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PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY May 2014 | Archived Issues

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Grand Rounds

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Surgery Scheduling - New Hours as of May 1

Click the "read more" for hours and contact information for surgery scheduling. As of May 1, hours of operation are Monday-Friday from 8:30 a.m.-5 p.m.

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FDA Airs Risks of Corticosteroids, Blood Thinners, Lunesta

Pharmacy Focus

The U.S. Food and Drug Administration is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis and death. In addition, the FDA has released a study comparing the risks of the blood thinners Pradaxa® and warfarin, and has said the insomnia drug Lunesta® can impair next-day alertness.

Corticosteroid injections are given to treat neck and back pain, and radiating pain in the arms and legs. The effectiveness and safety of epidural administration of corticosteroids have not been established, and the FDA has not approved corticosteroids for this use. 

The agency is requiring the addition of a warning to the drug labels of injectable corticosteroids to describe these risks.

For more information, click here.

Pradaxa: Lower Risk of Stroke and Death, Higher Risk of GI Bleeding Than Warfarin

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 of clot-related strokes, bleeding in the brain and death, than warfarin.

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 of a new warning 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. Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both.

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.