Meningitis Crisis Expands; More Infections, Deaths
First Joint Infection continued...
Ostrosky-Zeichner says fungal arthritis may require surgery and months of treatment with intravenous antifungal drugs, which are known to be toxic to the kidneys and other organs.
“We know how upsetting these recent events have been, and we send our deepest sympathies to all who are impacted by this tragic situation,” said Deborah M. Autor, JD, deputy commissioner for Global Regulatory Operations and Policy at the FDA.
The FDA’s role in regulating compounding pharmacies was limited in 2002. The agency is largely empowered to act only after a problem has already been identified.
“What this points out is that the practice of pharmacy has changed quite a bit. The world has changed a lot since the days of mortar and pestle. This is the time for pharmacists, for lawmakers, for regulators, for doctors, to sit down and grapple with this new model of pharmacy compounding and come up with a regulatory scheme that controls the risk,” Autor said.