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New label warnings for some common OTC medications
The U.S. Food and Drug Administration recently took aggressive steps to toughen regulation of some very common over-the-counter pain and fever medications.
By Eric Greenberg, Attorney-at-Law
The FDA issued a rule requiring new warnings on the labels of acetaminophen and aspirin, ibuprofen, naproxen, and ketoprofen (these last four are known as nonsteroidal anti-inflammatory, or NSAID drugs). The labels have to more prominently display the active ingredients on labels and bottles, and acetaminophen products need a warning about severe liver damage, while NSAIDs need one about stomach bleeding.
Manufacturers have to change their labels to comply by April 28, 2010. Some manufacturers have voluntarily placed similar warnings on their labels in recent years, but the new rules create additional requirements.
What makes a product safe, after all? Most people think first, and appropriately so, of the product’s chemistry, and whether ingesting it, inhaling it, or touching it will be toxic or irritating.
But FDAers and those who watch them know that label statements are just as important. Directions for proper use, including dosing, and especially warnings against use with other products or when you have other conditions, can make the difference between safety and danger when someone takes a drug.
The FDA says you risk liver damage from too much acetaminophen, and because it’s an ingredient in a variety of products, people might accidentally take too much when they take multiple products to treat a cold, for example.
With NSAIDs, FDA says stomach bleeding might occur if you take anticoagulants or steroids, or if you take multiple NSAIDs at once or in some cases when alcohol is used.
So the FDA decided to try to make the products safer, and chose to do it simply by changing what’s said about them on their labels. It’s a reminder of the crucial nature of labels, even to matters of safety.
Countering counterfeits on the front line
Pharmaceutical industry counterfeiting continues to grow, with U.S. Customs seizing $28.1 million in merchandise last year, a 152% increase from 2007. In a question-and-answer interview, Lawrence Friedman, partner with the law firm of Barnes, Richardson & Colburn, offers insights into uncovering counterfeit pharmaceuticals entering the U.S. In the story, which will appear in the August print issue of Healthcare Packaging magazine, he identifies three important steps:
- One, record your trademark with U.S. Customs and Border Protection. Friedman says, "Customs won’t be on the lookout for your products or your trademark unless it is in their system."
- Two, educate the enforcers. He says, "Nobody knows your product better than you. An average Customs Inspector is going to see a container full of pills. Industry folks…know what the packaging materials should look like."
- Three, whenever possible, prosecute. Prosecuting counterfeiters, Friedman says, "is a very high priority for Customs, particularly when health and safety is involved."
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