FDA Revokes Approval: Painkillers with Acetaminophen Cause Liver Damage
On Wednesday, July 16th, the US Food and Drug Administration revoked approval for seven powerful narcotic painkillers that contain acetaminophen, in response to claims that acetaminophen causes serious liver damage.
The FDA revoked the drugs’ approval three years after the regulatory agency announced it would cap acetaminophen doses in prescription painkillers to 325 milligrams per dose. The regulation went into effect in January of this year. Three versions of popular prescription painkiller Vicodin – which combines hydrocodone and acetaminophen – were affected by the decision.
The seven prescription painkillers whose approval was revoked feature levels of acetaminophen ranging from 356 mg per dose, to 750 mg. The FDA also requires black box warnings for any painkiller left on the market that has acetaminophen.
Although acetaminophen in prescription drugs will be limited, the FDA has, so far, not limited the dosing amount of acetaminophen in over the counter drugs like Tylenol. However, a recent study showed that overdosing on acetaminophen through over the counter drugs is very easy, as many OTC painkillers contain acetaminophen, and consumers do not often check labels for how many milligrams of acetaminophen they ingest.
The current recommended limit of acetaminophen for adults is 4,000 milligrams a day, but that number is shockingly easy to reach: one gel capsule of Tylenol Extra Strength, for example, contains 500 mg of acetaminophen. For people with chronic pain, who have painkiller prescriptions, it is easy to go over that limit and risk liver damage with just a few additional Tylenol pills.
“Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much,” the FDA said in a statement Tuesday, January 14th. Too much acetaminophen will cause liver damage.
“Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death,” said Sandra Kweder, in charge of FDA’s Office of New Drugs in 2011, in a statement.
In March of this year, the FDA withdrew 108 abbreviated new drug applications which contained more than 325 mg of acetaminophen. As of this Wednesday’s withdrawal, the FDA has achieved 100% compliance with its new acetaminophen regulations.
Tylenol and Acetaminophen Personal Injury Cases
Research shows that Tylenol® causes a variety of side effects and may increase the risk of liver failure and other serious health complications in otherwise healthy people prescribed the Acetaminophen pain reliever. Specifically, Tylenol® and other Acetaminophen products have been shown to increase the risk of liver problems, including liver damage and/or liver failure. These products have been sold for years with inadequate warning and instructions, which could have reduced or prevented the risk of serious and potentially life-threatening injury.
Have you experienced any of the following symptoms within a week of ingesting Tylenol® Acetaminophen products:
- Hospitalization resulting from severe liver injury or liver problems
- Liver failure
- Liver transplant or being placed on the transplant list
- Possible death or loss of life from liver failure
The Strom Law Firm is Investigating Cases of Tylenol or Acetaminophen Personal Injury
The personal injury attorneys at the Strom Law Firm, based in Columbia, SC, are now investigating and evaluating cases against Tylenol®, the popular Acetaminophen drug. Some users of Tylenol® have been diagnosed with liver damage after taking the medication. Contact us today for a free consultation to discuss your case. 803.252.4800
