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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.

Nearly 40% of Americans say they’ve suffered from mild insomnia at some point during the past twelve months.  Not surprising, this number has increased with the stresses in today’s world.  Ambien, the best-selling prescription sleep aid, has made its maker, Sanofi-Aventis, millions of dollars.  Unfortunately, some users have also experienced sleepwalking, sleep eating and some have even driven their vehicles while asleep.  This is what happened to a man in Wisconsin who froze to death after what investigators believe was a case of sleepwalking.  He was found just outside his

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home with temperatures of sixteen below zero.   After searching his home, a bottle of Ambien was found.  It’s not yet been determined if he’d taken Ambien before going to bed the previous night.  They do suspect, however, that he’d been drinking.  There is a very clear and definitive warning of mixing alcohol or other drugs - even over the counter medicines - that drug maker stress in their documentations.

So the question is, if Ambien is found in his system along with alcohol, does this make the drug maker liable for his death?  What if the prescribed dosage is discovered, but his system is absent of any alcohol or other drugs; does this make Sanofi-Aventis responsible then?  And how much

“warning” from drug makers is enough?  Have they met their responsibility for advising potential users the consequences of misusing a prescription drug?  It should be mentioned that this man had already drove his truck with no memory of having done so after taking this sleeping pill.  This begs the question of whether he should’ve ever taken the drug again at all. 

Accidental deaths due to prescription drugs are on the rise in this country and they keep climbing at alarming rates.  In 2005, there were more than 30,000 deaths due to accidental overdoses or the combination of either alcohol or other over the counter drugs that were combined with the prescriptions.  The Centers for Disease Control say this outnumbers the deaths due to automobile accidents and deaths due to firearms.  What’s even more surprising is who is actually overdosing.  Middle-class white Americans, with jobs and mortgages and kids are the ones who most often play Russian roulette with medicines.  Keep in mind - these numbers and profiles are indicative of only medications prescribed by doctors, not illegal drugs.  Oxycontin and Lorcet are two of the most abused prescriptions, but those prescribed for sleep disorders are catching up fast.  With nearly 46% of all Americans taking at least one legally prescribed medicine - whether it’s Albuterol for asthma, cholesterol reducing medications or any other of the thousands of FDA approved drugs - many are beginning to wonder how folks coped without all of these new drugs, even as recently as the 1970s and 1980s.  But then again, pharmaceutical companies spent a combined total of $1 billion last year in advertising and marketing campaigns to ensure more people would visit their doctors for all that ailed them. 

The economy may begin to play a larger role in this cycle, though.  Natural alternatives are on the rise and health food and nutrition stores are reporting a steady increase in their customers as people, who are concerned about the economy and fewer insurance benefits, are opting to hold on to their money.  One area they’re cutting back on are expensive prescriptions.  People are swapping their expensive sleeping pills for the natural alternative of Melatonin and anti-depressants are being shelved for their natural alternatives, such as DHEA.

Still, there are those who believe this shift will last only as long as the weak economy and many believe these shifts aren’t significant enough to make a dent in reducing the numbers of accidental deaths. 

In the meantime, an autopsy will reveal if the man in Wisconsin had Ambien and/or alcohol in his system.

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