FDA: Endo opioids may be mixed in Novartis OTC packages

The FDA has added its two cents to the Novartis ($NVS) consumer-drug recall. The agency has issued an advisory to healthcare professionals and patients that says some Endo Pharmaceuticals ($ENDP) painkillers might have found their way into packages of the recalled Novartis meds. Endo's high-powered, prescription-only opioid drugs are manufactured by Novartis at the same facility, and they're manufactured on the same line as the Swiss-based company's Gas-X Prevention.

Novartis noted that reports of mixed-up pills in its OTC packages didn't involve Gas-X. And the FDA says while it's possible the Endo drugs were mixed in with the OTC remedies, it's unlikely, HealthDay reports. Nonetheless, the agency's Edward Cox said, "[W]e are still looking into this."

Endo had already warned that supplies of its drugs made at the Lincoln, NE, site could run short now that Novartis has shut it down for improvements. The 9 painkillers involved include Opana and Opana ER, Percocet, Endocet and Zydone. The FDA says alternatives to these pain drugs are available if Endo's versions do become scarce.

This latest wrinkle comes as analysts are totaling up the numbers on Novartis sales lost to the plant shutdown. As Pharmalot reports, Leerink Swann's Seamus Fernandez projects potential U.S. losses at $560 million over the next 12 months. Globally, the suspended operations could affect sales by $1.1 billion. And that doesn't include sales of animal health products also made at the plant. Basically, Fernandez is figuring that getting the Lincoln plant back up to speed won't be a speedy process, especially since the FDA is involved.

- read the FDA statement
- get more from the WSJ
- see the HealthDay piece
- check out Pharmalot's take

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