Parker Waichman LLP Injury Alerts
MORE DANGER IN THE MEDICINE CABINET: The Anti-Psychotic Drugs Seroquel, Risperdal, and Zyprexa.Sep 1, 2003 It has recently come to light that three drugs, which are commonly prescribed for schizophrenia and other psychotic illnesses are associated with an increased risk of developing diabetes or causing complications in patients who have already been diagnosed with diabetes. Seroquel (made by AstraZeneca), Risperdal (made by Jannsen Pharmaceutical), and Zyprexa (made by Eli Lilly), are now associated with higher rates of diabetes than older anti-psychotic drugs.
This information was obtained from the results of a study of patients treated at veteran’s hospitals and clinics throughout the United States. The study, which was based on the analysis of medical records from 19,878 veterans who were treated with anti-psychotics from October 1998 to October 2001, highlighted the risks associated with Risperdal as well as Seroquel and Zyprexa. Of 5,981 veterans who took Zyprexa, 200, or 3.34 percent, developed diabetes, compared with 170, or 2.43 percent, of 7,009 veterans taking Haldol or another older medication. Of 5,901 patients taking Risperdal, 193, or 3.27 percent, developed diabetes; 21, or 2.39 percent, of 877 veterans taking Seroquel developed the illness. All three drugs raised a patient's chances of developing the illness by about 50 percent, but the meaning of the increased risk among patients taking Seroquel was unclear because of the smaller number of subjects who took the drug, the researchers said. The risk also appears to be heightened for patients under age 54.
These three drugs, while intended to help, are now associated with serious side effects and, as a result, have become the subject of several lawsuits. This situation is just another example of drugs being rushed to market prematurely. The economic pressure on pharmaceutical companies to recover the money spent for research and development has become a significant factor in FDA approvals which are becoming more and more questionable with each new drug that manifests dangerous side-effects within a relatively short period after release. This has lead public interest watchdog groups like Public Citizen to strongly recommend that people wait five to seven years before taking any new drug in order to appreciate more fully the severity and extent of any potentially dangerous side effects. (http://www.citizen.org/hrg).
In addition, there is a growing concern that the scope of drug warnings given to the public in this country is often inferior, less informative, or too slowly updated when compared to warnings in other countries regarding the very same drugs. The United States has also lagged far behind other countries in ordering drugs off the market once their ineffectiveness or dangerous qualities have become known or strongly suspected. Parker & Waichman has consistently brought our subscribers timely information regarding dangerous drugs in numerous Newsletters and on our website.
Seroquel, manufactured by AstraZeneca, is an oral medication used to manage the symptoms of schizophrenia such as delusions, thought disorder, hallucinations, social withdrawal, lack of energy, apathy, and reduced ability to express emotion. The anti-psychotic, which was approved by the FDA for marketing in 1997, affects a broad range of neurotransmitter receptors, including serotonin receptors.
News of Seroquel’s side effects emerged as a result of data gathered at a medical conference in Philadelphia which showed that patients on Seroquel had 3.34 times as many cases of diabetes as those on older anti-psychotics.
Towards the end of August, news of the serious side effects associated with Seroquel caused AstraZeneca’s stock to slip almost one percent. Just a few days later, the law firms of Parker & Waichman and Aylstock, Witkens & Sasser announced that a class action lawsuit had been commenced in the United States District Court for the Middle District of Florida on behalf of all those who had used Seroquel. The lawsuit contends that AstraZeneca was aware that Seroquel caused a high occurrence of diabetes, yet did not take steps to adequately warn doctors or patients in the United States of this potential risk.
The Japanese label for Seroquel, however, includes a detailed warning regarding the risk of diabetes and instructs medical professionals to carefully monitor patients using the drug. The Japanese label reads as follows:
Seroquel (Quetiapine) is contraindicated for use in patients with diabetes or a history of diabetes. Seroquel (Quetiapine) should be used with caution in patients with risk factors for diabetes, including hyperglycemia, obesity or a family history of diabetes. Patients receiving Seroquel (Quetiapine) should be carefully monitored for symptoms of hyperglycemia and the drug should be discontinued if such symptoms occur. The symptoms of severe hyperglycemia include weakness, excessive eating, excessive thirst, and excessive urination. Physicians should educate patients and their family members about the risk of serious hyperglycemia associated with Seroquel (Quetiapine) and how to identify the symptoms of hyperglycemia.
AstraZeneca has still not adopted this safer and more accurate label for the distribution of Seroquel in the United States.
The pending lawsuit seeks statutory, exemplary and punitive damages from the defendants for the flagrant disregard for the lives and health of the plaintiffs and class members. The lawsuit also alleges that AstraZeneca aggressively marketed and promoted Seroquel for “off label” use that was beyond its FDA approved indications. AstraZeneca is accused of offering incentives to doctors and other medical professionals in order to increase the number of Seroquel prescriptions that were written. Finally, the class action lawsuit seeks to establish a medical monitoring fund to pay for anyone who has taken Seroquel so that they can be tested for diabetes and other blood sugar disorders.
Anyone who has used Seroquel is encouraged to visit www.seroquelclassaction.com to request a free, no obligation case evaluation. A case evaluation can also be requested by contacting Parker & Waichman at 1-800-YOURLAWYER (1-800-968-7529) or online at www.yourlawyer.com.
