A name tells people who we are and within an organization it should reflect our mission/goals.

After examination and consideration of all that we do, it appears our current name does not accurately reflect our role in protecting human research participants. Institutional Review Board (IRB), refers solely to an individual committee, which is only a segment of our department. Many of us are not members of the IRB committees and our primary mission is to support the committees, as well as to act as a liaison between the research community, the committee members, and the research participants in the protection of human research participants.

With the above in mind, we have officially re-named our department to be,

Vanderbilt’s Human Research Protection Program (VHRPP) “supporting the work of the IRB and providing HRPP oversight“

While our commitment to what we do and how we do it won’t change, our new department name now reflects our overall mission.

The Texas Department of State Health Services and FDA notified healthcare professionals and consumers, especially pregnant or breastfeeding women, to avoid consuming a product called “Nzu”, taken as a traditional remedy for morning sickness,because of the potential health risks from high levels of lead and arsenic, noted on laboratory analysis by Texas DSHS. Exposure to lead can result in a number of harmful effects, and a developing child is particularly at risk of effects on the brain and nervous system. Arsenic is a carcinogen, and excessive long-term exposure to it has been associated with a range of adverse health effects, including cancers of the urinary bladder, lung and skin. Nzu, which is sold at African specialty stores is also called Calabash clay, Calabar stone, Mabele, Argile and La Craie. It generally resembles balls of clay or mud and is usually sold in small plastic bags with a handwritten label identifying it as “Nzu” or “Salted Nzu.” Anyone who has been ingesting the product should contact their health care provider.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the Texas State Health Services press release.

McNeil Consumer Healthcare and FDA notified consumers that it is expanding a voluntary recall to include all available product lots of TYLENOL Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided in press release at link below). In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the presence of a chemical 2,4,6-tribromoanisole, believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious. Consumers who purchased TYLENOL Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement.

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

Encompass Group and FDA notified healthcare professionals of the voluntary recall of the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment. FDA has recommended that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. Encompass is in the process of sending labels to customers to be attached per instructions to remind hospitals that the product line should not be used in the MR environment. A complete list of Thermoflect products and additional information can be found at www.thermoflect.com.

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

The Medicines Company and FDA notified healthcare professionals of a nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated for treatment of hypertension, due to the potential presence of particulate matter found to be inert stainless steel particles. If the particles were to aggregate, or if larger particles were present, then they could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.

CLICK HERE to read the full report and to find a link to the company press release for information on specific lots affected by this recall.

The MedWatch November 2009 Drug Safety Labeling Changes posting includes 44 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm191946.htm

Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
• Actiq (fentanyl citrate)
• Adenocard (adenosine)
• Adenoscan (adenosine)
• Avandaryl (rosiglitazone maleate and glimepiride)
• Byetta (exenatide)
• Cimzia (certolizumab pegol)
• Cleocin HCL (clindamycin hydrochloride)
• Enbrel (etanercept)
• Humira (adalimumab)
• Lotensin (benazepril hydrochloride)
• Lotensin HCT (benazepril/hydrochlorothiazide)
• Lopressor (metoprolol tartrate)
• Norvir (ritonavir) capsule and solution
• Parnate (tranylcypromine sulfate)
• Plavix (clopidogrel bisulfate)
• Qualaquin (quinine sulfate)
• Rebetol (ribavirin), Soma (carisoprodol)
• Remicade (infliximab)
• Simponi (golimumab)
• Soma Compound (carisoprodol 200 mg and aspirin 325 mg)
• Soma Compound with Codeine (carisoprodol 200 mg, aspirin 325 mg and codeine phosphate 16 mg)
• Tekturna (aliskiren)

Atlas Operations, Inc. and FDA notified consumers of a nationwide recall of the company’s dietary supplements for sexual enhancement. These products are currently being sold as dietary supplements throughout the United States. FDA lab analyses found that the products tested from certain batches contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male erectile dysfunction, making these products unapproved drugs. The active drug ingredient is not listed on the product labels.

The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance. Read the company Press Release for a complete list of product names and lot numbers.

The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional.

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

Just a reminder that we have an IRB Office Hours session coming up on Friday. No appointment or sign-up needed, just drop by and bring your questions.

Bayer Consumer Care and FDA notified Consumers of a recall of a single product lot of the combination package of Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels. The labeling on the foil blister card of certain packages within the lot were printed with the label reversed. The label for the green Night product appears under some of the blue Day product and vice versa. Consumers using the affected product lot may not be aware of the warnings of an antihistamine in the product that could cause drowsiness.

The affected Alka-Seltzer Plus product lot number can be found on both the interior blister package (in black text adjacent to the expiration date) as well as on the exterior carton containing the blister packaging (embossed on the side panel under the Bayer logo). This product was sold only in the U.S. at retail outlets nationwide.

• Package size: 20 liquid filled capsules per carton (12 day formulation capsules and 8 night formulation capsules)
• UPC#: 016500537779
• Lot #: 296939L
• Expiration: 5/11

Consumers who purchased combination packages of Alka-Seltzer Plus Day and Night Cold Formula Liquid Gels from the lot included in this recall should stop using the product and contact Bayer with any questions or for instructions on a refund or replacement. See the company Press Release for contact information.

CLICK HERE to read the MedWatch safety summary, including a link to the Bayer Consumer Care Press Release.

IRB Essentials – Research in the School System will be presented on December 21 from 11:30-12:30 in the IRB Conference Room.

This session will provide information and cover the ins and outs of conducting research within the local school systems. This session counts toward IRB continuing education requirements.

CLICK HERE for more details.