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New Drugs Concern FDA as Fatal Meningitis Outbreak Continues


Fungal meningitis fears have spread across the country in recent weeks as a contaminated steroid batch sickened hundreds of victims. The most recent numbers say that around 250 people have contracted fungal meningitis and 19 of those cases were fatal. Given the long incubation period for fungal meningitis, however, more cases will certainly develop in the coming weeks.

Despite the gravity of the outbreak thus far, the FDA is now worried about other products from the same company. It has warned state health officials about numerous other substances, including another steroid, an open-heart surgery drug, and a drug used in eye surgeries. These new warnings suggest that something went really wrong at the company to contaminate its products. The victims will almost certainly be able to hold the company accountable by pursuing wrongful death lawsuits.

The steroid behind the current outbreak cannot include preservatives. This means that the company has to make it in a completely sterile environment. Although compounding companies normally manufacture drugs in small batches to fill individual orders, it shipped an enormous batch of this steroid in 17,000 doses. When these small-order facilities work on large quantities, the risk of contamination increases dramatically. Any small deviation from sterilization practices can result in a deadly contamination.

Given the broad concerns with all of the company’s products, it seems that the FDA is worried that a system-wide problem at this compounding facility contributed to the infection. This likely indicates a sloppy approach to sterilization and safety procedures. If this is the case, then the company should be held accountable to the victims of its contamination.

Source: New York Times, “New Scrutiny of Company That Made Tainted Drug,” Denise Grady and Abby Goodnough, Oct. 17, 2012