FDA announces new limits on acetaminophen in medications


The pain-reliever acetaminophen (also known as paracetamol or APAP) is one of the best-selling over the-counter medications. It is sold under many brand names, including Tylenol, and is an ingredient in nearly 200 medications and preparations. It is often combined in prescription pain medications with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet) and hydrocodone (Vicodin).

The recommended daily limit for acetaminophen is 4,000 mg per day.Yesterday, after years of deliberation, the FDA announced a new rule, limiting manufacturers of prescription combination products that contain acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule. They feel this rule should help reduce the number of accidental acetaminophen overdoses. Currently, many popular products have 500 or 650 mg of acetaminophen in each tablet. People who take these extra-strength medications every four hours can easily find themselves taking more than the recommended daily total dose….

When taken in high doses, acetaminophen can actually cause serious liver damage – and even acute liver failure and death. In fact, acetaminophen toxicity is one of the leading causes of liver failure in the United States, accounting for more than 56,000 emergency room visits, 2,600 hospitalizations and an estimated 450 deaths per year. Often the overdose happens inadvertently, when a patient takes one acetaminophen-based medicine for back pain, another for migraines, and perhaps a third for cough and cold symptoms.

Most people are only at risk for liver toxicity if they take significantly more than the normal recommended amount of acetaminophen. Most cases of liver damage occur in people who have taken at least 10-15 grams — more than twice the recommended dose. However, a study by the FDA showed that about 20% of people with acetaminophen-related liver toxicity had taken less than the recommended daily amount. These are usually people who combine acetaminophen with alcohol, or who have pre-existing liver disease.

The elimination of higher-dose prescription combination acetaminophen products will be phased in over three years and should not create a shortage of pain medication.

The following tips can help prevent acetaminophen related liver toxicity:
• Do not take more than the recommended dose of 4 grams within a 24-hour period (for example, 12 regular strength or 8 extra strength Tylenol tablets)
• Do not take the full day’s dose at one time; space it out over the course of the day
• Do not take acetaminophen for more than 10 days in a row.
• Avoid drinking alcohol when taking acetaminophen.
• People who do consume 2-3 alcoholic drinks per day should not take more than half the usual recommended dose of acetaminophen (2 grams within 24 hours).
• People with advanced liver fibrosis, cirrhosis, or Hepatitis B or C should speak with their specialist before taking acetaminophen.
• Check the labels of all medications; small doses of acetaminophen in combination remedies can add up to big trouble.

We’ll be reviewing our post-operative pain medications to make sure our patients don’t get more than the recommended dose

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