In February 2009, the U.S. Food and Drug Administration issued a Black Box Warning -the strongest warning the agency can require –on the drug Reglan, which is used to treat gastrointestinal problems such as acid reflux and gastroesophageal reflux disease (GERD). The drug works by increasing contractions in the digestive system. Reglan is also known as Maxolon, Octamide, and the drug’s generic name, metoclopramide hydrochloride.
Reglan works by increasing contractions in the stomach and small intestines. By speeding contractions, the drug causes food to pass through the system faster. In most cases, Reglan is taken about 30 minutes before a meal.
It is used to treat a number of intestinal problems, including:
Short-term use is recommended to minimize the risk of serious Reglan side effects. A course of Reglan treatment typically lasts between 4 and 12 weeks, and taking the drug for more than 12 weeks is not recommended. Unfortunately, this precaution is often overlooked or not adequately explained to the patient.
The FDA has warned that people taking Reglan have a significant risk of developing tardive dyskinesia. Regland-induced tardive dyskinesia is a central nervous system disorder that causes involuntary movements of the face, such as tongue thrusting or facial twitches, and jerking of the limbs. The disorder can affect the muscles of the face, mouth, jaw, eyes, and neck, as well as the torso and extremities. There is no known treatment. In some cases, the symptoms may lessen or subside after the patient stops taking Reglan, but tardive dyskinesia is often irreversible.
The side effects of Reglan can also cause other movement disorders, such as dystonia — uncontrollable muscle spasms that can involve the muscles of the face, neck, body or limbs. Reglan can also cause Parkinsonism — characterized by shaking, stiffness and difficulty in moving or maintaining balance. Parkinsonism mimics symptoms of Parkinson’s Disease, and Reglan also can aggravate your symptoms if you suffer from Parkinson’s.
The most common Reglan side effects include fatigue, drowsiness or restlessness. These side effects can be intense. Feelings of restlessness may be associated with agitation or anxiety, insomnia, pacing, jitteriness and an inability to sit still. It can also cause mild to severe depression and suicidal thoughts. Some patients taking Reglan have committed suicide.
In rare cases, Reglan use can cause Neuroleptic Malignant Syndrome (NMS), a rare but very serious complication that can result in death and requires hospitalization. NMS can cause high fever, difficulty thinking clearly, stiffness in the muscles, fast or uneven heartbeat as well as increased sweating.