FDA issues warning against high-dose prescription acetaminophen

by Michael Heygood

Acetaminophen relieves pain and fever. It is an active ingredient in hundreds of over-the-counter and prescription medicines. It is also combined with other active ingredients in medicines that treat allergies, coughs, colds, flu, and sleeplessness. In prescription medicines, acetaminophen is sometimes combined with other active ingredients to treat moderate to severe pain. Prescription drugs that combine acetaminophen with another ingredient intended to treat pain (such as hydrocodone or codeine) are commonly prescribed after injuries, surgeries and dental procedures.

Overdoses from acetaminophen send 56,000 people to emergency rooms and kill about 500 each year, according to FDA. The drug is also a leading cause of acute liver failure.

The FDA is now recommending that all health care professionals stop prescribing and dispensing prescription combination drug products that contain more than 325 milligrams of acetaminophen per tablet, capsule, or other dosage unit. The move to limit 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. According to the FDA, there are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefits that outweigh the added risks of liver injury.

The FDA is also recommending that health care providers prescribe combination drug products that contain 325 mg or less of acetaminophen. It also recommends that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit, the pharmacist should contact the prescriber to discuss a product with a lower dose of acetaminophen.

In January 2011, the FDA asked manufacturers to limit the amount of acetaminophen in prescription combination drug products to no more than 325 mg in each tablet or capsule by January 14, 2014. The action was requested to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. More than half of manufacturers have voluntarily complied with the request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available. The FDA has stated that it intends to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.

Acetaminophen is also widely used as an over-the-counter pain and fever medication, and is often combined with other ingredients, such as cough and cold ingredients. Many consumers are often unaware that many products (both prescription and over-the-counter) contain acetaminophen, making it easy to accidentally take too much, according to the FDA. Some non-prescription painkillers, such as Extra Strength Tylenol, contain 500 mg of acetaminophen in each pill. The FDA has announced that it will address over-the-counter acetaminophen products in another regulatory action.

Prescription Painkiller Overdoses and Medical Malpractice

When doctors overprescribe prescription painkillers to their patients, the results can be deadly. The improper prescription of pain medications can place patients at risk of addiction and dependence. In other cases, doctors may prescribe opioid medications that are too powerful or in combination with other drugs that decrease the activity of the central nervous system, increasing the risk of an overdose.

Despite warnings from the Food and Drug Administration about the danger of opioid painkillers such as hydrocodone, oxycodone, morphine, fentanyl and methadone, doctors continue to prescribe these drugs in ways that put the health and the lives of their patients at risk. Prescription drug overdoses are now the leading cause of accidental death in the U.S., killing tens of thousands of patients each year.

If you or a loved one were the victim of a prescription painkiller overdose, the doctor or hospital who prescribed these medications may be to blame. Patients whose lives have been affected by a painkiller overdose, addiction, or other complications caused by the reckless prescription of these drugs by a physician may be eligible to file a lawsuit and seek compensation for their injuries.

The lawyers at Heygood, Orr & Pearson have represented hundreds of patients who have been harmed by opioid painkillers or other dangerous prescription drugs. Our law firm has the experience to prosecute medical malpractice cases involving a wide array of serious opioid painkillers, including Vicodin, hydrocodone, OxyContin, oxycodone, methadone, hydromorphone, fentanyl, and others. Our attorneys have tried hundreds of cases to verdict, achieving verdicts and settlements for our clients totaling more than $200 million—including more than $50 million in 2010 alone.

For a free legal consultation and to find out if you are eligible to file a lawsuit, contact our law firm by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form.

by Michael Heygood

Michael Heygood is a licensed attorney and partner at HO&P who focuses on insurance and corporate litigation, and other civil arenas. Michael has been named multiple times to the Super Lawyers List.