US FDA says acid reflux drugs carry fracture risk

NEW YORK, UNITED STATES - U.S. 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 AZN.L top-selling Nexium and the company's Prilosec, an older generic treatment that is also available over the counter at a lower dosage strength.

The U.S. 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.

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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.

Other proton pump inhibitors used to treat heartburn, known formally as gastroesophageal reflux disease (GERD), include generically available Protonix, Johnson & Johnson's JNJ.N prescription Aciphex brand and Novartis AG's NOVN.VX over-the-counter Prevacid.

The FDA recommended that consumers report any side effects or other product problems to its MedWatch Adverse Event Reporting program at http:www.fda.gov/MedWatch or by calling 800-332-1088. - Reuters

What is heartburn

Heartburn is a painful condition involving the upper digestive system, not the heart itself. The reason why some people think that it has something to do with the heart is because of the pain that often radiates from the central chest region of out body. There are people who suffers from heartburn that confuses the symptoms of heartburn with a heart attack. Heartburn usually results from stomach acids reacting strongly to certain foods during digestion. Stomach acid is forced up the unprotected area of your esophagus which results to chemical burn and causes moderate to severe pain.

Even if a heartburn sufferer does not have GERD, he or she could have a condition known as acid reflux. The stomach can be overwhelmed with foods that has a lot of spices. The effect is a buring sensation followed by a sudden impulse to vomit. The heartburn pain can be experienced to the entire esophagus from the vocal cords to the stomach. Severe heartburn situation can even lead to excruciating pain and difficulty of speaking.

Gastroesophageal reflux disease (GERD) is a more serious form of gastroesophageal reflux (GER), which is common and usually called acid reflux or acid regurgitation. Acid reflux happen when digestive juices—called acids—rise up with the food to your esophagus which carries the food from the mouth to the stomach. Once the acid touches the lining of your esophagus it may cause a burning feeling in your chest or throat. That feeling is called heartburn or acid indigestion. Occasional GER is common and does not necessarily mean one has GERD. Persistent reflux that occurs more than twice a week is considered GERD, and it can eventually lead to more serious health problems. People of all ages can have GERD.