HER2 Support Group Forums - View Single Post - FDA Releases New List of Possible Drug Safety Concerns

ElaineM · 08-30-2010, 03:15 PM

I wonder what the FDA is up to these days?
Two months ago I got several letters from the FDA asking me for more information about a "reported" incident involving Herceptin several years ago.
I couldn't remember reporting anything to the drug company or the FDA, so I asked my doctors to check my files to see if anyone in their offices reported something on my behalf. None of my doctors could find anything. I have never had a low LVF reading on Ecco Cardiograms or Muga tests. I never had any major side effects from Herceptin.I did not reply to the inquiry, but I think I should fill out the forms and tell them I never reported anything. Interesting !!
Here is the link to the full list with the reasons for investigating each drug, including Herceptin.
http://www.fda.gov/Drugs/GuidanceCom.../ucm223734.htm

08-30-2010, 03:15 PM	#2
ElaineM Senior Member Join Date: May 2006 Posts: 3,142	Re: FDA Releases New List of Possible Drug Safety Concerns I wonder what the FDA is up to these days? Two months ago I got several letters from the FDA asking me for more information about a "reported" incident involving Herceptin several years ago. I couldn't remember reporting anything to the drug company or the FDA, so I asked my doctors to check my files to see if anyone in their offices reported something on my behalf. None of my doctors could find anything. I have never had a low LVF reading on Ecco Cardiograms or Muga tests. I never had any major side effects from Herceptin.I did not reply to the inquiry, but I think I should fill out the forms and tell them I never reported anything. Interesting !! Here is the link to the full list with the reasons for investigating each drug, including Herceptin. http://www.fda.gov/Drugs/GuidanceCom.../ucm223734.htm __________________ Peace, ElaineM 12 years and counting http://her2support.org/vbulletin/showthread.php?t=48247 Lucky 13 !! I hope so !!!!!! http://her2support.org/vbulletin/showthread.php?t=52807 14 Year Survivor http://her2support.org/vbulletin/showthread.php?t=57053 "You never know how strong you are until being strong is the only choice you have." author unknown Shared by a multiple myeloma survivor.