28 May 2010
New York, USA
However, the FDA advises consumers not to stop taking PPIs without consulting their doctors.
The advisory covers prescription brands like Astra–Zeneca Plc’s Nexium, and the company’s Prilosec, an older generic treatment that is also available over the counter at lower dosage strengths.
‘Try low doses, short periods of antacid use’
New York: The US Food and Drug Administration said on Tuesday that studies suggest a possible increased risk of bone fractures with the use of Proton pump inhibitors (PPIs) for one year or longer, or at high doses.
PPIs, including the drugs esomeprazole, dexlansoprazole, omeprazole, lansoprazole, pantoprazole, and rabeprazole, are used to treat gastroesophageal reflux disease (GERD), stomach and small intestine ulcers and inflammation of the oesophagus. Over–the–counter versions of Prevacid, Prilosec and Zegerid also fall into this class of drugs. Package insert labels for the drugs will be changed to describe the possible increased fracture risks, the FDA said.
“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,” Joyce Korvick, deputy director of safety in the FDA’s Division of Gastroenterology Products, said in an agency statement.
“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. Moreover, the FDA said doctors and patients should weigh whether known benefits of the drugs outweigh potential risks.
Dr Amar Deshpande, an assistant professor of gastroenterology at the University of Miami Miller School of Medicine, told a health journal that the data behind the FDA decision “is not new”. PPIs may disrupt the body’s ability to absorb calcium, which, in turn, can increase the risk for fractures, Deshpande explained. He also believes that this class of drugs is overused and often taken by patients for too long.
It is probably also a good idea to shy away from high doses of heartburn medications, unless absolutely necessary, he said.
- The FDA says there is an increased risk of fractures with the use of Proton pump inhibitors for one year or longer, or at high doses.
- PPIs are used to treat acidity, stomach and small intestine ulcers and inflammation of the oesophagus.
- According to the FDA, doctors and patients should weigh if known benefits of drugs outweigh risks.
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