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FDA Warns of Painkiller Mix-Up at Nebraska Plant
Date:1/9/2012

By Steven Reinberg
HealthDay Reporter

MONDAY, Jan. 9 (HealthDay News) -- The U.S. Food and Drug Administration issued a warning on Monday that some narcotic prescription painkillers made at a Nebraska plant may have been mixed up with some over-the-counter medicines packaged at the same facility.

"We issued a public health advisory to health care professionals and patients about a potential problem with opioid products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska, site," Dr. Edward Cox, director of the FDA's Office of Antiviral Products in the Office of New Drugs at the Center for Drug Evaluation and Research, said during a morning news conference.

On Sunday, Novartis issued a recall for some over-the-counter medications made at the same plant. These included Excedrin, NoDoz, Bufferin and Gas-X, Cox said.

"Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended, or receiving an unintended ingredient," Novartis said in the Sunday news release. "This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient."

Cox noted that it is possible, but unlikely, that these over-the-counter medications and prescription opioid painkillers could be mixed up together, although "we are still looking into this."

The narcotic painkillers in question include Opana, Percocet, Endocet and Zydone.

The problem occurred because the machinery used to package these products can retain pills from a previous packaging run, Cox explained.

"This could result in an incorrect pill ending up in the bottle of another product," Cox explained. "The likelihood of this occurring in medication dispensed to patients is estimated to be low."

Endo Pharmaceuticals officials claim they know of only three such mix-ups since 2009, Cox said. Moreover, the company is not aware of any patients who took the wrong pills or of "any adverse effects attributable to a product mix-up," Cox added.

The company and the FDA are providing information to help patients identify any stray pills. "We are asking patients to check their medicines to identify any pills of a different size, shape or color from their regular medicine," Cox said.

If any pills differ from the rest in the bottle, patients should stop taking their medicine and take the bottle to their pharmacist, Cox said.

Until these problems are fixed, manufacturing at the plant will remain shut down, the company said. Customers can call 1-888-477-2403 Monday to Friday, from 9 a.m. to 8 p.m., while patients can call Endo Pharmaceuticals' call center at 1-800-462-3636.

During the closure, there may be a shortage of certain painkillers, but several alternatives are available, the FDA noted.

Cox said that the agency decided not to issue a recall because of the small chance of a patient taking the wrong pill and the need for these prescription painkillers.

"After carefully considering the public health risks, [the] FDA does not believe that a recall of Endo's opioid analgesic product is warranted," Cox said.

Cox added that this plant has had problems in the past, and that the FDA's investigation is ongoing.

More information

For more on the painkiller mix-up, visit the U.S. Food and Drug Administration.

SOURCES: Jan. 9, 2012, press conference with: Edward Cox, M.D., director, Office of Antiviral Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Jan. 8, 2012, press release, Novartis Consumer Health


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