| FDA looks into possible suicide links to asthma, allergy drug | ||
THE ASSOCIATED PRESS WASHINGTON- The Food and Drug Administration said Thursday it is investigating a possible link between Merck's top-selling Singulair and suicide. The FDA said it is reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who have taken the allergy and asthma drug. Merck has updated the drug's labeling four times in the past year to include information on a range of reported side effects: tremors, anxiousness, depression, and suicidal behavior. The FDA said it asked the White-house, N. J. based company to dig deeper into its date on Singulair for evidence of possible links to suicide. The agency said it has not established a "causal relationship" between Merck's drug and suicidal behavior. An agency spokeswoman said the review was prompted by three or four suicide reports it received since October. It could take up to nine months before agency scientists can draw conclusions, the agency said on its Web site. The FDA recently began notifying the public earlier about possible safety issues. The policy change came after it was criticized for acting too slowly on information about the risks of Merck's painkiller Vioxx and GlaxoSmithKline plc's diabetes pill Avandia. Merck officials stressed that the FDA's inquiry is based on reports, not clinical studies, which are the standard tool for evaluating drug safety. The company said none of the 11,000 patients enrolled in 40 Singulair trials has committed suicide. "We have no indication that anything about the mechanism of Singulair is consistent with those events," said George Philip, director of research and product development. Merck said it recently added reports of suicide to Singulair's label, which already listed suicidal thinking and behavior as reported side effects. In clinical trials of asthma patients, the most common side effects were headache, flu, abdominal pain and cough. "Patients should not stop taking Singulair before talking to their doctor," the FDA said in its statement, adding that doctors should monitor patients for suicidal behavior and mood changes.
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| Asthma Medications Have Side Effects | ||
Instead of relying on asthma and allergy drugs that carry the risk of debilitating side effects, here are a few viable alternatives and guidelines to help you prevent or manage your asthma naturally.
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