Merck, Singulair and FDA
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)!!!!!!!!
My son is 5 years old and was diagnosed with asthma in early September of 2007. His pediatrician immediately put him on Singulair. I would say that within a month my son became a different person. He would have these outbursts that were not caused by anything. He started saying horrible things to his siblings, his father, and myself. His behavior was just completely abnormal. He started having anxiety attacks and he had never had one before. In February 2008 these rages and outburst became awful. I would have to hold him down if he got upset because he would hurt himself, or try to hurt me. He would always return back to normal within 15 minutes as if nothing happened. He would always say "I don't know why I did that." He then had a fit (over nothing) and started saying he wanted to kill himself, he just wanted to die, he didn't like the feeling in his body. This fit went on for about 45 minutes, and I could not calm him down. He's 5 years old and was threatening to kill himself because of this feeling in him. The next night he had the same fit only this time he wanted to kill his sister. We immediately contacted his pediatrician and multiple physiologists because something was seriously wrong. About a week later and multiple rages we had scheduled a physiological evaluation which was going to run us about $850 out of pocket. My husband did a search for Singulair and found a message board where mothers were talking about the effects of Singulair on their children, and I felt as if I were reading something I had written. I called the pediatrician and told her that we were taking him off Singulair immediately. I also called the school nurse, and the psychologists we were dealing with, and none of them knew about these side effects of Singulair. They were ready to diagnose him with Autism or ADHD. It's now almost 4 weeks later and my son is back to normal. He does not have that blank stare in his eyes, he focuses completely on the task at hand, but more importantly he has not mentioned killing himself again, no more rages. He loves all of us again and says "that feeling" has gone away. That was the most excruciating, heart wrenching thing I've ever gone through, and this drug really needs to be taken off the market. Think about all the poor parents out there going through the same thing as me and not knowing what is causing it. I hate to think if my son were a bit older and actually knew what killing himself meant, what would have happened then. This should have been taken off the market in 2007 when the teenager in NY killed himself 2 weeks after being on Singulair.
He had no preexisting conditions besides the asthma. Back in 2004 the doctors thought he had allergies so they put him on Singulair for that for about 6 months. He was a completely normal child before the Singulair. It turned him into an evil child who was tormented daily by the effects of Singulair.
Here's a quote from Merck's site "Merck voluntarily updated the worldwide product label for SINGULAIR in October 2007 to include "suicidal thinking and behavior" and included similar changes to the patient product information". So if they voluntarily updated their information, why aren't doctors aware, why is the public not privy to this information?
Take a look at this site, and read for yourself the devastating effects this has on people.
http://www.medications.com/se/singulair
Mom of 3
CT
Three weeks ago after seeing the Sunday News add for Singulair , I had my physician prescribe the product for my allergies. I am on Medicare and the cost to me was $30 for tabs. After taking two pills , the suicide news began associated with the drug.
The FDA announced that they will annalyze which will take nine months.
I am uncomfortable taking the pill with the adverse publicity and want my money back.The Merck website is reall not into the twenty first century as they have no e-mail link to communicate with the company on this issue. I called the 800 number and gave up after holding on three occassions for ten minutes.I am trying to have a company representative take care of my problem. Could you suggest a course of action???
thanks, Kent
I have the same problem as the person above.I spent $40 out of pocket and can't afford to throw away $40 and I want my money back.I wish I had done research before I got the prescription filled.Singular gave me crippling nausea, headaches, and dizziness.It worked well on my breathing problem but I felt so miserable otherwise I couldn't take it anymore.