Acetaminophen: Concerns over Liver Damage
Acetaminophen is effective for mild to moderate pain in children and adults and is considered to be safe if taken as directed. The current recommended daily dose of acetaminophen is 4,000 mg per day (4 g). However, recent concerns over the potential for liver damage in patients who take more than the recommended dose has prompted the FDA to recommend labeling changes to prescription acetaminophen products to limit the maximum dose, and to also consider additional action with regards to OTC products that contain acetaminophen. The chief concern is that because a number of OTC and prescription products combine acetaminophen with other medications, patients can be unaware that they have exceeded the recommended daily dose, thus increasing their risk for liver damage and other complications. In 2009, the FDA Patient Safety News (http://1.usa.gov/tYZmj6) issued an “Advice for Patients” bulletin that reminded physicians that “acetaminophen toxicity is a leading cause of acute liver failure,” because “people may not be aware that they are in danger of liver damage if they exceed the maximum recommended dose, or that alcohol exacerbates the risk. Also, they may not realize how much acetaminophen they are consuming if they take more than one product containing this drug.” The FDA noted that accidental overdose can happen “because acetaminophen is widely found in both OTC and prescription drug products, in as many as 600 of them, including analgesics, antipyretics, cough/cold remedies and sleep aids. In this situation, people may not even recognize that some of the drugs they are taking contain acetaminophen.”
Ibuprofen: Effective, but Patients with GI and Cardiovascular Complications should be Monitored
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is also effective for mild to moderate pain in children and adults and is considered to be safe if taken as directed. It may be more effective than acetaminophen for inflammatory pain, such as that associated with arthritis. The current recommended daily dose of ibuprofen is 1,200 mg (1.2 g). As with most NSAIDs, ibuprofen can increase the risk of stomach ulcers and gastrointestinal bleeding in patients. The authors of a recent study in Current Medical Research and Opinion (http://bit.ly/vnadah) conducted a literature review to “evaluate the risk of GI bleeding events related to OTC ibuprofen use.” They found 20 studies that reported “incidence rates and proportions of a GI bleeding-related event associated with OTC or OTC-specific doses of ibuprofen. Although they reported finding that the “incidence of a GI bleeding-related event increased with age and the use of concomitant medications,” as well as a “general, though not always statistically significant, ibuprofen dose–response relationship,” overall they reported that the studies found a “low incidence of GI bleeding events with use of OTC ibuprofen.” Ibuprofen may also increase the risk of heart attack and stroke in some patients, especially those with a history of heart attack or heart disease, smoking, high cholesterol, high blood pressure, or diabetes. Physicians are advised to exercise caution if recommending this medication in these patients.
As always, physicians and patients should discuss all OTC medications the patient is taking in order to make the safest, most effective medication choices, and ensure the patient is fully aware of the risks and benefits associated with those medications. There are several valuable online educational resources for patients, including MedLinePlus (http://1.usa.gov/fDq6Zg), FamilyDoctorg.org (http://bit.ly/LQ1Px), and the FDA (http://1.usa.gov/Vai8I) that can provide additional accurate and reliable information on OTC pain remedies.