FDA & Prescription Drugs

• Avandia Receives Black Box Warning

  Jeremy Thurman | August 15, 2007 3:14 PM | 0 CommentsOklahoma City, OK

  The diabetes drugs Avandia and Actos will be labeled with severe warnings about a risk of heart failure to some patients, health officials said Tuesday. The makers of the drugs, GlaxoSmithKline Plc and Takeda Pharmaceutical Company Ltd., have agreed to add the "black-box" warnings, the Food and Drug Administration said. The warnings, the most severe that prescription drugs can bear, stress the...

• Increase in risk of Thromobembolism among ortho evra users

  Jeremy Thurman | May 02, 2007 10:10 AM | 0 CommentsOklahoma City, OK

  STUDY FUNDED BY JOHNSON & JOHNSON FINDS A TWO-FOLD INCREASE IN THE RISK OF THROMBOEMBOLISM AMONG ORTHO EVRA USERSIn a study prepared by I3 Drug Safety, a service company for the pharmaceutical industry, the authors found that women using the Ortho Evra birth control were more than twice as likely to suffer venous thromboembolisms than woman using oral birth control. There was not sufficient...

• Nuvaring

  Jacob Diesselhorst | March 22, 2007 9:42 AM | 0 CommentsOklahoma City, OK

  The NuvaRing® is a hormonal contraceptive that works in a similar way to the oral birth control pill and the Ortho Evra birth control patch. The NuvaRing, however, is a flexible, soft, two-inch ring that is worn in the vagina for three weeks and removed for one week.During the fourth week, which is NuvaRing-free, the woman will have a menstrual period--like those using the pill or the patch....

• FDA Requests Label Change for All Sleep Disorder Drug Products

  Jacob Diesselhorst | March 15, 2007 10:00 AM | 0 CommentsOklahoma City, OK

  The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is...