FDA Warns that Nebraska Plant May have Mixed Up Painkillers

FDA Warns that Nebraska Plant May have Mixed Up PainkillersOn Monday, January 9, the U.S. Food and Drug Administration (FDA) warned that a group of narcotic prescription painkillers manufactured at a plant in Nebraska may have been combined with a group of over-the-counter medicines also packaged at the facility, HealthDay reports.

"We issued a public health advisory to healthcare 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, stated.

The day prior to the FDA announcement, Novartis announced a recall for some of its over-the-counter medicines made at the plant, which include Excedrin, NoDoz, Bufferin and Gas-X.

The company stated that if different products were indeed mixed into the same bottle, consumers could potentially take the incorrect product or receive a higher or lower strength than they intended. Novartis warned consumers may also take an unintended ingredient.

"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," the statement read.

Cox said that it was possible that the opioid painkillers could have been mixed up with over-the-counter drugs, and that the company is "still looking into this."

The prescription painkillers that could be found in other medications include Opana, Percocet, Endocet and Zydone.

According to the National Library of Medicine, hydrocodone and oxycodone, which are found in Percocet and similar painkillers, have serious risks associated with overdose. The most dangerous complication associated with painkiller overdose is the effect it has on breathing. Such an overdose has the ability to cause breathing to slow down, become shallow and possibly stop altogether.

The problem at the plant occurred when machinery used to package the products likely retained a few of the pills from a previous package job.

"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.

The Nebraska plant has been shut down until the problems are sorted, Novartis said. The FDA says that while the plant is incapacitated, there may be a shortage of certain painkillers, but that alternatives would be made available.