VMAC March24, 2010

We all know on 9/3/2004 Proheart 6 was voluntarily recalled.

We all know that on 1/31/05 there was a VMAC meeting and it was voted unsafe to return to market.

But.......

Did you know that June 5,2008 it was re-released? stating it was 'reformulated'

With restrictions called: Risk Minimization Action Plan (RiskMAP) (similar to black box warning)

"Conditions of ProHeart 6 use, including age eligibility, pre-existing health status, collection of CBC/chemistry panel, RBC and platelet count prior to treatment, and exclusion of concurrent vaccination"

Now.....

Another VMAC meeting is scheduled:

"The meeting is open to the public and interested persons may present data, information, or views, orally or in writing, on the issues pending before the committee. Written submissions may be made to Aleta Sindelar, CVM (HFV-3), FDA, 7519 Standish Place, Rockville, MD 20855 on or before March 17, 2010."

According to the Federal Register Announcement :

"the committee will discuss and make recommendations regarding modifications, if any, to the current risk minimization and restricted distribution program for Pfizer's PROHEART 6"

Do you believe it is safe to be used with no restrictions?

Write and let them know! Feel free to forward this information.