The FDA made an official statement today, saying it has requested class of asthma drugs called leukotriene modifiers be labeled with a “precaution” warning of potential psychiatric side effects, including suicidal thoughts and behavior. This family of drugs includes zileuton, marketed by Cornerstone as Zyflo and Zyflo CR; zarfirlukast, marketed by AstraZeneca as Accolate; and montelukast, marketed as Singulair, Merck & Co.’s number-one-selling drug.
In March of last year, the FDA began an ongoing safety review of a possible association between suicidal tendencies and leukotriene modifiers. In early January, the FDA said clinical trial data suggested that the products were not associated with an increased risk of mood changes or suicidal behavior. But in April, as the agency completed a review including not only clinical trial data but also post-marketing reports, it began to change its tune. The post-marketing reports included cases of neuropsychiatric events including agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior including suicide, and tremors.
Singulair has been associated with psychiatric side effects for some time; Merck began labeling Singulair to reflect those possible side effects in March 2007. In response to today’s FDA request, Merck stated that precautionary language is already included in Singulair’s labeling, and that the language will simply be moved from a section labeled as “side effects” to a higher section labeled as “precautions.” Merck also says it will provide health care providers with informative leaflets and communicate these latest findings to prescribing professionals face-to-face. Speaking as a St. Louis defective drug lawyer, I believe Merck not only should be held to these claims, but also should be held accountable for keeping consumers informed. AstraZeneca and Cornerstone have also said they will add precautionary language to their drugs’ labeling; they too should be held to their claims.
According to Reuters, analysts from Morningstar and BMO Capital Markets say the distinction between side effect advisements and precaution labeling will have little effect on sales. As a Southern Illinois harmful drug attorney, I say this is all the more reason for consumers to remain vigilant. That same article says Singulair’s U.S. sales are estimated at $4.4 billion for 2009; if the FDA is reporting an association between suicidal thoughts and these drugs in documented cases, imagine how many undocumented cases exist in the U.S. today.
If you or a loved one have had suicidal thoughts or other psychiatric side effects while taking Singulair, Accolate, Zyflo, Zyflo CR, or any of their generic equivalents, you have rights, and the Lowe Law Offices can help you protect them. With offices in St. Louis, Missouri and Belleville, Illinois, our pharmaceutical liability lawyers represent people who have suffered serious illnesses or injuries because they took a dangerous medication. In a defective drug lawsuit, you can win back the cost of the drug and all of the treatment it necessitated, as well as compensation for serious injury, permanent disability or the loss of a loved one. If this sounds like your situation, we can help you learn what your options are at a free, confidential consultation. To set one up, please contact the Lowe Law Firm online or call us toll-free at 1-877-678-3400.
