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.

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.

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.

BACKGROUND: The ShoulderFlex Massager is a personal massage device sold in retail stores, catalogs and over the Internet. It is intended to provide users with a deep tissue massage to the neck, shoulders and back area while lying down.

King International recalled the ShoulderFlex Massager on Aug. 31, 2011; however, during a recent compliance audit, the FDA found that the company has gone out of business. King International has not followed through with recall procedures; the 800 number established by the firm for this recall is no longer in service; and many of the companies that sell this device are not aware of the recall or did not properly notify customers who purchased the massager.

RECOMMENDATIONS: The ShoulderFlex Massager poses serious risks. Consumers should stop using this device, health care providers should not recommend it to their patients and businesses should stop distributing and selling the device,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.

The FDA recommends that customers and consignees safely dispose of the ShoulderFlex Massagers so that the device cannot be used. The massage fingers should be removed and disposed of separately from the device; the power supply should be disposed of separately, as well.

CLICK HERE to read the MedWatch safety alert, including links to the FDA Safety Communication and News Release.

The recall includes the following model numbers:
• Riata (8F) Silicone Endocardial Defibrillation Leads
Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
• Riata ST (7Fr) Silicone Endocardial Defibrillation Leads
Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042

BACKGROUND: The leads connect an implantable cardioverter defibrillator (lCD) or cardiac resynchronization therapy defibrillator (CRT-D) to cardiac tissue in order to monitor and regulate a patient’s heart rate by providing pacing and delivery of high voltage therapy for ventricular arrhythmias.

RECOMMENDATION: On November 28, 2011, St. Jude Medical sent a Medical Device Advisory letter to physicians via certified mail. The letter is an update to St. Jude Medical’s Important Product Information letter, dated December 15, 2010. The current Medical Device Advisory letter provides an update on the failure rates associated with externalized conductors of Riata and Riata ST leads. The letter also includes updated recommendations and mitigations for patients implanted with Riata and Riata ST leads.

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 Class I Recall notice.

BACKGROUND: Gilenya (fingolimod) is an oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults. Gilenya is used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability.
RECOMMENDATION: At this time, FDA continues to believe that Gilenya provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label. Patients with MS should not stop taking Gilenya without talking to their healthcare professional.

FDA will communicate any new information on Gilenya and this case when it becomes available.

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 Drug Safety Communication.

• Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
• Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
• Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF)
• Patients prescribed Multaq should receive appropriate antithrombotic therapy.

CLICK HERE to read the MedWatch safety alert, including a link to the Drug Safety Communication