Allergic Reactions Prompt Saphris Label Changes
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 health care professionals that Saphris should not be used in patients with a known hypersensitivity to the drug.
A search of the FDA’s Adverse Event Reporting System database identified 52 cases of Type I hypersensitivity reactions with Saphris use. Signs and symptoms of Type I hypersensitivity reactions may include anaphylaxis, angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash. These signs and symptoms are consistent with the reactions reported in the 52 cases. Several cases reported multiple hypersensitivity reactions occurring at the same time, with some of these reactions occurring after the first dose of Saphris.
Health care professionals should be aware of the risk of hypersensitivity reactions with Saphris and counsel patients who are receiving the drug about how to recognize the signs and symptoms of a serious allergic reaction. Saphris should not be used in patients with a known hypersensitivity to the drug.
Source.“FDA Drug Safety Communication: Serious Allergic Reactions Reported with the Use of Saphris (Asenapine Maleate).” (2011, September 1). Retrieved October 31, 2011, from http://www.fda.gov/Drugs/DrugSafety/ucm270243.htm.
Cranial Electrotherapy Stimulation Devices Face Marketing Challenge
Alpha-Stim cranial electrotherapy stimulation (CES) devices providing treatment for anxiety, depression, insomnia, and pain, has initiated a user-supported campaign to change a U.S. Food and Drug Administration (FDA) rule regarding pre-market approval (PMA), the medical device equivalent of a new drug application. The FDA is proposing a rule that would now require PMA for CES, while for the past 30 years CES devices have been legally cleared to market in the United States by the FDA.
Approved for over-the-counter sales in Europe, China, and Canada, the Alpha-Stim devices have gone through an extensive review process for the FDA six times since 1981 and have been cleared to market. Alpha-Stim is used widely in the medical industry and military communities, resulting, to date, in more than 100 written objections to this proposed rule on behalf of Alpha-Stim, indicating its safety, lack of side effects, and above all, its effectiveness.
EPI inc., Alpha-Stim’s parent company, is asking for the “valid scientific evidence” provided to the FDA for CES be reviewed thoroughly and fairly. EPI asks that FDA review all of the safety data provided and revise the findings within the proposed rule. EPI has provided the FDA with valid scientific evidence showing:
- 99.9% of actual Alpha-Stim users considered the device effective.
- Only 11 of more than 50,000 Alpha-Stim users (less than 0.02%) reported adverse effects from using Alpha-Stim.
- 49 completed studies and 12 ongoing studies conducted on Alpha-Stim support the safety and effectiveness of the device.
Through the use of its proprietary waveform, Alpha-Stim technology applies a mild electrical current via electrodes that clip onto the earlobes. The waveform works effectively in a safe and controlled manner to gently coax the brain’s electrical signals to normalize. The result is safe and effective treatment of anxiety, depression, insomnia, and pain.
The FDA docket, including the proposed rule and letters of support for Alpha-Stim, are located at http://www.regulations.gov, number FDA-2011-N-0504.
Source.“Leading Innovator Alpha-Stim Gains Support of Medical Professionals and Patients in Opposing New FDA Rule.” (2011, October 25). Retrieved October 31, 2011, from http://www.businesswire.com/news/home/20111025005700/en/Leading-Innovator-Alpha-Stim-Gains-Support-Medical-Professionals.