Pharmaceutical

FDA approves generic GERD treatment

nizatidine 150x150 FDA approves generic GERD treatmentThe Food and Drug Administration (FDA) has approved a generic version of a drug for treating gastroesophageal reflux disease, or GERD, in adolescents and adults. Amneal Pharmaceuticals’ nizatidine oral solution was approved in the 15-mg-per-15-ml strength, and is a generic version of Axid, made by Braintree Laboratories. The medication belongs to a class of drugs known as histamine H2 blockers.

Side effects of nizatidine include abdominal pain, diarrhea, dizziness, gas, headache, indigestion, inflammation of the nose, nausea, pain, sore throat, vomiting and weakness.

The new generic medication offers another drug choice for patients who suffer from uncomfortable and sometimes painful symptoms of GERD. Another popular prescription drug in the treatment of GERD includes Reglan (metoclopramide). Earlier this year the FDA issued a black box warning on metoclopramide products following reports of an involuntary movement disorder known as Tardive Dyskinesia in patients who took metoclopramide for more than 12 weeks.

People who suffer from Tardive Dyskinesia experience involuntary movements of their muscles which can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

This fall, the FDA approved an orally dissolving tablet form of metoclopramide under the brand name Metozolv ODT. That medication also falls under the same black box warning as other metoclopramide products, such as Reglan. Nizatidine is not the same medication as metoclopramide, and thus does not fall under the same FDA warning.

Source: FDA