Each year, more than 400 people die and an estimated 42,000 people are hospitalized due to liver damage associated with overdoses of acetaminophen, the ingredient found in over-the-counter medications such as Tylenol and Excedrin. When acetaminophen is combined with a narcotic, as it is in prescription drugs such as Vicodin and Percocet, the risks of liver damage and even death increase. This finding prompted the Food and Drug Administration to look more closely at these combination drugs. Recently, an FDA advisory panel voted to recommend a ban on these prescription drugs as well as a recommendation to reduce the maximum doses of acetaminophen in over-the-counter remedies.
One reason for the FDA’s action is the enormous popularity of these drugs. Acetaminophen is one of the most widely used drugs in the United States with approximately 28 billion doses consumed each year. Total sales of all acetaminophen drugs was $2.6 billion in 2008 and 80% of that amount was from over-the-counter products. Vicodin and its generic equivalents, for example, are prescribed more than 100 million times a year. The panel noted that patients who are prescribed these combination drugs for a long period of time require higher and higher dosages of acetaminophen to achieve the same effect. In turn, the higher dosages of acetaminophen are leading to severe liver injury and even death. Sometimes, even following recommended doses can still cause liver damage in some people.
At press time, the panel hadn’t yet decided on safety restrictions for over-the-counter acetaminophen, including changes to packaging and labeling, but decisions regarding these matters should be made soon. The panel also looked into over-the-counter children’s medicines containing acetaminophen and decided to limit these medications to a single formulation instead of selling them in two different concentrations. But the panel rejected a similar proposal to ban over-the-counter cough and cold medicines such as NyQuil, which also contain combinations of pain relievers and acetaminophen, because the risk associated with these combinations were not as great.
While the FDA isn’t required to follow an advisory panel’s recommendations to ban certain drugs from the market, the FDA usually does. Along with the ban, the panel’s recommendation also includes limiting the maximum single dose of over-the-counter acetaminophen to 650 milligrams, down from the 1,000 milligram dose found in many extra strength over-the-counter varieties. Panel members suggested that the best way to protect yourself as a consumer is to become better educated about the risks associated with popular medications and to keep track of what you are taking in order to prevent accidental overdose. If you need additional information on the matters discussed above, you can contact Danielle Mason in our firm at 800-898-2034 or Danielle.Mason@beasleyallen.com.
Sources: Associated Press and The New York Times
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