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Sildenafil trial stopped 1 year early because of safety concerns
American Pharmacists Association, 07/29/09

The National Heart, Lung, and Blood Institute of the National Institutes of Health has stopped a clinical trial testing a drug treatment for pulmonary hypertension in adults with sickle cell disease nearly 1 year early because of safety concerns, according to an NIH news release. In an interim review of safety data from 33 participants who completed 16 weeks of treatment, researchers found that, compared with participants on placebo, participants taking sildenafil were significantly more likely to have serious medical problems. The most common problem was episodes of severe pain resulting from sickle cell crises, which necessitated hospitalization. No deaths have been associated with the drug in the clinical trial.

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