News Briefs: Week of July 19-23

This roundup includes the following news briefs:

The FDA is conducting a review of angiotensin receptor blockers, or ARBs, after a study recently published in The Lancet suggested the medications may be associated with a small increased risk of cancer.

The FDA said in a July 15 safety communication that the review is ongoing, and the agency has not concluded that ARBs increase the risk of cancer.

According to FDA officials, the benefits of ARBs continue to outweigh their potential risks, and patients should continue to use the drugs as recommended in their approved labels.

ARBs are used to treat hypertension, heart failure, diabetic nephropathy and for cardiovascular risk reduction. Complete lists of single-ingredient ARBs and combination ARBs are included in the FDA's safety announcement.

The FDA said physicians should report adverse events involving ARBs to the agency's MedWatch program.

The FDA has announced the specific steps it will require Baxter Healthcare Corp. to take to carry out a recall of its Colleague Volumetric Infusion Pumps, which was announced in May, as well as requirements for providing customers with refunds, replacement pumps or lease terminations.

Baxter must recall up to 200,000 pumps and provide transition guides to affected customers. The guide will include a list of FDA-approved pump alternatives; suggestions to help minimize disruption and patient risk during the transition period; and detailed information on the refund, replacement, and lease termination programs, the agency said.

The company also will continue to provide batteries, spare parts and service for the affected pumps during the transition period for customers who submit a Certificate of Medical Necessity to Baxter.

The FDA said Baxter must complete the recall and the replace-or-refund programs by July 14, 2012.

The Accreditation Council for Continuing Medical Education, or ACCME, has released its 12th annual report (12-page PDF; About PDFs) on the size and scope of the U.S. CME enterprise.

The report is based on information from 707 ACCME-accredited providers. It includes statistics on CME program revenue, funding sources, numbers of physician and nonphysician participants, and format of educational activities.

In 2009, more than 95,000 CME activities were reported and more than 17.5 million physicians and others participated in these activities.