The Role of Adverse Event Reporting in the FDA Response to a Multistate Outbreak of Liver Disease Associated with a Dietary Supplement.

OBJECTIVE: Liver disease is a potential complication from using dietary supplements. This study investigated an outbreak of non-viral liver disease associated with the use of OxyELITE Pro(TM), a dietary supplement used for weight loss and/or muscle building. METHODS: Illness details were ascertained from MedWatch reports submitted to the U.S. Food and Drug Administration (FDA) describing consumers who ingested OxyELITE Pro alone or in combination with other dietary supplements. FDA's Forensic Chemistry Center analyzed samples of OxyELITE Pro. RESULTS: From February 2012 to February 2014, FDA received 114 reports of adverse events of all kinds involving consumers who ingested OxyELITE Pro. The onset of illness for the first report was December 2010 and for the last report was January 2014. Thirty-three states, two foreign nations, and Puerto Rico submitted reports. Fifty-five of the reports (48%) described liver disease in the absence of viral infection, gallbladder disease, autoimmune disease, or other known causes of liver damage. A total of 33 (60%) of these patients were hospitalized, and three underwent liver transplantation. In early 2013, OxyELITE Pro products entered the market with a formulation distinct from products sold previously. The new formulation replaced 1,3-dimethylamylamine with aegeline. However, the manufacturer failed to submit to FDA a required "new dietary ingredient" notice for the use of aegeline in OxyELITE Pro products. Laboratory analysis identified no drugs, poisons, pharmaceuticals, toxic metals, usnic acid, N-Nitroso-fenfluramine, pyrrolizidine alkaloids, aristocholic acid, or phenethylamines in the products. CONCLUSIONS: Vigilant surveillance is required for adverse events linked to the use of dietary supplements.

The influence of coronary artery bypass graft harvest site on women's pain, functional status, and health services utilization throughout the first post-operative year: a longitudinal study.

BACKGROUND: Coronary artery bypass graft surgery is a commonly performed procedure aimed at managing coronary symptoms and prolonging life. Researchers have typically examined morbidity and mortality outcomes of predominantly male populations. Less is known about the influence of graft harvest site on recovery outcomes such as surgery-related pain, functional status, and health services utilization, especially in women. OBJECTIVES: We aimed to examine the relationships between coronary artery bypass graft harvest site (saphenous vein, internal mammary arteries or both) and surgery-related pain, functional status, health services use at 6 weeks, 12 weeks and 12 months post-operatively. DESIGN: Longitudinal extension survey following participation in a clinical trial. SETTING: Ten Canadian centres. PARTICIPANTS: Women (222) who participated in the Women's Recovery from Sternotomy Trial, underwent coronary artery bypass graft surgery with or without heart valve surgery, and completed the 12-month follow-up interview. METHODS: Harvest site data were collected by health record audit at the time of hospital discharge. Surgery-related pain, functional status, pain medication use and health services use data were collected by standardized interview over the telephone at 6 weeks, 12 weeks and 12 months post-operatively. Surgery-related pain and functional status were measured using the short Health Assessment Questionnaire. Health services use was measured by questionnaire and recorded as reported by the participants. RESULTS: Surgery-related pain, functional disability and health services use decreased over the first post-operative year. Participants who had left internal mammary artery grafts were more likely to have surgery-related pain (Adjusted Odds Ratio (AOR)=2.79; 95% Confidence Interval (CI) 1.40-5.70) and use pain medication (AOR=4.32; 95% CI 1.44-12.91) than those who had saphenous vein grafts. Conversely, participants who had saphenous vein grafts reported significantly more functional disability (AOR=2.63; 95% CI 1.16-6.25) over 12 months post-surgery than those with left internal mammary artery grafts. Participants who had pain over the course of follow-up were more likely to visit their family physician or nurse practitioner (p=0.017), visit another type of provider (i.e., naturopath or chiropractor, p=0.004), or use any health care service (p<0.0001). CONCLUSIONS: Following coronary artery bypass graft surgery, women who had left internal mammary artery grafts reported more pain and health services use while those who had saphenous vein grafts were more functionally disabled. Women who reported surgery-related pain also used more health services.

Results of one-year follow-up of steroid-free immunosuppression in pediatric renal transplant patients.

Renal transplantation in children has traditionally required immunosuppression with multiple medications including glucocorticoids. Data collected over almost 30 yr suggest that although glucocorticoids are efficacious as part of a regimen to minimize the incidence of acute rejection episodes, their use is associated with increased risk for post-transplant hypertension, hyperlipidemia, and reduced growth rates. We desired to reduce these complications and thus used an immunosuppressive protocol including daclizumab, tacrolimus, and mycophenolate mofetil and study the efficacy of this protocol in a population with a high percentage of African-American recipients. No patient received glucocorticoids at any time post-transplant. Our results show that at 1 yr post-transplant, glomerular filtration rate, serum glucose, calcium and phosphorous metabolism, serum magnesium, and serum lipids were similar in patients receiving steroid-free and those receiving steroid-based immunosuppression. The incidence of acute rejection was similar in the two groups. Hematocrit and white blood count levels were lower 1 month after transplant in the steroid-free patients but these levels increased within several months. Systolic blood pressure was similar in the two groups, although this was achieved, in part, in the patients who received steroids by the administration of medications to lower blood pressure. Finally, tacrolimus levels were similar in the two groups, but patients receiving steroids required higher doses of tacrolimus at several time points studied during the first post-transplant year. Taken together, our data suggests that at one-year follow-up, steroid-free immunosuppression is safe, and efficacious in pediatric renal transplant recipients.