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Warnings on Xolair, ADHD Drugs, and Rosiglitazone

Several different drugs were the subject of alerts and warnings this week.

Based on new reports of anaphylaxis associated with the asthma drug Xolair (omalizumab), the FDA has requested that the manufacturer add a boxed warning to the drug's label. The agency says that anaphylaxis occurred in at least 0.1% of almost 40,000 people treated with the drug, and that some patients had delayed anaphylaxis, with onset more than 2 hours after injection.

The FDA also mandated that ADHD drug manufacturers develop patient medication guides warning of possible cardiovascular and psychiatric risks and advising of precautions that can be taken. The risks include sudden death, stroke, and heart attack in certain patient populations, as well as hearing voices, harboring irrational suspicion, and mania in patients without previous psychiatric problems.

GlaxoSmithKline notified clinicians that Avandia (rosiglitazone) was associated in two trials with an increased risk for fractures of the upper arm, hand, or foot in women, compared with metformin or glyburide. The company says it "believes the risk of fracture should be considered in the care of patients, especially female patients, with type 2 diabetes mellitus who are currently being treated with rosiglitazone, or when initiation of rosiglitazone treatment is being considered."

Link: FDA alert on Xolair (Free)

Link: FDA press release on ADHD drugs (Free)

Link: Draft medication guides for ADHD drugs (Free)

Link: FDA announcement on rosiglitazone (Free)

Link: Manufacturer letter on rosiglitazone (Free PDF)

Published in Physician's First Watch February 22, 2007