Reglan Lawyers Allege Reglan Is One of the Causes Of Movement Disorders

In the case of Stoddard v. Wyeth, the plaintiffs filed this document which alleges that Reglan causes movement disorders like tardive dyskinesia:

Reglan(R), also known as MCP, was initially marketed in the United States by A.H. Robins Co. (Robins) and later sold by Wyeth, Robins' successor, to Schwarz. Reglan(R) was first approved in 1979, by the FDA, for the treatment of diabetic gastroparesis; and subsequently approved in 1984 for the treatment of gastroesophageal reflux disease (GERD) (commonly known as “heartburn”). Appx., pp 125-133. Upon the expiration of the patent exclusivity, several drug companies began manufacturing generic versions of Reglan(R), also known as MCP (including Wyeth). The other Defendants are such generic MCP manufacturers.

It has been known for decades in the scientific community that MCP crosses the blood-brain barrier and causes central nervous system side effects, like tardive dyskinesia (a type of extrapyramidal movement disorder). Although the condition is rarely fatal, severe TD is extremely disabling, and there is no known cure. Physicians are most familiar with tardive dyskinesia through the experience of other older neuroleptic drugs, such as Thorazine and Haloperidol. These drugs were once widely prescribed and used in the treatment of psychosis until it became clear, by the late 1970s, that an extremely high percentage of patients exposed to neuroleptics on a long-term basis -about 1 in 4 *were developing tardive dyskinesia.[FN2] (Appx., pp 001-089.). The wisdom of prescribing a neuroleptic drug having the potential to induce tardive dyskinesia for minor illnesses, such as heartburn, was debatable even at the time Reglan(R) was first approved in 1984. At that time, however, Reglan(R) was the only drug approved for the treatment of heartburn. In response to increasing case reports of tardive dyskinesia in the published medical literature, the FDA mandated class-wide warnings for all neuroleptic drugs, including Reglan(R) because of its neuroleptic characteristics.[FN3] In 1989, Drs. L. Miller and J. Jankovic published a paper where they reviewed the available published scientific literature and identified 1,031 patients with MCP-induced EPS and concluded that MCP manufacturers' estimates of a 1/500 frequency for MCP-induced movement disorders was inaccurate. (See above footnote, Id.) Nevertheless, the 1/500 frequency ratio has been on the Reglan(R)/MCP label since 1984 and is still on the label, generic and brand-name, today. (Id.)

FN2. Yassa & Jeste, “Gender Differences In Tardive Dyskinesia: A Critical Review of the Literature,” Schizophrenia Bull. 18 (4) : 701-15 (1992).

The FDA only approved MCP for short-term use (4-12 weeks). Even though the MCP label specifically quantified the dosage associated with the 1/500 ratio, the label also did not qualify the duration of therapy. As reflected in the literature, as MCP long-term drug therapy, defined as greater than 12 weeks duration, became popular (to treat minor gastrointestinal complaints, such as heartburn), the incidence of tardive dyskinesia increased.[FN4]