Packaging errors in a Novartis drug plant could cause opioid painkillers to end up in bottles of over-the-counter medications, the Food and Drug Administration said today.
Opioid pills could have been retained in the machinery and then released into bottles of other types of prescription painkillers, or into over-the-counter medications including Excedrin, Bufferin, No-Doze, and Gas-X, according to Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
"The likelihood of this happening is low, but there is a potential" for mix-ups, Dr. Cox said during a press briefing. Although there have been no reports of stray opioids in other medications, the possibility of a mix-up is so serious that FDA was compelled to issue a public health advisory. Novartis voluntarily closed its Lincoln, Neb., plant that manufactured and packaged opiate products for Endo Pharmaceuticals after a mid-December inspection focused on packaging machinery.
The same manufacturing problem has damaged gel caps and tablets of the over-the-counter medications; these also could be mispackaged among themselves. Because of the problems, Novartis has issued a nationwide recall of all these brands with an expiration date prior to Dec. 20, 2014.
However, the manufacturing problems at the Lincoln, Neb., plant were not a surprise to the FDA. A 13-page document details the results of several federal inspections undertaken from 2009 to 2011. According to the document, Novartis failed to respond to almost 200 consumer complaints about solid drugs made at the plant, including cases in which Excedrin Migraine gel caps and tablets were packed in the same bottle (this was considered a case of "foreign tablets").
"You have failed to adequately investigate 166 instances of foreign tablets in your drug products since 2009," the report stated.
Dr. Cox said the latest inspection focused on the packaging machinery and was the impetus for the plant’s closing. Endo Pharmaceuticals, the company that uses the plant to manufacture its opioid products, has received three consumer complaints about the issue since 2009, Dr. Cox said.
These medications will be in short supply, at least temporarily, according to a company spokesman. "We really don’t know how long the situation will go on," Chris Clark, associate director of marketing and communications at Endo Pharmaceuticals, said in an interview. "We hope the [shut-down time] will be as minimal as possible."
Mr. Clark said the company is "working proactively" with physicians to conserve the drugs that are still available for patients already taking them. "We’ve issued a health care practitioner letter suggesting that physicians keep patients on their ongoing therapy, but consider limiting starts on new patients, as appropriate."
The affected medications include:
• OPANA (oxymorphone hydrochloride) Extended Release Tablets CII
• OPANA (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 has posted picture of the medications in question on its website.
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