FDA Drug Safety Podcast: FDA Reduces Dose of Acetaminophen in Combination Prescription Products
On January 13, 2011, the Food and Drug Administration issued a drug safety communication announcing that all prescription combinations of opioids and acetaminophen can no longer contain more than 325mg of acetaminophen per tablet. In addition, manufacturers must update the labels of all prescription acetaminophen products to warn of the potential risk for severe liver injury.
I am Yolanda Fultz-Morris from F-D-A's Center for Drug Evaluation and Research.
Acetaminophen is one of the most commonly used drugs for treating pain and fever. It is an important component in many prescription products in combination with drugs such as codeine, Percocet, Vicodin and some cough and cold medications.
In general, these products are safe when used as directed, however taking more than the maximum recommended dose of acetaminophen is a leading cause of drug-related liver injury.
To be aware of the potential for severe liver injury when using products containing acetaminophen, patients should:
- Check their prescription and over-the-counter medications to determine if they contain acetaminophen.
- Avoid taking multiple products containing acetaminophen at the same time.
- Ensure that the amount of acetaminophen taken in a 24-hour period does not exceed the currently labeled maximum dose of 4,000 milligrams.
There is no evidence that lowering the amount of acetaminophen in combination opioid/acetaminophen products will change the effectiveness of these products. These FDA requirements will be phased in over three years and should not create a shortage of pain medications.
Acetaminophen is also contained in many over-the-counter products. FDA is concerned about risks from acetaminophen in over-the-counter products and will continue to evaluate those risks.
FDA urges healthcare providers and patients to report any adverse events or side effects that may be associated with the use of products containing acetaminophen to FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.
Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.
- FDA Drug Safety Podcast: FDA Reduces Dose of Acetaminophen in Combination Prescription Products (MP3 - 2.6MB)
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