Reglan (metoclopramide) is a prescription drug used to treat certain gastrointestinal conditions such as diabetic gastric stasis and gastric reflux, or heartburn. Reglan is a dopamine antagonist that increases lower esophageal sphincter pressure and improves gastrointestinal emptying.
Reglan, manufactured by Baxter Healthcare Corporation, was FDA-approved for short-term treatment only after other methods of treatment have failed. However, evidence shows that one-third of patients are prescribed Reglan for longer than 12 weeks, which is against FDA recommendations.
Some of the more serious Reglan side effects are:
- Tardive dyskinesia - involuntary muscle movements, usually in the face and tongue, but sometimes in the trunk or extremities or Neuroleptic Malignant Syndrome (NMS)
- Parkinson's-like symptoms - slow movements, rigidity, and tremors
- Akathesia - a severe anxiety and inability to sit still
- Suicidal Tendencies and other mental depressions
- Seizures and convulsions
Some of these side effects progressively worsen and may eventually become irreversible. The label on Reglan does advise of these side effects but states that the incidence is rare. Yet studies have shown that the use of Reglan can cause Tardive dyskinesia in as many as 27% of its long-term users.
I am currently evaluating Reglan cases. If you or someone you know has experienced adverse side-effects from the use of Reglan similar to those listed above, please call me at (215) 790-7379. Evaluation of your case is free. Waiting too long may compromise your legal rights.
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Perspective of a Legal Specialist in Whistleblower Law and Pharmaceutical Injury
Friday, April 17, 2009
Thursday, April 9, 2009
RAPTIVA, Psoriasis Drug, Causes Brain Infection Risks
April 8, 2009: Genentech and FDA announced a voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML).
PML is a brain disease that gets worse over time and can attack many parts of the brain at once. The brain infection is caused by a loss of white matter, a substance that protects nerve fibers in the brain. Without this white matter or myelin, nerve signals don't compute from the brain to the rest of the body. PML is caused by the reactivation of a common virus in the central nervous system of immune-compromised persons. The JC virus is carried by a majority of people and is considered harmless except for persons with lowered immune defenses. PML is most common among people with acquired immune deficiency syndrome (AIDS).
Symptoms vary but include clumsiness, gradual but progressive weakness, and a change in visual acuity, speech, and personality. These symptoms lead to a life threatening disability and can decline leading to death.
By June 8, 2009, Raptiva will no longer be available in the United States. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis.
History
On February 19, 2009, the FDA announced that people who take Raptiva are at risk for developing the rare fatal condition known as PML. The FDA issued a public health advisory concerning three confirmed, and one possible report of PML, a rare brain infection, in patients using the psoriasis drug Raptiva. Three of those patients have died. All four patients were treated with Raptiva for more than three years. None of the patients were receiving other treatments that suppress the immune system.
On October 16, 2008, the FDA issued a black-boxed warning to highlight the risks of life-threatening infections from Raptiva, including PML.
The EMEA ("European Medicines Agency"), Europe's version of the FDA announced that the risks of Raptiva outweigh the benefits and should no longer be prescribed.
Please contact me to discuss your case at (215) 790-7379.
PML is a brain disease that gets worse over time and can attack many parts of the brain at once. The brain infection is caused by a loss of white matter, a substance that protects nerve fibers in the brain. Without this white matter or myelin, nerve signals don't compute from the brain to the rest of the body. PML is caused by the reactivation of a common virus in the central nervous system of immune-compromised persons. The JC virus is carried by a majority of people and is considered harmless except for persons with lowered immune defenses. PML is most common among people with acquired immune deficiency syndrome (AIDS).
Symptoms vary but include clumsiness, gradual but progressive weakness, and a change in visual acuity, speech, and personality. These symptoms lead to a life threatening disability and can decline leading to death.
By June 8, 2009, Raptiva will no longer be available in the United States. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis.
History
On February 19, 2009, the FDA announced that people who take Raptiva are at risk for developing the rare fatal condition known as PML. The FDA issued a public health advisory concerning three confirmed, and one possible report of PML, a rare brain infection, in patients using the psoriasis drug Raptiva. Three of those patients have died. All four patients were treated with Raptiva for more than three years. None of the patients were receiving other treatments that suppress the immune system.
On October 16, 2008, the FDA issued a black-boxed warning to highlight the risks of life-threatening infections from Raptiva, including PML.
The EMEA ("European Medicines Agency"), Europe's version of the FDA announced that the risks of Raptiva outweigh the benefits and should no longer be prescribed.
Please contact me to discuss your case at (215) 790-7379.
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