following the administration of ultrasound micro-bubble contrast agents used in echocardiography.
October 1, 2007 Bisphosphonates [alendronate (Fosamax, Fosamax Plus D), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel, Actonel with Calcium), tiludronate (Skelid), and zoledronic acid (Reclast, Zometa)]1 Ongoing safety review to further evaluate the risk of atrial fibrillation in patients who take bisphosphonates.
September 26, 2007 Fentanyl buccal tablets (Fentora) Reports of serious adverse events, including death, with prescribing to non-opioid-tolerant patients, misunderstanding of dosing instructions, or inappropriate substitution for other fentanyl- containing products.
September 17, 2007 Haloperidol (Haldol, Haldol Decanoate, and Haldol Lactate) Increased risk of Torsades de Pointes and QT prolongation.
September 11, 2007 Ceftriaxone sodium (Rocephin) Reports of fatal interactions in neonates treated with ceftriaxone and intravenous calcium-containing products.
August 17, 2007 Codeine Report of very rare, but serious side effect (morphine overdose) in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine.
August 15, 2007 Nonprescription cough and cold drug products Reports of serious and life-threatening adverse events associated with overdose and misuse of these products in children, especially in children under 2 years of age.
August 14, 2007 Rosiglitazone maleate (Avandia, Avandamet, and Avandaryl); Pioglitazone hydrochloride (Actos, Actoplus Met, and Duetact) Increased risk of developing congestive heart failure or worsening of heart failure.
Rosiglitazone maleate
Pioglitazone HCl
August 9, 2007
(updated December 10, 2007)
Omeprazole (Prilosec) and Esomeprazole (Nexium)1 Ongoing safety review of potential risk of heart attacks, heart failure, and heart-related sudden deaths based upon two small long-term clinical studies in patients with severe gastroesophageal reflux disease.
July 2, 2007 Omalizumab (Xolair) Update highlighting revisions to product labeling and a new medication guide to address the risk of anaphylaxis.
June 29, 2007 Colistimethate (Coly-Mycin M and generics) Report of death of a patient with cystic fibrosis after use of a liquid solution of colistimethate that was premixed for inhalation with a nebulizer.
June 15, 2007 Propofol (Diprivan and generics) Reports of chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia.

Notes:

  1. Early Communication about an Ongoing Safety Review.
  2. Withdrawn from marketing November 5, 2007.