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FDA issues 'Black Box Warning' in connection with prescribing Reglan

-RenoGazetteJournal

05/13/2009 - It's wonderful when prescription medications cure ailments, but what happens when they cause adverse medical side effects? I'm angry because I appear to be suffering from permanent central nervous system damage associated with the prescribed drug Reglan (brand name for "metoclopramide") prescribed over a year ago for a digestive disorder.

I received a letter dated April 30 from my GI's office noting the FDA has placed a "Black Box Warning" on Reglan, explaining, it's possibly linked "with the development of a condition known as "tardive dyskinesia", a permanent condition that's untreatable.

TD is a disorder of the tongue, mouth and jaw, causing them to move uncontrollably in abnormal ways --the drug can also cause face jerking or involuntary body movements, including:

Repetitive movements of the extremities

Lip smacking, pursing, puckering

Grimacing

Tongue protrusion

Rapid eye movements

Impaired movement of fingers

"The movements are pretty much constant, except during sleep," reported Dr. Jeff Bronstein in a Los Angeles Times article. He's with the UCLA David Gaffen School of Medicine.

If you have taken Reglan or are taking it now, the FDA says it's time to call your physician whether you are experiencing side effects or not. Although some people's systems aren't seriously affected, the FDA notes, unhealthy side effects are becoming more commonplace.

People can go on-line and Google FDA Medical Watch for information, to report a reaction caused by Reglan or call their toll-free number 1-800-FDA-1088.

An FDA Black Box Warning gives a strong message to prescribers, mandating they take action, said a friend who is the head instructor at a respected medical clinic in California. That's why my doctor's office sent a warning missive to patients.

The LA Times story indicates Reglan, Octamide and Maxolon (metoclopramides) are frequently used nowadays for gastrointestinal malfunctions, or to ease nausea and vomiting. The drug blocks the body's release of the neurochemical dopamine.

I'm mostly angry because I wasn't informed of side effect possibilities, which were known. Why didn't my gastroenterologist warn me? Why didn't he give me a choice? Why, when I called him noting I was having tremors, did he recommend I cut the dosage in half? Why did I have to insist on an appointment to discuss my failing health?

I didn't realize I was lip smacking until Stony brought it to my doctor's attention. I thought a gland was overproducing saliva. At that time, the doctor said: "You are allergic to Reglan -- don't take it again." It was too late to stop some lip smacking and other disorders.

And worse, with Reglan's shoddy reputation, why did daughter Nicole's gynecologist recommend Reglan when she had morning sickness? She told her, "no way", recalling what happened to me.

Another Dayton friend, treated with Reglan for digestive disorders, was admitted to the hospital within 12 hours of her first dose.

Today, there are sores on my tongue, lesions inside my mouth, and inflamed gums because they are constantly being irritated by my wiggling tongue. Although my perplexed dentist writes prescriptions to help, it's nerve racking.