FDA Actions Address Acetaminophen Toxicity Risks
The FDA recognized the risks of high doses of acetaminophen by asking prescription drug manufacturers to lower the maximum content per pill or capsule by January 2014. The request did not apply to over-the-counter preparations, so risks will remain until all the supplies of all high-content formulations are depleted.
In high doses, acetaminophen can cause toxicity and lead to serious liver damage or even death. In 2011, the National Council for Prescription Drug Programs (NCPDP), FDA and other interested parties focused attention on patient safety issues with the formation of the Acetaminophen Best Practices Task Group.1
To minimize patient risks, the FDA asked prescription drug manufacturers to limit acetaminophen content to a maximum of 325mg per tablet or capsule by January 1, 2014.2 The high dose acetaminophen products seen most frequently in workers’ compensation are Vicodin®HP, Vicodin® ES, Percocet® products, Lortab® and their generic versions.
In response to the FDA request, many manufacturers reformulated their products and received FDA approval for reduced acetaminophen content. Brand names were retained and a few products were discontinued. Generic manufacturers also complied with the request. As a result, there should be no impact on the use of generic products as substitutes for brand-name prescriptions with the lower acetaminophen dose.
The FDA made a provision for manufacturers and retailers to deplete existing supplies. Since they were permitted to continue manufacturing the higher dose products until the 2014 deadline, higher dose products remain on the market. Until supplies of the higher strength products are depleted, patients remain at higher risk for excessive use. This is especially true for patients who may take over-the-counter (OTC) formulations and prescription preparations containing acetaminophen since the FDA request did not apply to OTC.
Enhanced Patient Safety
The FDA is urging prescribers to use the lower dose formulations even if the older formulations are still available.3 Encouraging prescribers to reduce acetaminophen use and educate patients remains important in curbing patient risks. The limits placed on one source of acetaminophen and the increased awareness of patients, prescribers and insurers of the risks of taking too much should improve patient safety.
Safe Medication Use
Patient education is one of the key factors that influence safe medication use. All parties involved in patient care need to help patients understand which products contain acetaminophen and the daily use limits. Patients should be expected to keep track of all medical products they are using, both prescription and OTC, and total up daily acetaminophen milligrams to avoid overuse. The FDA website has a wealth of information for patients.4
Avoiding Acetaminophen Toxicity
- Read labels of all over-the-counter and prescription drug products to identify acetaminophen content
- Ask prescribers or pharmacists to identify acetaminophen in products when talking to patients
- Know the limits of daily acetaminophen doses from all sources
- 4000 mg daily for short-term use (a few days)
- 2600 mg daily for regular use
- 2000 mg daily if kidney function is low as in patients on dialysis or with severe kidney damage
- Avoid use if liver function is poor
- Avoid use with alcohol
- If possible, avoid use of more than one product containing acetaminophen
Regardless of the actions taken to protect patients, acetaminophen use remains a concern. Thousands of prescription and over-the-counter products contain this useful drug. All healthcare providers need to be alert to the presence of this common drug and help patients limit use to safe doses.
FDA Labeling Changes For OTC Products
Over-the-counter (OTC) products were not included in the FDA’s reformulation request though labeling changes were requested.5 Many consumers are not aware of the amount of acetaminophen contained in products. Even worse, consumers may not have realized acetaminophen was even present. Acetaminophen is a common ingredient in sleep aids and products made to treat general pain, coughs and colds, headaches and menstrual cramps.
Labeling changes requested to improve over-the-counter product identification included:6
- Clearly identify acetaminophen as an ingredient
- Include new warning about liver toxicity
- Include a warning that other products containing acetaminophen should not be used together
Look For Acetaminophen on the Label
Here is an example of how easy it is to exceed the recommended daily dose of acetaminophen. This patient is taking a prescription analgesic, cold medication and sleep aid. All contain acetaminophen.
Top 5 Acetaminophen Preparations in Workers’ Compensation*
|Product||Acetaminophen Content Before Change||Acetaminophen Content After Change||Generics Available?|
|Percocet family of products||325mg up to 650mg||All now 325mg||Yes|
|Lorcet, Lorcet Plus||650mg||Product discontinued||N/A|
*Based on a Healthesystems clinical analysis.
Many Factors Influence Acetaminophen Risks
A number of factors can escalate a patient’ risks for acetaminophen toxicity. They include excessive daily doses, concurrent alcohol consumption, diminished liver function, concurrent use of over-the-counter medications containing acetaminophen, kidney disease and smoking.
Healthesystems’ ongoing clinical outreach program alerts payers and prescribers to these risks and provides an opportunity for intervention to reduce the risks. This program was in place even before the FDA made its request to pharmaceutical manufacturers for a reduction in per pill and per capsule content. Excessive acetaminophen use is too important an issue to ignore. The risks are of liver damage and liver failure are serious and potentially fatal. The loss of even one life and the need for a single liver transplant are too high a price to pay.
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