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FDA Enforces Additional Warning Labels For Asthma Drugs

June 13, 2009

Federal regulators said on Friday new labels on popular asthma drugs like Merck’s Singulair must highlight language about suicidal behavior, depression and anxiety seen in a small number of patients, The Associated Press.

The Food and Drug Administration said after 15 months of investigation that drug companies Merck & Co. Inc., AstraZeneca and Cornerstone Therapeutics would have to raise label warnings about psychiatric problems reported by a handful of patients that were prescribed the drugs.

The FDA said in a posting to its Web site: “Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.”

The language already appears in Singulair’s label, but will be raised to the “precautions” section, according to a spokeswoman for Merck. She said the warning is now listed in a section about various side effects reported by users of the drug.

Merck spokeswoman Pamela Eisele said the company had been working with the FDA since Singulair came to market and every time it updates the label it’s in cooperation with FDA regulations.

Reporting U.S. sales of $3.5 billion last year, Singulair was Merck’s best-selling product.

New labeling on London-based AstraZeneca’s asthma drug would only mention two psychiatric problems: depression and insomnia, according to a spokesman for the company.

Last spring, FDA regulators began reviewing a handful of reports about mood changes, suicidal behavior and suicide in patients who had taken Singulair. Probes into other drugs in the class, including AstraZeneca PLC’s Accolate and Cornerstone Therapeutics Inc.’s Zyflo were also launched.

The agency said company studies of the three drugs earlier this year did not show an increased risk of suicidal behavior, though they were not designed to detect such problems. However, the FDA is monitoring ongoing reports of suicide and other psychiatric problems among patients, a company spokeswoman said on Friday.

FDA spokeswoman Karen Riley said the administration moved the language to the ‘precautions’ section to highlight that it was continuing to see these reports.

The FDA said that while the exact language of the labeling updates has not been released, it could mention a slew of psychiatric problems, including: “agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior – including suicide – and tremors.”

The slow warning concerning safety issues related to Merck’s painkiller Vioxx, which was removed from the market in 2004 because it doubled the risk of heart attack and stroke, prompted the FDA to start notifying the public earlier about possible safety issues with drugs.

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