The U.S Food and Drug Administration (FDA) have set a 325 mg limit on the amount of acetaminophen per tablet or capsule effective January 14, 2014. This was requested three years ago on January 2011 after several reports of liver damage.
Acetaminophen is often used as an over-the-counter drug for pain and fever relief and is commonly prescribed for patients who suffer from pain, acute injuries, post-operative pain, or following dental procedures. It is also usually found in cough and cold medicines.
While there are no data available showing that 325 mg of acetaminophen per dosage unit have advantages that offset the risks of liver damage, manufacturers were still asked to lessen their dosage to protect the consumers of these drugs from severe liver damage. It was said that by reducing the amount of acetaminophen per dosage unit can reduce the risk of severe liver damage, liver failure, liver transplant and possibly death.
Patients who have taken more than the prescribed dose of a product containing acetaminophen in a 24-hour period can suffer from severe liver damage. A patient can also suffer from liver damage if they have taken more than one acetaminophen-containing product at the same time or drank alcohol while taking acetaminophen.
Since the request from the FDA, more than half of the manufacturers have complied in them. With that said, there are still some prescription combination drug products that contain more than the 325 mg limit. The FDA aim to set up proceedings to disapprove prescription combination drug products with more than 325 mg of acetaminophen in the market.
According to the FDA, health care providers should consider prescribing drugs that contain less than or equal to the new dosage limit. They also recommend that if a prescription of a drug combination exceeding the limit is received, the pharmacist should contact the prescriber and discuss finding alternative medicine with lower dosage of acetaminophen.
