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FDA Advises to Check Certain Endo Pharmaceuticals Opioids to Ensure Correct Medication is Received
FDA Advises to Check Certain Endo Pharmaceuticals Opioids to Ensure Correct Medication is Received
Food and Drug Administration (FDA) and Endo Pharmaceuticals (Endo) are advising health care providers and patients to check certain prescription Endo opioid products to ensure that the correct medication is received, as a result of product manufacturing issues. Specifically, at a Novartis Consumer Health facility in Lincoln, NE, where certain opioid products are manufactured and packaged for Endo, manufacturing problems were discovered that could result in tablets from one product type being carried over into packaging of another product. FDA estimates that the likelihood of a patient receiving a stray pill of another medicine in their dispensed prescription medication is low, but to ensure patient safety, the agency advises that affected pills are examined. FDA advises that pharmacists visually inspect and verify the identity of all affected medications including “tablets counted out for dispensing in a separate container from the manufacturer’s bottle” and the contents of “bottles that have never been opened when the entire bottle is being dispensed.” Patients prescribed the affected medications should also examine all pills in their bottles, making sure the size, shape, and color of each pill is the same. For example, if a patient discovers that one or more tablets in their dispensed medication looks different from the others, the medication should be returned to his or her pharmacist.
The following drugs are 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
A list of these medications including descriptions and images of each pill are posted on the Endo Web site. FDA advises that patients discuss any related questions with their health care providers and that they may also contact Endo Pharmaceuticals at 800/462-3636.
FDA indicates in a Drug Safety Communication that Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up. Further, FDA indicates that only three product mix-ups with respect to these products have been reported by Endo since 2009 and that all three were detected by pharmacists.
Endo and FDA are also advising pharmacists that while manufacturing process improvements are implemented by Endo, there may be a short-term disruption in the supply of the affected products to patients. Information for pharmacists regarding potential supply disruption is posted on the Endo Web Site.
