If you have been injured by the gastrointestinal disorder drug Reglan®, you need Ken Nunn, The Indiana Injury Lawyer, to investigate filing a Reglan® lawsuit on your behalf. Dealing with large pharmaceutical companies can be a daunting task. Having an experienced class action law firm at your side, right here in Indiana, will help you protect your rights.
Reglan® is generically known as metoclopramide and is produced by Schwarz Pharma. Reglan® was first approved by the United States Food and Drug Administration (FDA) in 1985 to treat gastrointestinal disorders, such as gastro esophageal reflux disease (GERD), diabetic gastroparesis, persistent heartburn, nausea, vomiting, and a feeling of stomach fullness. Reglan® was approved for short-term use of approximately nine to 12 weeks.
Unfortunately, Reglan® is associated with a range of serious side effects, including depression, hallucinations, seizures and tardive dyskinesia. Tardive dyskinesia is a permanent condition that causes uncontrollable movement of the extremities and face. People with tardive dyskinesia commonly experience involuntary, repetitive, jerky movements, such as lip smacking, grimacing, tongue protrusion, puckering and pursing of the lips, rapid blinking, rapid limb movement and constant twitching.
In a February 2009 news release, the FDA stated that chronic use of metoclopramide had been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. According to one FDA study, 20 percent of patients who developed tardive dyskinesia had taken Reglan® for more than three months. High-risk groups for the condition include people less than 20 years old as well as pregnant women. The symptoms of tardive dyskinesia are irreversible in many cases, the FDA stated, while in other cases, the symptoms lessened over time but never fully disappeared.
In response to an increasing number of reports regarding tardive dyskinesia as a side effect of Reglan®, in February 2009 the FDA began requiring the manufacturer to add Black Box warnings on Reglan®’s label about the risks of high-dose use or long-term use of the drug. Black Box warnings are the strongest type of FDA warning and are used to indicate that a medication has the potential to cause life-threatening side effects. The FDA also required the manufacturer to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.
If you or a loved one have been harmed due to the use of Reglan®, contact us today about filing a claim. If you live in the state of Indiana, you need Ken Nunn to vigorously represent your rights and interests. Contact me today to receive a free consultation on your case at 1-800-CALL-KEN. I stand up for the rights of injured people.