Take a pill for heartburn and you could fracture a bone.
While it won’t happen overnight, the FDA released a warning last week informing consumers that long-term use of such drugs, known as proton pump inhibitors, could increase their risk of bone fractures in the wrists, hips and spine.
Proton pump inhibitors may sound more like an exotic engine part from a Star Trek space ship than a kind of antacid drug, but last year doctors wrote about 113.4 million prescriptions for them. They’re used to treat conditions like gastroesophageal reflux disease (GERD), ulcers and esophagus inflammation. In addition, millions of people buy the over-the-counter versions, Prilosec OTC, Zegerid OTC and Prevacid 24HR, to treat frequent heartburn.
The warning was trigged after the FDA reviewed seven new scientific studies, including this one and this one, published last month in the Archive of Internal Medicine. (The L.A. Times wrote about these studies in a May 11 article.) They suggest an increased risk of fractures in patients who either take PPIs for a year or longer or take them in high dosages, said Dr. Joyce Korvick, the deputy director for safety in FDA’s Division of Gastroenterology Products, in the release.
“Because these products are used by a great number of people, it’s important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition,” Korvick said.
The LA Time article said the studies also found that the drugs can more than double the risk of contracting a bacterium called Clostridium difficile, which can cause colitis with symptoms of fever, cramps, and diarrhea.
The FDA said it plans to update the following PPI brand labels with the bone fracture warning and recommendation that consumers take the drugs no longer than 14 days in a row and that they do so no more than three times a year.
The prescription brand drugs recommended to receive updated label warning are:
- Nexium (the Purple Pill)
- Dexilant
- Prilosec
- Zegerid
- Prevacid
- Protonix
- Aciphex
- Vimovo
As an advocate for consumers’ rights, the Simmons law firm encourages anyone who has suffered from fractures in their wrists, hips or spine, and/or contracted the bacterium Clostridium difficile while taking the above drugs for an extended period of time to contact our pharmaceutical lawyers who can evaluate your case, explain your legal rights and help you file a PPI case.
