FDA Public Health Alert: Tylenol® (acetaminophen) Linked to Severe Liver Damage
The most popular over-the-counter pain relief medication – Tylenol® (in its generic form, acetaminophen) – has been linked to severe liver damage and failure. Acetaminophen is contained in many medications such as Percocet, Vicodin and Tylenol with Codeine. It is also present in over-the-counter cold and flu remedies.
FDA SAFETY ALERT
On January 13, 2011, the Food and Drug Administration (FDA) confirmed the link between severe liver damage and Tylenol®/acetaminophen. The makers of Tylenol® and other acetaminophen drugs are now required to limit the dosage of acetaminophen to 325 mg in prescription medicine and to add the most severe warning (Black Box) for prescription products containing acetaminophen. The FDA hopes that this action will reduce the risk of severe liver injury.
Liver Injuries Associated with Tylenol® (acetaminophen)
- Acetaminophen-induced liver disease
- Liver transplant
- Liver death
- Prolonged hospitalization due to liver damage
If you or a loved one has taken Tylenol® or acetaminophen and suffered liver injury or damage, contact us or call toll free 1-800-448-0883 for a free case consultation and evaluation by our drug litigation team.
Unintentional Overdose
Recent studies suggest that the people most at risk are those with depression or chronic pain, or ones who take several products containing acetaminophen at one time. This can lead to unintentional overdose.
Acetaminophen overdose has been associated with severe liver necrosis and acute liver failure. To avoid overdose, the FDA advises patients to read all labels for prescription and over-the-counter medicines and ask the pharmacist if their medication contains acetaminophen. Patients are also advised not to take more than the recommended dosage or for more days than directed.
On the Web: More Information about Tylenol® (acetaminophen)
Tylenol lowers dose to reduce overdose risk
July 29, 2011, msnbc.com
FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure
January 13, 2011, U.S. Food and Drug Administration
Acetaminophen-Induced Acute Liver Failure: Results of a United States Multicenter, Prospective Study
Hepatology, Vol. 42, No. 6, 2005
APAP Brand Names and Combination Products
If you or a loved one has taken Tylenol® or acetaminophen and suffered liver injury or damage, contact us or call toll free 1-800-448-0883 for a free case consultation and evaluation by our drug litigation team.
