Singulair Still Prescribed Despite FDA Suicide InvestigationOct 3, 2008 | Parker Waichman LLP
Despite reports of serious adverse side effects, doctors are still prescribing Singulair, a popular allergy and asthma medication that the Food and Drug Administration (FDA) is investigating it for possibly causing behavioral changes and even suicidal thoughts. Some of Singulair’s side effects include stomach pain, cramps, unusual weakness, and upset stomachs; however, aside from mentioning irritability, Singulair’s packaging does not mention these or other side effects such as violence.
Singulair is indicated for the prevention and chronic treatment of asthma in adults and children 12 months of age and older and is prescribed for the relief of symptoms of seasonal allergic rhinitis (SAR) in adults and children two years and older, and for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and children six months and older. Since the FDA began its investigation, Merck, the drug's manufacturer, says it has been "informing doctors and patients of this new information in several ways"; however, no attempt has been made to update the prescription packaging to include verbiage such as "suicidal thinking and behavior."
On the patient information sheets included with Singulair prescriptions from two different pharmacies, neither lists behavioral changes or suicidal thoughts. One suggests patients or guardians should check with the manufacturer whenever a prescription is filled. “We could all be more vigilant in that respect,” said Terry Barks, a pharmacist at St. John's Hospital’s drug information center.
While the FDA and Merck are both still investigating, and despite consumer complaints to the contrary, leaders of the American Academy of Allergy, Asthma, and Immunology (AAAAI) and the American College of Allergy, Asthma & Immunology (ACAAI) claim no data indicates a link between Singulair and suicide. Merck claims it “is committed to patient safety, and has acted responsibly to give doctors and patients information to help them make informed decisions about their treatment choices.”
Meanwhile, we reported last month that some suicides might be linked to a variety of drugs that are surprising experts. In one case, the Associated Press (AP) reported that a 15-year-old high school football player taking Singular hanged himself. About two months following the teen’s suicide, Merck revised its prescribing literature to indicate that some patients experienced suicidal thinking and behavior. Merck said that the death could be a coincidence. "Singulair is a really effective drug that has been on the market 10 years and has been taken by millions of patients," said Dr. Alan Ezekowitz, an asthma expert with Merck. Some independent experts are now seeing a gap in the FDA's knowledge of how drugs affect the brain, says the AP, and that “even if medications are intended for physical conditions, some drugs can have unforeseen consequences if they are able to enter the brain.”
"Even though a drug is identified as a drug for weight control, or smoking cessation, or asthma, these drugs often also get into the brain, so there is always the potential for having psychiatric side effects," said Dr. Thomas Laughren, head of the FDA's division of psychiatric products. "But we don't have any unifying hypothesis as to why very different classes of drugs have psychiatric side effects."