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Singulair Linked to Behavioral Problems in Kids

Nov 10, 2010 | Parker Waichman LLP

Some parents say the drug Singulair is having a strange effect on their kids. According to a report on, some say their children have exhibited aggressive behavior, irritability, hostility and other problems since they started taking Singulair.

Singulair is drug maker Merck’s number one selling drug, bringing in $4.6 billion last year. It is approved to treat asthma, as well as allergies. 

In March 2008, the US Food & Drug Administration (FDA) FDA announced that it was reviewing the safety of Singulair because of reports linking it to neuropsychiatric events, including suicidal behavior. In September of that year, the “Precautions” section of the Singulair label was regarding its association with neuropsychiatric events. The precaution reads:

“Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking SINGULAIR. Post-marketing reports with SINGULAIR use include agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some post-marketing reports involving SINGULAIR appear consistent with a drug-induced effect.”

Parents interviewed by said that their children exhibited some of the problems detailed by the Singulair precaution shortly after starting the drug. In many cases, the problems ceased almost as soon as the kids stopped taking Singulair – a classic sign of a drug-induced problem. Before they were able to identify Singulair as the problem, some parents said their children were misdiagnosed with neurological disorders, including ADHD and Tourette Syndrome.

According to the report, Dr. Sidney Wolfe, author of “Best Pills, Worst Pills” has put Singulair on his list of “Do Not Use” drugs.

“Children haven’t been adequately studied for a lot of drugs and yet, because of heavy promotional campaigning, they wind up being treated with a number of drugs that have really questionable benefits,” said Dr. Wolfe.

He told that millions of kids are put on Singulair instead of other asthma-allergy drugs because Merck has launched an aggressive marketing campaign. This includes teaming up with groups like Scholastic Press and by giving money to the American Academy of Pediatrics to train doctors on “diagnosing” and prescribing “proper medication” for asthma.

“I mean the drug companies don’t spend $52 billion a year advertising and promoting drugs just because the like to give money away,” Wolfe said. “It works.”

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