Movement Disorder Lawyers Allege That FDA Alerts On Reglan Weren’t Sufficient

The movement disorder lawyers who filed the Reglan lawsuit of Carden v. Wyeth allege that neither the Reglan warning label nor the FDA alerts about Reglan were sufficient to warn users of Reglan:

By the early, 1990s, peer-risk for tardive dyskinesia or extrapyramidal reactions ratio were significantly higher than previously thought. Thus, the risk/benefit analysis for MCP had substantially changed after initial FDA approval. For instance, in other MCP litigation, Dr. Frederick Wilson, testified:

Q: Just so I'm absolutely clear on your answer - - are you telling me that it is your opinion, as Wyeth's medical monitor for Reglan, that Reglan should not be prescribed in long-term therapy for GERD, because its side effects are too dangerous, and because its efficacy in long-term use has never been established?

A: Today, as we sit here, and with the other drugs that are currently on the market, I would agree with that.

See Wilson deposition at p. 66, Appx., pp 134-143.

Moreover, two formal epidemiological studies published in peer-reviewed journals in the early 1990s specifically addressed the prevalence of tardive dyskinesia in MCP exposed patients. The article published by Linda Ganzini, et al., entitled “The Prevalence of Metoclopramide-Induced Tardive Dyskinesia and Acute Extrapyramidal Movement Disorders,” ARCH. INTERN. MED. 153:1469, 1471 (1993). Dr. Ganzini's study found that the frequency of tardive dyskinesia among her patients that were treated with MCP was over 29%, or at a frequency of about 1 in 4 - a prevalence that was 100 times higher than reported in the text of the MCP label. (See Id). A second epidemiological study (closely replicating Ganzini's) found that 27% of patients treated with MCP contracted tardive dyskinesia. (See Id. n. 6)

These same studies also found that diabetic patients exposed to MCP faced a particularly higher risk of developing tardive dyskinesia, and typically developed more severe forms of the disease than non-diabetic patients exposed to the drug. (See Gazini, fn 6). Nevertheless, the MCP label makes absolutely no reference to the particularly higher risk of tardive dyskinesia in this patient population of diabetics taking MCP.