FDA Alert: Mix-Up of Opioid Drugs Used for Chronic Pain

Karen Lee Richards Health Guide
  • If you take prescription opioid medications for your chronic pain, please read this alert.

    The FDA is advising patients and health care professionals of a potential safety risk with opioids manufactured for Endo Pharmaceuticals by Novartis Consumer Health at their plant in Lincoln, Nebraska.  Due to a problem with the packaging machinary, tablets of one type of medication may have been packaged with another medication.  

    The drugs involved are:

    • 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

    If you have been prescribed any of these medications, be sure to check the contents of your prescription carefully.  All of the pills in the bottle should look the same.  If the pills do not look like what you normally take or if you find any pills that are different in shape, size, color, or markings, take them to your pharmacist right away.  Since the FDA has alerted pharmacists and instructed them to carefully check these drugs before dispensing them, hopefully you won't have any problem.

    Endo Pharmaceuticals has provided a visual guide of the affected drugs that you can download if you would like to double check the tablets in your prescription:  Endo Pharmaceuticals Opioid Guide.

    Patients who have questions should call their pharmacist, healthcare provider, or Endo Pharmaceuticals’ call center at 1-800-462-3636.

    Possible Temporary Shortage of Some Drugs

    As a result of this mix-up, Endo Pharmaceuticals has announced a temporary shut-down of Novartis Consumer Health Inc.'s Lincoln, Neb., manufacturing facility to make improvements that would prevent this kind of problem in the future.  This action could cause a temporary shortage of some of these medications.  The most likely drug to be affected is Opana ER because Novartis is the sole manufacturer of that formulation. 

    From Endo's press release:  "We are working collaboratively with the FDA to minimize the disruption to patients currently on therapy.  Given existing inventories, the expected restart of Novartis production and our ability to shift production to other facilities we believe the supply constraints of our products should be limited,"  said Julie McHugh, chief operating officer of Endo Pharmaceuticals.  "With Novartis as the sole manufacturer of the current formulation of Opana ER, we plan to temporarily moderate demand of the product by asking physicians to refrain from starting new patients on Opana ER in order to minimize disruption for patients currently on the product.  We currently expect this to be a short-term issue and we remain focused on working with the healthcare community to optimize the continued supply of our products for current patients." 

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  • If you think the medication you take may be affected by this temporary shutdown, check with your pharmacist about possible supply disruptions.  In the event your medication is not available, ask your doctor if there is another brand or type of medication that could be prescribed for you in the interim. 

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    Some Over-the-Counter Medications Recalled

    Apparently Novartis Consumer Health, Inc. has had a similar problem with some of the OTC medications it manufactures and packages in the same Lincoln, Nebraska facility.  In this case, Novartis is recalling the products saying they may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.

    The OTC medications being recalled are:

    • Excedrin – with expiration dates of December 20, 2014 or earlier.
    • NoDoz – with expiration dates of December 20, 2014 or earlier.
    • Bufferin – with expiration dates of December 20, 2013 or earlier.
    • Gax-X Prevention – with expiration dates of December 20, 2013 or earlier.

    Novartis is instructing consumers that have the product(s) being recalled to stop using the product(s) and contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products and receive a full refund. 

    Cross-Contamination Not Known

    Although not mentioned in either of the FDA alerts, an FDA official admitted during a press conference that they did not know if any of the opioid drugs in question had cross-contaminated the OTC products that were recalled.  Maybe it's just me, but that seems like a pretty important point to leave out of the alerts.  

    That being said, if you take any of the opioids mentioned, check your prescriptions carefully.  If you have any of the OTC meds recalled, call Novartis to find out how to return them. 

    Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk. U.S. Food and Drug Administration. 1/9/2012.
    Novartis Consumer Health Inc. Issues Voluntary Nationwide Recall of Certain Over-The-Counter Products Due to Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps. U.S. Food and Drug Administration. 1/8/2012.

Published On: January 10, 2012