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Acetaminophen Overdose: McNeil & the FDA Slow to Act

Acetaminophen, or Tylenol, is marketed as the pain reliever used most by hospitals and recommended by pediatricians. By promoting itself as a safe and fast pain reliever, Tylenol has become one of the most popular medications in the U.S. and is used by tens of millions of people every week. Many users, however, are unaware that the margin between a helpful amount and a harmful amount is much smaller for acetaminophen than for other types of pain relievers. tylenol-2171-m

An acetaminophen overdose can have deadly side effects and could permanently damage or destroy the liver. Manufacturer McNeil Consumer Healthcare and the Food and Drug Administration have both been aware of the risks for more than 30 years but consumers still don't have adequate warnings. This sad fact illustrates that consumers cannot always count on the FDA or pharmaceutical companies to look out for their safety.

Victims of dangerous drugs can take legal action.  Contact a drug recall attorney at DeCarlo Law for help pursuing a claim if you are harmed by a dangerous drug or a recalled medication.

Not Every Dangerous Drug is Recalled

Consumers who hear about drug recalls on the news may assume that manufacturers or the FDA will always remove dangerous drugs from the market. When you see side effect labels on medication, you may believe that you are being warned of all of the possible risks of the drugs you take.

The FDA's actions toward Tylenol, and the actions of McNeil, prove that this simply is not true. Drugs with great potential to cause harm are sold every day, and consumers aren't always informed of the chance they take when they use a medication. Most consumers are unaware of the fact that more than 1,500 Americans died over the past decade after overdosing on acetaminophen, including a 5-month-old baby, a 12-year-old boy and a healthy 23-year-old construction worker.

These and other deaths could perhaps have been prevented if the U.S. had taken steps like the ones taken by regulators in Great Britain, Switzerland and New Zealand, where acetaminophen is sold only to pharmacies or to consumers in limited, restricted quantities.   The FDA could also have acted in a timely manner on the advice of an expert panel in 1977. The panel recommended that the FDA require a warning of severe liver damage on all acetaminophen labels.  Instead, the FDA waited 32 years to require the warning. Many of the 1977 panel's recommendations to reduce acetaminophen dangers still have not been implemented.

McNeil has actually done more to protect the public than the FDA in some ways, including funding research to find an antidote to acetaminophen poisoning.  However, the company has also engaged in dishonest and deceptive tactics. For example, when a 1990s attempt to create a safer acetaminophen failed, the company kept the experiment confidential. McNeil has also repeatedly opposed any government efforts to alert the public to risks of acetaminophen.

The actions of McNeil and the FDA show that warnings aren't always accurate and dangerous drugs aren't always recalled. Consumers face real risks from acetaminophen overdose, and they aren't being properly educated on the potential dangers of taking Tylenol. Those who are hurt could take action to recover compensation for the dangerous product and failure to warn, but it might be too late to get their good health back. 

A drug recall attorney can help victims harmed by dangerous drugs. Call DeCarlo Law today at 877-572-0065  or visit  to schedule a consultation. 

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