World sales of Merck's asthma drug Singulair were about $5 billion a year until 2012 when its patent expired and it was the U.S.'s seventh best-selling drug. But in September, data from an FDA committee were presented that acknowledge "safety concerns" about "neuropsychiatric adverse events, including suicide and suicide attempts" with the drug. Singulair was used by almost 9 million patients, many under 16, in less than two years according to FDA data and four deaths are linked to it. Like Vioxx, Fosamax, Paxil and Ambien, now that the p atent has run out on Singulair, its dangers are being acknowledged.
Singulair is one of several "asthma controller" drugs that debuted in the last few years that are supposed to be added on to rescue inhalers and inhaled corticosteroids instead of replacing them. In addition to the cost of adding a third drug to two drugs that are already used, Singulair cost almost $200 a month until it went off patent.
The concerns raised by an FDA committee in September are not the first time medical questions about Singulair have surfaced. Soon after its approval, FDA reviewers cautioned in the New England Journal of Medicine that adult studies of montelukast, Singulair's generic name "may not be predictive of the response," in children. In new drug approval documents from the 1990s hosted on the FDA website, reviewers note that Singulair levels in adolescents are different from "healthy adults," and that an infant monkey, four weeks old, had to be euthanized because "infants may be more sensitive to the toxicity," of Singulair. What? Three out of five guinea pigs also died from "severe anaphylactic responses."
In clinical trials before Singulair's safety was determined, scores of human subjects are reported to have withdrawn from trials because of "worsening" asthma and breathing problems. An asthma drug "worsens" asthma? Reviewers write that one study "demonstrates that it is better to leave patients on beclomethasone than to switch them to montelukast." Beclomethasone, sold as Qvar, is a steroid to treat asthma. Approval documents include 10 blanked out pages, marked "This section was determined NOT to be releasable," and the frequent phrase "Portions of this review were excerpted directly from the sponsor's submission."
William Busse, M.D., who chairs government expert panels on asthma despite listing 21 financial arrangements with drug companies, was involved in early Singulair testing and was issued an FDA warning letter when an inspection of his facility revealed incorrect consent forms, incorrect patient enrollments and drug inventory and labeling errors according to FDA approval documents. Just good science.
Nor was Singulair marketing to children without controversy. Many considered Merck's sales partnerships with Scholastic, a leading educational publishing group, and the American Academy of Pediatrics conflicts of interest. Sales materials urged parents to give their children Singulair for allergies and sports figures were used to further market the drug to children.
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