Saphris Lawsuits

September 1, 2011 — The FDA recently linked the antipsychotic medication Saphris (generic: asenapine maleate) to increased risks of serious allergic reactions, including anaphylaxis, which may be life-threatening or require hospitalization.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Saphris induced injury cases in all 50 states. If you or somebody you know has been injured by Saphris, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Saphris: An Overview

Saphris is an antipsychotic medication that was approved by the FDA on August 13, 2009. Saphris — also known as its generic asenapine or asenapine maleate — is used to treat medical conditions such as schizophrenia and bipolar disorder. According to FDA reports, approximately 235,000 prescriptions for the drug have been issued.

Manufactured by Merck & Co., Inc., Saphris belongs to a class of drugs known as “atypical antipsychotics.” Atypical antipsychotics work by changing the actions of chemicals in the brain. Other atypical antipsychotics include Zyprexa, Seroquel, Clozaril, Risperdal, and Abilify.

However, the FDA has recently received 52 reports that Saphris caused a serious allergic reaction in patients. Some of these reactions occurred in patients after only one dose. The common symptoms include life-threatening allergic reaction (anaphylaxis), swelling of the skin (angioedema), low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing or rash. Patients may experience more than one symptom at a time.

Due to the severity of the Saphris allergic reaction, Saphris patients may want to contact a Saphris lawyer or attorney with The Schmidt Firm, PLLC to discuss the possibility of a Saphris lawsuit.

Saphris Symptoms and Side Effects

Saphris has been linked to Type I allergic reactions in patients. Type I reactions are caused when the body is re-exposed to an allergen, a foreign substance outside of the body, which causes the body to have an allergic reaction. Patients may display multiple symptoms at the same time.

A Type I reaction may cause the following signs and symptoms:

• Anaphylaxis (life-threatening allergic reaction)
• Angioedema (swelling of the skin)
• Low blood pressure
• Lightheadness
• Rapid heart rate
• Swollen tongue, face or throat
• Difficulty breathing
• Wheezing
• Rash
• Itching

FDA Saphris Study

Between August 209 and September 2010, the FDA received reports of 52 cases of Type I hypersensitivity reactions (or allergic reactions) after Saphris use. Of these, 19 patients required hospitalization or an emergency room visit.

For eight patients, they experienced an allergic reaction after only just one does. These patients displayed symptoms of skin swelling, respiratory distress and possible anaphylaxis. 15 of these patients’ symptoms resolved after discontinuing Saphris use.

A Type I allergic reaction often occurs when a patient becomes sensitive to the product after previous exposure. However, patients do not have to have previous exposure to experience a reaction because they may have become sensitive to the drug through a cross-reactive compound in the past.

So far, no drug has shown to cross-react with Saphris.

Because of the risk of allergic reaction, the FDA revised the drug’s “Contraindications, Warnings and Precautions, Adverse Reactions and Patient Counseling Information” sections of the Saphris label. The FDA is also advising the drug should not be used in patients with a known hypersensitivity to the drug.

What is Anaphylaxis?

Anaphylaxis is a life-threatening allergic reaction. It causes 1,500 deaths per year in the United States, according to one study.

During anaphylaxis, the chemical histamine is released by the immune system, which can cause a number of different reactions in the body. It may cause the body to go into shock. It can also take seconds, minutes or even hours for symptoms to develop.

However, the severity of symptoms varies with each person. Anaphylaxis can present itself in many different symptoms, depending on the body’s reaction to an allergen.

Common symptoms include hives, itchiness or flushing of the skin, swollen lips, swollen tongue, swollen throat, shortness of breath, wheezing, low oxygen, abdominal pain, diarrhea, vomiting, chest pain, irregular heart rate, rapid and weak pulse, and anxiety.

People have been known to experience anaphylaxis as a result of food allergies (like peanuts or shellfish) or from the venom of a sting or bite (like a bee sting). Exposure to specific medications may also cause anaphylaxis.

Due to the severity of the symptoms, people who experience anaphylaxis should seek immediate medical attention.

What is Angioedema?

Angioedema is an allergic reaction similar to hives, occurring after histamines have been released into the bloodstream. However, the swelling in angioedema is usually beneath the skin, rather than on the surface. The swelling usually occurs on the face — around the eyes and lips. Feet, hands and throat may also swell. Often, the swelling may be itchy or painful.

Welts or swelling on the surface of the skin may also occur.

Most symptoms are mild and may not need treatment. Moderate to severe symptoms may require treatment in the form of medication. However, because swelling can cause airway obstruction and suffocation, people experiencing difficulty in breathing should seek immediate medical attention.

Saphris and Dementia

Saphris should not be used to treat any medical conditions related to dementia. In older patients with dementia-related conditions, Saphris has been linked to increased risks of heart failure, pneumonia and even sudden death.

You should speak to your doctor immediately if you have any of the following conditions, as they may affect how your body responds to Saphris:

• Dementia
• Liver disease
• Heart disease
• High blood pressure
• Seizures
• Low white blood cell counts
• Diabetes
• Trouble swallowing
• History of breast cancer
• History of heart attack
• History of stroke

Do I Have a Saphris Lawsuit?

The Schmidt Firm, PLLC is currently accepting Saphris induced injury cases in all 50 states. If you or somebody you know has been injured by Saphris, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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