A panel of experts convened by the U.S. Food and Drug Administration has voted to lower the maximum dosage of pain reliever acetaminophen, HealthDay reported June 30. The vote made big news because acetaminophen is an extremely common ingredient in over-the-counter cold and flu medicines taken by millions of Americans each year, including Tylenol and Excedrin. The panel acted out of concerns about liver damage, a known side effect of acetaminophen overdose. The FDA is not required to follow its panel’s recommendations, but it typically does.
Doctors have known for years that an acetaminophen overdose can cause liver damage. In fact, the FDA says acetaminophen is the leading cause of liver failure in the U.S., contributing to 200 deaths a year and sending 56,000 to emergency rooms. Acetaminophen is safe for most people at recommended doses, but an FDA report issued in May says many consumers don’t realize they’re endangered when they go over the recommended dosage, or combine multiple medications containing acetaminophen. That concern drove the vote to lower the recommended dosage, which is currently 4 grams daily and 1,000 milligrams in any individual pill. The panel did not set a daily maximum, but reduced the per-pill maximum to 650 milligrams for over-the-counter medicines.
This video from the Associated Press explains the issue:
Video from the Associated Press:
Of course, the pharmaceutical industry resisted the panel’s efforts to further regulate acetaminophen, arguing that the high doses currently allowed are necessary for patients treating chronic pain. According to the AP, acetaminophen-containing drugs saw $2.6 billion in sales last year, with over-the-counter medicines representing 80% of those sales. However, as a dangerous drug lawyer, I’m pleased that the panel took steps to keep American consumers safe. Many millions of Americans keep these medications in their homes as medicine-cabinet staples, and some use acetaminophen every single day. That means millions of people are exposed to injuries from acetaminophen overdose. Even if only a fraction of these end up accidentally overdosing, they could still represent thousands of unnecessary and preventable deaths.
When most people think of dangerous drugs, they think of medications that are defective by design or manufacture, like Vioxx — that is, the medicine is dangerous no matter how it’s used. But manufacturers of drugs (and other consumer products) can also be legally liable if they fail to give consumers sufficient warning of a serious safety problem with their products. Consumers need clear information to make informed decisions about what medications are safe for them. If manufacturers fail to warn patients about the dangers of their products in a way that meets FDA standards, and patients are hurt as a result, those patients have the right to hold the manufacturer legally responsible with a defective drug lawsuit.