Label Change: The FDA is warning that people using Takeda Pharmaceuticals’ diabetes drug Actos at higher cumulative doses and for longer periods of time may be at a higher risk of bladder cancer, the WSJ reports . The product’s label and medication guide will be updated to reflect the possible risk after interim study results suggested no overall link with cancer — but signs of an association amongst the heavier users. Takeda is sponsoring the study, which runs through 2012, and says that it remains committed to the drug. Eyeing Approval: In other FDA-related news, agency reviewers said VEGF Trap-Eye, Regeneron’s experimental drug for a form of macular degeneration is effective and doesn’t raise any major safety worries, the WSJ reports . Studies sponsored by the company suggest the drug works as well as Roche’s drug Lucentis; an outside advisory panel will consider the Regeneron drug Friday. The More Things Change …: Efforts to make OxyContin more difficult to abuse by reformulating the highly addictive drug may only have led former users to find other alternatives, the New York Times reports . Thirty-milligram pure oxycodone pills, a painkiller similar to OxyContin and heroin are all showing up more frequently on the street and in overdose reports, the paper says. Reformulated
Excerpt from:
A.M. Vitals: FDA Says Heavy Actos Use May Be Tied to Bladder Cancer


John


