MADELEINE BRAND, host:
From NPR News, this is Day to Day. Federal regulators are looking into possible safety problems with the widely used asthma drug Singulair. There have been anecdotal reports of a link between Singulair and suicidal behavior. The Food and Drug Administration says it is investigating three or four suicides. Marketplace's Bob Moon is here now, and Bob, is the FDA saying consumers should immediately stop taking this drug until they've concluded their investigation?
BOB MOON: No. In fact, the government is telling doctors and patients to keep using Singulair unless it turns up more information that might establish that there is a problem. Right now, as you say, the FDA says it's only received a small handful of reports of suicides that might have had something to do with the drug, but for now, it says it hasn't even established a casual link. It's asking Merck and Company, the New Jersey-based pharmaceutical giant that makes Singulair, to search deeper into its clinical trial data on Singulair and these patient reports since the drug has gone to market and they going to see if there is anything that might establish any kind of a connection here.
BRAND: Well, this is an extremely popular drug, a big moneymaker for Merck. What does Merck say?
MOON: It is a critical profit center for Merck. Singulair is the company's biggest product, in fact, and it's the country's most prescribed respiratory medicine. Just last year, sales grew 19 percent to more than four and a quarter billion dollars. Merck officials say that none of the 11,000 patients that were enrolled in their pre-market clinical trials has committed suicide. It also says there is no indication there is anything to associate the way the drug works with possible suicidal behavior, and the commercials that Merck runs for Singulair make no mention of anything like this. This is the pitch from one of their TV ads.
(Soundbite of Merck's ad)
Unidentified Announcer: Side effects are generally mild and vary by age and may include headache, ear infections, sore throat, and upper respiratory infection. Singulair, a different way to treat allergies.
MOON: Now, beyond what the TV ads say, Merck has updated the drug's labeling four times in the past year and they have added several new possible side effects including tremors, anxiousness, depression, and suicidal behavior. The company says that's an effort to be on the safe side. The research director of Merck says that's because suicide is a life-threatening event, and the company thought it was important to include the information on the label.
BRAND: Now, this action from the FDA. It's coming very early on in the process, as you say, before there are any definite conclusions. So, but does it signal a change in any way by the agency in terms of how it handles these kind of questions?
MOON: Actually, it does reflect a change that came about after some congressional pressure over - with the withdrawal of Merck's painkiller Vioxx from the market back in 2004, you may recall. Last year, the FDA started a program to disclose when it has identified possible risk in this way through patient reports or later studies, and by the way, they say they're looking into two similar asthma and allergy drugs from other companies, Accolate and Zyflo. Their labeling doesn't contain any reports of suicide.
BRAND: Thank you, Bob. That's Bob Moon of public radio's daily business show Marketplace.
(Soundbite of music)
NPR transcripts are created on a rush deadline by Verb8tm, Inc., an NPR contractor, and produced using a proprietary transcription process developed with NPR. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.