Merck issued a press release today responding to the FDA’s investigation. Along with the standard "we didn’t know about this problem until after it the market" disclaimer, the PR mentioned:
In a cumulative analysis recently provided to the FDA of Merck’s randomized, double-blind, placebo-controlled clinical trials, which included over 11,000 adults and children in over 40 studies who were treated with SINGULAIR, there were no reports of suicidal thoughts or actions and no completed suicides in the patients who received SINGULAIR.
Additionally, in a cumulative analysis recently provided to the FDA of Merck’s randomized, double-blind, clinical trials that compared SINGULAIR with other active agents to treat asthma (which included over 3,900 adults and children who were treated with SINGULAIR and over 3,400 who were treated with other asthma therapies), there was 1 patient who attempted suicide who received SINGULAIR, and there were 3 patients who attempted suicide who received other asthma therapies (including inhaled corticosteroids and long-acting beta-agonists). These studies were not designed to compare the rate of suicide in patients taking SINGULAIR with the rate of suicide in patients taking these other asthma agents.
Did Merck report that one suicidal attempt when compared to "other active agents to treat asthma"? It doesn’t say anything in their patient safety or prescribing information when I checked. Perhaps someone can find out whether they reported this in their clinical trials?
In the meantime, the Singulair section of medications.com is ablaze with parents who are now expressing concern over their children’s well-being on the drug. Apparently, issues have cropped up with the drug even before the FDA announced their investigation.
In a particularly odd link, the FDA is looking into Singulair, the asthma and allergy drug and its correlation with suicidal behavior. I’ve taken Singulair in the past and not once did it ever occur to me to think about an allergy medication being linked to suicidal behavior. The FDA also says that it could cause mood and behavior changes. The situation that alerted the FDA to this possibility is the story of 15-year-old Cody Miller who killed himself 17 days after switching from allergy medication Allegra to Singulair. Miller’s mother, Kate, approached his medication switch with extreme caution and informed herself of the possible side effects:
She checked the Merck website and the information sheet she got from the pharmacist on Singulair and found no red flags, so they were stumped when Cody started acting out of character.
I have to hand it to Merck: Once the Millers reported Cody’s death, they immediately updated Singulair’s warnings to include suicidal thoughts and actions. However, Cody died on August 4, 2007. Merck updated their information two months later. As of February 29, 2008, the FDA still hadn’t taken any action. Despite the updated warnings, however, doctors and pharmacists were unaware of the new information.
The Singulair website carries the updated side effects, but you have to search it out in the patient information PDF on the fourth of five pages.
If you check with the FDA, you’ll find nothing. That’s because they admit they haven’t updated their website on Singulair since 2001.
According to the FDA’s MedWatch safety information, they have only begun their investigation today. They say it will take 9 months for them to “complete their investigation.” We may not hear of the FDA’s conclusions until early 2009. If this is a single, isolated incident, the FDA may just say the results are inconclusive and allow Merck rip the warning off their patient safety information. It is also important to note, however, that Singulair has also been linked to depression and anxiety.
Continue reading “Singulair and Suicidal Behavior”
An article in the NYTimes addresses the issue of diagnosing mental health in developing countries. A startling fact:
Depression and anxiety have long been seen as Western afflictions, diseases of the affluent. But new studies find that they are just as common in poor countries, with rates up to 20 percent in a given year.
In India, as in much of the developing world, depression and anxiety are rarely diagnosed or treated. With a population of more than one billion, India has fewer than 4,000 psychiatrists, one-tenth the United States total. Because most psychiatrists are clustered in a few urban areas, the problem is much worse elsewhere.
Looks like depression is really more than just a whiny rich American kid who chooses to be upset because he’s got nothing better to do. That’s “emo” for those who aren’t hip-to-the-jive. 😉
On The Elite Agenda, Dr. Fred Baughman mentions Swedish writer Janne Larson who asserts that “over 80 percent of persons killing themselves were treated with psychiatric drugs.” Thank God for FOIA that provides the docs to back this up:
According to data received via a Freedom of Information Act request, more than 80 percent of the 367 suicides had been receiving psychiatric medications. More than half of these were receiving antidepressants, while more than 60 percent were receiving either antidepressants or antipsychotics. There is no mention of this either in the NBHW paper or in major Swedish media reports about the health care suicides.
I guess Sweden isn’t the only country in the world that wants to sweep unfavorable mental health coverage under the rug. By the way, Sweden also is considered to be the seventh happiest country in the world.
While the FDA has recognized that antidepressants can cause an increase in suicidal behavior (as indicated by the “black box warning”), antipsychotics seem to have fallen under the radar. In fact in 2002, Clozaril was approved to combat suicidal behavior in schizophrenic patients. Since then, research has shown that antipsychotics can increase suicidal behavior in schizophrenic patients twenty-fold.
Akathisia – a serious side effect that has occurred for nearly all psych drugs in clinical trials – has been found to be linked to suicidal behavior with not only antidepressants but also in conjunction with antipsychotics.
Finally, Baughman closes with this:
It is important to note that nearly every school shooting that has happened in the United States over the last decade has been conducted by young males who were taking antidepressant drugs. The drugs not only cause suicidal behavior, they also seem to promote extreme violence towards other individuals. In most school shooting cases, the young men committing the violence also committed suicide after killing classmates and teachers. These are classic signs of antidepressant use.
I don’t know if that’s wholly true but it’s a trend I’ve seen with Cho, Kazmierczak, and Eric Harris of Columbine. Since 1996, there have been 55 major school shootings all around the world; 43 of them occurred in the U.S. Makes you wonder how many of these gunmen were on a psychotropic drug – prescribed or not – of some kind.
(Image from Style Hair Magazine)
I am a 26-year-old black female who suffers from bipolar disorder. I was diagnosed with the illness in November 2006. I’d been diagnosed as suffering from major depressive disorder (MDD) beginning at the age of 14. I still consider myself to suffer primarily from depression although I do have occasional manic episodes.
This blog has helped me to recognize many of the things that I am. That
I truly am more than my diagnosis and that my diagnosis does not define
me. I am not just a person with manic and depressive episodes. I am a person with a personality. I’m smart, witty, drop-dead gorgeous—okay, I wish, but I’m not ugly—musically inclined, and ambitious. And that’s just scratching the surface.
I can be happy, sad, angry, and joyful. I have so many emotions that could classify me as anything. I have a short attention span, for instance. The docs missed the attention-deficit hyperactivity disorder (ADHD) diagnosis (although I lack the hyperactivity). I suffer from anxiety as well but not a single medical record lists me as suffering from generalized anxiety disorder (GAD). So I self-diagnose. It helps me to realize that all of my flaws can pigeonhole me into any diagnosis I choose. I accept my flaws – “diagnosable” or not – and my strengths. This is my journey to learn more about myself, my diagnosis, my medical treatment, and anything relating to my personal life and general mental health.
I’m skeptical of pharmaceutical companies. I don’t hate them; however, many of their practices are shady and I—along with some of my favorite medical blogs —hope to shed light on the “unfavorable” news they choose to keep hidden from the public.
I highlight celebrities who admit to mental illnesses. Many of them suffer from depression, which is the fashionable mental illness of the moment, but others truly suffer from problems that are worth talking about.
I also write about my personal life relating to mental illness. I struggle with constant thoughts of suicide. Readers of this blog will note a pronounced emphasis on suicidal thoughts and behaviors.
Feel free to read on to the next entry about my Perfectionistic Tendencies. Chronicling my journey to managing and treating my illness can hopefully aid me. And eventually, someone else.