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FDA Issues Reglan Warning About Serious Movement Disorders

FDA Issues Reglan Warning About Serious Movement Disorders

The medication known as metoclopramide came under fire in early 2009 when the FDA issued a Reglan warning pertaining to ties between the drug and the disease Tardive Dyskinesia (TD). Those at risk for developing Tardive Dyskinesia are individuals who have taken the medication for long periods of time, the elderly, and women. Health care professionals have been advised to counsel their patients regarding the risks involved with the medication and to only prescribe it if they believe the benefits outweigh the considerable risks. The FDA also ruled that all prescriptions must be labeled with an appropriate “black box” Reglan warning to convey the new information.

Unfortunately for those who have developed the condition after taking Reglan, Tardive Dyskinesia has no cure, and is called a movement disorder due to its affects on the body. A typical patient exhibits repetitive movements of the face, including lip smacking, cheek puffing, and tongue thrusting. These repetitive actions are entirely involuntary, and the victim has no control over them in any capacity. In more severe cases, the patient experiences continued lack of motion control, moving from the face to the limbs and trunk. The first step in treating TD is stopping all metoclopramide containing drugs. In some cases, the victim sees a slackening of symptoms when the drug is out of their system; however, for many others, the symptoms persist. In some instances, health care professionals have seen improvements with other therapies.

Aside from the FDA’s alert, there is also a long list of other drugs that are considered culprits in developing TD. Doctors should instruct about the dangers of the other drugs as well, including: Thorazine (Chlorpromazine), Clozaril (Clozapine), Haldol (Haloperidol), Seroquel (Quetiapine), Loxitane / Loxapac (Loxapine), Mellaril (Thioridazine), Navane (Thiothixine), Prolixin / Modecate (Fluphenazine), Piportil (Pipotiazine), Trilafon (Perphenazine), Orap (Pimozide), Stelazine (Trifluoperazine), Risperdal (Risperidone), Serentil (Mesoridazine), and Zyprexa (Olanzapine). There are also non-neopleptics including Prozac (Fluoxetine), Zoloft (Sertraline), Nardil (Phenelzine), Elavil (Amitriptyline), Asendin (Amoxapine), Sinequan (Doxepine) and Tofranil (Imipramine). Other risk factors include old age, heart conditions, high blood pressure, or cirrhosis.

Additionally, many common drugs and different kinds of prescription medication can cause serious interactions when used in conjunction with the drug, such as acetaminophen, alcoholic beverages, antispasmodic drugs, cimetidine, cyclosporine, digoxin, insulin, MAO inhibitor antidepressants, levodopa, narcotic painkillers, sleeping pills, tetracycline, and tranquilizers. Medical professionals are expected to adequately provide detailed information when instructing their patients to take the medication. Other severe side effects not included in the “black box” Reglan warning are confusion, abnormal thinking, unusual weight gain, sudden and increased sweating, shortness of breath, hallucinations, loss of bladder control, decreased sexual ability, changes in heart beat or heart rhythms, seizures, mental and mood changes including increased depression or anxiety, and suicidal thoughts or actions.

One of the most difficult facets about developing Tardive Dyskinesia is that it makes day-to-day existence extremely difficult for the patient. Even basic tasks require an inordinate amount of concentration due to the repetitive movements brought on by the disease. To the untrained eye, the symptoms mirror other similar diseases with repetitive movements, such as Tourette’s Syndrome and Parkinson’s Disease. Obtaining a positive diagnosis from a doctor can be a long process, but is necessary if the victim is seeking to file lawsuits in the future.

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