Onglyza Could Lead to Heart Failure

6/9/2015 Onglyza could lead to heart failure, according to a recently-issued FDA warning. The agency also asked AstraZeneca and Bristol-Myers Squibb, manufacturers of Onglyza, to turn over all of their clinical trial data for review. In addition, the FDA asked that all medical professionals report occurrences of Onglyza side effects, heart-related or not, to the


Johnson and Johnson settles Arkansas Risperdal Suit for $7.8B

6/9/2015 Johnson and Johnson settles Arkansas Risperdal suit for $7.8B. The suit has been ongoing for eight years and the state’s AG alleges that J&J’s marketing of the psychiatric drug was flawed. The AG claims J&J misrepresented the drug’s safety and effectiveness, especially concerning diabetes risks. The state will take $2M of the settlement to


FDA to consider new Class of Cholesterol Drugs

6/9/2015 A new class of cholesterol drugs will undergo a preliminary review this week from a Food and Drug Administration (FDA) advisory panel. The drugs, Amgen’s Evolocumab and Alirocumab from Sanofi SA and partner, Regeneron Pharmaceuticals, block a protein called PCSK9, which can prevent the liver from eliminating bad cholesterol. Early studies show the drugs


Viagra May Increase Melanoma Risk by 84%

6/8/2015 Viagra may increase melanoma risk by 84%. This is hard news to report, but something every man must understand: your “little blue pills” may end up giving you “little brown spots,” according to recent studies showing a correlation between Viagra use and incidence of melanoma skin cancer. At present, only one federal suit has



FDA Ban on Ephedra Has Been Spectacularly Successful!

6/2/2015 The FDA ban on ephedra has been spectacularly successful in preventing harm and death. Despite the fact that I regularly bust the FDA’s chops, I believe in giving credit where credit is due and the FDA has earned some in this case. The FDA banned the popular weight loss and energy boosting herbal supplement


Olympus Corporation Set Aside $450M for an Expected Settlement

6/1/2015 Olympus Corporation set aside $450M for an expected settlement regarding its marketing practices. It’s already on the hook for its duodenoscopes, which are very hard to clean and have caused a number of superbug outbreaks in the U.S. Olympus failed to timely warn hospitals in the U.S. and three people died. Now federal investigators



How long until Power Morcellators are Banned?

5/29/2015 Despite the ongoing FBI investigation of Johnson & Johnson’s manufacturing division, Ethicon, and a strong Food and Drug Administration (FDA) warning issued last year, power morcellators are still legal. The device grinds up tissue mass, and is then removed through a series of small incisions. The device, which is used to provide minimally invasive