PHARMACY

Researchers find link between oral contraceptive use, body composition and exercise performance

BY Michael Johnsen

NEW ORLEANS Many active young women use oral contraceptives yet the contraceptives’ effect on the womens’ body composition and exercise performance has not been thoroughly studied, researchers presenting this weekend at the 122nd Annual Meeting of the American Physiological Society stated Friday.

A team of researchers has now examined the effects of OC on female muscle mass, and found that oral contraceptive use impairs muscle gains in young women, and is associated with lower hormone levels.

During the course of a 10-week study, researchers found that there were significant differences in lean mass gains for women on an OC regimen. However, other muscle responses such as strength gains and arm/leg circumferences were similar between the OC and non-OC users. Resting/fasting blood concentrations of the anabolic hormones were significantly lower in women taking OC vs. non-OC users throughout the study period.  At the same time, plasma concentrations of cortisol (catabolic hormone) were elevated. And those OC users had reduced DHEA hormone at the end of the training period. By contrast, the other participants’ levels did not change.

“We were surprised at the magnitude of differences in muscle gains between the two groups, with the non-OC women gaining more than 60% greater muscle mass than their OC counterpart,” stated Chang-Woock Lee of the Department of Health and Kinesiology, Texas A&M University. Even though the study has observed negative effects of oral contraceptive use on muscle gain in the context of resistance exercise training, “future studies are needed to help explain the reasons behind the results.”

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PHARMACY

FDA approves hypertension generic

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of Abbott’s Oretic, agency records show.

The FDA approved Ipca Labs’ hydrochlorothiazide capsules in the 12.5 mg strength. The drug is used to treat hypertension.

Oretic was originally approved in 1959, and its active pharmaceutical ingredient is used in a number of hypertension drugs.

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Biogen Idec receives FDA approval for multiple sclerosis, Crohn’s disease treatment

BY Alaric DeArment

CAMBRIDGE, Mass. The Food and Drug Administration has given approval to a drug for treating multiple sclerosis and Crohn’s disease.

Biogen Idec announced Thursday that the FDA had approved Tysabri (natalizumab), which already has approval in more than 40 countries as a treatment for moderate to severe Crohn’s disease and relapsing forms of multiple sclerosis. Biogen Idec co-markets the drug with Ireland-based Elan Corp.

Biogen Idec will use a high titer process for which it received approval in the European Union in December to manufacture the drug in higher quantities at its plant in Research Triangle Park, N.C.

“Developing this high titer process is another example of our world-class expertise and leadership in biologics manufacturing,” Biogen Idec COO Bob Hamm said. “We expect this new process to result in about a four-fold increase in yield.”

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