FDA Warns of Possible Painkiller Shortage After Issues at Novartis Plant

On Monday, FDA officials issued a public health advisory to warn about potential shortages of several prescription painkillers made by Endo Pharmaceuticals as the result of manufacturing issues at a Nebraska Novartis facility, the AP/San Francisco Chronicle reports.

Novartis on Sunday recalled 1,645 lots of over-the-counter drugs -- including Excedrin, Bufferin, NoDoz and Gas-X -- after the drugmaker received hundreds of complaints about broken and chipped pills and inconsistent bottle packaging.

FDA noted that some of the Novartis drugs could have inadvertently been packaged with painkillers sold by Endo that were produced at the same facility (Perrone, AP/San Francisco Chronicle, 1/9).

Edward Cox, an FDA official, said the issue likely was caused by improperly cleaned packaging machinery, which could have allowed pills from one product to be carried into containers of other drugs (Petrochko, MedPage Today, 1/9).

Endo officials said the company is not aware of any mix-ups reaching patients or causing injuries. A spokesperson for Novartis said that only Gas-X is produced on the same line as the Endo medications (Corbett Dooren, Wall Street Journal, 1/10).

FDA officials said there could be shortages of Endo's drugs including Opana, Percocet, Percodan, Endocet, Endodan and Zydone as a result of the issue. The plant at which the issues occurred is currently closed. Meanwhile, Endo has expedited production of the painkillers at a separate facility and anticipates that there will be "minimal" disruption in the supply (Norman, CQ HealthBeat, 1/9).

FDA in a statement said "the degree of shortage will depend on how quickly safeguards can be put in place to prevent this manufacturing issue from happening in the future" (AP/San Francisco Chronicle, 1/9).


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