A New York state couple whose teenage son committed suicide while taking the anti-allergy drug Singulair told their story to Food & Drug Administration (FDA) officials last week, prompting regulators to say that the agency would start collecting the personal stories of people experiencing unusual side effects while taking Singulair.
Singulair was approved in 1998 to prevent asthma in people one year and older, and in 2003, its approval was expanded to include the treatment of seasonal allergies in adults and children 2 years and older. Then in 2007, the FDA approved Singulair as a treatment to prevent exercise-induced asthma in patients 15 years and older.
Singulair is Merck & Co.’s best-selling asthma medication. The drug posted sales of $4.3 billion last year, and the drug is used by millions of patients in the U.S. Known side effects of Singulair include gastrointestinal disturbances, hypersensitivity reactions, sleep disorders and increased bleeding tendency. In 2007, Merck revised Singulair’s prescribing information to include reports of tremors, depression, suicide, and anxiousness as possible side effects. In March 2008, the FDA said it was reviewing the safety of Singulair due to a “handful” of reports linking it to suicidal thoughts and behavior. According to media reports, Merck had received “3 or 4” reports of Singulair patients committing suicide since October 2007.
One of those suicide victims was 15 -year-old Cody Miller of Queensbury, NY, who took his life in August 2007, just 17 days after starting Singulair. Cody had previously taken Allegra to control his allergies before his doctor decided to switch his medication. Within two weeks of starting Singulair, Cody became agitated and started having problems with sleep.
Cody’s parents said in interviews that they had thoroughly researched Singulair before he switched, and found no red flags to indicate the drug might pose such a serious problem. Just two months after Cody’s death, Merck updated the Singulair label to include suicide as a possible side effect. However, pharmacists interviewed for one Albany television station said they were unaware of the label update. Some were even still including patient information sheets with Singulair that pre-dated the October 2007 modification.
On Friday, Cody’s parents met with FDA officials to discuss their son and the dozens of stories they’ve gotten from other parents about strange behavior in children taking the medication. Rep. Kirsten Gillibrand, D-Greenport, who arranged the hour-long, closed-door meeting, called it productive. She said the Millers “were able to give a lot of detail about the information that they have learned because of their advocacy.” Gillibrand said one of the FDA officials took particular interest in how the children’s behavior changed after stopping the drug and plans to continue working with the Millers to get information from other parents who have had similar experiences. For their part, the Millers told the FDA they want the medication to bear a “black box” label — the FDA’s most serious warning — to caution that some patients can experience suicidal thoughts and mood changes.
At the time it announced its Singulair safety review, the FDA said it would also be reviewing post-marketing reports of other leukotriene receptor antagonists for evidence of an association with mood swings and suicidal thoughts and behaviors. The FDA also requested that Merck evaluate Singulair study data for more information about suicidality and suicide. The FDA said it anticipated that it would take up to 9 months to complete the ongoing Singulair safety evaluations. 05