After anecdotal reports that people who used the popular allergy drug Singulair may develop suicidal tendencies, the Food and Drug Administration announced March 27 that it would investigate. How big the problem might be depends on which network you watch.
Even though CBS’s “The Early Show” and NBC’s “Today” included statements from Merck ( [1]NYSE:MRK), the manufacturer of the prescription medicine to help control symptoms of asthma and allergies, analysis of the investigation was mixed.
On “The Early Show” CBS anchor Maggie Rodriguez stressed “disturbing” questions about the drug and correspondent Kelly Wallace alleged information about new behavioral side effects was not easily accessible on Merck’s Web site. The broadcast also interviewed the parents of a teenager who committed suicide while using the drug.
But NBC’s Dr. Nancy Snyderman put the investigation into perspective on “Today,” explaining it was a small number of cases where suicide and use of the drug coexisted.
“Let me caution, with 31 million prescriptions written we’re talking about three or four cases of suicide reported to the FDA,” Snyderman said.
Snyderman also explained that drug companies are now using [2]post-marketing surveillance, which means that even after a drug is on the market, users can report their side effects to the drug company Web site or through the FDA— a phenomenon that takes into account a worldwide number of users of drugs like Singulair.
Due to post-marketing surveillance, Merck has made four label changes in the last year to accommodate behavioral symptoms experienced by some users. Snyderman said viewers should understand the company was adapting in real time.
“Now, you might say, ‘See something’s fishy, something’s going on,’ or you can say, ‘How responsive, how responsible to change labels according to what they’re hearing,’” said Snyderman.
Dr. Mangala Narasimhan of Beth Israel Medical Center told Maggie Rodriguez that Singulair is commonly prescribed for patients with moderate or severe asthma and that she would monitor patients more closely for mood changes or depressed thoughts.
Snyderman said that patients should also have questions of their own.
“You have to pay attention, for any medication you give anybody, for any changes around the time that you give it,” she said.
Snyderman noted that drugs always have to be evaluated on a long-term basis, and every drug has a reaction for somebody.
"This speaks more to a very cautious, safety-focused agency than it does to safety of Singulair," said Seamus Fernandez, an analyst who covers Merck for the health care investment bank Leerink Swann, to [3]The Boston Globe March 28. Fernandez said the issue will come up again since a full investigation will take close to nine months, but expects it to be resolved in a “benign way."
USA Today [4]reported March 28 that the FDA will investigate whether similar medications like Zyflo, Accolate and Zyflo CR have negative effects on behavior and mood as well.
Singulair is Merck’s biggest seller and, as [5]Reuters pointed out March 28, one of the world's top selling drugs with global sales of $4.3 billion in 2007.