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fda issues black box warning for reglan

Medication commonly used to treat heartburn linked to permanent involuntary muscle movement

Recently the FDA required the manufacturers of the drug metoclopramide, more commonly know as Reglan, to place a black box warning on its label. A black box warning is the strongest warning that the FDA can require.

Metoclopramide increases muscle contractions in the upper digestive tract, which speeds up the rate at which the stomach empties into the intestines. It is used short-term to treat heartburn caused by gastrophageal reflux, and also used to treat slow gastric emptying in people with diabetes, a condition called diabetic gastroparesis.

However, in recent studies, it has been shown that people taking metoclopramide can develop a serious condition called Tardive Dyskinesia.

Tardive Dyskinesia is a condition in which a person develops involuntary movements of their muscles which could include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

Long-term users of the drug, and elderly patients, especially women are at an increased risk of developing Tardive Dyskinesia. There is no known cure for Tardive Dyskinesia and even after discontinuing the drug, symptoms may still persist.

The FDA has advised physicians to avoid long term use of metoclopramide except in rare cases where the benefit outweighs the risks.

Metoclopramide is available in formulations including tablets, syrups and injections, under names including Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injections. According to the FDA, it is estimated that more than 2 million American use these products.

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Metozolv label has new tardive dyskinesia warning

Posted: December 9, 2010 Pharmaceutical

The new chewable heartburn medication Metozolv, an orally disintegrating version of Reglan (metoclopramide), has added a warning to its label alerting users of a risk of the serious movement disorder Tardive Dyskinesia with long-term use of the drug. The change

Heartburn drugs before pregnancy may increase risk for birth defects

Posted: December 1, 2010 Pharmaceutical

Women who use heartburn medication during pregnancy should not be overly concerned about the drugs causing birth defects, but using the drugs before they become pregnant may cause problems for the unborn child, according to a new study from Denmark

Restless leg syndrome turns out to be movement disorder caused by Reglan

Posted: November 12, 2010 Pharmaceutical

PHOENIX, ARIZONA – Ron, a musician and artist, was having trouble sleeping. His legs would move involuntarily back and forth under the sheets. At first, both Ron and his doctors thought he suffered from restless leg syndrome. But after a

Reglan as morning sickness treatment still carries risks for mom

Posted: October 12, 2010 Pharmaceutical

A study into the safety of the anti-nausea drug metoclopramide, also known as the brand name Reglan, on pregnant women indicates that the drug is safe in mothers and their unborn children, according to a first-time study of the drug’s

People feared link between Reglan and suicide 20 years ago

Posted: October 11, 2010 Pharmaceutical

In 1992, a woman wrote to the People’s Pharmacy, a syndicated column in her local newspaper by King Features, asking if her father’s heartburn medication Reglan (metoclopramide) may have led to his suicide. “Looking back, mother started noticing gradual changes

Women warn new mothers of Reglan’s depression risk

Posted: October 8, 2010 Pharmaceutical

It might surprise some to learn that the prescription heartburn drug Reglan (metoclopramide) has an off-label use of helping new mothers increase their milk supply. An appropriate level of the hormone prolactin permits lactation to proceed normally, but when a

Woman blames Reglan for causing her young child permanent disability

Posted: October 7, 2010 Pharmaceutical

Dawn Harris says she was never made aware that long-term use of the acid reflux drug Reglan (metoclopramide) could cause her young child to suffer a serious, permanent and disabling neurological injury that results in involuntary movements of the face,

Medical journal studies case of Reglan-induced depression, suicide

Posted: September 28, 2010 Pharmaceutical

There was nothing in their 47 years of marriage that would make Lucy* suspect her husband Joe* was anything besides energetic and optimistic. That all changed when the 70-year-old was prescribed the drug Reglan, also known by the generic metoclopramide,

Reglan users blame depression, suicidal thoughts on heartburn drug

Posted: September 21, 2010 Pharmaceutical

The prescription drug Reglan, also known by the generic metoclopramide, is taken by more than 2 million people to treat the symptoms of gastrointestinal problems such as severe heartburn, gastroesophageal reflux disease (GERD) and gastroparesis. Many people have become aware

Long-term use of heartburn drug can cause serious movement disorder

Posted: September 16, 2010 Pharmaceutical

Thousands of people who suffer from gastrointestinal problems such as severe heartburn, acid reflux and gastroparesis, are treated with the prescription drug Reglan, known by the generic metoclopramide. These drugs were originally prescribed for daily use for as long as