Saunders and Walker Class Action Law Firm
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Seroquel

Seroquel Recall Possible Class Action Lawsuit

Please note: Our firm is no longer reviewing or accepting Seroquel cases”

AstraZeneca’s blockbuster antipsychotic drug Seroquel (generic quetiapine) was first approved for use in 1997. It was designed to treat patients suffering from bipolar disorder and schizophrenia. Last year, Seroquel was AstraZeneca’s second best selling drug in spite of the fact that the drug has been the subject of more than 15,000 lawsuits.

In one court document, AstraZeneca Global Safety Officer Wayne Geller admits that the company knew as far back as 2000 that Seroquel could cause diabetes.

Seroquel lawsuits contend that AstraZeneca executives attempted to quash scientists’ attempts at revealing serious risk factors associated with the drug including weight gain, diabetes, and high blood pressure. The lawsuits also contend that the AstraZeneca marketing team aggressively advertised Seroquel for uses for which it had not received FDA approval. For instance, according to court documents related to the lawsuits, Seroquel has been marketed to physicians for the treatment of MDD (major depressive disorder).

In 2003, the FDA ordered AstraZeneca to include on its Seroquel label a warning concerning diabetes and related illnesses. In January 2004, AstraZeneca updated its label to include the mandatory diabetes warning.

In April 2005, the FDA mandated a black box warning for Seroquel citing the dangerous side effects associated with the drug. Here’s an FDA excerpt:

“FDA has found that older patients treated with atypical antipsychotics for dementia had a higher chance for death than patients who did not take the medicine. This is not an approved use. FDA has asked the companies that make these medicines to change their labels to include this important information.”

In addition to diabetes and high blood pressure, Seroquel has been linked to Neuroleptic Malignant Syndrome (NMS), a potentially life-threatening nervous system disorder characterized by high fever, achy muscles, irregular heart beat, and mental confusion. Tardive dyskinesia, a muscle movement disorder, has also been associated with the use of Seroquel.

In a subsequent FDA warning letter to AstraZeneca’s Director of Promotional Regulatory Affairs, James L. Gaskill, the FDA cites errors and omissions of material fact concerning their marketing of Seroquel. The FDA states in the letter that AstraZeneca is in violation of FDA regulations and must address these violations concerning the diminution of the warning concerning diabetes, tardive dyskinesia, and Neuroleptic Malignant Syndrome.

Dosage Forms And Strengths
25 mg tablets,
50 mg tablets,
100 mg tablets,
200 mg tablets,
300 mg tablets,
400 mg tablets

25 mg Tablets (NDC 0310-0275) peach, round, biconvex, film coated tablets, identified with ‘SEROQUEL’ and ‘25′ on one side and plain on the other side, are supplied in bottles of 100 tablets and 1000 tablets, and hospital unit dose packages of 100 tablets.

50 mg Tablets (NDC 0310-0278) white, round, biconvex, film coated tablets, identified with ‘SEROQUEL’ and ‘50′ on one side and plain on the other side, are supplied in bottles of 100 tablets and 1000 tablets, and hospital unit dose packages of 100 tablets.

100 mg Tablets (NDC 0310-0271) yellow, round, biconvex film coated tablets, identified with ‘SEROQUEL’ and ‘100′ on one side and plain on the other side, are supplied in bottles of 100 tablets and hospital unit dose packages of 100 tablets.

200 mg Tablets (NDC 0310-0272) white, round, biconvex, film coated tablets, identified with ‘SEROQUEL’ and ‘200′ on one side and plain on the other side, are supplied in bottles of 100 tablets and hospital unit dose packages of 100 tablets.

300 mg Tablets (NDC 0310-0274) white, capsule-shaped, biconvex, film coated tablets, intagliated with ‘SEROQUEL’ on one side and ‘300′ on the other side, are supplied in bottles of 60 tablets, and hospital unit dose packages of 100 tablets.

400 mg Tablets (NDC 0310-0279) yellow, capsule-shaped, biconvex, film coated tablets, intagliated with ‘SEROQUEL’ on one side and ‘400′ on the other side, are supplied in bottles of 100 tablets, and hospital unit dose packages of 100 tablets. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP].

AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Rev 09/08. FDA Rev date: 10/24/2008

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Saunders & Walker
3491 Gandy Blvd
Pinellas Park, FL 33781
Phone: (727) 579-4500
Phone: 1-800-748-7115

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