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Reglan – the Reason for the Cases

By July 2, 2010July 9th, 2019Uncategorized

Sometimes a look back is the best way to gain perspective. Often the most difficult time when attempting to gain recognition for harm done by a prescription medication is after trouble becomes known, but before that knowledge is widespread. Pharmaceutical companies often play a role in the confusion of information as they take steps to protect their products and reputations.

In the case of Reglan, warnings about the potential link between the medicine and Tardive Dyskinesia (TD) go back to 2004. However, most of the cases have only been set for trial in the last year or so. This leads to a discrepancy of perception: Weren’t these people warned about it, and didn’t they choose to take it?

However, consider that up until fairly recently, Reglan was only indicated by its parent company as linking to TD in .2% of cases. This is technically true, if you accept that the company is talking about doses taken in the short, no-more-than-12-week time span indicated on the label. However, in as many as 30 percent of cases, doctors had been prescribing Reglan for much longer periods. Correspondingly, the rate of those affected by TD was significantly increased.

Now, a great deal can be said about the doctors who prescribed Reglan for longer periods than indicated. However, the parent company was representing the information in a skewed way, giving the impression that the absolute numbers of patients was much lower than it actually ended up being. This raises doubts about the “weren’t they warned?” argument.

The matter came to a head recently, with the FDA ordering a black-box warning put on all packaging for Reglan, stressing the potential effects of TD and mentioning that the ailment could be permanent. This occurred in 2009, four years after the initial warnings appeared. Thus, it is on good ground that most of the Reglan cases are going forward: There has been a disconnect in the matter, and it must be resolved.