FDA Advises Doctors to Discontinue Prescribing Certain Acetaminophen Medications

FDA Issues Acetaminophen Warning

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FDA Advises Doctors to Discontinue Prescribing Certain Acetaminophen Medications

To reduce the risk of liver injury and liver failure, the FDA plans to withdraw approval of prescription combination medications containing more than 325 mg of acetaminophen.

The U.S. Food and Drug Administration (FDA) has issued a new warning indicating that high doses of the pain reliever acetaminophen found in prescription combination drugs like Vicodin, Percocet and Tylenol with Codeine may result in life-threatening liver damage. As a result, the agency is calling for stricter regulations on combination medications with acetaminophen, and has advised doctors to stop prescribing those that contain more than 325 mg of acetaminophen per dose, to limit the risk of liver damage side effects among consumers. If you believe you have been adversely affected by Tylenol or another potentially dangerous acetaminophen-containing medication, contact a reputable product liability attorney in your area to discuss your legal options.

Link Between Acetaminophen, Liver Damage

According to the FDA, there is no available data that suggests that consuming more than 325 mg of acetaminophen per dose provides additional benefits that outweigh the associated risks for serious liver injury. On the other hand, limiting the amount of acetaminophen in prescription combination drugs can reduce the risk of liver injury associated with accidental acetaminophen overdose, with can lead to devastating liver failure and possibly even death. The agency notes that cases of liver injury side effects linked to acetaminophen have occurred in patients who:

  • took more than one acetaminophen product at the same time;
  • took more than the prescribed dose of an acetaminophen product in a 24-hour period; or
  • drank alcohol while taking an acetaminophen-containing product

Hospitalizations, Deaths Tied to Acetaminophen Overdose

Because acetaminophen is so readily available in various prescription and over-the-counter medications in the United States, most consumers assume that the pain reliever is completely safe. However, the FDA has been aware of a significant connection between acetaminophen overdose and liver failure since the 1990s, and, despite efforts by the agency to reduce this risk, thousands of cases of acetaminophen-associated liver injury are reported every year. In fact, according to the FDA, acetaminophen-related overdose resulted in an estimated 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths every year during the period between 1990 and 1998.

FDA Withdrawing Approval of Certain Acetaminophen Products

The latest FDA warning comes on the heels of prior action taken by the agency to curb the risk of liver damage linked to acetaminophen and Tylenol side effects. In January 2011, federal regulators asked manufacturers of prescription combination products containing acetaminophen to limit the amount of the drug to no more than 325 mg per tablet or capsule. While more than half of manufacturers complied with the FDA request, some prescription combination drugs containing more than 325 mg of acetaminophen per dose are still available in the United States. Moving forward, the agency intends to begin proceedings to withdraw approval of these potentially dangerous medications to protect consumers from unnecessary harm.

Contact a Tylenol Attorney in Your Area

Per the new FDA warning, medical professionals are advised to consider prescribing medications that contain 325 mg or less of acetaminophen, to reduce the risk of patients suffering from liver damage or liver failure. If you took Tylenol in the past and you have since suffered from liver injury, liver failure, or another potential side effect of acetaminophen, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by dangerous medications, and can help put you in touch with a qualified Tylenol lawyer in your area who has experience handling product liability cases. With a knowledgeable attorney on your side, you can protect your legal rights and pursue the compensation you deserve.

[box type=”note” align=”aligncenter” ]Source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery[/box]

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