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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

Generic Metoclopramide HCl

Metoclopramide HCL (Hydrochloride), also referred to simply as metoclopramide, is the generic name for Reglan, a drug available only by prescription, that is used to treat the symptoms of diabetic gastroparesis, a condition where the stomach does not contract. Symptoms include vomiting, nausea, heartburn, indigestion, persistent fullness after meals and loss of appetite. Metoclopramide is also used to treat heartburn in people with gastroesophageal reflux disorder (GERD) and to treat nausea and vomiting that is caused by cancer chemotherapy and surgery.

The U.S. Food and Drug Administration (FDA) approved Reglan, a dopamine receptor antagonist, in 1985, for short-term use by patients suffering from severe nausea or vomiting when all other treatment methods have been attempted and have failed. However, about 30% of prescriptions written for metoclopramide are for more than the approved twelve weeks, with many written for over one year! There are many reasons for this including 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.

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

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

Other serious side effects from prolonged use of metoclopramide-containing drugs 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. Metoclopramide HCL is counterindicated during the first trimester of pregnancy and should only be used in lactating patients in extreme cases.

Generic Drug Information

Today, almost half of the prescriptions filled in the United States are for generic drugs. Generic drugs are copies of brand-name drugs that have exactly the same dosage, effects, side effects, risks, safety and strength as the original brand name drug. They also must have the same dosage form – whether pill, tablet, capsule, caplet, liquid or injection. The drug regulatory boards in Australia, Canada, Chile, Israel and the United Kingdom all have the same requirements as in the U.S. Since generic drugs are normally substantially cheaper than their branded counterparts, some people question if they are as good. The simple answer is “yes”; the FDA ensures than generic drugs are just as effective and safe as the brand name drugs.

Generic drugs are less expensive since their manufacturers have not had the expenses of developing and initially marketing a new drug. When a company markets a new drug, that firm has spent a lot of money on research, development, marketing and promotion of the drug. Patents are granted for all new drugs, giving the company the exclusive right to sell the drug for the duration of the patent period.

When a patent nears expiration, other companies can apply to the FDA for permission to manufacture and sell generic versions of the drug. Since there are no costs for development of the drug, these companies can afford to produce and sell it more cheaply. When multiple companies begin producing and selling a drug, competition can drive the price down even further.

Generic drugs often have different colors, flavors or inactive ingredients than the original medications. Trademark laws in the U.S. do not allow the generic drugs to look exactly like the brand-name preparation, although the active ingredients in both preparations must be exactly the same, resulting that both have the same medicinal effects. In some cases, the generic drugs are even made by the same brand name company; just with different packaging!

You should know that some drugs do not have a generic equivalent. Your physician or druggist can tell you if there is a generic version of the medication you are talking or if there is a medication in the same family of drugs that has a generic. However, some physicians may prefer to write prescriptions for the brand name of a drug in a few instances, such as for some antibiotics, hormones and digitalis (heart medicine).

Have You Taken Metoclopramide HCL?

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!

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