O FDA adverte sobre o risco da fratura para drogas antacid
por Brendon Nafziger, DOTmed News Associate Editor | May 26, 2010
FDA releases warning
about acid reflux drugs.
about acid reflux drugs.
Oft-prescribed acid reflux disease drugs present a fracture risk, the U.S. Food and Drug Administration warned Tuesday evening.
The FDA said epidemiological studies indicate that high doses and long-term use of prescription proton pump inhibitors, a class of drugs used in the treatment of heartburn, acid reflux disease, ulcers, inflammation of the esophagus and gastritis, up the risk of hip, wrist and spine fractures, mainly in patients over age 50.
These drugs are available both by prescription and over-the-counter, and work by decreasing stomach acids, the FDA said.
Brands include Nexium, Dexliant, Prilosec, Zegerid, Prevacid, Protonix and Aciphex, 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 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," FDA's deputy director of safety for gastroenterology products Dr. Joyce Korvick said in a statement.
The FDA has altered the warnings and precautions sections on drug labels, the agency said.
The FDA said epidemiological studies indicate that high doses and long-term use of prescription proton pump inhibitors, a class of drugs used in the treatment of heartburn, acid reflux disease, ulcers, inflammation of the esophagus and gastritis, up the risk of hip, wrist and spine fractures, mainly in patients over age 50.
These drugs are available both by prescription and over-the-counter, and work by decreasing stomach acids, the FDA said.
Brands include Nexium, Dexliant, Prilosec, Zegerid, Prevacid, Protonix and Aciphex, 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 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," FDA's deputy director of safety for gastroenterology products Dr. Joyce Korvick said in a statement.
The FDA has altered the warnings and precautions sections on drug labels, the agency said.
