FDA Drug Safety Communication

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

no smokiing no vaping

Today, we’re also announcing that we’ve sent letters to more than 40 companies seeking information about whether more than 50 products – including a variety of flavored e-cigarette products – are being illegally marketed and outside the agency’s current compliance policy. Some of these companies may be attempting to capitalize on the troubling popularity of products like JUUL among kids by illegally selling similar products and outside of the compliance policy. We also need to determine if any of these products may be counterfeit knockoffs. If tobacco products are being unlawfully marketed and sold outside the FDA’s compliance policy, we’ll take action. We simply cannot tolerate this behavior and will take additional action as needed.

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FDA Adds Boxed Warning for Increased Risk of Death with Gout Medicine Uloric (Febuxostat)

Doctor is warning against side effects of medicine

Uloric was FDA-approved in 2009 to treat a type of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Uloric works by lowering uric acid levels in the blood. Gout is a chronic disease that affects approximately 8.3 million adults in the U.S.1 The number of medicines to treat gout is limited and there is an unmet need for treatments for this disease.

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