FDA Advisers: Vicodin and Percocet Belong off the Market

Camryn Hansen — Wed, 01 Jul 2009 23:29:29 GMT

Yesterday, an FDA advisory panel voted to recommend that all drugs combining acetaminophen (commonly known as Tylenol) with narcotics be taken off the market due to their elevated risk for severe liver damage and overdose.

Combination drugs like these include Vicodin and Percocet—two prescription painkillers that can be addictive and are sometimes sold on the street. If the FDA does not remove these drugs from circulation, the panel said, it should reduce the amount of acetaminophen in them and make sure patients fully understand the risk of liver damage associated with taking them.

The group recommended that the FDA "send a clear message that there's a high likelihood of overdose from prescription narcotics and acetaminophen products," Dr. Sandra L. Kweder of the FDA's Office of New Drugs said at a news conference after Tuesday's meeting.

Although acetaminophen is one of the most commonly used drugs in the United States for treating pain and fever, overdoses of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s, according to the FDA, citing one study.

The agency cited another study, a 2007 Centers for Disease Control and Prevention population-based report, that estimated acetaminophen was the likely cause of most of the estimated 1,600 acute liver failures each year. -CNN

Following up on earlier recommendations, the panel also recommended that to prevent overdose and consequent liver damage, the FDA should lower the maximum daily dose of acetaminophen in OTC and prescription medications as well as pay more attention to doses of the drug in children’s medicines.

Though the FDA doesn’t have to follow advisory committee recommendations like these, it usually does.

As a consumer, please pay attention to the ingredients in your medications. Whenever you take an over-the-counter product containing acetaminophen, make sure that you are not taking more than the recommended dose, and supervise children’s dosages vigilantly. Just because you can get a drug over the counter does not mean that it’s safe.

Originally posted at InjuryBoard by Camryn Hansen

FDA: We Need Stricter Liver Damage Warnings on Acetaminophen (Tylenol)!

Mike Ferrara — Thu, 28 May 2009 23:40:30 GMT

In late April, the FDA announced that many over-the-counter painkillers and fever reducers will now require warning labels about the risks of liver damage and stomach bleeding associated with taking them.

Now, FDA advisers plan to meet in late June to review a new FDA report calling for even stronger language in label warnings, better consumer education, and dosage limits for prescription as well as over-the-counter acetaminophen (most of us know it as Tynenol).

According to the report, released yesterday, consumers don’t know that acetaminophen can cause severe liver damage, and so aren’t careful enough when they use it. In general, many people take more than the recommended dose of over-the-counter pain medication, mistakenly thinking that more of the drug will equal more pain relief but without dangerous side effects. Many people are also unaware that acetaminophen is numerous OTC products (not just Tylenol) including cold remedies and headache and fever medicines, making it fairly easy to accidentally exceed recommended dosages.

Despite more than five years of FDA-sponsored consumer education campaigns, "recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity continue to occur," the report said.

The report also calls for limiting the maximum adult daily dose to no more than 3,250 milligrams, but with a lower daily maximum for patients consuming three or more alcoholic drinks every day while using acetaminophen products. It also recommends limiting the tablet strength for immediate-release formulations to a maximum of 325 milligrams, and the single adult dose to a maximum of 650 milligrams. -Steven Reinberg, HealthDay

Warnings will have to appear on all over-the-counter products containing acetaminophen as well as on all non-steroidal anti-inflammatory drugs (NSAIDs) drugs such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve) and Excedrin—which all pose risks of stomach bleeding.

Originally posted at InjuryBoard by Mike Ferrara

Cherry Hill, New Jersey Personal Injury Lawyer - acetaminophen

FDA Advisers: Vicodin and Percocet Belong off the Market

FDA: We Need Stricter Liver Damage Warnings on Acetaminophen (Tylenol)!