FDA Warns of Painkiller Mix-Up at Nebraska Plant

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.

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