Neurontin Side Effects and Lawsuit
Neurontin Side Effects and Lawsuit
Pfizer’s Neurontin, brand name of gabapentin, is one of the best selling anti-epileptic drugs. Approved by the FDA in 1983, the medication is used to treat seizures caused by epilepsy and neuropathic pain. Neurontin is also administered during the expensive Prometa Treatment Protocol for addiction rehabilitation. The drug has been linked to serious nervous system problems and psychiatrist disorders, including cases of suicides. Manufacturer Pfizer faces numerous lawsuits for marketing the drug for a dozen uses not approved by the FDA.
Neurontin Warnings and Complaints
In 2008, the FDA asked Pfizer to put label warnings highlighting risk of suicidal thoughts on Neurontin. In 2009, the federal regulator updated the warning stating that the drug significantly increased the risk of depression, suicide, and behavioral changes. In April 2010, an epilepsy drug research study published in the Journal of the American Medical Association, warned against off-label use of the drug for migraine, bipolar disorder, and depression. According to the report, the drug increases suicidal risk in such conditions that have already made patients prone to these kinds of thoughts.
An investigating report published in the Archives of Internal Medicine in June 2011 has alleged that Pfizer deceived doctors and patients on the safety and effectiveness of Neurontin. According to it, the original motive of the manufacturer in recruiting doctors for anti-epilepsy medication study was to increase the prescription of the drug.The study cited market reports and internal communication among Pfizer employees to substantiate its claim that the disguised effort was a “seeding trial” and also aimed at preventing introduction of a rival drug by a competitor. The doctors were rewarded by increased prescriptions.
Neurontin Side Effects
Neurontin has been linked to several cases of suicides, violent deaths, and self-injury cases. The drug substantially impacts the energy level and nerves in the body, which in turn influence the behavioral changes and mood swings. Patients become subject to the increased risk within a week of taking the drug. The risk is greater for people with psychiatric disorders.
Withdrawal Side Effects:
Abrupt discontinuation of Neurontin after long-term use provokes symptoms similar to alcohol or any banned substance withdrawal. According to research reports, patients taking the drug experience nervous system disorders, such as insomnia, anxiety, disorientation, hypersensitivity, hypertension, restlessness, headaches, and chest pain. There were reports of seizures even in non- epilepsy patients triggered by withdrawal symptoms.
Nervous System Problems:
According to post-marketing reviews, Neurontin creates medium to severe nervous system problems. Its common side effects include somnolence, lack of muscle coordination, and fatigue. On a more serious note, the drug leads to reflex problems, hyperkinesia, paresthesia, tumor in the Central Nervous System, abnormal dreaming and hostile behavior, intracranial hemorrhage, facial paralysis, hallucination, paranoia, and psychosis. Depression, personality disorder, motor control disorder, hysteria, and amnesia are long-term effects of the drug.
Gastrointestinal Side Effects:
Neurontin is responsible for frequent gastrointestinal problems, such as anorexia, flatulence, and gingivitis. Patients are also at the risk of suffering from stomatitis, gum hemorrhage, constipation, hemorrhoids, breast enlargement, bloody stools, and inflammation of the tongue. There were also reports of pancreatitis, blisters in mouth, tooth discolor, peptic ulcer, salivary gland enlargement, irritable bowel syndrome, and hematemesis in patients taking the drug over a period of time.
Though hematologic side effects of Neurontin are rare, yet they can be serious. Fluctuation in white blood cell counts, purpura, anemia, reduced number of platelets, and abnormal lymph node enlargement, and non-Hodgkin's lymphoma have also been reported in patients taking the drug.
Hypertension is the most frequent cardiovascular side effect of Neurontin. Patients are also likely to have angina pectoris, myocardial infarction, tachycardia, pulmonary thrombosis, and peripheral vascular disorder. Congestive heart failure, heart block, edema and pericarditis have also been reported in patients using Neurontin for long time.
Other Side Effects:
The drug leads to abnormal vision, risks of cataract, eye itching and pain, eye hemorrhage, and blurred vision. The FDA has received a complaint of oculogyric crisis caused by Neurontin. Dermatologic side effects f the drug includes alopecia, leukocytoclastic vasculitis, urticaria, and skin necrosis. Neurontin causes arthralgia, joint stiffness and swelling, and improper muscle coordination problems. Aspiration pneumonia, hepatotoxicity, hearing loss, and inner ear infection have also been reported in patients taking the drug.
Pfizer is facing over Neurontin 1,200 lawsuits on off-label use and side effect of the drug. In May 2004, Warner-Lambert, the subsidiary of Pfizer responsible for Neurontin marketing pleaded guilty on charges of promoting the drug for unapproved uses. It agreed to pay $430 million – $240 million criminal fine, $83.6 million to settle civil liabilities, $68.4 million to states, and $38 million for personal injury caused to consumers.
In October 2008, a lawsuit filed in a Boston federal court sued Pfizer for suppressing medical studies on side effects of the drug. It accused the manufacturer of influencing, withholding, and altering scientific reports to boost sales of the drug until 2003. In July 2009, Pfizer reached a clandestine deal to settle the first Neurontin wrongful death lawsuit, filed by the family members of a Massachusetts woman alleging that the drug was responsible for suicide committed by the victim.
In March 2010, a Boston jury asked Pfizer to pay $142.1 million to Kaiser Foundation Health Plan for off-label marketing of the drug that caused the plaintiffs to pay $90 million to plan buyers. In May 2010, Pfizer paid undisclosed amount to settle another wrongful death lawsuit involving a Tennessee minister. The victim’s family had alleged that he committed suicide due to side effects of the drug.