Quinidine/Class I anti-arrhythmics should bear boxed warning on increased risk of death -- HRG petition.
QUINIDINE/CLASS I ANTI-ARRHYTHMICS BOXED WARNING ON INCREASED DEATH RISK in patients with non-life-threatening cardiac arrhythmias is urged by Public Citizen's Health Research Group in an Aug. 10 petition to FDA. The citizen petition calls for FDA to "immediately add warning labels on quinidine and strengthen the warning on other Class I anti-arrhythmic drugs" and "inform all U.S. physicians, pharmacists and other health professionals via FDA Medical Bulletin about these new restrictions and warnings."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth