On February 26, 2009 the Food and Drug Administration announced that manufacturers of metoclopramide (REGLAN), a drug used to treat gastrointestinal disorders, must add a boxed warning about the risk of long-term or high-dose use, which has been linked to tardive dyskinesia, a condition which may include involuntary and repetitive movements of the body, even after the drugs is no longer taken.
What is Reglan?
What is GER or GERD in infants?
What is tardive dyskinesia?
Reglan and tardive dyskinesia
How is Reglan-induced tardive dyskinesia treated?
Other risks are associated with Reglan
For whom is Reglan NOT an appropriate treatment?
Have you suffered Reglan side effects?
Reglan (metoclopramide) is a prescription drug used to treat gastrointestinal problems in children and adults. Post-operative patients and those undergoing cancer treatments may be given Reglan to reduce nausea and vomiting. Children and adults with gastroesophageal reflux (GER) and gastroesophageal reflux disease (GERD), diabetic gastroparesis, and other related conditions are often prescribed Reglan. Infants are commonly given Reglan to treat GER and GERD.
Reglan is a dopamine antagonist that increases lower esophageal sphincter pressure and improves gastrointestinal emptying. The FDA approved Reglan, which is manufactured by Baxter Healthcare Corporation, for short-term treatment (between 4 and 12 weeks) of these conditions only after conservative methods of treatment have failed. However, evidence shows that one-third of patients are prescribed Reglan for longer than 12 weeks, which is against FDA recommendations.
Evidence shows that Reglan can cause Tardive Dyskinesia, a serious and often irreversible movement disorder. Infants who are given Reglan appear to be at an even greater risk for this serious drug side effect.
GER, or gastroesophageal reflux, is a common condition in infants, which typically resolves between six and twelve months of age. Infants with GER often regurgitate or spit up and have difficulties feeding. An estimated two-thirds of all infants suffer from GER, though the pathological condition called GERD (gastroesophageal reflux disease) affects only one in 300 babies.
GERD in infants can result in regurgitation and other more serious symptoms including poor weight gain, marked irritability, respiratory complications, and other serious symptoms.
When GER or GERD develop, parents are naturally concerned and often bring their child to the doctor on numerous occasions in hopes of finding a solution to this troubling condition. There are certain conservative treatments that are to be used before prescribing medications. Should these treatments prove ineffective, a doctor may prescribe a prokinetic agent like Reglan.
It is important for a medical professional to adequately explain the increased risk of tardive dyskinesia posed by use of Reglan. It is also crucial that Reglan is only used for short-term relief of gastrointestinal problems when other treatments have failed, since the risk of developing serious Reglan side effects appears to increase with prolonged use. A medical professional’s failure to follow these precautions may constitute medical malpractice.
Tardive dyskinesia is a serious and potentially irreversible movement disorder caused by certain prescription medications. While antipsychotic medications are the common culprit in cases of tardive dyskinesia, Reglan and other gastrointestinal medications can also cause this severe drug side effect. Patients with tardive dyskinesia suffer abnormal muscle movements, which can affect the muscles of the face, mouth, jaw, tongue, eyes, neck, shoulders, torso, larynx, diaphragm, arms, legs, feet, and hands.
Impairments in movement caused by tardive dyskinesia can be:
- Athetoid (slow, continual, and sinuous)
- Choreiform (rapid, non-repetitive, jerky, and purposeless)
When these involuntary movements affect the muscles of the face and mouth, it can cause tongue licking, smacking, and sucking; lip pursing or puckering; facial grimacing; chewing movements, cheek puffing, abnormal blinking, and more. When this movement disorder afflicts the muscles of the arms and legs, it can cause hand clenching, toe curling or jerking, foot tapping, ankle flexing, and other abnormal movements. When tardive dyskinesia affects the muscles of the trunk, it can cause twisting, rocking, thrusting, swaying, and head tilting to the side or the back. Tardive dyskinesia can adversely affect the ability to breathe, swallow, walk, and talk.
The FDA and Baxter Healthcare recognize that Reglan increases the risk of tardive dyskinesia. However, they have failed to adequately convey the seriousness of Reglan side effects.
Treatment duration-dependant risk
At least two independent studies have found that 27 to 29 percent of patients who are prescribed Reglan for periods exceeding 12 months develop tardive dyskinesia. However, this condition can develop in patients even after short-term use.
Studies have shown, and the FDA has confirmed, that the risk of developing tardive dyskinesia is greater for children (including infants) than for adults taking Reglan. While tardive dyskinesia can afflict anyone taking Reglan, children are much more susceptible to the effects of Reglan.
It can be extremely difficult to diagnose tardive dyskinesia in a patient taking Reglan because the drug actually conceals the very symptoms it is causing. For this reason, symptoms of tardive dyskinesia can break out suddenly when Reglan use is reduced or terminated. This factor can also increase the severity of tardive dyskinesia since a patient may have the condition for quite a while before Reglan is stopped.
There is no known treatment for tardive dyskinesia. In some cases, the syndrome may disappear or symptoms may be reduced weeks or even months after a patient stops taking Reglan. In some cases, tragically, the damage is irreversible.
In addition to tardive dyskinesia, patients should also be aware that Reglan could cause the following rare but serious side effects:
- Mental depression
- Other types of severe movement disorders, including Neuroleptic Malignant Syndrome
- Abdominal pain
- Trouble breathing
- Cardiovascular conditions (including rapid heart beat and high blood pressure)
- Blood problems (infants may be at a particularly high risk when exposed to Reglan)
There are a variety of other more common side effects associated with Reglan use including diarrhea, fatigue, restlessness, irritability, sleep problems, and more.
Patients with the following conditions may not be good candidates for Reglan use due to the increased risk of adverse drug events:
- History of allergy to Reglan or related medications
- Breast feeding (Reglan can pass into breast milk, causing unwanted effects in nursing babies)
- Central Nervous System (CNS) depressants and alcohol
- Kidney disease
- Cardiovascular conditions
- Certain stomach conditions
It is important to speak with your doctor about Reglan. Together, you can weigh the risks and benefits of Reglan use for you.
If you or a loved one has developed tardive dyskinesia or another serious Reglan side effect, you may be eligible to seek compensation for your medical bills, losses, and suffering. Please contact us today to speak with a qualified Reglan attorney at Oshman & Mirisola. We can evaluate your case to determine the best way to protect and maximize your legal interests.