Safety Announcement
Possible Increased Risk of Fractures
On May 25, 2010, the FDA released a drug-class announcement stating that all prescription and over-the-counter proton pump inhibitors (PPIs) product labeling will be revised as a precautionary measure to include a possible increased risk of hip, wrist, and spine fractures.
We will update our labeling in accordance with the FDA's request for all PPI class drugs and continue to thoroughly evaluate this topic as part of our standard regulatory and safety process. Prilosec OTC® has a strong safety track record, which includes an ongoing monitoring program, as well as comprehensive reviews of clinical trials. Millions of consumers have tried Prilosec OTC since it became available over the counter in 2003.
Keep in mind that our label indicates you should only use Prilosec OTC as directed to treat frequent heartburn and you should not exceed three 14-day treatments in a year, unless directed by your doctor. This indication will not be changing with the latest update.
As with all medications, there are risks and benefits. Talk to a medical professional before you stop or start taking any medication, or if you have additional questions.
Please refer to the FDA's official release for more information about the safety announcement.
