The lawsuit alleges that pharmaceutical company Pliva did not adequately warn consumers about the risk of tardive dyskinesia in the Physician's Desk Reference, a medical reference book. The plaintiff, Susan Swicegood, alleges she and her doctor could not make an informed decision about the use of Reglan because they did not know about the possible side effect.
According to the lawsuit, the Physician's Desk Reference was required by law to be updated with information about generic Reglan and tardive dyskinesia when that information became available.
Swicegood was reportedly prescribed 10 mg Reglan capsules daily.
Reglan is used to treat gastrointestinal problems, including gastroesophageal reflux (GERD). It has been linked to tardive dyskinesia, a disorder that causes involuntary, repetitive motion in the face, arms, legs and torso. Those movements include twitching, grimacing, lip smacking, lip puckering, lip pursing, and rapid blinking. There is currently no successful treatment for tardive dyskinesia and symptoms can persist even after patients discontinue medication.
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Reglan is approved for short-term use not exceeding three months, but it is often prescribed off-label for long-term use. The new warning label advises patients that Reglan should not be taken for longer than three months in all but rare cases.
The makers of some generic drugs argue that they are not responsible for their warning labels because the FDA mandates that generic drugs must carry the same warning labels as name brand medications. The issue is being dealt with in court. The FDA has reportedly been asked by the court to clarify its stance on the generic label issue.
There are approximately 150 Reglan lawsuits underway in US federal courts.