FDA asks healthcare professionals to hold off administering rotavirus vaccine
SILVER SPRING, Md. The Food and Drug Administration has asked healthcare professionals to temporarily stop using a vaccine used to prevent severe diarrhea in infants following the finding of DNA from a virus that affects pigs.
The FDA said Monday that an academic research team had found material from the porcine circovirus in some supplies of GlaxoSmithKline’s Rotarix, used to prevent infection by rotavirus. Rotavirus can cause severe diarrhea and dehydration and is responsible for the deaths of round half a million infants around the world each year, particularly in poorer countries and resulted in more than 50,000 hospitalizations and several dozen deaths in the United States each year before rotavirus vaccines were introduced earlier this decade.
The FDA said there was no evidence yet that the porcine circovirus posed a safety risk, and PCV is not known to cause illness in humans or other animals. Follow-up tests by GSK confirmed the findings of the academic research team. Material from the virus has not been found in a competing vaccine, Merck & Co.’s RotaTeq.
“We are making clinicians aware of information recently received by FDA about the Rotarix vaccine,” FDA commissioner Margaret Hamburg said in a statement. “There is no evidence at this time that there is a safety concern. FDA is recommending that clinicians temporarily suspend use of Rotarix until we can learn more about the situation.”
GSK said it confirmed its notification of regulatory authorities, but that porcine circovirus doesn’t multiply in humans and occurs regularly in meat products without causing any health problems.
“No safety issue has been identified by external agencies or GSK,” GSK Biologicals chief medical officer and global research and development head Thomas Breuer said in a statement. “GSK is committed to patient safety and to the highest manufacturing standards for all our vaccines and medicines. We are already working closely and discussing this finding with regulatory agencies around the world.”
Retail Clinician special report focuses on patient-centered care
NEW YORK Drug Store News’ sister publication, Retail Clinician, has issued a special report on an exclusive study conducted by Take Care Health Systems in conjunction with Gallup Consulting that measured patient engagement levels among Take Care Clinic visitors, with an eye toward elevating the patient experience.
The report, which is anchored by the original white paper — written by Sharon Glave Frazee, Ph.D., VP corporate healthcare analytics and research team for Walgreens, along with John H. Fleming, Ph.D., principal, chief scientist customer engagement and humansigma®, Gallup, and Margaret Ozan Rafferty, R.N., M.H.A., M.B.A., healthcare global practice leader for Gallup — and also includes an interview with Take Care CEO Peter Miller discussing the significance of the findings and what it means both for Walgreens and Take Care, and the impact Take Care’s unusually high levels of patient engagement is having on clinic traffic.
A copy of the report can be downloaded here.
High doses of cholesterol drug may raise muscle injury risk, FDA warns
SILVER SPRING, Md. Patients taking a common drug for treating high cholesterol may be at increased risk of muscle injury, the Food and Drug Administration warned Friday.
The FDA warned patients and healthcare professionals of the risk of muscle injury, also known as myopathy, in patients taking simvastatin in the 80-mg strength. Though muscle injury is a side effect common among all statins, the agency said patients taking higher doses of simvastatin run a higher risk. Of particular concern is the risk of rhabdomyolysis, a severe form of myopathy that can lead to kidney damage, kidney failure and sometimes death.
Merck originally marketed simvastatin under the brand name Zocor, and it is now available as a generic from several suppliers. It’s also an active ingredient in several other cholesterol-lowering drugs, including the Merck’s Vytorin (ezetimibe and simvastatin) and Simcor (niacin and simvastatin), marketed by Abbott and Solvay Pharmaceuticals. All formulations of Simcor contain only 20 mg of simvastatin, though Vytorin is available with 80 mg, according to an FDA database.
“Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available,” FDA Division of Metabolism and Endocrinology Products deputy director Eric Colman said in a statement. “It’s important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”