Risperdal, which is manufactured by Jannsen Pharmaceuticals, a division of Johnson & Johnson, is another anti-psychotic drug which has been linked to diabetes and, more specifically, Type 2 diabetes. Other serious side effects, however, include Neuroleptic Malignant Syndrome (NMS), Tardive Dyskinesia, stroke or stroke-like events, and even death. (NMS is a potentially fatal syndrome involving muscle rigidity, and irregular blood pressure and pulse. Tardive Dyskinesia is a central nervous system disorder which results in involuntary movement of the limbs and twitching of the face and tongue.) Although it is primarily used for treating schizophrenia, Risperdal is also used to control other behavioral disorders in elderly patients with dementia and Alzheimer’s disease such as delusions, aggression, and anxiety.
For the past few months, Risperdal has been under scrutiny for causing the aforementioned severe side effects. Although the drug was approved by the FDA in 1994, it took some time before the dangerous side effects were completely identified though a series of studies.
On April 11th of 2003 Johnson & Johnson sent letters to thousands of physicians in the United States advising them of the possible risk of stroke among elderly patients taking Risperdal. This came after Johnson & Johnson had received 37 reports of stroke or related events such as blood clots or hemorrhages, including 16 deaths. As a result of these findings, Johnson & Johnson updated the warning label on Risperdal to include more specific information about strokes in the elderly. At this time it became apparent that Risperdal should not be used to treat dementia as there is no evidence that it is safe or effective in that capacity.
Risperdal has been known to cause irregular headaches, muscle weakness and spasms, high fever, constipation, weight gain, and headaches. Anyone who is currently taking Risperdal and has not already been made aware of the various health risks associated with the anti-psychotic should speak to their medical professional immediately.
Zyprexa, like Risperdal and Seroquel, has been found to cause serious side effects in patients, especially those who have already been diagnosed with diabetes. Knowledge of the dangers of Zyprexa were discovered as a result of a series of findings beginning in 2001 when the FDA was alerted to 19 case reports of diabetes associated with the drug. One of these cases resulted in death due to necrotizing pancreatitis, a condition in which cells in the pancreas die.
An emergency report issued by the Japanese Health and Welfare Ministry in April of 2002 concerning the side effects of Zyprexa noted that there had been two deaths of patients who had diabetes prior to taking the anti-psychotic medication. It also reported that there had been seven other patients who lost consciousness or slipped into comas after taking the drug.
In April of 2003, the Wall Street Journal ran a front page article on Zyprexa and the other anti-psychotics mentioned in this Newsletter and their connection to developing cases of diabetes in patients. The article estimated that somewhere around 11 million people have taken Zyprexa. An eight-year study found that nearly 300 patients developed diabetes, 75 became seriously ill, and 23 died. Although the FDA was aware of these cases, it has not decided whether Zyprexa is directly responsible for the illnesses and deaths and still does not require that a warning appear on the label.
In addition to the Wall Street Journal article, five lawsuits were filed against Eli Lilly and Co. accusing the company of failing to warn Zyprexa patients of the risk of diabetes. The plaintiffs are seeking damages of up to $35 million. In order to confront the charges, Lilly sponsored two patient trials and opened its files of Zyprexa patients to an outside researcher to study the issue. The lawsuits claim that Lilly knew that the product was extremely dangerous and unsafe and that it never took the necessary steps to provide this critical information to medical professionals or patients.
Finally, in May of 2003 forty reports of hyperglycemia (elevated blood sugar), diabetes mellitus, or exacerbation of diabetes were received in the UK including one which proved to be fatal.
Despite all the negative publicity, Zyprexa has, in fact, been proven to successfully treat schizophrenia. Lilly officials are concerned that the lawsuits might cause doctors to abstain from prescribing the anti-psychotic and that people who need the drug may never actually begin treatment. If you are currently taking Zyprexa and are not aware of the updates on side-effects, you should contact your physician or other medical professional immediately to receive all the necessary information.
Seroquel, Risperdal, and Zyprexa are three drugs with dangerous side effects which should not be overlooked and should be taken very seriously. The issue of these present risks has become more pressing as the drugs are now being prescribed for adults with milder medical conditions and even children who may not really need as strong a prescription drug to treat their various symptoms. At this point, the critical consideration is whether the actual benefits of these drugs outweigh the potentially dangerous side effects, the rate of adverse incidents reported, and the cost of the drugs themselves. The option of prescribing older, less risky drugs is also a consideration.
Another factor which must be taken into account is the strong connection between diabetes and schizophrenia which has been noted and studied by scientists since the 1920’s. Patients with schizophrenia and other forms of mental illnesses develop diabetes at a rate up to four times higher than the general population, whether they are on anti-psychotics or not. This is due to the fact that people with schizophrenia often display many of the risk factors associated with diabetes such as leading a sedentary lifestyle, lacking good medical care, and having poor diets and high rates of obesity.
The research surrounding Seroquel, Ripserdal, and Zyprexa is still developing and will undoubtedly be updated in the near future. It is the opinion of many physicians that although people with schizophrenia and other serious mental illnesses are at a greater risk of developing diabetes anyway, if they did not have diabetes before being prescribed an anti-psychotic and developed symptoms as a result of taking any of the above medications, then it is the drug that should be held responsible for their deteriorating physical health.
For more information on Seroquel, Risperdal and Zyprexa please visit the Parker and Waichman website at http://www.yourlawyer.com and continue to check the website for further information and updates on the current health risks and lawsuits surrounding these potentially dangerous drugs.