Healthy Skepticism Library item: 11483

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

FDA launches its first 'drug safety newsletter'
Pharma Times 2007 Sep 19
http://www.pharmatimes.com/WorldNews/ViewArticle.aspx?id=11778

Full text:

The US Food and Drug Administration has sent out its first ‘drug safety newsletter’, part of the agency’s response to criticism that it had taken its eye off the ball particularly when it comes to checking on marketed drugs.

In introducing the new missive, FDA Commissioner Andrew von Eschenbach claimed that “knowledge not communicated almost invariably is knowledge wasted” and “if the information can help better protect and promote the health of our public, the waste is intolerable”. This is especially true about “the wealth of data that are developed or received by our agency about the safety of new or widely used medications”.

As such, the role of the newsletter “is to keep our medical community posted…about selected postmarketing drug safety reviews, important emerging drug safety issues, and recently approved pharmaceutical products,” he said, noting that it will be published quarterly and e-mailed for free to all subscribers.

Every year, the FDA receives more than 400,000 reports of adverse events but its inability to pass on necessary safety information was savaged by the Institute of Medicine, an independent government body, which issued a report on the agency in 2006. That report concluded that the FDA has a “dysfunctional” structure which hampers its duty to protect public health and the newsletter represents one attempt by the agency to rectify the problem.

The first issue contains three post-marketing reviews – Roche/Genentech’s cancer drug MabThera/Rituxan (rituximab), Cephalon’s sleep drug Provigil (modafinil) and Schering-Plough’s brain cancer drug Temodar (temozolomide) – and an ‘early safety findings’ section which reports on Novartis’ Exjade (deferasirox), a novel iron chelator product that reduces the iron overload that can occur in patients who have to undergo multiple blood transfusions. In May, the FDA reported cases of kidney failure and deaths in patients taking the drug, but the agency claimed that the relationship between Exjade and the side effects are unclear.