Washington Post: June 21, 2019. The Food and Drug Administration on Friday approved sales of a new drug intended to enhance sexual desire in women.
Marketed as Vyleesi, also known as bremelanotide, the medication is a shot that comes in a push pen device, but it isn’t much more effective than placebo. And is it safe?
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VA Will Restrict Use of New Nasal Antidepressant
Lev Facher and Ed Silverman, STAT News; June 21, 2019 WASHINGTON — A Department of Veterans Affairs committee has declined to approve widespread coverage of a new depression treatment that has generated controversy but also received an express endorsement from President Trump. Instead, the drug was approved on a more limited basis. Many experts have […]
Read More »More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database
KHN: May 30, 2019. Thousands of patients were harmed and dozens killed by malfunctioning surgical staplers. Most of that information was hidden in an FDA database that was not publicly available, which NCHR criticizes as covering up information patients and physicians need to make informed decisions.
Read More »How the FDA Handles Recalls of Life-Saving Implants Could Put People at Risk, Patients Say
Nicole Carr, WSBTV; May 20, 2019 Geraldine Robinson is one of millions of Americans who use an implanted medical device to improve, and possibly extend her life. But when the implant was recalled years later, nobody told her. We help explain why.
Read More »FDA Ending Controversial ‘Alternative Summary Reporting’ Program
DOTMed News: May 8, 2019. The FDA’s alternative summary reporting system hid information about patients who were harmed by medical devices. FDA says it will stop this cover-up and require reporting of each patient harmed by a device.
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