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Understand the FDA’s Warning About the Side Effects of Reglan

Be Alert For Repetitive Facial Movements Especially In Older Women

It is estimated that over 2 million Americans were prescribed the drug metoclopramide in various forms to cope with ailments, mostly regarding the gastrointestinal track. Doctors often treated patients with chronic illnesses, such as gastroparesis, diabetic gastric stasis, and severe acid reflux disease or heartburn. The medication was also given to women seeking to increase milk production during lactation, as it stimulates the hormone prolactin, essential for successful nursing. However, recent warnings by the FDA have prompted serious concerns about the side effects of Reglan - the branded name of the drug - as many of these are severe and sometimes irreversible.

Many patients with heartburn and gastroesophageal reflex disease (GERD) were prescribed the medicine to help strengthen the lower esophageal sphincter. When this muscle is weakened, it allows more stomach acid through and can cause severe irritation and heartburn.

The side effects of Reglan most often cited are relatively mild, and were known to many patients. These were provided in the information present on the packaging of the medicine and included: decreased energy, diarrhea, dizziness, drowsiness, headache, nausea, restlessness, tiredness, and insomnia. A second class of adverse effects were also occasionally reported, mostly mimicking symptoms found when there is indication of a severe allergic reaction. These symptoms included skin irritation, difficulty breathing, and increased depression and/or suicidal thoughts. Many neuroleptics carry these same warnings. Young adults and individuals with a history of suicidal thoughts are often advised to refrain from use unless deemed absolutely necessary by their physicians.

The most severe associated health problems ultimately resulted in a “black box” warning mandated by the Food and Drug Administration (FDA), as well as stern warnings to doctors and physicians, many of whom had deemed the medicine to be both safe and effective. An alarming instance of Reglan induced Tardive Dyskinesia among patients raised serious questions about the risks of using the medication. Tardive indicates the slow progression of the disease, which often exhibits symptoms far after a patient has stopped use.

While the disease itself is often difficult to diagnose, there are a few common symptoms that ought to be reported immediately to a doctor. They will use the information and advise a course of treatment. These include:

• Repetitive, involuntary movements of the arms and legs
• Lip smacking and other mouth and lip movements
• Rapid blinking
• Diminished movement of the fingers.

According to the FDA, older women are at a higher risk for developing the disease. There are other known movement disorders associated with the drug, such as Akathisia, Dystonia, blepharospasm, Parkinson’s disease-like symptoms, and neuroleptic malignant syndrome. Patients with a history of Parkinson’s disease are not advised to take this drug. There are also additional risks in individuals with heart conditions, high blood pressure, or cirrhosis. There have also been further instances of drug interaction which can intensify the complications, including acetaminophen, alcoholic beverages, antispasmodic drugs, cimetidine, cyclosporine, digoxin, insulin, MAO inhibitor antidepressants, levodopa, narcotic painkillers, sleeping pills, tetracycline, and tranquilizers. 

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