The risk of over-the-counter meds: How many Tylenols have you taken today?

When you buy over-the-counter drugs, do you read the label carefully? Do you follow the instructions to the letter? If you have a few over-the-counter drugs, do you look at the ingredients to make sure you're not double dosing or taking contradicting meds? Or, do you give into your headache and just glance over the instructions of the 500-tablet bottle assumimg that the drugs are pretty safe since they were sold to you in such large quantities without a prescription?

I'd venture to guess that for most people, it's the latter.

Despite the FDA's attempts to educate the public and issue warning labels, many regard over-the-counter drugs as generally safe, without considering the consequences of taking too many such medications. It's not that people are irresponsible, but it could be that they trust the FDA and believe they would be warned if necessary. Has the FDA failed them?

The fact is, over-the-counter drugs are not without risks. Many of them contain similar ingredients, which means taking them together would cause an overdose of one of the ingredients. It is this exact issue that the Food and Drug Administration is considering in a vote today, trying to prevent overdose with acetaminophen -- the pain-relieving, fever-reducing ingredient in Tylenol and other prescription and over-the-counter medications.

The problem with acetaminophen is that it can cause liver disease. According to the FDA , from 1998 to 2003, acetaminophen was the leading cause of acute liver failure in the United States, with 48 percent of acetaminophen-related cases associated with accidental overdose. There were an estimated 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths related to acetaminophen-associated overdoses per year during the 1990-1998 period.

The statistics are not surprising considering that the more stomach-friendly acetaminophen is one of the most widely used drugs in the U.S. Not only do we take it for most pains, it is also used in common combination cold and flu drugs sold over-the-counter and in prescription drugs like Vicodin and Percocet that combine stronger narcotics with acetaminophen.

Today, outside advisers to the FDA backed reducing the 4-gram maximum daily dose for Tylenol and other over-the-counter products containing acetaminophen in a 21-16 vote. They voted 24-13 to lower the single adult dose to 650 milligrams, or two regular strength tablets, from 1,000 milligrams, or two extra-strength tablets. The 500-milligram, extra-strength dose should be available by prescription only, the panel said. The panel also voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market and that if they stay on the market, 36-1 said they should carry a black box warning, the most serious safety label available. Other issues discussed included pack size restrictions and labeling and advertising.

These were the recommendations, but the FDA is not required to follow them.

Not surprisingly, pharmaceutical companies defended their products, claiming they pose relatively small risk and that most fatalities were due to suicide rather than accidental overdosing, according to the CHPA (a not-for-profit association representing the makers of over-the-counter medicines). Tylenol maker Johnson & Johnson (JNJ), along with Abbott Labs (ABT), which makes Vicodin (and was hit on another matter today) could lose hundreds of millions of dollars in sales if the FDA accepts these recommendations. They prefer a stronger effort to warn buyers about the risks of liver damage from acetaminophen.

The ball is in the FDA's court now. While the FDA has been more concerned with safety since Obama took office, Big Pharma still has clout.

The FDA's Acetaminophen and Liver Injury: Q & A for Consumers
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