Meningitis Outbreak Fuels Calls For More Oversight
According to the Centers for Disease Control and Prevention, eight people have died and 105 people in nine states have been sickened by a type of fungal meningitis they were exposed to when they received tainted spinal steroid injections.
The Wall Street Journal: Outbreak Spurs Calls For New Controls
As many as 13,000 patients may have been exposed to fungal meningitis from tainted spinal steroid injections, authorities said Monday, as some lawmakers called for bringing certain specialized pharmacies under greater regulatory scrutiny. The oversight of compounding pharmacies, which create customized versions of medicines, is gaining greater attention as the death and illness tolls in the outbreak continue to rise. On Monday, the Centers for Disease Control and Prevention said eight people had died and 105 people in nine states had been sickened by fungal meningitis, a rare but potentially deadly inflammation to the brain or central nervous system (Martin, Burton and Dooren, 10/8).
Also in the news, an examination of safety issues associated with fast-track drugs --
Medpage Today: Safety Issues Seen With Fast-Track Drugs
About a quarter of new drugs introduced to the Canadian market over a 15-year period developed serious safety issues, a researcher said. The probability of a New Active Substance -- the Canadian equivalent of a New Molecular Entity -- acquiring a serious safety issue between 1995 and 2010 was 23.7 percent, Joel Lexchin, MSc, MD, of the University of Toronto, reported in a research letter in the Archives of Internal Medicine. That figure is similar to previous American analyses that have put the probability of new drugs being slapped with a black box warning or being withdrawn from the market at 20 percent over a 25-year period. That should make clinicians cautious about prescribing certain new drugs, Lexchin wrote (Zalenznik, 10/8).