Tegretol Side Effects Lawsuit
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Tegretol Side Effects Lawsuit
Tegretol Side Effects Lawsuit
According to a research report published in the July 2011 issue of the Journal of the American Geriatrics Society, epilepsy drug Tegretol leads to reduced brain functioning and early death among the elderly. The study conducted by researchers at the Norwich-based University of East Anglia has found that the drug blocks acetylocholine, a key neurotransmitter responsible for anticholinergic activity of the brain. This creates cumulative effect on the functioning of the brain and puts people over the age of 65 at the increased risk of death.
Tegretol, brand name of carbamazepine, is manufactured by Swiss pharmaceutical giant Novartis. The anticonvulsant drug, approved by the FDA in 1974, is available in both tablet and liquid forms and is used as a medication for certain types of epilepsy-related seizures, bipolar disorder, and intense nerve pain linked to diabetic neuropathy and trigeminal neuralgia, and post-traumatic stress disorder. Tegretol side effects have been linked to reduced brain functions, neurological disorders, motor coordination impairment, stomach problems, cardiovascular problems, vision problems, thyroid problems, serious adverse cognitive anomalies, fatal skin reactions, and serious birth defects.
Tegretol Side Effects Warnings
In 1989, a report published in the New England Journal of Medicine highlighted the link between Tegretol and the incidence of birth defects. Researchers found that the drug interfered with fetal development when taken by expectant mothers and caused fetal malformations, such as craniofacial defects, developmental delays, and hypoplasia of the nails. Another study published in 2001 also warned that Tegretol and other anticonvulsants put a fetus at the risk of potential harmful side effects.
In December 2010, a research report published in the British Medical Journal claimed that women using of Tegretol during pregnancy are likely to have babies with major birth defects, including spina bifida, a birth problem that affects the development of spinal cord in the foetus. According to the report, the risk of spina bifida among new borns exposed to the drug is 2.6 times higher than unexposed infants.
In 2007, the FDA warned health care professionals about the risk of deadly skin reactions, such as toxic epidermal necrolysis, skin lesions, and the Stevens-Johnson syndrome caused by Tegretol side effects in people with the HLA-B*1502 gene variant, exclusively found in people of Asian origin. It recommended that doctors should test patients for the gene variant before prescribing the drug. The European patients with two genetic variants, HLA-B58 and HLA-A*3101, are also subject to the adverse reactions of the drug.
In January 2008, the FDA issued a safety alert warning consumers and doctors about the potential risk of suicidal thoughts or actions caused by the side effects of Tegretol and other antiepileptic drugs. Twelve months later, the FDA
mandated necessary label changes adding the warning to the prescribing information on the drugs. In May 2009, the federal regulator updated product labeling and asked manufacturers of all epilepsy drugs to include a medication guide explaining the risk to patients.
Findings of a study published in January 2011 issue of the Archives of Neurology linked Tegretol side effects with the risk of fractures in elderly patients. Researchers studied 15,792 Canadian patients above 50 years of age between 1996 and 2004. They ascertained that Tegretol therapy could increase the risk of wrist, hip, and vertebra fractures by about 24%.
Detailed Tegretol Side Effects
Birth Defects
Tegretol therapy during pregnancy causes major birth defects, such as heart problems, skeletal defects, developmental delay, and limb defects. Spina bifida or malformation involving the spinal cord is the most serious side effect that affects infants. The spinal cord remains incomplete and lacks some vertebrae. In such conditions, portions of the spinal cord may bulge out through the bone openings and cause serious injuries for the life. Cleft lip and palate, hypoplasia of the midface and fingers, and death of infant due to severe malformations are also linked to Tegretol side effects.
Cardiovascular Problems
Tegretol cardiovascular side effects include cardiac arrhythmia, congestive heart failure, syncope, worsening of coronary artery disease, pulmonary embolism, and increase in hypertension. The post-marketing reviews have also documented cardiovascular problems, such as heart block, electrocardiographic changes, lupus development, cardiac tamponade, and aggravated hypotension.
Nervous System Disorders
Tegretol causes nervous system side effects, such as headache, dizziness, muscle movement coordination problems, drowsiness, confusion, involuntary eyeball movements, and speech disturbances. Patients treated with the drug therapy are likely to suffer from rigidity, euphoria, and oculogyric crises. The drug has also been linked to cognitive anomalies, such as EEG slowing.
Skin Problems
The drug can cause fatal skin reactions and dermatological side effects, such as Toxic epidermal necrolysis, rashes, skin pigmentation alterations, hives, exfoliative dermatitis, photosensitivity, diaphoresis, and Stevens-Johnson syndrome. Patients of Asian origin and with HLA-B 1502 gene variant are more likely to suffer from dangerous skin reactions.
Gastrointestinal Side Effects
Tegretol causes oral ulceration, nausea, diarrhea, and constipation. There are also reports of dry mouth and chemical pancreatitis caused due to the side effects of the drug.
Endocrine Side Effects
The drug increases T3 and T4 metabolism in the body, which may result in hypothyroidism. Tegretol also increases cholesterol and causes hyponatremia or low sodium level in the blood. Hyponatremia leads to dehydration and fatigue.
Psychiatric Side Effects
Tegretol therapy leads to a number of psychiatric side effects, including suicidal thoughts and actions. The discontinuation can cause withdrawal symptoms, including rebound mania.
Other Tegretol Side Effects
Hematologic side effects include leukopenia, neutropenia, and blood diseases, such as hemolytic anemia, erythroid arrest and thrombocytopenia.
Hypersensitivity side effects include intense itching sensation, pneumonitis, hives, and skin rashes.
Hepatic side effects include liver function abnormalities, bile duct inflammation, and granuloma formation.
Renal problems leading to renal failure and acute kidney inflammation.
Oncologic side effects include large-cell lymphoma.
Tegretol Lawsuits
A number of law firms are reviewing potential Tegretol lawsuits on behalf of parents of children born with spina bifida problem. In April 2010, a group 19 plaintiffs filed a Tegretol class action lawsuit in St. Clair County Circuit Court against Novartis, CIBA and Sandoz, claiming that they suffered serious injuries, including Stevens-Johnson syndrome, skin problems, and fractures, after using the drug therapy for epilepsy and bipolar disorder. Many medical and pharmaceutical malpractice lawsuits alleging fatal side effects to the plaintiffs due to Tegretol overdose are pending in various courts across the United States. Tegretol lawsuits is sure to add to the problems of Novartis, which has already paid more than $500 million in the past two years to settle a number of drug injury lawsuits and wrong marketing practices.