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Asthma Drug Singulair Linked to Suicidal Behavior
by
findingDulcinea Staff
The FDA is looking into reports of people experiencing suicidal thoughts and behavior while taking Singulair. The probe may expand to similar drugs.
30-Second Summary
Singulair is a popular medication prescribed to help control asthma and treat some types of allergies. It has been on the market for about 10 years.
The Food and Drug Administration has announced that it is looking into reports that people taking the drug had suicidal thoughts and even acted on them at times.
The medication’s manufacturer, Merck, changed the drug’s labeling last year so that suicidal thinking was listed among the potential side effects. The company said in a statement that there were no reports of suicidal thinking or suicide during Singulair’s clinical trial, which involved more than 11,000 participants.
Bloggers have been quick to respond to the news. Reactions range from “how did someone not discover this before the drug was approved?” to concern that the reputation of Singulair and similar drugs could be ruined before all the facts are in.
Allergies and asthma affect millions of people. Singulair and medications in the same class, such Accolate and Zyflo, are among the many types of drugs available to relieve symptoms.
The Food and Drug Administration has announced that it is looking into reports that people taking the drug had suicidal thoughts and even acted on them at times.
The medication’s manufacturer, Merck, changed the drug’s labeling last year so that suicidal thinking was listed among the potential side effects. The company said in a statement that there were no reports of suicidal thinking or suicide during Singulair’s clinical trial, which involved more than 11,000 participants.
Bloggers have been quick to respond to the news. Reactions range from “how did someone not discover this before the drug was approved?” to concern that the reputation of Singulair and similar drugs could be ruined before all the facts are in.
Allergies and asthma affect millions of people. Singulair and medications in the same class, such Accolate and Zyflo, are among the many types of drugs available to relieve symptoms.
Headline Links: ‘FDA probes suicide risk in Merck’s Singulair’
The Food and Drug Administration is reviewing reports that suggest a link between Singulair, an asthma medication, and suicidal behavior in children and adults. The agency is also going to look at other drugs similar to Singulair—Accolate, made by AstraZeneca, and Zyflo, made by Critical Therapeutics Inc.—to see whether they have been associated with behavioral changes.
Source: Reuters
Reactions: Merck, bloggers weigh in
In a statement, Merck says Singulair has been on the market for a decade and been prescribed to millions of people. In 2007, based on reports the company received, the drug’s labeling was changed to mention suicidal thinking. However, the company says the reports don’t necessarily prove cause and effect. “The fact that an adverse event has been reported to Merck and to regulatory agencies does not reflect a conclusion that the post-marketing event is caused by SINGULAIR,” Merck said in a statement.
Source: Merck
A blogger who is known as ENT Lawyer reacted to the FDA’s announcement by wondering how Merck didn’t notice this side effect earlier. “The FDA is also reviewing Accolate and Zyflo, but has not determined if they make you want to kill yourself or not. I thought the idea was that they were supposed to do all this reviewing and testing BEFORE people started taking it,” he wrote.
Source: Crazy Days and Nights
Dana Blankenhorn, a business journalist, asks in the ZDNet Healthcare blog, “How fast should news destroy a business?” Singulair and the drugs like it are being “blown out of the water at a stroke” when warnings like the FDA’s are issued. “Some of this is worthwhile, but the fact is we don’t know all there is to know about aspirin, and science ‘changes its mind’ all the time. If you want certainty, get a dog,” Blankenhorn writes.
Source: ZDNet Healthcare
Reference: Asthma, allergies, Singulair
Approximately 20 million people have asthma, according to the National Heart Lung and Blood Institute, and there are four to six types of it, depending on which medical resource is referred to. Asthma is the constricting, or narrowing, of a person’s airways, causing coughing, a feeling of tightness in the chest and breathing problems. FindingDulcinea has compiled an asthma Web guide.
Source: findingDulcinea
Allergies occur when a person’s immune system overreacts to a substance, such as pollen, pet dander or food. For many people, allergies are an inconvenience, but they can be deadly for some. FindingDulcinea has an Allergies Web guide that discusses how allergies are treated, how people can cope with them and how to find support.
Source: findingDulcinea
Drug Digest explains how Singulair is used, how to take it and what kind of side effects can occur. This page was last updated in 2005, and doesn’t include Merck’s warning about possible mood changes. To read about Accolate and Zyflo, type their names in the search box on the left side of the page.
Source: Drug Digest
© 2012 Dulcinea Media, Inc.
