Pain Relievers: Recent Action Taken by FDA
Pain Relievers: Recent Action Taken by FDA
During the last few months, the FDA has issued rulings that affect
pain relievers and fever reducing medicines. In April the agency issued a
final rule that requires companies that make over-the-counter (OTC) pain,
cold and fever medicines to revise their product labels within 12 months
regarding the safety of these drugs. In particular, the FDA is requiring
OTC products containing acetaminophen (Tylenol) to carry label warnings
about the possibility of severe damage to the liver when large doses
are taken. OTC products that contain any of several drugs known as an
NSAID (non-steroidal anti-inflammatory drug) such as aspirin, ibuprofen,
naproxen and others will be required to carry precautions about stomach
bleeding, especially in persons who are also taking steroids or blood
thinning medicines.
More recently the FDA has provided an update regarding the use of
propoxyphene (Davon), a popular pain reliever. The agency indicated
that while there are some concerns about the safety of the drug, the
benefits of this prescription pain reliever, at recommended doses, outweigh
safety concerns, at this time.