Jan 20, 2018 | Updated: 09:54 AM EDT

FDA To Toughen NSAID warnings

Jul 14, 2015 06:30 PM EDT

The US Food and Drug Administration (FDA) already gathered stronger evidence to link nonsteroidal anti-inflammatory drugs (Nsaids) to heart failure.

With millions of Americans taking NSAIDs on a daily basis, FDA is keen to taking measures that would ensure that NSAIDs would be properly labeled with the statement: "cause an increased risk" of serious heart failure. The agency would also see to it that NSAID manufacturers would emphasize to consumers that using it may place them at risk even in treatment, which could worsen with longer use of the medication.

Over-the-counter and prescription drugs will be affected by FDA's decision. The agency also advises individuals with heart conditions to ask their doctor first what pain reliever is best for them before opting for over-the-counter NSAIDs. 

 "In basic, sufferers with heart disease or danger aspects for it have a higher likelihood of heart attack or stroke," FDA announced.

In 2005, FDA required drug-makers to label their boxes containing prescription NSAIDS with warnings. The likes of Pfizer's Celebrex and stronger types of ibuprofen and naproxen will be affected by the relabeling. Celebrex is so far the only Vioxx drugs available in the market. NSAIDs are usually prescribed to individuals who are suffering from chronic pain, including arthritis. Usually, these drugs should not be taken to treat pain that exists for more than 10 days, as specified in their box labels.

"These medicines have a long history of security and efficacy when applied as directed," a statement from the Customer Healthcare Goods Association, which speaks on behalf of drug manufacturer. The association nevertheless guaranteed that its members will comply to the request of FDA.

Advil is sold by Pfizer Inc., while Aleve is Bayer's NSAID flagship. There are also smaller-scale drug manufacturers that sell cheaper, generic NSAIDs. 

More: FDA, NSAIDs
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