FDA: Administering rotavirus vaccines ‘appropriate’
SILVER SPRING, Md. It is “appropriate” for healthcare professionals to continue use of GlaxoSmithKline’s rotavirus vaccine Rotarix and to continue using Merck’s RotaTeq, the Food and Drug Administration said Friday.
The FDA said it revised its recommendations for rotavirus vaccines, used to prevent gastroenteritis in infants. The decision was based on reviews of lab results and scientific literature and input from scientific and public health experts, the agency said.
The FDA also said it reached the conclusion that both vaccines have strong safety records and that despite the possible presence of porcine circovirus in some vaccine supplies, the virus does not pose a safety risk in humans and is not known to cause infection or illness.
Walgreens puts hold on its plan to sell genetic test kits in stores
DEERFIELD, Ill. Apparently having second thoughts on a deal that would have put genetic testing kits up for sale in its stores, Walgreens said Thursday it would delay any move to offer the products until questions posed by the Food and Drug Administration about the product are resolved.
Those questions arose following published reports that Pathway Genomics would begin selling its genetic test kits in most Walgreens stores this week. The reports triggered new scrutiny from the FDA, which indicated this week that it has no record of having approved the kits for sale.
The federal agency – which may be adopting a more assertive stance to product reviews and approvals under commissioner Margaret Hamburg – told Reuters news service that it would “take a hard look at any claims made by the company.”
Both Walgreens and Pathway asserted earlier this week that FDA approval is not needed for the sale of test kits in a retail setting. But FDA spokesperson Erica Jefferson told Reuters on Tuesday, “If a company is making claims about a product that hasn’t been reviewed or validated by FDA, we want to make sure the information to consumers is accurate and the test will do what it says it will do.”
In response, Walgreens reversed course. The company said Thursday has shelved, for now, its plan to go ahead with a rapid rollout of the kits.
“In light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we’ve elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter,” said Walgreens spokesman Jim Cohn.
The tests are saliva-based, and are intended to assess via DNA analysis patients’ genetic markers for such potential conditions as diabetes and cancer.
Mayo Clinic Health Manager seeks to organize personal medical information
REDMOND, Wash. Managing a health condition can be difficult enough, but organizing personal medical information can be even more time-consuming, according to a study commissioned by the Mayo Clinic and Microsoft, which operates the online resource HealthVault. The two have developed the Mayo Clinic Health Manager, a HealthVault application that helps people organize health information.
The study was the result of a survey of 1,065 adults conducted by Opinion Research Corp. in April. Nearly one-third of respondents said they spent more time keeping information organized than finding answers to health questions or dealing with chronic conditions.
At the same time, almost half said they regularly left doctor’s offices without asking an important medical question or giving the physician crucial information affecting their health, while 9-in-10 had reported doing so in the past.