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FDA Limits Acetaminophen in Combination Prescription Products

By , June 14, 2012 10:21 am

Acetaminophen is a commonly prescribed medication indicated for the relief of pain/fever and is found in both OTC as well as prescription medications. Recently, the FDA released a notice limiting the amount of acetaminophen in prescription combination products to 325 mg per tablet, capsule, or other unit of dose and requiring updated labeling to include liver toxicity warnings. 

No restrictions are being placed on OTC acetaminophen products due to the fact that they already have appropriate labeling which warns of possible toxicity if taken over the recommended daily dose. Acetaminophen is considered a safe medication, but can potentially be dangerous if the maximum recommended dose of 4,000 mg in a 24 hour period is exceeded.  According to the FDA Center for Drug Evaluation and Research “overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen related liver failures in the United States; many of which result in liver transplants or death.”

Acetaminophen is often times combined with other medications in numerous prescription products- most commonly with opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet) and hydrocodone (Vicodin). Unlike OTC acetaminophen products, it is not always clear to consumers that acetaminophen is present within the prescription product they are taking. Because it is not clear to the consumer, the lack of warning can result in consumers taking OTC acetaminophen or another product containing it in conjunction with their prescription acetaminophen product. The FDA therefore realized that consumers could be completely unaware that they are taking an excessive dose of acetaminophen.

Prescription combination products containing acetaminophen are frequently prescribed for workers’ compensation injuries. Pursuant to PMSI’s 2012 Annual Drug Trends Report for Workers’ Compensation, the prescription combination medications hydrocodone/acetaminophen and oxycodone/acetaminophen were ranked number one and two respectively under the top 20 generic medications by total transaction. The DHHS has noted that prescription combination drugs account for approximately 20% of the total acetaminophen products on the drug market today. Of this 20%, hydrocodone/acetaminophen accounts for more than half of all prescriptions written and for many years has been one of the most prescribed medications in the Unites States market.  

The FDA has given manufacturers until January 14, 2014 to remove medications containing more than 325 mg of acetaminophen from the market. The FDA’s purpose in limiting acetaminophen is to make prescription combination products safer by reducing the patient’s exposure to acetaminophen. Some manufacturers are already in the process of reformulating the current prescription combination acetaminophen products available (i.e. Brand Vicodin 5/500 mg is expected to be removed from the market by the third quarter of 2012 and replaced by Brand Vicodin 5/300mg) while others are creating single hydrocodone products containing no acetaminophen (an application was submitted to the FDA in May 2012 for approval of Zohydro- a new version of pure, extended-release hydrocodone). These new products will likely drive up the cost of medications in the workers’ compensation industry since it is expected that they will be released at a higher price than the existing products. 

Critics of these new single formulations fear that they will lead to more abuse, misuse, and deaths due to the removal of the acetaminophen. Excessive use of acetaminophen will no longer be a deterrent for patients tempted to take the medications at higher doses than prescribed.   

PMSI will be watching to see if any actions are taken to block the approval of these medications due to these concerns. Additionally, if these new single formulation medications are approved, a question that remains is what steps will be taken by their manufacturers to guard against abuse and misuse. Additionally, PMSI will most particularly be monitoring how this FDA alert will impact the workers’ compensation industry’s cost of prescription claims due to the high use of acetaminophen for treating work related injuries.

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