January 9, 2012 — The US Food and Drug Administration (FDA) is advising patients and healthcare professionals of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska, manufacturing site.
In a telebriefing today, Edward Cox, MD, from the FDA's Center for Drug Evaluation of Research, said: "Due to problems incurred when these products were packaged and labeled at the site, it's possible that tablets from 1 product may have been retained in the packaging machinery, and then may have carried over into packaging of another product."
"This could result in an incorrect pill of 1 medicine ending up in the bottle of another product," he said. "The likelihood of this occurring in medication dispensed to medication is low," he emphasized.
According to the public health advisory the FDA posted today, the following products may be affected:
Opana ER (oxymorphone hydrochloride) extended-release tablets CII
Opana (oxymorphone hydrochloride) CII
oxymorphone hydrochloride tablets CII
Percocet (oxycodone hydrochloride and acetaminophen USP) tablets CII
Percodan (oxycodone hydrochloride and aspirin, USP) tablets CII
Endocet (oxycodone hydrochloride and acetaminophen USP) tablets CII
Endodan (oxycodone hydrochloride and aspirin, USP) tablets CII
morphine sulfate extended-release tablets CII
Zydone (hydrocodone bitartrate/acetaminophen tablets, USP) CIII
"Endo Pharmaceuticals reports that they are aware of only 3 product mix-ups with respect to these products since 2009," Dr. Cox said. "Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up," he added.
He also noted that an FDA review of the Adverse Event Reporting System database from January 1, 2009, through January 6, 2012, for the Endo Pharmaceutical opioid products manufactured at the Lincoln, Nebraska, facility failed to turn up any reports of adverse events directly related to manufacturing problems.
The FDA advises patients and healthcare professionals to check any opiate medicines made by Endo in their possession and to ensure that all tablets are the same.
"We are asking patients to check their medicines to look for any tablet of a different size, shape, or color from their regular medicine," Dr. Cox said. "We are asking pharmacists to perform a visual inspection when dispensing the potential affected Endo opioid medications, according to the instructions provided by FDA."
For more information, patients and healthcare providers can also contact Endo Pharmaceuticals' call center at 1-800-462-3636.
In the advisory, the FDA says they expect there will be "periods of shortages for these products" in the coming weeks, and they are actively working with Endo Pharmaceuticals and Novartis to "minimize the degree of impact."
As a precautionary measure, Novartis Consumer Health has initiated a voluntary recall of the other nonopiate products made at their Lincoln, Nebraska, manufacturing facility.
These products include all lots of Excedrin and NoDoz products with expiration dates of December 20, 2014, or earlier, as well as Bufferin and Gas-X Prevention products with expiration dates of December 20, 2013, or earlier, in the United States.
Healthcare professionals and patients are encouraged to report adverse events related to the use of these products to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Cite this: FDA Issues Public Health Advisory on Certain Pain Meds - Medscape - Jan 09, 2012.