Safety Alerts & Recalls

What does this mean?

There is no immediate danger to patients who take prescription acetaminophen combination products as directed by their doctor or other healthcare professional. If you take prescription pain medicine containing acetaminophen, you should not stop taking your medicine unless told to do so by your health care professional. The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4000 mg within a 24-hour period. This alert is a good reminder to speak to your healthcare professional and review the maximum amount of acetaminophen you can take in one day. Be sure to talk to your health care professional about all of the medicines - prescription and OTC - you are taking and have them help you identify which medicines contain acetaminophen.

You can help reduce the risk of adverse effects from acetaminophen by:

1) taking prescription acetaminophen combination pain products only as prescribed by a healthcare professional

2) not taking more of an acetaminophen-containing medicine than directed by your healthcare professional

3) not taking more than one product that contains acetaminophen at any given time

4) not drinking alcohol when taking acetaminophen

5) not taking more acetaminophen than the maximum daily dose recommended by your healthcare professional

Please stop your medicine and seeking medical help immediately if you think you have taken more acetaminophen than directed or if you experience allergic reactions such as swelling of the face, mouth, and throat; difficulty breathing; itching; or rash. If you have any other questions about acetaminophen or any acetaminophen containing products, please speak to your healthcare professional.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of acetaminophen products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The FDA Takes New Steps Aimed at Cutting Risks of Severe Liver Injury from Acetaminophen

The FDA has announced it is asking all makers of prescription products that contain acetaminophen to limit the amount of the drug to 325 milligrams (mg) per tablet or capsule. The FDA is also requiring a Boxed Warning on all prescription acetaminophen products that highlights the potential risk for severe liver injury. Boxed Warnings are FDA's strongest warnings for prescription drug products, used for calling attention to serious or life-threatening risks. In addition, FDA is requiring a Warning on labels of all prescription products that contain acetaminophen that highlights the potential for allergic reactions. These allergic reactions include swelling of the face, mouth, and throat; difficulty breathing; itching; and rash.

Also called APAP, acetaminophen is used in many prescription products in combination with other drugs, usually opioids such as codeine (brand name Tylenol with Codeine), oxycodone (brand name Percocet, Tylox, and others), and hydrocodone (brand name Lortab, Vicodin, and others) as well as caffeine in products that are used for migraine headaches. Acetaminophen is also found in the combination product Ultracet (acetaminophen with tramadol) and Talacen (acetaminophen with pentazocine). No drug shortages are expected, because the drug companies will have three years make the changes to limit the amount of acetaminophen in their prescription drug products.

Over-the-counter (OTC) products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. The FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products.

Examples of prescription acetaminophen combination products may be found in the "List of Marketed Acetaminophen-Containing Prescription Products", available online at: more information here

For more information about this alert, please visit: more information here

To view the FDA's Question and Answer webpage about this alert, please visit: more information here

Source: FDA
Publication Date: 2011-01-13
Last Updated: 2011-01-15
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