Aspirin, A Possible “Out Of The Frying Pan, Into The Fire” Situation

December 20, 2006 1:19pm CST
The Food and Drug Administration is asking for more serious warnings on apparently innocuous pain killers such as aspirin – the general public is not aware of possible risks. Aspirin, ibuprofen and acetaminophen are very popular with the general population and do not require a prescription to be purchased. The FDA warns though that there are some risks that people are not taking into consideration and that medical directions should be closely followed in order to stay safe and healthy. Federal health officials are cautioning Americans that the side effects can be quite nasty and worse than what was troubling the person in the first place – an “out of the frying pan, into the fire” kind of situation. They also released the revised label changes. For example, overdoses of acetaminophen (or paracetamol) can cause serious liver damage and even death, due to liver failure. Aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs pose a risk of gastrointestinal bleeding and kidney injury – even when the medication is taken in the correct doses. It appears that thousands of people die every year due to the ingestion of such drugs. The FDA did add that the risk is low when compared to the number of patients who take the drugs. Federal advisers notified health officials on the need to revise warning labels on pain killers in 2002 and are saying that it took the FDA quite a while to get here. An FDA official has offered the explanation that new regulations require a long time to be written. In 2004, some of the warnings included in the new proposal were printed on pharmacy brochures and public service ads, but some said this wasn’t effective enough. These analgesics are widely available and can be found in drugs treating fever, pain and headache. Health officials are concerned because of the high possibility of patients inadvertently overdosing. The most recent proposal of a revision of drug labels proposes higher visibility of the warnings, using fluorescent or bold-faced type, to attract users’ attention. Labels on medicines including acetaminophen among their ingredients would warn of the risk of severe liver damage in case of over doses or of combinations with alcohol or other drugs. Labels on drugs containing aspirin, ibuprofen, naproxen and other nonsteroidal anti-inflammatory drugs would hold cautions of the risk of stomach bleeding. The labels would note the risk is higher in patients older than 59, or in those who have stomach ulcers, take blood-thinning drugs or steroids, use other drugs that contain a nonsteroidal anti-inflammatory drug. Approximately 56,000 people end up in the emergency room each year because of acetaminophen ingestion. About 100 people die each year after unintentionally overdosing on the drug. More than 200,000 Americans come to the hospital every year because of nonsteroidal anti-inflammatory drugs, 16,000 deaths being related to these drugs, the FDA said. The proposal appeared Tuesday on the FDA's Web site, ahead of its expected December 26 publication in the Federal Register. The FDA is encouraging companies to update their labels as soon as possible. The rule could take over a year to become final.
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