Tuesday—a federal advisory panel for the Food and Drug Administration voted 20-17 to recommend a ban on Percocet and Vicodin, both of which combine a narcotic with acetaminophen. The two medications represent two of the most popular prescription painkillers in the world, but high doses of acetaminophen have been traced to liver damage. Furthermore, patients who take Percocet or Vicodin often need increasingly higher doses to achieve the same “painkilling” effect.
While the FDA is not required to follow the advice of its panel, it is likely to do so, which will affect several other combination drugs. Specifically, at least seven other prescription drugs that combine a narcotic and acetaminophen will also be banned if the FDA follows the advisory panel’s advice.
The panel originally called the meeting over concerns about the rising number of Americans that take over-the-counter drugs that contain acetaminophen. In fact, in 2005, American consumers bought 28 million doses of painkillers containing acetaminophen. Many consumers are unaware of the danger of taking more than the recommended dosage of over-the-counter painkillers, such as Tylenol, but more than 400 people die and 42,000 are hospitalized each year in the United States for complications arising from overdoses. Ultimately, the members of the panel voted 24-13 to reduce the highest dosage of over-the-counter painkillers from 500 to 325 mg, and 21-16 to reduce the maximum daily dosage to less than 4,000 mg.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.