3006, 2009

FDA Calls for Reduced Maximum Dosage of Common Pain Reliever Acetaminophen

June 30th, 2009|Drug Safety|Comments Off on FDA Calls for Reduced Maximum Dosage of Common Pain Reliever Acetaminophen

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.

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2606, 2009

FDA Seizes Most of Generic Company Caraco’s Drugs Due to Manufacturing Mistakes

June 26th, 2009|Dangerous Drugs|Comments Off on FDA Seizes Most of Generic Company Caraco’s Drugs Due to Manufacturing Mistakes

On Thursday, by order of the U.S. Food and Drug Administration, U.S. Marshals raided generic drug company Caraco’s factories and seized more than 30 of the 40-odd medications it markets. The seizure was ordered after the FDA found manufacturing problems at all three of the […]

2606, 2009

Woman and Daughter Injured in Crash when Tractor-Trailer Failed to Yield

June 26th, 2009|Trucking Accidents|Comments Off on Woman and Daughter Injured in Crash when Tractor-Trailer Failed to Yield

A few days ago, I saw an article in the Marshfield Mail about a woman and her daughter who got into a wreck on I-44 because a tractor-trailer had failed to yield the right of way. Apparently in order to avoid colliding with the big […]