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The U.S. Food & Drug Administration (FDA) has issued a warning regarding the antipsychotic drug Saphris (asenapine maleate) and potentially life-threatening allergic reactions. To date, the FDA has identified more than 50 cases of hypersensitivity reactions associated with Saphris use. In response to the numerous adverse event reports linked to Saphris, the administration is requiring that the drug’s label be updated to include information about this risk.
What’s the problem?
On September 1, 2011, the Food & Drug Administration issued a Drug Safety Communication indicating that it had received at least 52 cases of Saphris Type I hypersensitivity reactions reported to the agency’s Adverse Event Reporting System (AERS). Unfortunately, 19 of these cases resulted in hospitalization or visits to the emergency room, and seven individuals required emergency medical interventions.
Taking these numbers into consideration, the FDA stated that it is requiring Saphris labels to be updated to include warnings about the risk of potentially life-threatening allergic reactions associated with the drug.
Saphris Allergic Reactions: Signs and Symptoms
Signs and symptoms of a Saphris-induced allergic reaction may include:
- swelling of the deeper layers of the skin (angioedema)
- low blood pressure
- rapid heart rate
- swollen tongue
- difficulty breathing
Sadly, in a number of cases multiple symptoms occurred following a single dose of Saphris. In its press release, the FDA advised patients to seek emergency medical attention if they experience any of the side effects listed above. Additionally, the administration is asking that any and all serious Saphris side effects be reported to the AERS.
First approved by the FDA in 2009, Saphris is an atypical antipsychotic medication prescribed to treat the symptoms of schizophrenia and bipolar disorder. Since it was first released on to the market, Saphris has been prescribed nearly a quarter million times to approximately 87,000 patients around the country.
The FDA Drug Safety Communication concluded by advising healthcare professionals to educate patients in the signs and symptoms of Saphris hypersensitivity, and to watch for these indicators in patients taking the antipsychotic. While some individuals were able to continue being administered Saphris with no further reactions, the drug should be contraindicated for any patient with a medical history of hypersensitivity to allergic reactions.
What is Anaphylaxis?
Anaphylaxis is a whole-body allergic reaction that occurs in response to a toxic substance. The reaction is quick to manifest after exposure, is extremely severe, and involves the entire body. In response to the introduction of a substance the body deems to be a toxic allergen, tissues in different parts of the body release histamines and other substances. This tightens the airways and leads to a host of other symptoms including (but not limited to):
- abdominal pain or cramping
- abnormal (high-pitched) breathing sounds
- difficulty breathing
- difficulty swallowing
- nasal congestion
- heart palpitations
- skin redness
- slurred speech
In nearly every case, anaphylaxis requires immediate medical intervention, including an injection of epinephrine and a trip to the emergency room. If the condition is not treated properly and in a timely manner, anaphylaxis can be fatal. In certain cases, telltale signs may go away only to return a few hours later, which is why it is crucial to take precautionary steps as soon symptoms are recognized.
Once you’ve brought your anaphylactic reaction under control, your healthcare provider may recommend that you visit an allergy specialist for a proper diagnosis. An allergist will take your medical history and conduct a number of tests to determine, among other things, the exact cause of your reaction. He or she can provide valuable information about how to avoid the dangerous allergen, as well as a treatment plan if you are ever again exposed in the future. Specific advice may include information about:
- Food – How to read ingredient labels, dine out safely, an avoid hidden food allergens.
- Insects – You should not wear strong colognes or perfumes, and avoid bright colored clothing and high risk activities.
- Drugs – Your allergist will tell you which drugs (such as Saphris) and treatments to avoid, and provide a list of alternative medications.
If you are taking Saphris
If you are considering undergoing treatment with Saphris, tell your healthcare provider if you are allergic to it or if you have any other allergies. Additionally, tell your doctor or pharmacist if you have a medical history of any of the following conditions, as they may influence your body’s response to Saphris:
- liver problems
- heart problems (such as past heart attack, angina, abnormal heart rhythm)
- low blood pressure
- low white blood cell count
- loss of too much body water (dehydration)
- breast cancer
- drug/alcohol/substance abuse
- Alzheimer’s disease
- trouble swallowing
Saphris may contain inactive ingredients, which can cause unanticipated allergic reactions or other adverse side effects. Consult your healthcare provider for more details.