Reglan is a prokinetic drug made and manufactured by Wyeth, a company that was acquired by the Pfizer Company in 2009. Carrying the generic name metoclopramide, Reglan and its generic counterparts have been used to treat gastroparesis. The drug was approved by the FDA in 1980.
Gastroparesis is a condition in which the stomach is unable to empty itself into the intestines, and this is where Reglan comes in – to aid in emptying the stomach. This is not the only ailment that Reglan was approved to treat. The drug is also intended to treat heartburn, gastroesophgeal reflux disease, and acid reflux disease. Off-label uses also include treatment of nausea, and pregnancy related issues including morning sickness and nausea. Reglan is also used to help cancer patients, to help treat nausea from chemotherapy.
Many patients have filed lawsuits not just against Wyeth, but also against generic drug manufacturers and companies due to reports of a neurological disease called Tardive Dyskinesia that were allegedly a result from the use of metoclopramide. Claims against the various drug manufacturers include negligence, fraud and deceptive marketing methods, among others. Plaintiffs are seeking to gain compensation for medical expenses, lost wages and earning capacity, loss of quality of life, and punitive damages.
There have been many attempts on consolidating federal cases into litigations, these efforts were denied. However, Reglan state lawsuits filed in the New Jersey state courts have been centralized and are overseen by Superior Court Judge Carol E. Higbee.
In another state, the Alabama Supreme Court has allowed plaintiffs who have used generic versions of Reglan to filed cases against brand-name companies for charges on failure to warn drug risks on warning labels. This is so because companies that make generic versions of a drug are required to use the same packaging labels as those of a brand name drug.
Reglan Lawsuits and Litigation
Over 5,000 lawsuits regarding tardive dyskinesia have been filed against various drug companies that market the generic metoclopramide or Reglan. Experts say that the FDA’s requirement of the black box warning was one of the factors that led to patients filing lawsuits against various drug manufacturers.
People who have been using Reglan that have been diagnosed with Tardive Dyskinesia have filed lawsuits against Wyeth claiming that the manufacturer hid the side effects of the drug and failed to warn the public about them. Other complaints filed in court against the drug companies have been alleged of negligence, fraud, and deceptive marketing activities as well as the companies’ failure to ensure that the drug warnings were accurate, failure to sufficiently warn the public regarding he dangers of long term use, failure to report all the information regarding the drug’s risks to the FDA, and failure to adequately test and research the risks of long and short term use of the drug.
Plaintiffs say that they suffered permanent neurologic damage due to the negligence of the companies involved, which includes tardive dyskinesia and other nervous system disorders. People who filed the lawsuits are demanding compensation for medical expenses, lost wages and earning capacity, loss of quality of life, and punitive damages.
Pfizer is not the only manufacturer facing lawsuits for the development of Tardive Dyskinesia. Other manufacturers who make the generic version of the drug have also been receiving lawsuits due to the development of the side effect in patients. Companies have been paying compensations in millions to patients suffering from tardive dyskinesia as a result of metoclopramide and Reglan use.
In 2009, lawyers in federal lawsuits attempted to consolidate the cases into a federal litigation for pretrial motions and discovery. However, the court rejected the movement. It was in July 2010 when the New Jersey Supreme Court ordered that all Reglan lawsuits that were filed in New Jersey state courts be consolidated for case management purposes under the supervision of Superior Court Judge Carol E. Higbee. All New Jersey state court lawsuits with regard to Reglan must be filed in the court of the said judge.
As reported in The New York Times, the Alabama Supreme Court ruled in January 2013 that a patient could sue a brand-name company even if the patient in question had taken generic versions of the drug that the company did not make. This is simply due to the fact that companies that manufacture generic versions of a drug has no control over drug label because generic manufacturers are required to use the same labels as the brand name products; which means that these companies cannot be sued for failing to warn patients and doctors about the risks associated with the drug.
What is Reglan?
Reglan was initially marketed by A.H. Robins, which is now referred to as Wyeth – a company owned by Pfizer since 2009. The drug carries the generic name of metoclopramide. The prokinetic drug is used to increase muscle contractions in the upper digestive tract so that the process of the stomach emptying into the intestines is accelerated for individuals who have tried other medication but haven’t had relief of symptoms. Reglan is also used for treatment of heartburn that is caused by gastroesophageal reflux, but only for short term uses (four to twelve weeks) – no longer than 12 weeks of use.
Reglan is used in patients who have diabetes that have gastroparesis – a condition wherein the stomach cannot empty itself normally. Metoclopramide blocks dopamine receptors so that nausea can be treated in patients. The drug works in such a way that it interacts with acetylcholine and dopamine receptors in the gastrointestinal muscles and nerves in order to speed up stomach emptying and progression of the upper intestines. Reglan is mainly used to treat gastroesophageal reflux disease, acid reflux disease and heartburn, as approved by the FDA for short term uses.
Some patients are being prescribed of the medication for off-label uses such as treatment of nausea and morning sickness associated with pregnancies, lactation stimulation, and migraine headaches.
