Dangerous Side Effects, Dangerous Labels

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According to an Associated Press article on Friday, After fifteen months of investigation, the Food and Drug Administration said Merck & Co. Inc., AstraZeneca, and Cornerstone Therapeutics will have to raise label warnings about psychiatric problems reported by a handful of patients taking their [asthma] drugs. Potential problems include depression, anxiety, suicidal thoughts, and insomnia.

ACSH staffers fear that this, like other warnings with similarly horrific language, might discourage patients from seeking much-needed medication. It s important for any doctor to discuss the risks of a medication with patients, says ACSH's Jeff Stier, but it s also important to discuss the benefits of the medication as well as the risk of not taking it.

Hopefully, this won t follow the trend of counterproductive and unanticipated effects of excessive black-box warnings from the FDA, says ACSH's Dr. Gilbert Ross. Some people correctly read them as alerts that there can be these effects, but some doctors and parents of sick children will be so fearful that they won t give kids the medication they require.

The most effective solution to a problem like this is for parents and doctors to pay attention to possible effects that a medication might be having on their child, says ACSH's Dr. Ruth Kava, but of course, that s true for any medicine.
For more information, including asthma treatment options, see ACSH s publication on asthma.