"We now have the fourth quarter data from the FDA [Food and Drug Administration] Adverse Event Reporting System," McGinn says. "New cases of tardive dyskinesia or other movement disorders rose significantly in that time. They rose by more than 6 percent in the fourth quarter and more than 14 percent over the second half of 2008."
That may not sound like a massive increase on its own, but consider this: the FDA did not announce a black box warning for Reglan until 2009. That means that the increase in 2008 came without the benefit of media coverage—and therefore increased patient awareness about the risks of Reglan—implying that there could be an even bigger increase in adverse events reported when data from the first and second quarter of 2009 is taken into account.
"What generally happens is that, with the Adverse Event Reporting System, people often do not make the connection between their symptoms and a drug they may be taking until they hear about an FDA order," McGinn says. "Once people are aware of an order and realize the connection between the drug and their symptoms, reporting [of adverse events] may go up. In this situation, the increase in 2008 cannot be attributed to the FDA's orders. This is not in response to new FDA warnings."
Although the complications linked to Reglan may not seem all that harmful, McGinn warns that they can be debilitating.
"People who use Reglan should know that the injuries can be severe and permanent," McGinn says. "There is no known cure. The FDA has warned that Reglan should not be used for longer than 12 weeks, but many people may be using Reglan for months or years, which substantially increases the risk of tardive dyskinesia and other movement disorders. These disorders are extremely debilitating and have an enormous impact on a patient's quality of life."
READ MORE REGLAN LEGAL NEWS
That means, and it cannot be stressed enough, if you have taken Reglan and are experiencing a movement disorder it is vital that you see a doctor. Do not simply write it off as being normal or being a phase that will pass, because it might not.
If you have been harmed by the use of Reglan, consult with an attorney. It may not be too late to join a lawsuit to protect your rights. McGinn says Hissey Kientz is currently accepting cases regarding Reglan.