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FDA: Certain asthma medications need new prescribing, side effects information

WHITEHOUSE STATION, N.J. The Food and Drug Administration has asked manufacturers of a class of asthma drugs to revise their prescribing information to include information about the possibility of psychiatric side effects.

The FDA cited reports of some people taking leukotriene modifiers experiencing mood and behavior changes. The drugs inhibit leukotrienes, chemicals that the body releases in response to such inflammatory stimuli as allergens and can lead to obstruction of the airways. The leukotriene modifiers Merck & Co.’s Singulair (montelukast), AstraZeneca’s Accolate (zafirlukast) and Cornerstone Therapeutics’ Zyflo (zileuton).

In response, Merck said it had updated the prescribing information for Singulair to include the psychiatric side effects the FDA cited, and that it would continue working with the agency to revise the prescribing information to include a precaution about them.

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Study finds sodium oxybate might significantly improve pain, core symptoms of fibromyalgia

PALO ALTO, Calif. Jazz Pharmaceuticals’ sodium oxybate showed statistically significant and clinically meaningful improvement in pain and the core symptoms associated with fibromyalgia, according to phase 3 data.

Most patients with fibromyalgia suffer from widespread chronic pain, but the vast majority of patients also are affected by a broader spectrum of symptoms, including fatigue, sleep disturbances, cognitive dysfunction and impaired physical function.

“The data showed that sodium oxybate improves the key symptoms of fibromyalgia: pain, fatigue and sleep disturbances,” said Todd Swick, one of the study’s investigators, medical director of the Houston Sleep Center and assistant clinical professor of neurology at the University of Texas – Houston School of Medicine. “Millions of people are diagnosed with fibromyalgia, and there is a continuing unmet need for therapies that address the constellation of symptoms that can have a significant impact on patients’ quality of life.”

The 14-week study included 548 patients with fibromyalgia and was presented last week at the 2009 Associated Professional Sleep Societies meeting in Seattle.

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Report: Obama to sign tobacco legislaton

WASHINGTON President Barack Obama has said he will quickly sign a bill that passed in the House Friday that would impose tough new regulations on tobacco, according to published reports.

The bill would place regulation of tobacco products under the authority of the Food and Drug Administration, while also banning such products as cigarettes flavored with cloves and strawberry, and banning cigarette makers from advertising their products with such labels as “light” and “mild.”

More than 400,000 Americans die of smoking-related illnesses every year, and more than 35 million live with chronic lung disease, according to the American Lung Association.