Reglan & Tardive Dyskinesia

Marketed by Alaven Pharmaceuticals, Reglan is prescribed for a number of gastrointestinal problems. The drug comes with the risk of several serious side effects, including tardive dyskinesia, a condition involving involuntary facial and body movements. In 2011, Reglan was estimated to be used by more than 2 million Americans.

*Please seek the advice of a medical professional before discontinuing the use of this drug.

Reglan 5mg Pill

Used to Treat: Gastrointestinal issues, including gastroparesis, chemotherapy-related nausea and vomiting, as well as nausea and vomiting in some post-surgery patients

Manufacturer: Alaven Pharmaceuticals

Black Box Warnings: Treatment with metoclopramide can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities.

FDA Approval: 1980

Generic Form: Metoclopramide

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Reglan (metoclopramide) is used to treat conditions including acid reflux, migraines and heartburn.

It has been available in the United States since 1979, and was approved by the Food and Drug Administration the following year. It is available in orally disintegrating tablets or injections.

It is used to address several gastric issues, including:

  • Slow stomach emptying in people with diabetes, also known as gastroparesis
  • Nausea and vomiting that can happen with cancer chemotherapy
  • Nausea and vomiting that may happen after surgery in patients whose doctors do not want them treated with a stomach tube and suction
  • Facilitating the insertion of tubes into the small intestine in both adults and children in some instances
  • Helping to empty stomach contents or to help barium move through patients’ intestines during an X-ray examination of the stomach or small intestine

Gastroparesis is a chronic disorder that affects an estimated 5 million people in the United States and involves symptoms including nausea, vomiting, bloating, abdominal pain, heartburn, anorexia, and weight loss. It is sometimes associated with diabetes.

Reglan works for gastroparesis, in part, by affecting different receptors in the gastrointestinal (GI) tract, including a dopamine receptor that has a relaxant effect on the gut. Overall, the drug facilitates increased gastric emptying by enhancing contractions in the gastric system and decreasing relaxation in part of the stomach after meals.

GI Tract within Human Body Outline
Reglan affects different receptors in the GI tract in order to facilitate gastric emptying

Reglan has also been found effective at decreasing post-operative nausea and vomiting in patients who received general anesthesia.

FDA: Tell Doctor About Medical Conditions

If you have kidney problems, your doctor may opt to prescribe a lower dose. For patients with liver problems and heart failure, Reglan may cause the body to retain fluids. And in diabetics, patients taking Reglan may have to have their insulin dose adjusted.

According to the FDA, it is not known if Reglan will harm the unborn. It can pass into breast milk and may harm a breast-feeding infant.

Still, according to some reports, nursing mothers have taken drugs, including Reglan, to help them produce more milk, even though doctors say this can be risky. Lactation consultants have prescribed the drugs, saying they can increase the hormone responsible for breast milk production, prolactin.

Common side effects for Reglan include feeling restless, sleepy, dizzy, or exhausted; headaches; confusion; and trouble sleeping.

The FDA recommends telling your doctor about all medical conditions before taking Reglan, including:

  • Depression
  • Parkinson’s Disease
  • High blood pressure
  • Kidney problems
  • Liver problems
  • Heart failure

Reglan Side Effects Include Tardive Dyskinesia

Potential serious side effects of Reglan include depression, thoughts about suicide, suicide, Parkinson’s disease and Neuroleptic Malignant Syndrome, a rare, but serious condition that can be fatal and must be treated in a hospital. Symptoms include high fever, stiff muscles, thinking problems, a fast or uneven heartbeat, and increased sweating.

Symptoms of Parkinson’s include slight shaking, body stiffness, trouble moving, and balance issues. For patients who already have the disease, taking Reglan could make the symptoms worse.

Use of Reglan, especially for longer than 12 weeks, carries the risk of developing a condition known as tardive dyskinesia (TD), a neurological disorder that involves involuntary, rapid movements of the face and body. The definition of tardive is “delayed,” and dyskinesia means “abnormal movement.” The “delay” is the time between the beginning of drug treatment and the onset of symptoms.

TD symptoms include:

  • Grimacing
  • Finger movement
  • Jaw swinging
  • Tongue thrusting
  • Rapid, uncontrolled movements of arms, fingers, toes, legs, hips

In addition to the typical facial movements that are part of tardive dyskinesia, the condition can also involve twitching and rapid and uncontrolled movements in the patient’s arms, fingers, toes, legs, hips, and torso. These random body movements can be uncomfortable and painful as well as embarrassing, making it a social handicap. Severe cases of this disorder can be debilitating and make it difficult to perform simple tasks like talking, walking and eating. In some instances, patients have trouble breathing.

“Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the Food and Drug Administration’s Center for Drug Evaluation and Research.

Because there have been no large-scale studies of TD, it is unclear how many people suffer from the condition, but it is estimated that 50-60 percent of people on neuroleptics will develop the disorder during their lifetimes. People who are 65 or older, particularly women, also show a higher risk for developing it.

Depending on the person, TD symptoms may be mild and only last for a short time or they may continue indefinitely. If the condition is diagnosed early enough, changing medications may be enough. In some instances, however, it can be permanent.

Ingrezza 40mg Capsule Label
The FDA recently approved Ingrezza to treat tardive dyskinesia

The FDA recently approved the first drug to treat tardive dyskinesia, Ingrezza. Patients in a clinical trial who took Ingrezza showed improvement in the severity of their symptoms. Ingrezza has its own potential serious side effects, however, including sleepiness and hearth rhythm problems. According to the FDA, it should not be given to patients with certain heart conditions, and patients taking it should not operate heavy machinery or participate in other dangerous activities until the drug’s effects on them are known.

Tardive Dyskinesia Cause Not Known

Even though tardive dyskinesia was identified more than 50 years ago, its precise cause is not well understood.

Most drugs associated with TD are neuroleptics, which work by affecting the way the brain processes a chemical called dopamine. Dopamine controls the reward and pleasure centers of the brain and helps regulate movement and emotional response. Imbalances of this chemical are linked to diseases like Parkinson’s, schizophrenia, bipolar disorder and attention deficit hyperactivity disorder (ADHD).

Anyone who takes or has taken an antipsychotic medication is at risk of developing TD.

Most antipsychotic drugs lower a person’s level of dopamine activity by targeting and blocking Ddopamine receptors. Because these drugs affect dopamine, they are also called dopamine antagonists.

Anyone who takes or has taken an antipsychotic medication is at risk of developing TD. The risk increases if you take the medication for several months or years, though there have been cases that occurred after just a few weeks of use. While older neuroleptic drugs are more likely to cause TD, there is also a risk with newer drugs.

These drugs are not used just for psychotic disorders. They treat a wide array of primarily gastrointestinal, medical conditions.

In addition, some drugs not classified as neuroleptic may also cause tardive dyskinesia, including Triavil and Aventyl, used to treat depression, and Reglan.

In one study, Reglan, or generically metoclopramide, was among three drugs and one drug pairing most commonly associated with the onset of tardive dyskinesia. The others were haloperidol, or Haldol, thioridazine or Mellaril, and a combination of perphenazine (Triavil) and amitriptyline (Elavil).

FDA Requires Black-Box Warning for Reglan

According to an FDA study conducted in 2007, a number of patients were prescribed Reglan for long-term use (defined as longer than 3 months) and this increased the number of people who suffered side effects, including TD. The incidence of TD in long-term Reglan users is cited to be as high as 20 percent in the literature. This led to the FDA requiring a black-box warning in 2009. The warning advises patients about the dangers of developing tardive dyskinesia after long-term use of Reglan and its generic counterparts.

Reglan Tardive Dyskinesia Black-Box Label

The FDA recommends avoiding treatment with Reglan for longer than 12 weeks in all, but rare cases in which the therapeutic benefit of the drug is deemed to outweigh the risk of TD. Its use should be discontinued in patients who develop signs of TD. In some instance, taking the drug can suppress or partially suppress the signs of TD, masking the underlying disease process.

Following the warning, the proportion of patients receiving metoclopramide for gastroparesis dropped from nearly 70 percent to less than 24 percent, according to one study.

If you are taking Reglan, alert your doctor and get medical help immediately if you feel depressed or have suicidal thoughts, have high fever, stiff muscles, problems thinking, or if your heartbeat becomes very fast or uneven. Also, seek immediate medical help if you experience increased sweating, or new, unusual, or uncontrollable muscle movements.

Author

Elaine Silvestrini is a career journalist with a strong desire to learn, explain, and help people. While working at Drugwatch, Elaine has reported on breaking news involving prescription drugs and medical devices and has written pieces on several large pharmaceutical companies and other topics. She is dedicated to telling people what they need to know about developments in the news, and helping consumers understand what they can do when something goes wrong with their drugs and medical devices.


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