Amid concerns over "behavioral issues" linked with Singulair, Merck's & Co.'s top-selling allergy and asthma drug, the Food and Drug Administration (FDA) on Wednesday announced an investigation examining its possible link with increased incidents of suicide.
Marketed in the US for over 10 years, millions of patients in the US and across the world are prescribed Singulair for the prevention and chronic treatment of asthma in adults and toddlers over 2 months of age.
Singulair provides relief from symptoms of seasonal allergic rhinitis (SAR) in adults, and for symptoms of perennial allergic rhinitis (PAR) in adults and children six months and older.
During the past year, Merck has updated Singulair's labeling to include information on tremors, anxiety and depression. In October 2007, Merck voluntarily updated the worldwide product label explicitly adding ‘potential for suicidal thinking and behavior’.
"When the company does that (voluntarily update labels), we think there's a reason to look at it, we'll go back and analyze the data," said FDA spokesperson Susan Cruzan. "We are going back to review all of the data to determine whether there is a cause-and-effect relationship."
While FDA’s decision to review and investigate Singulair is prompted by post-marketing reports from patients and health care providers regarding "adverse events" including suicide and suicidal behavior, Merck defends stating that no reports of suicidal thoughts or actions were reported among the 11,000 adults and children enrolled in 40 Singulair clinical trials.
The investigation may take as long as nine months, according to the FDA reports. At the end of the investigation process, if found guilty, Singulair may require a stronger and more detailed warning, or in the most extreme case, FDA may seek to have the drug removed from the market. Contrary, the FDA could also find ‘no connection’ and remove all charges against the drug.
Meanwhile, neither the FDA nor Merck has recommended patients to stop taking Singulair. The company declined to say how many deaths have been reported till date.
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