June 28, 2013 |
Is it hot in here, or am I just depressed? For many menopausal women, hot flashes are just depressing. And depression, which affects at least one in four women ages 40 to 59, can intensify the misery of hot flashes, as well. No surprise, then, that a pharmaceutical company came up with the idea to market an antidepressant for treatment of vasomotor symptoms, a.k.a. hot flashes. And on Friday, bucking the recommendation of its advisory committee on reproductive health drugs, the Food & Drug Administration approved the idea.
October 31, 2013 |
The U.S. Food and Drug Administration announced Thursday that it was stepping up efforts to prevent and address prescription drug shortages, calling the shortfalls a significant public health threat. In addition to expanding early reporting requirements for drug manufacturers, the FDA said it was launching a smartphone app that would give consumers instant information on pharmaceutical shortages. "The complex issues of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
March 11, 2014 |
The U.S. Food and Drug Administration has approved the marketing of an electronic medical device intended to treat migraine headaches. In an announcement released Tuesday, officials said the transcutaneous electrical nerve stimulation, or TENS, device was the first ever to receive such approval. The device, which will be marketed under the name Cefaly , is manufactured by Cefaly Technology of Belgium. "Cefaly provides an alternative to medication for migraine prevention," read a prepared statement from Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health.
July 13, 2011 |
WASHINGTON – Following a spike in reported complications, the Food and Drug Administration released an updated advisory Wednesday about a surgical mesh implanted in women to strengthen vaginal tissue that can become weakened, especially after childbirth. In its report, the FDA says a review of industry literature and the adverse event reports has shown little evidence that the device, which is implanted vaginally or abdominally, improves pelvic organ prolapse, where a woman's uterus, bladder, or rectum can slip out of place.
April 21, 2011 |
Hey, hand sanitizers. You can only do so much – and preventing MRSA infection isn’t one of those things -- so stop over-promising! That was the gist of warning letters from the Food and Drug Administration to four makers of the popular products. Apparently, the manufacturers of Staphaseptic, Safe4Hours, Dr. Tichenor’s and CleanWell products had suggested that various gels, protectants and what-not could protect against infection with methicillin-resistant Staphylococcus aureus bacteria.
July 8, 2013 |
In a recent post , I noted the Catch-22 that the Supreme Court insists Congress created with its fast-track approvals for generic drugs. Those who are injured by a brand-name drug can win compensation from the manufacturer if they can show the drug was unreasonably dangerous or that its warning label didn't disclose the risks properly. But those injured by a generic medicine can't hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.