Reglan’s injectable version is approved to treat nausea associated with cancer chemotherapy. Be that as it may, the following illnesses are used as off-label of the drug: radiation nausea (cancer-related), oral version of Reglan for chemotherapy nausea, and post-operation nausea.
Reglan Symptoms and Side Effects
Every drug has its own side effects and Reglan is no exception. While taking metoclopramide, minor side effects may occur such as anxiety, confusion, depression, decreased sexual ability, inability to keep still, muscle spasms, abnormal production of breast milk, enlarged or tender breasts, swelling of hands or feet, and changes in menstruation. More adverse occurrences such as Tardive Dyskinesia, and Neuroleptic Malignant Syndrome may also occur. These two severe side effects can be fatal or permanent in patients.
Neuroleptic Malignant Syndrome is often fatal. The other side effect can develop in patients even after short exposures to a drug; symptoms of this disease include the following: high fever, sweating, unstable blood pressure, fast heartbeats, confusion, stupor, rigid muscles, hyperthermia, alerted consciousness, cognitive changes (i.e. delirium), and autonomic dysfunction. These side effects can appear as early as the first two weeks of drug use.
Another side effect that can occur from the use of Reglan is Parkinsonism. Symptoms of this disease include slight shaking, stiffness of the body, difficulty in movement, and difficulty in staying balanced. Patients who have Parkinson’s disease that take Reglan can also experience worse Parkinson’s symptoms.
Tardive Dyskinesia can be permanent in some patients. The neurological disorder causes rapid movements of the face and the body in patients. It can also arise from the use of neuroleptics, specifically those used to control schizophrenia.
There has been no study on Tardive Dyskinesia on a large scale. An estimated figure of 50 to 60 percent of people on antipsychotics and neuroleptics, however, may develop the disorder. In addition, patients aged 65 and above have been deemed to have higher risks of getting the disorder.
This disorder is identified through repetitive, involuntary, and insignificant movements (i.e. grimacing, tongue protrusion, lip smacking, puckering and pursing of lips, and rapid eye blinking), as well as fast arm, legs or trunk movements can also arise. Because Tardive Dyskinesia is a disease that can last for the rest of an individual’s life, it affects victims in various levels – physical, mental, social, emotional, and vocational.
Tardive Dyskinesia symptoms can vary from mild to short term, depending on the patient, and has no cure; forcing patients to live with Tardive Dyskinesia for the rest of their lives in cases of permanence. Patients with this disease can opt to use tetrabenazine – the only drug approved to treat tardive dyskinesia that can aid in controlling the symptoms. However, tetrabenazine also has its share of side effects, particularly, drowsiness, Parkinsonism, depression, insomnia, anxiety, and restless leg syndrome.
Other drugs can also be used to treat but not cure tardive dyskinesia. However, results have not been well documented yet. These other drugs are Tocopherol, Opiates, calcium channel blockers, Lithium, Botulinum toxin – more commonly known as botox, Niacin, and atypical neuroleptics – which are newer antipsychotics.
FDA Warnings, Recalls and Reports
Approved by the FDA in 1980, Reglan has become a widespread drug in the United States. In 2011, about 1 million people had filled Reglan prescriptions. The Institute for Safe Medication Practices released a report in the same year, stating that there have been 1,180 cases of Tardive Dyskinesia associated with the use of Reglan.
Various medical journals have published studies over the past decades regarding metoclopramide’s relation to serious side effects including Tardive Dyskinesia. In fact, the Archives of Disease in Childhood published a review of the drug back in 1970. Doctors reported in the review that children who were given metoclopramide for inconsequential stomach illnesses showed dangerous reactions during the treatment. The symptoms were seen in a span of one to three days which included pain and inability to move the neck, irregular movements in the eyes, restless or spasm movements of the torso and arms, inability to speak, and facial grimacing.
A 2007 FDA study revealed that a significant number of patients were prescribed Reglan for use longer than three months. This also raised the figure of patients that developed tardive dyskinesia. Because of the study, the FDA required that the drug should have a black box warning.
In the warning label of the drug, Tardive Dyskinesia was mentioned as a rare side effect. It was in February of 2009 when the FDA reported that Reglan would begin to have a black box warning in their labels to alert patients that the use of Reglan or its generic counterparts for over three months may lead to Tardive Dyskinesia.
Many patients were unaware of the tardive dyskinesia risks of the drug until the FDA required a black box warning on the packaging labels. As to what was initially disclosed in the package inserts of Reglan, the manufacturer actually downplayed the risks of developing the side effect; the actual risk of development of the drug is 100 times greater than what was written in the inserts.
Reglan is the only drug in the market that is approved to treat gastroparesis. A recent review found that there were no benefits in taking the drug beyond one month for treatment of gastroparesis; and that the risk of tardive dyskinesia development increases with longer use of the drug.
Long-term use of Reglan, specifically lasting longer than 12 weeks, has been associated with the occurrence of Tardive Dyskinesia. The FDA had approved the drug only for short term uses. However, about 30 percent of patients are being prescribed for long term uses such as 12 months or even longer.