Endo addresses possible short-term supply of Opana ER, other drugs
CHADDS FORD, Pa. — Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.
"We are working collaboratively with the [Food and Drug Administration] 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," Endo COO Julie McHugh said. "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."
The following products may experience a short-term supply constraint include:
Opana (oxymorphone hydrochloride) tablets 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; and
Zydone (hydrocodone bitartrate/acetaminophen tablets, USP) CIII.
As previously reported, Novartis Consumer Health suspended production at its Lincoln, Neb.-based facility to implement manufacturing process improvements, which will address possible rare instances of errors in production.
Novartis Consumer Health issues voluntary recall of certain OTCs sold in the United States
BASEL, Switzerland — Following the recent voluntary suspension of operations and shipments from its Lincoln, Neb.-based facility, Novartis Consumer Health announced a voluntary recall of some of its over-the-counter products sold in the United States.
The company said it is voluntarily recalling all lots of select bottle packaging configurations from retailers of Excedrin and NoDoz products with expiration dates of Dec. 20, 2014 or earlier, in addition to Bufferin and Gas-X Prevention products with expiration dates of Dec. 20, 2013 or earlier.
The voluntary recall is precautionary, the company said, and follows consumer complaints of chipped and broken pills and inconsistent bottle packaging. There have been no related adverse events reported with the issues leading to the recall, the company noted.
Information on the affected bottle sizes, and related expiration dates will be available at NovartisOTC.com.
Novartis Consumer Health’s parent company, Novartis Group, said it is fully committed to ensure the quality, safety and integrity of its products.
Survey: 1-in-10 patients don’t tell their healthcare practitioner they’re still smoking
WASHINGTON — Approximately 13% of smokers do not disclose their tobacco habit to their healthcare provider, according to a survey released Friday by Legacy.
And while a majority of smokers did admit their smoking status, only some 25% sought help from their doctors or healthcare providers during their last quit attempt.
"Healthcare providers play a critical role in reaching smokers with appropriate messages and resources for quitting, especially now that insurance coverage has expanded to include some smoking-cessation treatments," stated Cheryl Healton, Legacy president and CEO. "It becomes a missed public health opportunity if what amounts to more than 6 million smokers in the United States [who] do not talk to doctors and nurses about smoking and quitting."
To address the void between doctors and all smokers, Legacy has developed a guide for healthcare providers with strategies on how to conduct more meaningful and effective conversations with their patients about smoking and quitting. For a copy of the guide, click here. (And for a Spanish-language guide, click here.)
The survey included 3,146 adult participants in the United States, both smokers and former smokers.
Legacy is the national, independent public health foundation that was created in 1999 out of the landmark Master Settlement Agreement between the tobacco industry, 46 state governments and five U.S. territories.