One woman who suffers from tardive dyskinesia after taking Reglan for almost 13 years has filed a lawsuit against Wyeth, the makers of the drug, seeking to have the drug banned from being marketed in the United States as a safe treatment for gastro reflux complications.
Charlene Evans’ lawsuit, Charlene Evans v. Wyeth LLC, is asking the court to stop Wyeth from marketing Reglan as a safe drug to use for periods lasting longer than 12 weeks amid claims that the drug causes patients to suffer from tardive dyskinesia. At the time that Evans was taking Reglan, neither she nor her doctor knew of the risks that were associated with long-term Reglan use. Evans began taking the drug in 1989 and continued taking it until 2002, which is well beyond the 12 weeks that the drug’s label now lists as safe.
Tardive dyskinesia is an involuntary movement disorder that causes patients to suffer from symptoms including “involuntary lip smacking, tongue protrusions, eye blinking, repetitive body movements and disability.” Other serious adverse side effects linked to Reglan use include “neuroleptic malignant syndrome (NMS), secondary Parkinson’s disease, severe anxiety and depression, agitated restlessness, insomnia and paranoia.”
Evans’ lawsuit, which was filed in the Superior Court of San Francisco County on Nov. 1, 2011, points out that using the drug for longer than 12 weeks made patients 100 times more likely to suffer from Reglan side effects than the patients who used it for less time than that. The lawsuit claims that Wyeth knew of this increased risk, but that the company hid this fact from healthcare professionals and the public until the FDA issued a black box warning against the drug in 2009. It is for this reason that Evans wants the drug banned from long-term use. Wyeth is still marketing the drug for short-term use (12 weeks) use in patients suffering from gastro reflux disorders including GERD.