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Saphris® Lawyer & Lawsuit

Saphris (asenapine maleate) is a prescription antipsychotic medication intended to be administered in the treatment of schizophrenia and bipolar disorders in adults. However the U.S. Food and Drug Administration (FDA) recently acknowledged an influx of adverse events associated with the use of Saphris. Saphris treatment may coincide with severe, life-threatening type I hypersensitivity allergic reactions.

If you or a loved one has been injured by Saphris, you should contact our lawyersimmediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.

Saphris Lawsuit Overview

As a subsidiary of the world renown pharmaceutical company Merck & Co., Organon Pharmaceuticals USA Inc. introduced Saphris to the U.S. market on August 13, 2009. Saphris gained the approval of the FDA after the medication trumped placebos at reducing schizophrenia and bipolar symptoms in adults during pre-market clinical trials. Subsequently, Saphris quickly became a viable treatment option for nearly 87,000 patients in the United States suffering from behavioral disorders.

Asenapine maleate, otherwise known as an atypical antipsychotic, is the active ingredient found in Saphris. As an atypical antipsychotic, Saphris has the inherent ability to block receptors in the brain’s dopamine pathways. Therefore, the suppression of these receptors may assist in the treatment of schizophrenia and bipolar disorders in many adults.

Off-label uses have also been witnessed in the treatment of dementia-related psychosis and those suffering from post traumatic stress disorder (PTSD). However, Saphris is not approved by the FDA to treat these behavioral problems.

Unfortunately, treatment with Saphris may significantly increase the risk of patients experiencing severe type I hypersensitivity allergic reactions. Researchers believe the potential mechanism for the association between Saphris and these dangerous allergic reactions may be directly related to the pharmacodynamics of asenapine maleate. Due to the severity of type I hypersensitivity allergic reactions, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Saphris lawsuit.

FDA Saphris Safety Communication

The following FDA Safety Communication acknowledges the dangers associated with Saphris treatment:

The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris (asenapine maleate). The Contraindications, Warnings and Precautions, Adverse Reactions, and Patient Counseling Information sections of the Saphris drug label have been revised to include information about this risk and to inform healthcare professionals that Saphris should not be used in patients with a known hypersensitivity to the drug.

Adverse Events Associated With Saphris

Contained in the FDA’s Adverse Event Reporting System (AERS) database are 52 cases of Type I hypersensitivity reactions (allergic reactions) associated with Saphris treatment. Signs and symptoms of Type I hypersensitivity reactions may include the following:

  • Anaphylaxis (a life-threatening allergic reaction)
  • Angioedema (swelling of the deeper layers of the skin)
  • Low blood pressure
  • Rapid heart rate
  • Swollen tongue
  • Difficulty breathing
  • Wheezing
  • Rash

According to the reports identified in the AERS database, these side effects are consistent with all 52 cases. Furthermore, numerous patients reported numerous allergic reactions occurring simultaneously. Signs and symptoms of these reactions have been reported following a single dose of Saphris. Eight of which reported hypersensitivity reactions shortly after treatment.

Angioedema, respiratory distress, and possible anaphylaxis have been associated with Saphirs following a single dose. Out of the 52 patients identified in the AERS database, 19 resulted in hospitalization or emergency room visits. Due to the severity of type I hypersensitivity allergic reactions, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Saphris lawsuit.

Saphris Anaphylaxis

Anaphylaxis is a severe, life-threatening allergic reaction that may result from Saphris treatment. It is a whole body allergic reaction that may occur as soon as the medication is ingested or moments later. Regardless, the introduction of a foreign allergen may be enough to induce anaphylaxis.

As a safety response, the body releases chemicals in an attempt to fight the invader. The resulting flood of chemicals released by your immune system during anaphylaxis may cause shock. As a result, blood pressure drops suddenly and airways narrow, making it difficult to breathe. Signs and symptoms of anaphylaxis include a rapid, weak pulse, a skin rash, and nausea and vomiting. Common triggers of anaphylaxis include certain foods, insect venom and latex. However, medications such as Saphris have recently been associated with this severe allergic reaction.

Anaphylaxis is a severe disorder that can be life-threatening without prompt treatment. However, symptoms usually get better with the right therapy, so it is important to act right away. Due to the severity of anaphylaxis, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Saphris lawsuit.

Do I Have a Saphris Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Saphris lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by Saphris, you should contact our lawyers immediately by clicking the link below or calling toll free 1-800-773-0849. You may be entitled to compensation for your injuries and we can help.

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