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Just trying to keep track of the latest battle between makers of acetaminophen, NSAIDS and the FDA is enough to have many of us reaching for a BC for the sudden headache we’ve developed.  Today, the FDA  announced it’s considering tighter restrictions on Tylenol, the brand name for   acetaminophen, due to the high numbers of liver failures each year caused by overdosing on the pain medication and fever reducer.  Tylenol and other makers responded that these restrictions would result in more people using nonsteroidal anti-inflammatory drugs (NSAIDs) such as Advil, which, they say cause kidney failure and 5,000 deaths a year and countless lawsuits.

With 2.6 billion dollars a year in profits for Tylenol, they have a lot at stake.  Further, nearly 85% of these profits are due to over the counter sales versus prescriptions of stronger medicines that include Tylenol.  This speaks to the number of people who have inadequate or no health insurance who rely on these over the counter medicines.

Tylenol provided arguments against reducing the recommended dosage of its medicines, which is one option the FDA is considering, saying that the exact label dosage is what seems to be the magic number for those suffering from osteoarthritis.  Seems there’s no middle ground in the pain reliever wars.  One suggestion included pulling multi-medicines, such as those that include sleep-aids or medicines for cold or allergy symptoms, from the market.  The FDA suggested this might be what’s contributing to the high number of liver failures.  While it’s true many take products such as Tylenol PM to induce sleep at night, it’s not uncommon for many users to become used to the standard dosage and find themselves over-medicating with double or more the recommended dosage in order to get to sleep at night.  It could be this will be the middle ground the FDA is searching for, while trying to keep manufacturers of both acetaminophen and NSAIDs happy.

In the meantime, the battle continues.  The FDA insists it’s not interested in making any one pain reliever the “king”, but rather, to reduce the number of liver failures in this country.