The prominent consumer watchdog group is urging federal health regulators not to allow Singulair Allergy to be sold over-the-counter, indicating that it provides only minimal benefits and poses potentially serious health risks.
In testimony (PDF) submitted to the FDA’s Nonprescription Drugs Advisory Committee on May 2, Drs. Michael Carome and Sidney Wolfe of Public Citizen’s Health Research Group urged the panel to reject a bid by Merck to sell Singulair without a prescription.
The experts testified that the Singulair’s side effects are too dangerous and that there is no proof that the medication provides more than a marginal benefit as an allergy treatment.
Singulair (montelukast) is a Merck & Co. asthma drug in pill form, which was part of a class of medications known as leuktriene inhibitors. It was prescribed 28 million times in 2011.
In 2009, the FDA called for increased label warnings on Singulair and similar asthma drugs due to the psychiatric side effects.
According to Public Citizen, research has shown that side effects of Singulair can include nightmares, insomnia, hallucinations and other psychiatric problems, especially among children. In addition, the drug provides minimal benefits as an allergy treatment.
The group has listed prescription Singulair on its “Do Not Use” drug list since July 2013.
Children may be more susceptible to the Singulair problems, with research suggesting they are more likely to suffer nightmares when given the drug. While those nightmares are likely to stop when they are taken off the drug, some research has also shown that the nightmares returned when some children were placed back on Singulair, which many see as a strong sign of a causal link.
According to testimony provided by Public Citizen, a number of studies provide evidence of a causal link between Singulair and psychiatric side effects. The FDA funded ten sample suicide case reports that appear to be linked to the use of Singulair.
“With allergies affecting as much as 30 percent of U.S. adults, there is a high likelihood that people who shouldn’t be taking it will use it and place themselves in harm’s way,” Carome said in a press release. “No other country has approved montelukast for sale over the counter. The FDA should not make the mistake of allowing the United States be the first to do so.”
The testimony warns of a high likelihood of off-label use, intentional and accidental. Public Citizen warns that the drug is likely to be given to children and adolescents and is likely to be used by those suffering from asthma, who mistakenly think the allergy drug is an asthma medication because it carries the Singulair name.
While the decisions reached by the FDA’s advisory committees are not binding on the agency, the recommendations are often a significant factor in any final decision-making process about whether to approve or reject new applications for medications.