Nightmares and other psychiatric side effects of the asthma drug Singulair have led the consumer watchdog Public Citizen to place the medication on their “Do Not Use” list.
In the July edition of the “Worst Pills, Best Pills” newsletter (subscription required), the group urges consumers not to use Singulair (montelukast), even though it is the third-most prescribed brand name drug in the country.
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.
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.
Singulair is a Merck & Co. asthma drug in pill form. It was prescribed 28 million times in 2011. It belongs to a class of drugs known as leuktriene inhibitors.
In 2009, the FDA called for increased label warnings on Singulair and similar asthma drugs due to the psychiatric side effects.
Although the FDA indicated in January 2009 that no evidence had been found to suggest a link between Singulair and suicide, the warning label update was requested to highlight that they are continuing to see the psychiatric problems among patients.
According to a statement posted on the FDA’s website June 12, 2009, the agency recommends that patients and healthcare providers should be aware of the potential risk of suicide and neuropsychiatric events with the drugs, and patients should be encouraged to contacted their doctor if they notice any potential side effects. Doctors have been advised to consider discontinuing the drugs if signs of suicide or other psychiatric symptoms develop.
While Public Citizen recommends that those using Singulair to treat asthma do not stop using it until they have had a discussion with their health care provider, the organization recommends consumers not start on Singulair, and instead rely on an inhaled corticosteroid, like Flovent, to treat asthma. According to the organization, inhaled corticosteroids have a proven track record of treatment that is missing from Singulair without the psychiatric side effects.