Reglan Side Effects Spark Class Action Suit
The instructions on prescription labels are the primary source of information a patient has when taking medication, and manufacturers who fail to reveal the side effects of their products knowingly place customers in danger. The recent crisis surrounding the prescription drug Reglan is one case in which the lack of information provided to physicians has given rise to significant health issues in unsuspecting patients.
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While commonly prescribed for gastrointestinal disorders, such as gastroparesis and gastroesophageal reflux, Reglan, or metoclopramide, was originally developed as a neuroleptic intended to treat psychosis. Prolonged use or high dosages of Reglan are now known to cause the neurological disorder, tardive dyskinesia, as well as less frequent side effects, including dystonias, seizures, mild depression, and neuroleptic malignant syndrome.
Since February 2009, the FDA has required that manufacturers of Reglan and generic metoclopramide include a black label warning on all boxes outlining the risk of developing tardive dyskinesia and advising against use of the drug for more than the recommended 12 weeks. The FDA also suggested that makers of metoclopramide inform medical professionals by letter of the updated warning, as many physicians were unaware of the effects of extended usage. Elderly women, young children, and long-term users of metoclopramide are most likely to experience serious, irreversible side effects.
In the 1960s, metoclopramide was developed as a dopamine antagonist, but the drug proved to be more effective at blocking dopamine receptors in the digestive system and strengthening muscles in the gastrointestinal tract. As one of the most effective medications for gastrointestinal disorders, physicians prescribed Reglan unreservedly because the drug company instructions indicated only minimal risks of developing serious side effects. Doctors are still uncertain of how antipsychotic drugs cause tardive dyskinesia, but many have associated the condition with a sudden increase of dopamine receptors in the brain.
Tardive dyskinesia is a serious and emotionally exhausting disorder that reportedly affects 1 in 3 patients prescribed long-term dosages of metoclopramide. The disorder is characterized by several types of recurrent involuntary movements, including rapid jerking or twitching of the toes, limbs, and fingers, uncontrolled facial movements, lip smacking, protrusion of the tongue, blinking, and eyebrow raising.
Tardive dyskinesia is difficult to detect in the early stages. Metoclopramide may also mask the symptoms until after use is suspended. It is not only a physical problem, but an emotional one as well. Living with tardive dyskinesia can lead to feelings of helpless and embarrassment, and in times of stress these involuntary movements are often exacerbated.
In 2008, two Reglan lawsuits involving the use of generic metoclopramide received opposite rulings. One judge found the Wyeth company guilty of misleading doctors and patients, while another denied accountability for drugs manufactured through other companies. Now that the FDA has recognized Wyeth’s fault in misreporting information, Reglan users are more likely to get the justice they deserve. Victims of side effects who are in need of legal advice should contact a Reglan attorney immediately.
A class action suit is currently being organized to provide representation for the injured parties. Symptoms of tardive dyskinesia or other side effects may not be manifested until months after use of Reglan is discontinued. Any patient who has or is currently using Reglan long-term should contact a physician for more information and consult with a lawyer should symptoms appear.
