FDA MedWatch – Mallinckrodt Sodium Chormate Cr-51 Injection

Covidien and FDA announced the recall of one lot [#370-9004] of Mallinckrodt Sodium Chromate Cr-51 Injection as a result of routine post-market testing in which the product was found to be subpotent. Sodium Chromate Cr-51 Injection is a radiopharmaceutical agent used in a diagnostic test to determine the presence of a disease known as Polycythemia rubra vera. Using subpotent product could lead to an incorrect test result. A misdiagnosis or delayed diagnosis followed by a delay in treatment puts patients at an increased risk of embolus or stroke. This recall is being conducted to inform healthcare providers of the potential for a false low reading of red blood cell volume and to prevent further use of the product. Customers who have product from the recalled lot in their possession should discontinue use immediately. Customers with questions about the recalled product, including returns, should contact Product Monitoring at 800-778-7898 (7:00 am to 5:00 pm CT).

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the Covidien press release.

FDA MedWatch – Stealth Chocolate, Stealth Vanilla Powdered Dietary Supplement: Vital Pharmaceuticals, Inc.

Vital Pharmaceuticals Inc. and FDA notified healthcare professionals and consumers of a nationwide recall of the powdered dietary supplement, Stealth Chocolate and Stealth Vanilla, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. The product was distributed nationwide, including GNC Distribution Centers, VPX Sports Distribution Center, and internationally. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. Consumers should return the product to the store where it was purchased.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the firm press release.

FDA MedWatch – BiPAP Focus Non-Invasive Ventilator System

Respironics California, Inc. and FDA notified healthcare professionals of a Class I recall of the BiPAP Focus Non-Invasive Ventilator System, model number PCM120PS18-2315P. Power supply failures have occurred on some ventilators. This product was distributed from August, 2006 through April 11, 2008. Customers/distributors may contact Respironics U.S. Customer Service at 1-877-387-3377 or Respironics International Customer Service at 1-724-387-4000.

CLICK HERE to read the complete MedWatch Safety summary, including a link to the FDA Recall notice.

FDA MedWatch – Propoxyphene-containing Products

FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. The agency will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a medication guide to patients stressing the importance of using the drugs as directed.

FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action. To further evaluate the safety of propoxyphene, FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.

CLICK HERE to read the complete MedWatch Safety summary.

FDA MedWatch – Arthroscopic Shavers

FDA informed healthcare professionals of instances in which pieces of tissue have remained within arthroscopic shavers, a device used in orthopedic surgical procedures, even after the cleaning process was believed to have been completed according to the manufacturer’s instructions. Since retained tissue in these devices can compromise the entire sterilization process, FDA is actively working with the manufacturers of these devices to gather more data about this situation and to understand its potential public health impact. FDA encourages facilities that use any of these types of devices to evaluate the adequacy of their cleaning procedures and has provided recommendations for minimizing the potential risk to patients.

FDA asks that surgical facilities that discover retained tissue in arthroscopic shavers after following the manufacturer-recommended cleaning procedures file a voluntary report with MedWatch, the FDA Safety Information and Adverse Event Reporting program online. These voluntary reports will help FDA gather additional information related to this problem and assess its public health impact.

CLICK HERE to read the complete MedWatch 2009 Safety summary.

Device Encryption and Individually Identifiable Health Information

Any device (e.g., personal computer, laptop, etc.) used to save or store individually identifiable health information must be either encrypted or saved on a server housed in an approved data center. Vanderbilt Medical Center has agreed to use Check Point. For more information and how to obtain Check Point please visit the Information Privacy and Security website.

IRB Essentials – Exempt vs Expedited Research

We’ve got another educational opportunity coming up in a couple of weeks. You can register by CLICKING HERE to access our workshop schedule.

FDA MedWatch – Varenicline (Chantix) and Bupropion (Zyban, Wellbutrin, and generics)

FDA notified healthcare professionals and patients that it has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products.These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease.

Healthcare professionals should advise patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior.

CLICK HERE to read the complete MedWatch 2009 Safety summary.

FDA MedWatch – Lantus (insulin glargine)

FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects.

FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus. Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. FDA will communicate the results on its ongoing review to the public, as appropriate, as our review continues.

The FDA encourages both healthcare professionals and patients to report side effects from the use of insulin glargine to the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/medwatch/report.htm.

CLICK HERE to read the complete MedWatch Safety summary, including a link to the Early Communication and supporting documents, at:

FDA MedWatch – Nestle Toll House Prepackaged, Refrigerated Cookie Dough

FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). The warning is based on an ongoing epidemiological study conducted by the CDC and several state and local health departments. Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome (HUS). No one has died. E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS, which can lead to serious kidney damage and even death.

FDA advises that if consumers have any prepackaged, refrigerated Nestle Toll House cookie dough products in their home that they throw them away. Cooking the dough is not recommended because consumers might get the bacteria on their hands and on other cooking surfaces. Individuals who have recently eaten prepackaged, refrigerated Toll House cookie dough and have experienced any of these symptoms should contact their doctor or health care provider immediately. Any such illnesses should be reported to state or local health authorities.

CLICK HERE to read the complete MedWatch 2009 Safety summary including links to the FDA news release and consumer update and the CDC information page.