By the end of 2007, you can expect to see new labels and stricter safety warnings on your over the counter pain relievers. The U.S. Food and Drug Administration proposed the new warnings in December, which would affect hundreds of prescription and nonprescription products.
What will the warnings address?
- Acetaminophen (the pain reliever in Tylenol) will come with a warning about the potential for “severe liver damage” if they take more than the maximum daily dose, combine the pills with other drugs, or drink alcohol while taking the drug.
- NSAIDs (nonsteroidal anti-inflammatory drugs like Advil’s ibuprofen, aspirin, and Aleve’s naproxen) will come with a warning about the risk of gastrointestinal bleeding with overuse. People at special risk include those over sixty, those with previous ulcers or intestinal bleeding, and those who take certain medications like corticosteroids or blood thinners.
Why does the FDA want the new warnings? Injuries related to common over the counter pain relievers are not all that common BUT still more prevalent than the FDA is happy with. With larger and more specific warnings on over the counter pain medicines, the FDA hopes consumers will stop and think about what (and how much) they are taking. The warning labels will also be required for combination products like cold medicines that contain painkillers.
The FDA does believe that over the counter pain medications are quite safe when used appropriately. However, there is also a concern about package size. In the United Kingdom, pain medicines are limited to sixteen or twenty-four pills in a pack; in the U.S., consumers can get hundreds of pills in a single bottle. The FDA is looking for public comment on the package quantity issue; visit the FDA website for more information.
Some drug manufacturers are already incorporating the FDA’s suggested warnings in their packaging. Compliance is voluntary for now, but may be mandatory within the next year or so.
Read about some over the counter allergy medicines.