Medical Staff Pulse Newsletter

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CME Newsletter - May 2014


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FDA Compares Blood Thinners, Airs Lunesta Risk

Pharmacy Focus

The U.S. Food and Drug Administration recently completed a study in Medicare patients comparing Pradaxa® (dabigatran) to warfarin for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal bleeding, myocardial infarction (MI) and death.

The new study included information from more than 134,000 Medicare patients 65 or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk than warfarin of clot-related strokes, bleeding in the brain and death.

The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.

For more information, click here.

Lunesta® Can Impair Next-Day Alertness, FDA Warns

The FDA has notified health professionals and their medical care organizations that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness.

The agency recommends decreasing the starting dose of Lunesta to 1 mg at bedtime.

The FDA approved changes to the Lunesta prescribing information and the patient medication guide to include these new recommendations. The drug labels for generic eszopiclone products also will be updated.

For more information, click here.