The U.S. Food and Drug Administration says that as many as 79,000 illnesses and 30 deaths due to consumption of eggs contaminated with the bacterium Salmonella Enteritidis may be avoided each year with new food safety requirements for large-scale egg producers. The new food safety requirements will become effective on July 9, 2010, through a [...]
The U.S. Food and Drug Administration warned that Que She, marketed as an herbal weight loss supplement, contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions. People who have purchased Que She should stop taking the product immediately and consult a health care professional. Que [...]
U.S. Food and Drug Administration (FDA) approved Abbreviated New Drug Application for Granisetron Hydrochloride Tablets USP, 1 mg (base) (granisetron tablets). Taro’s granisetron tablets is a prescription product used for the prevention of nausea and vomiting associated with chemotherapy and radiation treatment and is bioequivalent to Hoffman-La Roche, Inc.’s Kytril® tablets, 1 mg (base). According [...]
The FDA approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures. Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80 percent of the people in the United [...]
A new study found that tanning salons significantly increase the risk of melanoma, one of the most aggressive cancers. The cancer epidemiologist and principal investigator of the University of Minnesota, DeAnn Lazovich, said the risk of melanoma was 74 percent higher for people who used tanning beds at least one time compared with those who did not. [...]
U.S. Food and Drug Administration is warning consumers about potentially serious side effects from mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel, an over-the-counter (OTC) product that should only be used on the skin. The FDA has received reports of serious side effects in people who have mistakenly swallowed the product. Some OTC Benadryl products [...]
InterMune, Inc. (Nasdaq: ITMN) today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter for the New Drug Application (NDA) for Esbriet(TM) (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function. A complete response letter is issued by the FDA’s Center for [...]
Following McNeil’s recall announcement on Friday evening, the FDA is providing additional advice to consumers. “We want to be certain that consumers discontinue using these products and that they know what to do if they have concerns about a specific product,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “While the potential for [...]
Preliminary review suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists Gonadotropin-Releasing Hormone (GnRH) agonists, a class of medications primarily used to treat men with prostate cancer, have been associated with a small increased risk for diabetes, heart attack, stroke, and sudden death in men treated [...]
Working in consultation with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare is implementing a voluntary recall of infant and children’s liquid products due to manufacturing deficiencies which may affect quality, purity or potency. Following McNeil’s recall announcement on Friday evening, the FDA is providing additional advice to consumers. “We want to [...]