Fresenius Medical Care North America issued a recall notice for NaturaLyte Liquid Bicarbonate Concen

April 17, 2014 -- The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.
Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves. Treatment with Ragwitek is started moles 12 weeks before the start of ragweed pollen season and continued throughout the season. moles The first dose is taken in a health care professional s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home.
The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease, said Karen Midthun, M.D., director of the FDA s Center for Biologics Evaluation and Research.
Individuals with allergic rhinitis with or without conjunctivitis may experience a runny nose, repetitive sneezing, nasal itching, nasal congestion, and itchy and watery eyes. Short ragweed pollen is one of the most common seasonal allergens moles and is prevalent during the late summer and early fall months in most of the United States. Short ragweed pollen induced allergies moles are generally managed by avoiding the allergen, medications to relieve symptoms, or with allergy shots.
The safety and effectiveness of Ragwitek was evaluated in studies conducted in the United States and internationally. Safety moles was assessed in approximately 1,700 adults. moles The most commonly reported adverse reactions by patients treated with Ragwitek were itching in the mouth and ears and throat irritation. Of the 1,700 adults, about 760 were evaluated to determine effectiveness. moles Some patients received Ragwitek; others received an inactive substitute (placebo). The patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one ragweed pollen season, patients who received Ragwitek experienced approximately a 26 percent reduction in symptoms and the need for medications compared to those who received a placebo.
The Prescribing Information includes a boxed warning to inform that severe moles allergic reactions, moles some of which can be life-threatening, moles can occur. Ragwitek also has a Medication Guide for distribution moles to the patient.
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