December 2007 Issues

FDA Issues Second Safety Warning for Fentanyl Transdermal Patch -- Quick Pulse

Summary: The FDA issued its second safety warning about the fentanyl transdermal system, an adhesive patch, and asked manufacturers of all fentanyl patches to update their product information and develop a medication guide. The agency issued a similar warning in July 2005, saying that the directions on the product label and on the patient package insert should be followed exactly in order to avoid overdose.

FDA Advisory Committee Split on Avastin for Breast Cancer

Summary: Genentech failed to convince members of the FDA’s Oncologic Drugs Advisory Committee that Avastin should be approved to treat first-line metastatic breast cancer. Yes, Avastin prolongs progression-free survival, the panel agreed, but the meaningfulness of that was unclear since it didn’t significantly improve either quality of life or survival – and Avastin added some significant side effects and even a few deaths. The FDA is likely to make its final decision on approval by February 23, 2008 .

ICD Lead Performance Conference

Summary: This one-day conference on ICD lead failure issues heard from academia, regulators (FDA), and industry. ♦ There was a call from some – but not all clinicians – for additional premarket clinical testing of ICDs, but industry, expectedly, and the FDA, perhaps unexpectedly, did not appear to be supporting the idea. Rather, the emphasis was on boosting post-market surveillance efforts. ♦ Proposals for a tougher stance on the approval process for new leads and for large premarket clinical trials didn’t have any real support. ♦ The key point of agreement appeared to be that ICD lead failures need standard definitions in the manner of the ARC definitions of definite/probable/possible stent thrombosis for drug-eluting stents, and it is likely there will be collaborations/meetings to come up with standard definitions of failure. ♦ Overall, the meeting did not appear likely to change much of anything relating to ICD leads or lead manufacturers.

PPIs do not cause Heart Problems – But Association with Hip Fractures Still Under Study -- Quick Pulse

Summary: The FDA announced on December 10, 2007 , that it has determined that proton pump inhibitors (PPIs) – e.g., AstraZeneca’s Prilosec (omeprazole) and Nexium (esomeprazole) – do not cause heart attacks or cardiac problems. After issuing a written statement, FDA officials spoke by teleconference with reporters about the decision.

FDA Panel Recommends Approval of Abbott's Xience Drug-Eluting Stent -- Quick Pulse

Summary: For more than three years there have been only two drug-eluting stents ( DES ) on the U.S. market – Johnson & Johnson’s Cypher and Boston Scientific’s Taxus – but two new second-generation DES may soon be available. On October 10, 2007 , the FDA’s Circulatory System Devices Advisory Committee voted to recommend approval of Medtronic’s Endeavor. Then, seven weeks later the same advisory panel voted 9 to 1 to recommend approval of Abbott Vascular’s Xience V EECSS with two conditions.