Tag: Drug Administration

U.S. probes deaths for links to Monster energy drink

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Two cans of Monster Energy drink are pictured in this photo-illustration shot in Los AngelesNEW YORK/WASHINGTON (Reuters) – The Food and Drug Administration said on Monday that it was investigating reports of five deaths that may be associated with Monster Beverage Corp's namesake energy drink, and the company's shares fell more than 14 percent. Monster is also being sued by the family of a 14-year-old Maryland girl with a heart condition who died after drinking two cans of its Monster energy drink in a 24-hour period. Monster, the top-selling energy drink in the United States, said it does not believe its energy drink was "in any way responsible" for the girl's death. …

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Epilepsy drug leads to weight loss, side effects

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NEW YORK (Reuters Health) – A drug approved to prevent seizures may also help obese people lose a few pounds when it’s added to therapy and nutritional guidance, a new small trial suggests. But people who took zonisamide also reported more side effects, from nausea and vomiting to anxiety and depression. And two researchers not involved in the study questioned how much the drug would actually help people in the real world. Although zonisamide is only approved by the U.S. Food and Drug Administration for seizures, doctors can prescribe it “off-label” for non-approved purposes. …

U.S. House panel seeks FDA documents on meningitis-linked firm

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WASHINGTON (Reuters) – A U.S. congressional committee that oversees drug safety issues asked the Food and Drug Administration on Wednesday to provide documents on federal and state inspections of a Massachusetts pharmacy linked to a deadly meningitis outbreak that has killed 19 people. In a letter to FDA Commissioner Margaret Hamburg, the House of Representatives Energy and Commerce Committee said it was requesting documents dating back to 2004 as part of a probe to determine what actions regulators took after they concluded that the pharmacy’s facilities posed potential risks to public …

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Feds raid Massachusetts lab tied to meningitis outbreak

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A security guard looks out from the front doors of pharmaceutical compounding company NECC, a producer of the steroid methylprednisolone acetate, in Framingham, MassachusettsBOSTON/NEW YORK (Reuters) – Federal agents on Tuesday raided the Massachusetts pharmacy linked to a meningitis outbreak that has killed 15 people and sickened more than 200 others, federal prosecutors said. Agents from the U.S. Food and Drug Administration searched the New England Compounding Center (NECC) in the Boston suburb of Framingham, with officers from the local police department on site providing support, Framingham police said. Carmen Ortiz, U.S. …

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FDA warns Avon to smooth out claims on skin care products

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(Reuters) – The U.S. Food and Drug Administration warned beauty products company Avon Products Inc to stop advertising its Anew range of skin care products using language that makes them sound like drugs. In September, the regulator had warned L’Oreal SA for making similar claims. The FDA reviewed the company’s website in August, and objected to claims made about the products Anew Clinical Advanced Wrinkle Corrector, Anew Reversalist Night Renewal Cream, Anew Reversalist Renewal Serum, Anew Clinical Thermafirm Face Lifting Cream, and Solutions Liquid Bra Toning Gel. …

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Feds raid Massachusetts lab linked to meningitis outbreak

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A Framingham Motorcycle Unit officer stands by while federal agents search New England Compounding Center in Framingham, Massachusetts(Reuters) – The top federal prosecutor in Massachusetts on Tuesday said federal agents raided the New England Compounding Center, the pharmacy linked to a meningitis outbreak that has killed 15 people and sickened more than 200 others. U.S. Attorney Carmen Ortiz said: "I can confirm that this office and our law enforcement partners are investigating allegations concerning the New England Compounding Center." On Tuesday afternoon, agents from the U.S. Food and Drug Administration searched the NECC facility in Framingham, Mass., while local police provided support, local police said. …

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FDA advisers back NPS’s drug for short bowel syndrome

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(Reuters) – U.S. drug advisers on Tuesday backed a drug to treat a rare and serious bowel disorder for which there is no long-term treatment available in the United States. A panel of outside advisers to the U.S. Food and Drug Administration agreed that NPS Pharmaceuticals Inc had demonstrated that the drug is safe and improves absorption of fluid and nutrients in the intestines of adults with short bowel syndrome. The 12-member panel voted unanimously in the drug’s favor. The FDA usually follows the advice of expert panels. …

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More drugs may be linked to meningitis outbreak: FDA

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A sign for pharmaceutical compounding company NECC, a producer of the steroid methylprednisolone acetate, is seen in Framingham, MassachusettsCHICAGO/NEW YORK (Reuters) – Two other drugs made by the Massachusetts pharmacy at the center of a deadly meningitis outbreak may be linked to the disease, U.S. health regulators said on Monday, potentially widening the scope of the health crisis. The Food and Drug Administration said it was looking into reports of a patient with possible meningitis who received an injection of a different steroid than the one found to have caused 15 deaths. …

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