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US drug regulators have advised that top-selling drug Singulair and similar medicines, which are used to treat asthma and allergies, should carry warnings of possible psychiatric side effects.
The Food and Drug Administration has requested that manufacturers such as Merck & Co which produces Singulair should inform patients being treated with potential neuro-psychiatric events on labels.
Other drugs to be issued with the precaution include AstraZeneca’s Accolate and Cornerstone Therapeutics Inc’s Zyflo and Zyflo CR.
The warning comes after some patients issued the drugs started to suffer from agitation, aggression, suicidal thoughts, suicide, depression, insomnia and irritability.
Although psychiatric problems were uncommon in clinical trials, the data was not designed to evaluate those issues.
The FDA said: “The post-approval reports of psychiatric events included clinical details consistent with a drug-induced effect.”
Merck has issued a statement saying it was confident in the safety of Singulair, which has been prescribed to tens of millions of patients since its approval in 1998, but would revise the drug label as requested.
Copyright Press Association 2009
