Drug Recalls and Safety Alerts:

05/25/07

 Recent Drug Recalls and Safety Alerts: A selection compiled by Dr. Myatt.

• Rosiglitazone (Avandia) Increases MI and CV Death in Meta-Analysis
  The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.(1,2)

• Hormone Replacement Therapy Linked to Ovarian Cancer
  April 24, 2007 -- The Million Women Study, a trial in the United Kingdom of postmenopausal women, has found that those receiving hormone replacement therapy (HRT) were 20% more likely to develop and die from ovarian cancer than women who never received therapy.

• Pergolide Withdrawn From US Market
  With both branded and generic versions being pulled due to potential for serious heart valve damage, the FDA is urging clinicians to consider transitioning any Parkinson's disease patients to other dopamine agonists.(7)

• Use of Zolpidem Tartrate (Ambien) for ADHD-Related Insomnia in Pediatric Patients Linked to Hallucinations
  On March 28, the FDA approved safety labeling revisions for zolpidem tartrate tablets (Ambien; Sanofi-Aventis US, Inc) to warn of adverse events associated with its use in the treatment of insomnia associated with attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 to 17 years. The drug is linked to risks for dizziness, headaches, and hallucinations. (4)

• Desogestrel/Ethinyl Estradiol Tablets (Cyclessa) Linked to Risk for Stroke in Obese Women
  On March 26, the FDA approved safety labeling revisions for desogestrel/ethinyl estradiol tablets (Cyclessa; Organon USA, Inc) to update information regarding the risks for cerebrovascular events, breast cancer, and depression in women taking desogestrel/ethinyl estradiol tablets for contraception. (5)

• Excessive Exposure to Benzyl Alcohol in Triamcinolone Hexacetonide Injectable Suspension (Aristospan) Linked to Pediatric Toxicity
  On March 1, the FDA approved safety labeling revisions for triamcinolone hexacetonide. Benzyl alcohol dosages higher than 99 mg/kg/day in neonates and low-birth-weight neonates have been linked with "gasping syndrome,"  gradual neurologic deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.(6)

• FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications
  The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months). (3)

References:

1.) FDA Press Release #P07-88, May 21, 2007.
2.) Nissen SE and Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;DOI.
3.) FDA Press Release #P07-77, May 2, 2007.
4.) FDA Safety Changes: Ambien, Cyclessa, Aristospan. Medscape, May 16, 2007.
5.) ibid.
6.) ibid.
7.)  FDA Press Release #P07-54, March 29, 2007.
8.) Ovarian cancer and hormone replacement therapy in the Million Women Study. Lancet. 2007 May 19;369(9574):1703-10.