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Reglan:
Side Effects And Problems Of Reglan

Reglan Drug:
Reglan - FDA Issues A Black Box Warning

Reglan Lawsuits:
Reglan Lawsuits And Injury Claims

FDA Actions On Reglan

In 1985, the Food and Drug Administration (FDA) approved Reglan, a dopamine receptor antagonist, for short-term use by patients suffering from severe nausea or vomiting when all other treatment methods have been attempted and have failed. However, statistics show that about 30% of prescriptions written for Reglan are for more than the approved twelve weeks, with many written for more than one year! There can be many reasons for this; pressure from the patient to continue the medication if it affords relief not found from other medicines, physician lack of knowledge of dosing protocols as well as extreme pressure from the manufacturers of metoclopramide drugs to prescribe their drugs.

On February 29, 2009, the FDA issued a ‘black box warning’(the strongest warning available) for Reglan and its generic, metoclopramide HCL, because, when this drug is taken for more than the prescribed four to twelve weeks or at higher than advised dosages, devastating and often permanent side effects can occur. The most devastating side effect, perhaps, is tardive dyskenesia. This syndrome presents as involuntary and repetitive spasms of the face and extremities. Symptoms include:

• Grimacing, pursing, smacking or puckering of the lips
• Tongue protrusions
• Rapid eye movements and uncontrolled blinking
• Involuntary arm and leg movements
• Impaired finger movements

Additional Side Effects of Reglan

Other serious side effects from prolonged use of metoclopramide include: dystonia (a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures), depression, raised prolactin levels, epilepsy, hypertension, persistent vomiting, Parkinson’s disease, renal insufficiency or fatigue. Reglan is counterindicated during the first trimester of pregnancy and should only be used in lactating patients in extreme cases.

Although it has been known for years that prolonged use of metoclopramide drugs can cause tardive dyskinesia and other dangerous side effects with prolonged use, manufacturers indicated that the rate of this syndrome was only about 0.2% when studies show that the actual rate may be 100 times higher!

Defective Drugs

Before a prescription drug can be marketed and sold in the United States, it must pass a series of trials in order to gain the approval of the FDA. After a drug has been aqpproved, the FDA monitors it through post-marketing reports submitted by the manufacturer and through MedWatch, an FDA program that allows both consumers and health care professionals to report serious side effects, quality control issues and medical problems possibly associated with drugs and products that are regulated by the FDA.

When an unforeseen side effect occurs after a drug has come onto the market, the FDA may issue a warning to the public and/or request that changes be made to the drug's label, i.e. the ‘black box warning’ on Reglan. If the side effect is deemed serious, with the FDA deciding that the risks of the drug outweigh its benefits, the agency may recall the drug.

As of this writing, just a few of the drugs that have been issued warnings or recalled by the FDA include:

• Vioxx®, manufactured by Merck & Co. and Bextra®, manufactured by Pfizer, were both recalled from the market by the FDA, in 2004 and 2005, respectively. Both drugs are NSAIDS, non-steroidal pain relievers and were effective at relieving arthritis-type pain. Unfortunately, severe gastrointestinal problems often accompanied these drugs.

• Celebrex®, another effective NSAID, has undergone several label revisions, warning physicians and patients of the risk of cardiovascular and gastrointestinal problems associated with prolonged use of this drug.

• Zyprexa®, an anti-psychotic medication that has been used by over 14 million people over the past 13 years, has a number of serious side effects, necessitating a number of label changes. Side effects include blood sugar disorders, tardive dyskinesia, kidney failure, pancreatitis, heart arrhythmias and seizures. These serious side effects can lead to coma and death and remain even after the drug is stopped.

You may also be familiar with many of the products from the Hydroxycut product line that were recently recalled by the FDA for dangerous side effects. Although technically not a drug, these supplements still fall under the auspices of the government regulatory agency.

If you or a loved one has taken Reglan or other dangerous drugs, and have experienced these devastating symptoms, please contact our experienced and compassionate personal injury attorneys with your injury claims, by filling out the form on this page. We are here to see that you receive the monetary compensation that you deserve!