Seroquel®

SEROQUEL® RECALL ALERT — Pancreatitis, Tardive Dyskinesia, Birth Defects, Diabetes

Seroquel® is in a class of medications called atypical antipsychotics, which are used to treat symptoms of schizophrenia that may include hearing voices, seeing things, or sensing things that are not there, mistaken beliefs or unusual suspiciousness. Seroquel® has been linked to a high incidence of type 2 diabetes, hyperglycemia and other blood sugar disorders.  Data from a 2003 study, reported at a International Society for Pharmacoepidemiology conference, suggests that patients taking Seroquel® had 3.34 times as many cases of diabetes as those on older antipsychotic drugs.

The FDA approved a new drug application for Zeneca Pharmaceuticals and Astra Zeneca (“Zeneca’) in 1997. The medical community recognizes Seroquel as an effective treatment for patients suffering from schizophrenia; however, the risks of diabetes and increased levels of blood sugar outweigh its benefit for the vast majority of patients receiving the medication.

Clinical studies have demonstrated a connection between Seroquel and increased blood sugar and diabetes. However, the company has been slow to adopt a proper warning to reflect the risk of diabetes. In January, 2004, the FDA asked manufactures of this class of drugs to add a warnings statement describing the increased risk of hyperglycemia and diabetes in patients taking these medications. The warning mentions a possible connection but downplays the data indicating that background rates and precise adverse event data complicate any conclusion or causal evidence. As a result, the warning has not affected growth, and in 2006, Seroquel’s (change to Seroquel )earned $3.4 billion in sales.

Indeed, the Japanese Seroquel label includes a more prominent warning, specifically stating that there is a link between diabetes and the use of Seroquel. The United States label, however, does not unequivocally reflect this known problem, which is misleading and deceptive to consumers and physicians.

“Off Label Marketing”
When the FDA approves a drug it also approves the label, which lists the indications, adverse events, warnings, and patients for which the drug can be prescribed. Once a drug is approved to treat one condition, it is within a physician’s judgment whether to prescribe it for others if they think it will be effective. This provision is geared to not restrict prescribing drugs where it is clear that the risk of not giving the drug outweighs the use. Off label uses should be rare because there is insufficient safety data to support the use outside the approved class. By law, drug companies are not allowed to influence physicians to prescribe a drug for indications other than those listed on the label.

Seroquel® has also been linked to pancreatitis.  Pancreatitis is dangerous inflammation of the pancreas.  The pancreas secretes digestive enzymes into the small intestine that help digest fats, proteins, and carbohydrates in food. The pancreas also releases the hormones insulin and glucagon into the bloodstream that help the body use the glucose it takes from food for energy.

FDA Information

The FDA’s Patient Information Sheet for Seroquel® (Quetiapine Tablets) includes warnings for the following risks:

• Neuroleptic malignant syndrome (NMS) – a life-threatening nervous system problem that can cause high fever, confusion, stiff muscles, sweating, a fast or irregular heart beat, change in blood pressure and may effect an individuals kidneys.
• Tardive dyskinesia (TD) – a chronic disorder of the nervous system characterized by involuntary jerky movements of the face, tongue, jaws, trunk, and limbs — usually developing as a late side effect of prolonged treatment with antipsychotic drugs.
• High blood sugar and diabetes.

The FDA reported in 2005 that Seroquel® posed a higher risk of causing DEATH in certain elderly patients taking Seroquel for dementia.

What should you do?

If you are using Seroquel® and you have experienced pancreatitis or an onset of diabetes, you should consult your prescribing physician as soon as possible.

Should you contact an attorney?

If you or a loved one have used Seroquel® and have been diagnosed with an inflamed pancreas or pancreatitis while using Seroquel® or your loved one has died while using Seroquel® you should contact an attorney immediately for review of a potential claim against the manufacturer. Statutes of limitation, which are deadlines set by state law, regulate the filing of lawsuits, and they vary from state to state. If the statute of limitations in your state expires, your right to pursue a claim against the manufacturer may be forever barred. If you or a loved one was harmed by Seroquel®, you should not delay in contacting an attorney.

Who should I call?

Call Tim Edwards and Ed Wallis at (901) 527-4673, fill out the evaluation form below, or send us an e-mail by clicking HERE. We will provide you a case evaluation and discuss steps you may be able to take to address your concerns.

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Our firm has over thirty years experience helping injured persons, and we have the dedication to try and help you. We provide our e-mail, work telephone and cellular telephone numbers to our clients so they have access to us day or night, weekday or weekend. We invite you to call us to discuss your case, and let us talk with you on how we can try and help.

For More Information

Tim Edwards
Ed Wallis
Glassman, Edwards, Wade & Wyatt, P.C.
26 N. 2nd Street
Memphis, TN 38103
Telephone: (901) 527-4673
(901)275-0600 AFTER HOURS
E-Mail: CLICK HERE

The authors practice across the State of Tennessee and associate with attorneys across the nation to help achieve justice for our clients.  Although not limited to these areas, the authors, Tim Edwards and Ed Wallis, do practice in the Mid South and Metropolitan Memphis area, an area encompassing Western Tennessee, Eastern Arkansas and Northern Mississippi. Some cities covered in our wide range of practice include Memphis (TN), Cordova (TN), Bartlett (TN), Collerville (TN), Millington (TN), Covington (TN), Somerville (TN), Ripley (TN), Dyersburg (TN), Tiptonville (TN), Union City (TN), Dresden (TN), Humboldt (TN), Milan (TN), Trenton (TN), Alamo (TN), Brownsville (TN), Jackson (TN), Bolivar (TN), Henderson (TN), Lexington (TN), Selmer (TN), Savannah (TN), Parsons (TN), McKenzie (TN), Huntingdon (TN), Paris (TN), West Memphis (AR), Marion (AR), Southhaven (MS), Olive Branch (MS), Hernando (MS), Horn Lake (MS), and Senatobia (MS). This also includes the following counties: SHelby (TN), Tipton (TN), Lauderdale (TN), Dyer (TN), Lake (TN), Obion (TN), Gibson (TN) Crockett (TN), Haywood (TN), Fayette (TN), Hardeman (TN), Madison (TN) Henderson (TN), Carroll (TN), HHenry (TN), Benton (TN), Chester (TN), Decatur (TN), McNairy (TN), Hardin (TN) Perry (TN), Tunica (MS), Desoto (MS), Tate (MS), Marshall (MS), Lafayette (MS), Crittendon (AR), Mississippi (AR), Poinsett (AR), Craighead (AR), Cross (AR), St. Francis (AR), Lee (AR), Phillips (AR).

The authors also accept free case evaluations to persons across the state of Tennessee, including Nashville, Franklin, Brentwood, Knoxville, Chattanooga, Johnson City, Bristol, Kingsport, Lebanon, Clarksville and beyond.

Even if you live outside the State of Tennessee and Mid South, we may still be able to help, so please contact us today, as our attorneys are licensed in numerous state courts and federal courts, and can still by associating with counsel across the country to help you with your needs.