After weathering the Vioxx storm for the past three years, Merck again finds itself in choppy and unchartered waters. Still reeling from the Vytorin flap that erupted two months ago, there are new allegations that its blockbuster allergy and asthma medicine, Singulair, may be linked to suicide. The US Food and Drug administration (FDA) was quick (this time) to announce that it is launching an investigation into reports that suggest that Singulair may cause patients taking the medication to commit suicide. Merck received approval for Singulair in 1998 and it had sales of $4.3 billion in 2007.
There are several reasons why FDA quickly alerted the American public to its investigation into Singulair. First, FDA has been relentlessly chastised in recent months by Congress for not notifying Americans early enough in drug safety investigations. Historically, FDA has waited until the end of an investigation (rather than the beginning) before alerting the public about possible drug safety issues. Second, the agency was well aware of emerging and ongoing safety issues with Singulair. For example, over the last year, FDA regulators asked Merck to update Singulair’s label four times. These changes included information on side effects such as tremors, anxiousness, depression and suicidal ideation.
As part of its current investigation, FDA requested that Merck “dig deeper into its clinical data on Singulair for any evidence of possible links to suicide.” Merck quickly responded and noted that none of the 11,000 patients enrolled in 40 Singular clinical trials had committed suicide. Of course this doesn’t mean that people taking Singulair didn’t think about committing suicide. In Merck’s defense, the company may not have thought to include a question about suicidal thoughts as part of Singulair’s clinical development program. Nevertheless, it is important to note that the safety profiles for many approved drugs are not fully realized until the drug has been on the market for several years. This is because the small numbers of patient used in the clinical trials for approval of a new medication are usually not sufficient to identify all potential safety problems. Unforeseen or unanticipated side effects typically begin to emerge only after a drug is used by larger numbers of people in the general population.
For this reason, the Food Drug and Cosmetic Act requires that all companies that win approval for new medications are required to set up post marketing surveillance programs. The purpose of these programs is to report any and all side effects of approved drugs to the agency. The post marketing surveillance regulation stipulates that physicians, patients and drug manufacturers must report any side effects or adverse events to the agency. Based on the number of adverse events reports that it receives, FDA can launch an investigation to determine what regulatory actions, if any, should be taken by the drug’s manufacturer to deal with the safety problems. Possible regulatory actions include label changes, black box warnings, physician notification letters, Phase IV clinical trials and possible suspension or revocation of a drug license.
Luckily for Merck, the jury is still out (no pun intended) on Singulair. That said, the good news is that the drug safety and post marketing surveillance programs outlined in the FD&C act are working exactly the way they were designed to!
Until next time…
Good Luck and Good Job Hunting (avoid Whitehouse Station NJ)!!!!!!!!
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As I mentioned in previous posts, things are simply not going Merck’s way. Merck has been battered in the past several months by the Singular flap, precipitous drops in Vytorin and Zetia sales and, most recently, FDA’s rejection of its follow-up Cordaptive anti-cholesterol drug. This has left the drug maker with little choice but to cut an additional 1,200 jobs from its rapidly shrinking US sales force. 
