Singulair and the FDA: Are they keeping us safe?
Did you see the reports last week that Singulair was going to be investigated by the Food and Drug Administration for reports of a “casual relationship” between the drug and suicidality? According to the FDA’s report on the asthma drug:
"FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide.
Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma.
Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008)."
This is one public story of Singulair user’s death that may have prompted the investigation: “Cody Miller was an active 15 year old who took his life on August 4, 2007, just 17 days after starting Singulair for his fall allergies.”
I recall hearing murmurs of this story back in the fall, which seemed to back up earlier stories I heard a few years back about behavioral problems with children taking Singulair. According to the Merck website: “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.”
These studies were part of the reason, no doubt, that many doctors pushed the drug, as it was virtually side effect free. My own pulmonoloist suggested I try Singulair a few years back, saying it would help me attend parties with pets, for example (I experience allergic asthma when exposed to cat and dog saliva and dander).
Over the years, I informally and anecdotally polled several adults who I knew to be taking the drug. None of these adults reported increased emotional changes but as we know, children and adults have very different and complicated physical and emotional systems. I never tried Singulair, as I am not quick to try new medications and, given this recent development, I won’t be running to try that sample pack.
But what does this latest investigation say about the efficacy of the Food and Drug Administration? They act as the gatekeepers of new medications among other consumer products. How does the recent spate of several fatal missteps such as allergic reactions to heparin made with Chinese components or heart attacks due to Vioxx speak to the FDA’s stated mission:
“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”
Undoubtedly, the FDA has a very difficult and complicated mission and millions of lives are at stake when they make mistakes or missteps. But when missteps like these happen, all at once, one has to wonder what is breaking down within the system. What crucial testing stages are being overlooked? How has globalization of raw ingredients changed how medicines are being produced? How is the global process of sourcing ingredients changing the reliability of a medicine’s desired and undesired effect? What pressures are being places on the FDA’s bureaucratic system? In the public clamor for more medication, are pharma companies skipping valuable steps in the testing process?
And the biggest question of all for us, the consumers, whom do we trust? The doctors that are suggesting the medications?
The FDA that says they are safe?
The online chat rooms that tell of side effects not mentioned on the inserts?
Or do we trust all three?
Sloane wrote for HealthCentral as a patient expert for Allergy and Asthma.