FDA investigation finds no link between Singulair use and suicide
ROCKVILLE, Md. A class of asthma drugs that includes Merck’s Singulair did not appear to increase the risk of suicide, according to an analysis of clinical trials by the Food and Drug Administration.
Last March, the FDA requested data from Merck, AstraZeneca and Cornerstone Therapeutics for data on adverse side effects, specifically suicidal tendencies, from placebo-controlled clinical trials of asthma drugs belonging to the leukotriene receptor agonist class, namely Merck’s Singulair (montelukast), AstraZeneca’s Accolate (zafirlukast) and Cornerstone’s Zyflo (zileuton).
According to an FDA update on the analysis of the studies, all three submitted data on thousands of patients treated with the drugs or placebos, but no patients completed suicide. In the Singulair study, one patient out of the 9,929-patient study group had suicidal thoughts, but did not commit suicide. There were no reports of suicidal thoughts in the other two studies.
The agency said it will continue reviewing clinical trial data to assess other psychiatric side effects, such as mood problems. As such, it has not reached a definitive conclusion.
Assurant Health announces benefits partnership with Take Care
MILWAUKEE Assurant Health has announced that its health plan members can now receive in-network benefits at all Take Care Clinics.
With the addition of the 322 Take Care Clinics, which are located within Walgreens stores, Assurant Health customers with Individual Medical, Short Term Medical and Real Choices Small Group plans have access to more than 800 retail health clinics throughout the United States.
“This agreement is part of our continuing commitment to give our customers more choices and convenient access to affordable health care options,” said Scott Krienke, SVP of product lines for Assurant Health.
Added Peter Miller, president and CEO of Take Care Health Systems, “Our goal is to provide access to care to as many individuals as possible. Partnering with companies like Assurant Health allows us to offer our model of care to more individuals across the country, and this national contract sets the stage for continued coverage as we expand our model to new markets and states.”
FDA approves generic version of Medicis’ Loprox
ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of Medicis’ Loprox, FDA records show.
The agency approved Paddock’s ciclopirox gel in the 0.77 percent strength on Jan. 7. The gel is used to treat seborrheic dermatitis.
Medicis’ non-acne skin medicines had sales of $173 million in 2007, according to Medicis financial data, which did not list separate figures for Loprox. Nycomed also makes a generic version of the 0.77 formulation, while Medicis continues to market the 1 percent formulation.