Did you know…

that an IRB must have at least five members? CLICK HERE to learn more.

FDA MedWatch – Endo Pharmaceuticals Opiate Products by Novartis Consumer Health

• 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

ISSUE: FDA is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site. Due to problems that occurred when these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product. This could result in a stray pill of one medicine ending up in the bottle of another product.

BACKGROUND: Opiates are potent medications used to alleviate pain and are available only by prescription. Endo Pharmaceuticals reports that they are aware of only three product mix-ups with respect to these products since 2009; all three were detected by pharmacists. Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up.

RECOMMENDATION: FDA advises patients and healthcare professionals to examine opiate medicines made by Endo in their possession and ensure that all tablets are the same.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

CLICK HERE to read the medWatch safety alert, including a link to the FDA Public Health Advisory.

FDA MedWatch – Novartis Consumer Health Over-The-Counter Products: Recall

ISSUE: Novartis Consumer Health Inc. is voluntarily recalling all lots of over-the-counter products Exedrin, Bufferin, Gas-X Prevention and NoDoz. Reports were received of chipped and broken pills and inconsistent bottle packaging clearance practices at the Lincoln, Nebraska facility, which could result in the bottles containing foreign tablets, caplets, or capsules.

Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.

BACKGROUND: This voluntary recall pertains to all lots of select bottle packaging configurations from retailers of Excedrin and Nodoz products (expiry dates of December 20, 2014 or earlier), and Bufferin and Gax-X Products (expiry dates of December 20, 2013 or earlier), in the United States.

RECOMMENDATION: All of the pills in the bottle should look the same. If patients find a pill that is different in shape, size, color, or markings, they should bring their medicine bottle to their pharmacist and not take any of those pills.

Consumers that have the product(s) being recalled should stop using them 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

CLICK HERE to read the MedWatch safety alert, including a link to the company Press Release.

FDA MedWatch – Ikaria INOmax DS Drug Delivery System: Class I Recall

ISSUE: FDA notified healthcare professionals of a Class I recall of Ikaria INOmax DS Drug Delivery System. Erratic nitric oxide (NO) monitoring readings were being caused by fretting corrosion at the electrical contact interface of certain metals. Adverse consequences may include inadequate oxygen reaching the tissues in the body (hypoxia), low blood pressure (hypotension), slower than normal heart rate (bradycardia), cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.

Affected serial numbers include DS20070005-DS20100865. This product was manufactured from March 12, 2007 through February 2, 2011 and distributed from September 4, 2007 through February 2, 2011.

BACKGROUND: INOmax DS Delivery System is a drug delivery system used with ventilators to deliver a preset concentration of INOmax therapy gas (nitric oxide for inhalation) for critically ill patients.

RECOMMENDATION: Ikaria implemented a service process change involving the application of DeoxIT, an anti-corrosion lubricant specifically created to prevent fretting corrosion. DeoxIT was added to the preventive maintenance plan for all INOmax DS Drug Delivery Systems and was performed when the Systems rotated through Ikaria’s Regional Service Centers for any routine service activity. On December 22, 2011, Ikaria sent a communication to health care professionals informing them of the completion of this action and that no further action was necessary.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

CLICK HERE to read the MedWatch Safety Alert.

Did you know…

that Vanderbilt has a policy/procedure related to complaints related to research studies? CLICK HERE to read more.