The consequences seem to outweigh the benefits when it comes to certain doses of acetaminophen.
"There are no available data to show that taking more than 325 [milligrams] of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death," the Food and Drug Administration (FDA) said in a news release.
The FDA now suggests healthcare providers only prescribe medications that contain 325 mg or less of the liver-harming substance.
The Administration also recommended pharmacists keep their eyes out for prescription than contain more than the recommended dose of acetaminophen. If the dose is exceeded they are asked to contact the prescriber and discuss a safer alternative.
"A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units).
In January of 2011 the FDA requested that drug manufacturers limit their of acetaminophen doses to no more than 325 mg per tablet by January 14, 2014. Over half of the manufacturers have complied but some medications with of acetaminophen doses over 325 mg remain in the market. The FDA plans to "institute proceedings to withdraw approval of prescription combination drug products containing more" than the recommended dose, the news release reported.
Acetaminophen is usually combined with other drugs (mainly opioids) to treat various types of pain including: "acute injuries, post-operative pain, or pain following dental procedures," the news release reported.
Liver injury has been reported in patients who took a higher dose of acetaminophen than was prescribed within a 24-hour period or at once, and patients who combined the drug with alcohol.
