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FDA last week approved the first treatment for reducing allergic reactions from multiple foods after accidental exposure, in today's bite-sized hospital and health industry news from Connecticut and Maryland.
- Connecticut: Yale New Haven Health has named Katherine Heilpern as president of Yale New Haven Hospital, effective March 11. Heilpern currently serves as chief of the Office of Provider Professionalism and Support at NewYork-Presbyterian and previously oversaw three hospitals as group SVP at NewYork-Presbyterian. Heilpern also previously served as COO for Weill Cornell Medical Center. (Hudson, Modern Healthcare, 2/15)
- Connecticut: CooperSurgical, a major medical supply company, is currently facing several lawsuits from patients claiming that its product, culture media, destroyed embryos created through invitro fertilization. Culture media is a nutrient-rich liquid that helps fertilized eggs develop into embryos. Last week, FDA announced a recall notice indicating that almost 1,000 bottles of culture media had been recalled, half of which had been purchased by U.S. clinics. In the filing, CooperSurgical said it had notified impacted clinics on Dec. 13 and instructed them to stop using the product since "performance issues may lead to impaired embryo development." Although it is currently unclear how many patients may have been affected, Mitchel Schiewe, an embryologist and a laboratory director at California Fertility Partners, said as many as 20,000 patients could have been impacted if even half of the affected products were used. So far, eight lawsuits have been filed against CooperSurgical. Collectively, the patients say they lost over 100 embryos that were kept in the defective culture media. CooperSurgical has not commented on any of the current lawsuits. (Kliff/Ghorayshi, New York Times, 2/15)
- Maryland: FDA last week approved the first medication to reduce allergic reactions from multiple foods following accidental exposure. The drug, which is a monoclonal antibody called omalizumab (Xolair), is indicated for use in adults and children one year and older to help them reduce the risk of certain allergic reactions, including anaphylaxis, after accidental exposure to certain foods. Omalizumab has also been approved to treat moderate to severe persistent allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps. The new approval was based on data from a multicenter, double-blind, placebo-controlled trial of 168 adult and pediatric patients who were allergic to peanuts and at least two other foods, such as milk and eggs. At the end of the 16-to-20 week treatment period, 68% of patients who received omalizumab could eat a single dose of peanut protein without experiencing moderate to severe allergic reactions, such as full-body hives, persistent coughing, and vomiting. In comparison, only 6% of patients who received the placebo could eat the peanut protein without experiencing these allergic reactions. "This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies," said Kelly Stone, associate director of the division of pulmonology, allergy, and critical care at FDA's Center for Drug Evaluation and Research. "While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs." (Firth, MedPage Today, 2/16)
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