(from 1997 through May 15, 2012)
FDA has opened the shelves of MedWatch to those of us wishing to review for ourselves the status of statin adverse drug reports (ADRs). This has been all the more imperative since FDA has been extremely reluctant to report side effect data on the statin class of drugs.
I was last able to access MedWatch data in 2006. Following that, in the beginning of 2007, my access to MedWatch data was denied despite legal pressure from my lawyers. Even in 2006 the process had not been easy, for it meant I had to tackle the immense challenge of reviewing manually some 64,000 Lipitor ADRs using the "find" mechanism on my PC. This was necessary, I was told, since the appropriate software for reading MedWatch data was available only to FDA and drug company officials. The rest of us had to be content with the time-honored and accurate but painfully slow process of counting each case one by one using the search mechanism on our PC.
I was last able to access MedWatch data in 2006. Following that, in the beginning of 2007, my access to MedWatch data was denied despite legal pressure from my lawyers. Even in 2006 the process had not been easy, for it meant I had to tackle the immense challenge of reviewing manually some 64,000 Lipitor ADRs using the "find" mechanism on my PC. This was necessary, I was told, since the appropriate software for reading MedWatch data was available only to FDA and drug company officials. The rest of us had to be content with the time-honored and accurate but painfully slow process of counting each case one by one using the search mechanism on our PC.