Reglan, Tecfidera Carry Serious, Life-Altering Side Effects

May 8, 2013

doppelganger-1_l.jpgDangerous drug lawyers at Pintas & Mullins warn patients taking the acid reflux and heartburn drug Reglan that it has been linked to serious, permanent, and fatal side effects. Similarly, patients taking multiple sclerosis medication Tecfidera may be at risk of developing a fatal brain disease.

Reglan, which is the brand name for generic metoclopramide, is often used to treat Gastroesophageal Reflux Disease (GERD), along with other acid reflux and heartburn conditions. Unfortunately, some Reglan patients are experiencing serious side effects, including Tardive Dyskinesia, which is a disorder involving involuntary movements, particularly in the lower face.

Tardive Dyskinesia can be reversed by stopping Reglan immediately, however, in some cases, the involuntary movements may become permanent or even significantly worse. Symptoms of this condition include repetitive chewing, facial grimacing, finger movement, and jaw swinging. There is no known treatment for the condition.

Another significant and potentially fatal side effect is Neuroleptic Malignant Syndrome, which is a rare disease that can itself cause a wide range of side effects. If not treated properly, this syndrome can be fatal, especially if the medication is taken in higher-than-recommended doses. Symptoms are often immediate and have a severe impact on the body, and include muscle rigidity or cramping, fever, instability, cognitive changes, and convulsions, among many others.

Neuroleptic Malignant Syndrome occurs most often in males, although women have developed the condition post postpartum. However, about 10% of the patients who experience this side effect do die. As a result of this, in February 2009, the FDA announced that Reglan would now come with a black box warning, which alerts patients that the drug may cause serious side effects if used longer than three months. The black box warning states that the elderly, particularly elderly women, were at the highest risk of experiencing Tardive Dyskinesia.

Another drug, Tecfidera, manufactured by Biogen/Idec and used to treat multiple sclerosis, is now associated with a serious and fatal brain disorder called progressive multifocal leukoencephalopathy (PML). The FDA approved Tecfidera just a few months ago in March 2013. Shortly thereafter, medical officials in Germany and the Netherlands (where the drug is called Fumaderm), reported at least four case of patients taking the medication for several years developing PML.

Although the release of Tecfidera was much anticipated in the MS community, scientists are largely unsure of the drug's exact mechanisms of action. PML is a fatal brain disease that inflames the brain's white matter in several separate locations. The disease destroys portions of the patient's brain cells, impairing electrical communications and signals. Symptoms of PML include impaired speech, paralysis, vision loss, and cognitive deterioration, and detection can be accomplished through an MRI. No known treatment for PML exists, and patients usually pass away within four months of diagnosis.

Another multiple sclerosis and Crohn's disease medication, Tysabri, is also associated with PML, with more than 100 reported cases in the U.S. In 2011 the FDA released a Safety Announcement for Tysabri patients, stating that the agency is continuing its evaluation of the risk of PML. The agency also revised the drug's label to include a table summarizing the rates of PML and information on a newly identified PML risk factor: patients who took an immune system suppressing drug prior to taking Tysabri.

Numerous lawsuits have been filed against Reglan manufacturers, many of which resulting in multi-million dollar awards. Some lawsuits are being settled out of court, ranging in amounts between $1.2 and $5.2 million.

Reglan and Tecfidera lawyers at Pintas & Mullins encourage patients to educate themselves and stay informed about new medications coming onto the market. Too often, patients are prescribed to a medication and blindly adhere to doctor's recommendations without first doing their own research. If you or a loved one was seriously injured by Reglan, Tedfidera, Tysabri, or any other dangerous drug, you may be entitled to significant compensation through a lawsuit against the manufacturer.