July 30, 2010

Merck will add new precautions to Singulair's label

by Cara Restelli, KY3 News

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By Cara Restelli, Contact KY3

Story Published: Jun 22, 2009 at 9:23 PM CDT

Story Updated: Jun 23, 2009 at 12:07 AM CDT

Changes are on the way for a popular asthma and allergy medication. The Food and Drug Administration wants the makers of Singulair and other leukotrienes to include precautionary labeling about behavioral symptoms and mood changes. A Contact KY3 investigation last year showed that children taking Singulair had adverse side effects ranging from agitation to suicidal thoughts.

It was hard for Cherie Norman to believe it was her son's asthma medication that was causing his bizarre behavior last year.

“He started hitting me and kicking and screaming at me, to the point where I had to lock myself in the bathroom,” she said in an interview last April.

Then Norman read about hundreds of other parents with the same experiences, including Emily Williams.

“He said, 'I'm just going to kill myself so I don't have to see you anymore,” Williams said in an interview in late 2008.

After going off Singulair, both boys improved dramatically.

Merck began including depression and suicidal thoughts in the post marketing experiences section of Singulair's prescribing information in 2007 but that information often wasn't making it onto the inserts that patients receive with their prescriptions. That could soon change.

The FDA is asking Merck and other manufacturers to include aggression, depression and other mood changes as a precaution on the drug labeling. An FDA representative said the changes must also be included on all prescription inserts.

It's a relief for pediatricians like Dr. Daniel Mesch. who says parents sometimes don't think about a medication causing mood changes in their children.

“Any patient on this medication, I will make a point to ask about behavioral changes,” he said.

While Mesch says Singulair has provided a great benefit to many patients, the more information provided to parents about possible side effects, the better.

“If there is any question that there might be a link, than we need to sit down and discuss it," said Mesch.

According to the FDA representative, manufacturers have 30 days to comply or say why they won't. In the case of Merck, it is complying with the FDA's request.

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