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Metoclopramide Side Effects Lawsuit
Metoclopramide Side Effects Lawsuit
Metoclopramide, generic name of Reglan, is an antiemetic medication that offers short-term relief from heart burn and vomiting caused by gastroesophageal reflux. It speeds up stomach muscle functions that help in quick digestion of food. However, metoclopramide side effects lead to drug-induced movement disorders, nervous system breakdowns, and numerous major health problems. The drug has been linked to tardive dyskinesia, a serious and irreversible movement disorder.
Metoclopramide FDA Warning
The FDA allows metoclopramide drugs only as a short-term measure – up to 12 weeks. It has notified both doctors and consumers about the serious side effects of the drug associated with the off-label use. In February 2009, the FDA issued a public health advisory alerting healthcare professionals in the United States to the possible link between metoclopramide and tardive dyskinesia. It added a black box warning to the drug informing consumers and doctors about the possible side effects due to long-term use and overdose of the drug. The new label changes were made mandatory for both metoclopramide tablets and injections. The FDA also asked the manufacturer of these drugs to make necessary arrangements to put in place a proper risk evaluation and mitigation strategy so that patients receiving their drugs would be fully informed about the risk associated with metoclopramide side effects.
Metoclopramide Side Effects
Metoclopramide can cause tardive dyskinesia, a rare and fatal movement disorder. The risk of this irreversible disorder is proportionate to the duration of the drug therapy and the total cumulative dose. The longer is the duration, the greater is the risk. This neurological disorder leads to involuntary and repetitive movements of upper limbs and the lower face. Lip smacking, pursing one’s lip, chewing, impaired finger movements, unexplained and uncontrolled grimacing, troubled respiration, and brisk eye movements are the common symptoms of this syndrome. These conditions inducedby this disorder remain even after the discontinuation of the drug, and no effective treatment of the disorder is available.
Nervous System Side Effects
Metoclopramide induces nervous system problems, including tongue protrusions, muscle rigidity, wryneck condition caused by side muscle contraction, and opisthotonos. There are a few reports of hyperthermia and fatal neuroleptic malignant syndrome caused by the drug. These disorders result in altered consciousness and autonomic dysfunction leading to death. Patients suffering from Parkinson’s-like symptoms due to the drug are at the risk of being misdiagnosed. Metoclopramide leads to Parkinson’s-like symptoms within 6 months of the drug therapy. The drug may cause acute dystonia in AIDS or HIV-positive patients. Other metoclopramide side effects include drowsiness, restlessness, hallucinations, akathisia, lightheadedness, and fatigue.
Endocrine Side Effects
Metoclopramide side effects cause galactorrhea, suppression of normal menstrual flow, breast development in males, increase in aldosterone levels, and impotence.
Psychiatric Side Effects
Patients taking metoclopramide drugs are likely to suffer from depression, psychosis, and other psychiatric illness. Withdrawal and reintroduction of the drug can cause insomnia, anxiety, and mania.
Cardiovascular Side Effects
The post-marketing study reports have linked metoclopramide to hypertension, hypotension, abnormally heartbeat, and sudden cardiac arrest. The drug reportedly causes congestive heart failure induced by sinus arrest and aggravates hypertensive crisis in patients with vascular tumor in adrenal gland.
Hematologic Side Effects
Overdose of metoclopramide is responsible for methemoglobinemia in both adults and children. Other hematologic side effects of the drug include leukopenia, abnormal metabolism leading to abdominal pains and confusion, and agranulocytosis blood disorder.
Hepatic Side Effects
Abnormal liver function, jaundice, arteriovenous diversion, and obstruction in bile flow are documented hepatic side effects of metoclopramide.
Other Metoclopramide Side Effects
Patients receiving metoclopramide therapy are likely to develop hypersensitivity and gastrointestinal side effects. The FDA has also received a report of dystonic reaction, caused by musculoskeletal side effects of the drug. Metoclopramide induces renal problems, such as urinary frequency and incontinence, and ocular problems, such as visual disturbances caused by decline in pupil diameter.
About 1,000 metoclopramide Lawsuit have been filed in the State of New Jersey alone. All but 120 Lawsuit are less than six months old. The New Jersey state law had set a February, 2011 time limit for all metoclopramide personal injury claims to be filed. Most of these Lawsuit are seeking compensation against life-threatening side effects. The plaintiffs have accused the manufacturers of failing to inform consumers about possible metoclopramide side effects, including tardive dyskinesia. In July 2010, all metoclopramide Lawsuit were centralized at the court of Atlantic County Judge Carol Higbee under the multidistrict litigation provision. The number of consolidates cases now stands at 983.
On February 23, 2011, three Texas residents filed a lawsuit against four metoclopramide manufacturers, Teva Pharmaceuticals, Barr Laboratories, Pliva, Richmond Pharmaceuticals, and Watson Laboratories, claiming that they developed tardive dyskinesia and Parkinson’s disease because of the drug side effects. While two of the plaintiffs used the drug for about a year and a half, the third one took it for 10 years.
Two metoclopramide Lawsuit filed in New Orleans in July 2010 are also awaiting trial. The plaintiffs, Leslie Keeper and Ellen Austin, have claimed that metoclopramide-based drugs caused them to suffer from nervous system disorders, including tardive dyskinesia and injuries to the extrapyramidal motor systems. Watson Pharmaceuticals and Actavis are named as defendants in the cases. The Lawsuit want drug manufacturers to compensate the plaintiffs for medical expenses, suffering, psychological pain, disfigurement, and loss of earnings.