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Warnings issued for painkillers

If I can buy a painkiller over the counter at a supermarket then I assume it’s safe. So do most people, which is why the U.S. FDA now requires some painkillers to carry additional warnings on the packaging.

The new rules require more and stronger label warnings about the risk of liver damage and internal bleeding for common painkillers. Whether you live in the US or not being aware of the FDA’s warnings for easily accessible medications is good to know.

Which painkillers need greater warnings?

The drugs to be relabeled are acetaminophen and a class of drugs known as non steroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen.

The FDA requires the following painkillers to carry greater warnings on their packaging within a year:

  • Acetaminophen, e.g. Panadol and Tylenol.
  • Aspirin, e.g. Bayer.
  • Ibuprofen, e.g. Advil, Motrin and Nuprin.
  • Naproxen, e.g. Aleve and Naprosyn.
  • Ketoprofen, e.g. Orudis.

Why do they need warnings?

The drugs listed are effective at relieving pain and fever, however they do carry risks. The FDA is most concerned about the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Risks of NSAIDs: The risk of stomach bleeding increases in people who use NSAIDs, especially for those who take blood thinning drugs like warfarin or steroids. The risk of internal bleeding also increases for those who take many NSAIDs at the same time and drink alcohol.

Risks of Acetaminophen: People with liver disease are at an increased risk of damage when taking acetaminophen, especially for those who drinking alcohol. In addition, people who manage their INR with the blood thinning drug warfarin are at risk of acetaminphen interacting with warfarin.

The report was published on the U.S. Food and Drug Administration website.

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Kellie is 37 years old and together with her brother Steve makes up the My Health Software team.

She helps on the websites and gathering news for the programs. Kellie worked in the medical industry prior to having her two children (8 and 6) and has a strong interest in self awareness and management of health conditions.


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