Side Effects & Recall Lawsuit
Zyprexa Side Effects Lawsuit
Zyprexa by Indiana-based pharma major Eli Lilly is atypical antipsychotic medication useful for the treatment of psychotic conditions, including schizophrenia and bipolar disorder. Approved in 1996, the drug raked $5 billion in annual sales last year. However, Zyprexa has been linked to diabetes, disorders caused by nervous system breakdown, and metabolic disorders in patients. The drug is also harmful for fetus and may cause defective birth – infants born with nervous system and respiratory disorders.
Zyprexa Complaints and Warnings
The FDA has received around 400 reports of diabetes caused by Zyprexa use. The British and Japanese national drug regulators have also identified serious hyperglycemia and diabetes cases caused by the drug. In November 2001, an article in the Journal of the American Medical Association was the first to report the possible association between the drug and hyperglycemia in adolescents. The FDA staff review in December 2001 also echoed the same apprehensions.
A study conducted by Duke University Medical Center in 2002 reported that patients taking Zyprexa are susceptible to ketoacidosis, a serious complication induced by diabetes. The research identified 300 Zyprexa-linked diabetes cases, including 100 patients with ketoacidosis, 22 with fatal pancreatitis, and 20 deaths caused by Zyprexa side effects. The British Medical Journal also reported extensively on the diabetes risk to schizophrenia patients taking Zyprexa.
The Japanese Ministry for Health and Welfare and the nodal medicine control agency in the United Kingdom immediately issued warnings highlighting diabetes-related complications from the drug. The British National Formulary also recommended gradual recall of the drug citing acute withdrawal syndrome associated with it.
In 2003, the FDA asked manufacturer Eli Lilly to strengthen the label warnings on Zyprexa. The new product information alerted consumers and doctors of diabetes related potentially fatal side effects. In 2004, the U.K. Committee on the Safety of Medicines called for restrictions on prescribing Zyprexa to elderly patients with dementia. In December 2006, a report in New York Times claimed Eli Lilly made subtle attempts to play down reports on the health risks of Zyprexa. It cited several internal communications in the company on the possible diabetes side effects observed during the trial but never published or reported to the FDA.
Zyprexa Side Effects
Diabetes and Metabolic Side Effects:
Zyprexa carries a greater risk of inducing and aggravating diabetes compared to other antipsychotic medication. It affects the metabolic process, promotes fat deposition, decreases insulin sensitivity, and increases triglyceride levels. The drug makes our body obtain energy from fat. As a result, carbohydrates remain unutilized in the body. This leads to development of insulin resistance. The drug also increases appetite leading to binge eating, weight gain, acidosis, hypoglycemia, hypokalemia, and hyponatremia. Diabetes patients are at the risk of ketoacidosis accumulation of glucose and carbohydrates in the body
Nervous System Problems:
Zyprexa overdose causes somnolence and neuroleptic malignant syndrome. The disorder, which causes autonomic dysfunction, muscle rigidity, and altered cognitive performance, has above 20 percent mortality rate. The drug also develops sleep-related eating disorder, acute withdrawal symptoms, insomnia, hypertonia, emotional lability, agitation, and facial paralysis.
Cardiovascular Side Effects:
The common side effects include
tachycardia and hypertension. The post-marketing studies have reported congestive heart failure, hemorrhage, atrial fibrillation, cerebrovascular accident, and pulmonary embolus linked to the drug. Elderly patients with dementia are at greater risk of death due to heart failure caused by Zyprexa.
Gastrointestinal Side Effects:
Zyprexa leads to flatulence, increased appetite, frequent dry mouth, constipation, and increased salivation. Other side effects, such as dysphagia, gastroenteritis, mouth ulceration, periodontal abscess, and rectal hemorrhage, have also been reported. The FDA has also received a few complaints of Zyprexa -induced acute pancreatitis.
Hepatic Side Effects:
A 78 year-old woman, who had no prior lever problem, reportedly developed severe hepatic side effects within 13 days of taking Zyprexa. The drug has also been linked to rare side effects, such as hepatitis, mixed liver injury, and liver fatty deposit.
Respiratory Side Effects:
Zyprexa infection causes pneumonia and other fatal respiratory problems in elderly patients. Asthma, apnea, increased cough, dyspnea, hypoxia, voice alterations, lung edema, and fatal lower respiratory tract infection have also been reported.
Other Zyprexa Side Effects:
Ocular problems attributed to Zyprexa include amblyopia, abnormal vision, cataract, eye hemorrhage, and ocular muscle abnormality. The drug can lead to hematologic disorders, resulting in anemia, leukocytosis, leukopenia, and thrombocythemia. Zyprexa musculoskeletal side effects include extremity pain, arthritis, and osteoporosis.
Eli Lilly faced the first Zyprexa class action lawsuit in 2004, seeking compensation for all those who had suffered from the side effects of the drug. In September 2008, a New York federal judge allowed another class action to proceed. The plaintiffs, third party payors, accused the manufacturer of selling the drug at high prices, overstating its benefits, and hiding the Zyprexa side effects. In November, an Ontario court certified another Canadian class action seeking recovery of the money the consumers had paid for the drug purchase. It cited the sufferings the consumers had undergone due to failure of Eli Lilly to inform about the drug side effects.
In 2005, Lilly announced that it would set up a $700 million fund to settle 18,000 personal injury Lawsuit. In 2007, it paid $500 million to 12,000 plaintiffs, who claimed to have developed diabetes after taking Zyprexa. There are still 1,200 Lawsuit awaiting trial or settlement in the United States. The Canadian class action is to cost a whopping $900 million to the pharma major. In 2009, Eli Lilly was fined $1.4 billion for illegally marketing and promoting off-label use of Zyprexa.