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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

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 to the drug’s safety label was approved by the Food and Drug Administration (FDA) and announced this month. The updated information to the drug’s WARNINGS section reinforces the Boxed Warning that was added to all metoclopramide-containing drugs in June 2009. The new warning states, “Treatment with metoclopramide can cause Tardive Dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by ... Read More

Heartburn drugs before pregnancy may increase risk for birth defects

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 published in the New England Journal of Medicine. The study looked at nearly 841,000 births registered with national databases from 1996 to 2008. In about 5,000 cases, the mothers had taken PPIs at some point during the four weeks prior to pregnancy through their first trimester. Overall, 3.4 percent of the babies whose mothers took PPIs had a major birth ... Read More

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

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 battery of tests conducted by neurologists, and a review of his medical history and medications, doctors determined that Ron suffered from a Parkinson’s-like condition known as Tardive Dyskinesia. They say it was caused by the heartburn medication Reglan. Reglan, also known by the generic metoclopramide, is a prescription medication used to treat severe heartburn, acid reflux, gastroparesis and other gastrointestinal ... Read More

Reglan as morning sickness treatment still carries risks for mom

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 affects on expectant mothers. The drug is not indicated for pregnant women but the drug has an off-label indication for the treatment of morning sickness. Metoclopramide is approved by the Food and Drug Administration (FDA) to treat severe heartburn, gastroesophageal reflux disease (GERD), and gastroparesis. Last year, the federal agency ordered a black box warning be placed on the drug ... Read More

People feared link between Reglan and suicide 20 years ago

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 in his behavior after his doctor prescribed Reglan for heartburn associated with a hiatal hernia,” she wrote. “We have done some research and found that this drug can indeed cause depression, confusion and even suicide. We were unaware of this side effect when Daddy was taking Reglan. “Why don’t doctors and pharmacists warn patients about this deadly reaction?” she asked. ... Read More

Women warn new mothers of Reglan’s depression risk

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 mother has low prolactin levels, milk supply may suffer. Drugs used to stimulate lactation work by blocking dopamine, which results in increased prolactin levels and, in many cases, an increase in milk supply. But mothers need to be aware that the drug has serious side effects. KellyMom.com, a breastfeeding and parenting blogger, warns that one major side effect of Reglan ... Read More

Woman blames Reglan for causing her young child permanent disability

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, arms and torso. The Louisiana mother has filed suit against the makers of the drug, claiming the medication caused her child to develop Tardive Dyskinesia. Harris’ lawsuit, on behalf of her minor child, claims the defendants “encouraged the long term use of these drugs, and concealed the drug’s dangerous side effects.” Last year, the Food and Drug Administration (FDA) ordered ... Read More

Medical journal studies case of Reglan-induced depression, suicide

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, to treat a sliding hiatal hernia with moderate gastroesophageal reflux. Just three months after starting Reglan, Joe began to complain that he was depressed. His depression continued to worsen, and three months later he was prescribed Zoloft. When Zoloft did nothing to improve his spirits, Joe tried three other antidepressants, Prozac, Effexor and Celexa. Nothing seemed to help. Joe became ... Read More

Reglan users blame depression, suicidal thoughts on heartburn drug

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 of the drug’s serious side effects, including the debilitating neurological disorder known as Tardive Dyskinesia in which the muscles move involuntarily. Reglan’s safety label now includes an FDA black box warning for the risk of the disorder. But another serious condition is being blamed on the medication – suicidal ideation. “My life is unbearable because of Reglan, and if the ... Read More

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

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 two years in some patients. What patients may not realize is that long-term use of the drug is no longer recommended – and, in fact, falls under an FDA black box warning – as it can cause a serious and sometimes permanent neurological disorder known as Tardive Dyskinesia. Tardive Dyskinesia is an involuntary movement disorder that causes repetitive movements of ... Read More