6/10/2015 It’s depressing when a drug with as many positive uses as Cymbalta (duloxetine) ends up creating more problems than it solves. So many, and to such severity, that it’s been given its own diagnosis title: Cymbalta Discontinuation Syndrome. Those with Cymbalta Discontinuation Syndrome often experience mental and physical suffering that lasts for several weeks.
6/9/2015 The FDA backtracks on labels, Big Tobacco drops its suit. America’s three largest tobacco giants, Phillip Morris USA (owned by Altria Group, Inc.), RJ Reynolds (owned by Reynolds American) and Marlboro, Camel & Newport (owned by Lorillard Tobacco) sued the FDA for overstepping its bounds by considering requiring approval for label changes such as
6/9/2015 Pfizer may have lied about Zoloft birth defects. According to research reports recently uncovered in one of the many suits claiming Zoloft causes birth defects, there may actually be a true causal link. This is despite Pfizer denying such a link. The Big Pharma giant successfully defended one such suit in April; however, the
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
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
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
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
6/5/2015 An FDA advisory committee voted 18-6 on Thursday, April 4th to recommend the approval of the drug, flibanserin, a medicine designed to increase the sexual desire in women. Known colloquially as “female Viagra,” two prior attempts at moving the drug through the Food and Drug Administration (FDA) process had been rejected. Drug developer Boehringer
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
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