Enviado por Maria el Vie, 02/27/2009.
La metoclopramida (Reglan) presenta riesgos para personas con la EP y la EH
La metoclopramida (Reglan) presenta riesgos para personas con la EP y la EH
No causará sorpresa para algunas familias de la EH leer sobre la exigencia de la FDA hecha en febrero pasado de que la Metoclopramida (Reglan) deba ser etiquetada en una caja negra debido al potencial para provocar Disquinesia Tardía luego de ser usada por un largo término. Si lees la información sobre esta droga, aparece que la gente que sufre de las siguientes tres condiciones, no debería tomar Reglan y son: una historia de depresión, enfermedad de Parkinson o desórdenes del movimiento y epilepsia y otros desórdenes que provoquen convulsiones.
Aún así, esta droga suele ser prescripta por los médicos clínicos a los pacientes con EH, incluso aquellos con la EHJ, quienes suelen experimentar problemas etomacales, vómitos, úlceras del esófago, hipo incontrolable, etc. Mucho de esos pacientes con la EH, a quienes se les prescribe Reglan han experimentado no sólo síntomas del Síndrome Neuroléptico Maligno (SNM) y/o Disquinesia Tardía, sino también alucinaciones, pensamiento suicida, arranques severos de ira, etc. En un paciente con la EH, los efectos secundarios serios no desaparecieron ni siquiera 18 meses luego de haber abandonado Reglan.
Esperamos que con la advertencia de la FDA respecto de Reglan, los médicos clínicos sean más cautos a la hora de recetar Reglan para alguien con la EH. Sin embargo, las familias de pacientes con la EH deberían siempre ser cautos cuando un médico clínico quiere prescribir esta medicación, especialmente en aquellas personas que estén en las fases finales de la enfermedad o sean alimentados mediante tubos. Si aún así se toma la decisión de dar esta medicación a un ser querido, se debe prestar especial atención a los efectos secundarios serios que aparecen enlistados en este sitio web http://www.nationmaster.com/encyclopedia/Reglan, como se debe informar inmediatamente al medico de cualquiera de ellos que esté siendo experimentado.
Agency warns against chronic use of these products to treat gastrointestinal disorders
The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.
Manufacturers will be required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.
“The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.”
Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.
Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Metoclopramide works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines. It is used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies, and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines). It is recommended that treatment not exceed three months.
Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.
Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders. Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months. The FDA has also become aware of continued spontaneous reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months.
Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20852-9787, or online at: www.fda.gov/medwatch/report.htm
For information about REMS see: Public Law 110-85