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FDA Delays Decision on the Heart Risks of Naproxen

Accoridng to WHTC, an advisory panel to the US Food and Drug administration has suggested that evidence does not prove that the painkiller naproxen causes lower cardiac risks than its rival products.

NSAIDs and Cardiovascular Risks

The concern relates to a 2005 FDA regulation that stated the need for all nonsteroidal anti-inflammatory drugs (NSAIDs) to carry warnings about the risk of cardiovascular disease.

The issue was brought up after the data presented in a meta-analysis in The Lancet last year, seemed to suggest that naproxen was less dangerous to the heart than other NSAIDs such as ibuprofen and Celebrex.

The panel voted 16:9 that the evidence in the study was not sufficient to conclude that Naproxen posed less of a cardiac risk than other NSAIDs.

The Weight of the Panel’s Decision

The FDA, which is not required to comply with the decisions of its panels, has decided to postpone its final decision until the conclusion of a current ongoing study known as Precision. The study is designed to compare the effects of naproxen, ibuprofen, and Celebrex, and is set to conclude in 2015.

The final FDA verdict can have implications for the method in which the drug is prescribed and used in the future.

For the time being, panelists have advised that the current FDA product labeling of the drugs remain unchanged.

Description/Common Side Effects

According to data from Drugcite.com, reported adverse events include:

  • Headaches
  • Nausea
  • Dizziness
  • Gastric ulcer
  • Chest pain
  • Hemorrhage
  • Anaphylactic reaction
  • Renal Failure
  • Death

The drug is sold under the names Naprosyn, Advil, and Aleve. Over-the-counter, generic versions of the drug are also available.

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