Seroquel
By Jane Mundy
Seroquel belongs to a class of drugs known as atypical antipsychotics, originally prescribed to manage the symptoms of schizophrenia It has since been prescribed "off label" to treat a wide variety of conditions, from depression to sleep disorders. (Health Canada approved its sale in 2004 for the treatment of bipolar disorder.)
Manufactured by AstraZeneca, Seroquel (known generically as Quetiapine fumarate) was approved by the FDA for marketing in 1997. Since that time, Seroquel has also been associated with many serious side effects, including a high incidence of diabetes, hypoglycemia (low blood sugar), and pancreatic cancer.
In August 2003, a study published in the Wall Street Journal reported that Seroquel users had a higher rate (3.34 times) of diabetes than patients taking older antipsychotics such as haldoperidol.
The study was based on medical reports gathered from almost 20,000 U.S. military veterans and concluded that Seroquel and other members of a new class of anti-psychotic drugs were linked to a higher risk of diabetes, but the risk of diabetes was greatest with Seroquel. (Other atypical antipsychotic medications are Zyprexa, Geodon, Risperdal and Clozaril.)]
This study resulted in a class action lawsuit filed against Seroquel on behalf of the US veterans for not being adequately warned of the potential risk for diabetes and other serious side effects. According to the Seroquel class action lawsuit, AstraZeneca was aware of the risk for diabetes and even had detailed warnings about it on Japanese Seroquel labels. As well, the drug company allegedly marketed the drug aggressively in the US even though it was aware of the potential risks involved and for "off label" use -- indications not FDA approved. AstraZeneca is also accused of unfairly offering incentives to doctors and other medical professionals in an effort to increase the number of Seroquel prescriptions that were written.
This is yet another case of motivation by profit and total disregard of safety.
Since the lawsuit, a growing number of reports have found a link between atypical antipsychotic drugs such as Seroquel and Type 2 diabetes.
In January 2004, the drug maker sent a Dear Health Care Provider letter to doctors throughout the US, informing them of "important labeling changing regarding SEROQUEL ® (quetiapine fumarate)." The FDA asked AstraZeneca Pharmaceuticals to add a Warnings statement describing the increased risk of hyperglycemia and diabetes in patients taking SEROQUEL:
"...Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Seroquel."
A Long List of Warnings
Common side effects of Seroquel included the following:
Abdominal pain, constipation, diminished movement, dizziness, drowsiness, dry mouth, excessive muscle tone, headache, indigestion, low blood pressure (especially upon standing), nasal inflammation, neck rigidity, rapid or irregular heartbeat, rash, sleepiness, tremor, uncontrollable movements, weakness.
Call your doctor immediately if you develop muscle stiffness, confusion, irregular or rapid heartbeat, excessive sweating, and high fever. These are signs of Neuroleptic Malignant Syndrome (NMS), a serious--and potentially fatal--reaction to the drug. Be especially wary if you have a history of heart attack, heart disease, heart failure, circulation problems, or irregular heartbeat.
Animal studies suggest that Seroquel may increase the risk of breast cancer, although human studies have not confirmed such a risk.
There is a chance that Seroquel may cause cataracts, and you may be asked to see an eye doctor when you start Seroquel therapy, and every 6 months thereafter.
Seroquel poses a very slight risk of seizures, especially if you are over 65, or have epilepsy or Alzheimer's disease. The drug can also suppress an underactive thyroid, and generally causes a minor increase in cholesterol levels.
Patients with schizophrenia and other forms of mental illnesses develop diabetes at a higher rate than the general population, whether they are on anti-psychotics or not. However, if a patient did not have diabetes before being prescribed an atypical antipsychotic such as Seroquel, and developed symptoms shortly after first taking the drug, then it is possible that the drug may responsible for their deteriorating physical health.
What is even more disturbing is that this drug has also been prescribed to patients with less serious medical conditions and it has also been prescribed to children -- the safety and effectiveness of Seroquel have not been studied in children.
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