0

EL DORADO, Ark. - After a year of taking a drug to combat a medical condition involving paralysis of stomach muscles, an Arkansas resident started exhibiting abnormal muscle movements throughout her body.

Kecia Neal has filed suit against Teva Pharmaceutical, Schwarz Pharma and Wyeth Inc., the manufacturers of the drug Reglan and its generic equivalent metoclopramide. The product liability suit was filed on May 27, 2009, in the El Dorado Division of the Western District of Arkansas.

The drug Reglan is used to treat gastrointestinal disorders but has been linked to an increase risk of tardive dyskinesia, a condition that results in involuntary and repetitive movements of the body. Currently, there is no known treatment for tardive dyskinesia. In some patients, the syndrome’s symptoms may be reduced in the weeks or months following the cessation of the drug.

Neal was taking the drug for treatment of gastroparesis.

The Food and Drug Administration required the drug’s manufacturers to provide the addition of a boxed warning in February 2009. The new warning stated “chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement that is often irreversible.”

In addition, the new warning stated “prolonged treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases.”

The plaintiff states that she did not have access to these warnings and therefore, took the drug for more than a year. She states her use of the drug as prescribed resulted in overexposure and caused her to suffer serious, permanent and disabling injuries.

Original Article

Continue Reading

0

The FDA announced that the heartburn drug, Reglan, and all other drugs containing metoclopramide will carry the administration’s strongest  “black box” warning. The change was made to alert consumers, and health care professionals of an increased risk of developing tardive dyskinesia.

Tardive Dyskinesia is a repetitive involuntary movement disorder.

Original Article

Continue Reading

Stomach Drugs Need Movement Disorder Warning

Published on 28 February 2009 by admin in News

0

A class of drugs to treat stomach disorders needs a strong warning about the risk of involuntary, repetitive movement on several parts of the body seen with long-term use or high doses, U.S. regulators said on Thursday.

The drugs contain the ingredient metoclopramide and are available in various forms including tablets, syrups and injections, the Food and Drug Administration said. Makers include Baxter International Inc (BAX.N) and several generic drug companies.

More than 2 million Americans use the medicines to treat gastroesophageal reflux disease and other stomach ailments, the FDA said.

Chronic use has been linked to tardive dyskinesia, which causes repetitive movements of the limbs, lip smacking, grimacing, tongue protrusion and rapid eye movements and blinking. The symptoms are rarely reversible but may lessen or resolve after metoclopramide treatment ends, the FDA said.

Original Article

Continue Reading