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New option approved for treating GERD

Teresa Tanoos's picture
FDA approves generic version of drug for treating GERD

Options for treating gastrointestinal reflux disease (GERD) offer new hope for those suffering from the condition, including FDA-approved generic drugs that provide greater access to healthcare for Americans.


The FDA has approved the nation’s first generic version of the drug Nexium for the treatment of gastroesophageal reflux disease, also referred to as GERD, which occurs when an excessive amount of gastric juice causes content in the stomach to rise back up into the esophagus.

AstraZeneca’s Nexium (esomeprazole magnesium) is administered in delayed-release capsules to adults and children to treat the symptoms of GERD. The generic version of the drug will be marketed by Ivax Pharmaceuiticals and administered in 20- and 40-milligram capsules containing esomeprazole, which the US Food and Drug Administration has also approved for decreasing the risk for gastric ulcers due to non-steroidal anti-inflammatory drugs.

In addition, the FDA has approved esomeprazole to be used with specific antibiotics for the treatment of Helicobacter pylori infection.

Patients taking generic esomeprazole capsules will receive a pamphlet with details about the drug’s side effects and most serious risks. Among the possible adverse effects, stomach problems and severe diarrhea top the list, as well as an increased risk for bone fractures for those taking multiple daily doses of the medication for an extended period.

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Nevertheless, Kathleen Uhl, MD, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, released a statement reassuring the public that this generic drug has met the FDA’s strict standards for approval.

Those who suffer from GERD can often reduce acid reflux by staying away from certain foods and beverages known to make symptoms worse. Making other changes in their diet, such as decreasing how much fat they consume and eating smaller, more frequent meals instead of three large meals, can also help. If the patient needs to lose weight, doing so may also help to reduce symptoms of GERD.

Common signs and symptoms of GERD are heartburn, regurgitation, chronic cough, wheezing, chest pain, hoarseness and laryngitis. Other symptoms may include asthma or recurrent pneumonia, difficulty swallowing or painful swallowing, and pain in the upper abdomen.

The generic form of Nexium, along with other generic drugs, provide consumers with more choices that enable them to have greater access to health care options. There are many generic versions of brand-name medications that are identical as it pertains to safety, strength and overall quality. To learn more about generic drugs, click here.

SOURCE: FDA News Release, FDA approves first generic esomeprazole, published January 26, 2015.