Serious concerns about the possible increased risk of heart attacks and strokes in patients using “low-T” products, have led the Food and Drug Administration to issue a new ruling requiring the makers of these dugs to alter labeling to reflect the dangers associated with them.
The FDA will now require the makers of “low-T” products, to make clear that using these products carries the possible increased risk of heart attacks and strokes. The new labeling will also state that these drugs are only approved to treat low testosterone levels caused by disease or injury, not normal aging. Continue reading
Last month, after little outside input, the Food and Drug Administration swiftly approved Vyvanse — originally marketed as an attention deficit hyperactivity disorder drug — to treat Binge Eating Disorder (BED), calling it “an effective option to help curb episodes of binge-eating.”
Days after Vyvense was approved, retired professional tennis player Monica Seles coincidentally began appearing on popular television talk shows and was featured in People magazine sharing her struggle with binge eating. The timing wasn’t coincidental; Seles is a paid spokesperson for Shire, the makers of Vyvanse, and the face of the BED drug’s marketing campaign. Along with Seles, Shire also launched a website to spur social media and began providing funding for patient groups. Continue reading