NEW YORK: If you routinely pop antacid
pills, now would be a could time to stop. US health regulators have cautioned
doctors and patients of an increased risk of fractures of the hip, wrist, and
spine from high doses or long-term use of a widely used class of drugs to
control the amount of acid in the stomach.
The class of heartburn
drugs, called proton pump inhibitors, include prescription brands such as
AstraZeneca Plc's Nexium and the company's Prilosec, an older generic treatment
that is also available over the counter at a lower dosage
strength.
The FDA is advising consumers to not stop taking PPIs until
they have consulted with their doctor. However, patients should be aware of the
increased risk for fractures.
Proton pump inhibitors include the
drugs esomeprazole, dexlansoprazole, omeprazole, lansoprazole, pantoprazole, and
rabeprazole. These medicines are used to treat gastroesophageal reflux disease
(GERD), stomach and small intestine ulcers and inflammation of the esophagus.
Over-the-counter versions of Prevacid, Prilosec and Zegerid also fall into this
class of drugs.
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 for one year or longer, or at high
doses.
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 for 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 the heartburn medications, unless absolutely necessary, he said.
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