FDA alerts stomach disorder drug must have boxed warning!

FDA announced drug makers of metoclopramide must add risk box to medication label.

San Francisco, CA (JusticeNewsFlash.com)–The U.S. Food and Drug Administration (FDA) www.fda.gov issued an immediate press release, on Thursday, warning against the possible adverse effects from long-term use of metoclopramide containing drugs. Metoclopramide is a common medication prescribed by medical doctors and professionals to treat various gastrointestinal disorders.

Chronic high doses and long term uses of metoclopramide have been linked to tardive dyskinesia, which includes involuntary repetitive body movements. The development of tardive dyskinesia, which can remain even after the drug’s use, has been directly linked to the how long a patient is taking metoclopramide and the number of doses.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, rapid eye movements, blinking, puckerting and pursing of the lips along with impaired movements of the fingers according to the FDA. These symptoms are rarely reversible and there is no known treatment.

The FDA has released this strong warning and increased labeling requirements to educate doctors, nurses and other health care professionals when using metoclopramide for treatment. There are numerous formulations of the drug and it is marketed under names like: Reglan tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products are recent studies indicate it is the most common cause of drug induced movement disorders.

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Heather L. Ryan, R.N., C.L.N.C- Heather Ryan is a Certified Legal Nurse Consultant with 15 years of experience in the health care industry. Her expertise in reviewing medical records and assisting lawyers with the determination as to whether legal action should be taken provides an invaluable asset to the newsroom. Medical-malpractice, products liability, personal injury and workers’ compensation are some of the recent areas of litigation Ms. Ryan has focused her efforts on. A member of the Florida Justice Association, Heather maintains a long list of certifications and credentials to support her areas of expertise and stays up-to-date with her clinical knowledge working as an emergency room/trauma nurse, at a Level 1, Adult/Pediatric trauma and teaching institution in South Florida.