Friday, October 01, 2010

An ex-drug rep writes...

Hello,

My name is John Fratti. I have been injured by Levaquin, a widely prescribed fluoroquinolone antibiotic. I was healthy and athletic prior to my adverse reaction in 2005. I have nerve, tendon, and central nervous system damage. I require multiple prescription pain medications. I was ironically a pharmaceutical sales representative for seven years prior to my Levaquin injuries. I worked hard in life to obtain my master's degree. 

I had a meeting with the FDA concerning fluoroquinolone antibiotics on July 13th, 2010. I sent out a press release below. I am trying to promote awareness and advocacy on fluoroquinolone antibiotic toxicity. Fluoroquinolone antibiotics are often prescribed indiscriminantly and not judiciously. This class of antibiotics was meant to be reserved as a last line of defense against very severe and life threatening infections. Not as a first line of defense as they are often used today. 

I recently became an official FDA employee. I had my training in Bethesda, Maryland on September 23rd and 24th. My official title is FDA Patient Representative. It is a paid part-time position. I am unable to work full time with my injuries from Levaquin.

I would very much like to provide the documentation I have concerning fluoroquinolone antibiotics at a government oversight committee. Fluoroquinolone antibiotics were given a black box warning for tendon rupture and tendonitis in July of 2008. This warning is still not on the pharmacy handout given at the pharmacy. It has been over two years since this warning was issued. People deserve the right of informed consent. The fine print of the package insert for Levaquin mentions that it can cause irreversible peripheral neuropathy and can cause prolonged neurological disorders. I have copies of the package insert for Levaquin and Cipro. I have collected a wealth of medical documentation on fluoroquinolone antibiotics during the last couple years. There has to be some avenue that I can pursue to provide documentation on the severe injuries caused by fluoroquinolones. 
 
Currently, Johnson and Johnson is being investigated for the recall of their pediatric medications. Johnson and Johnson is also the manufacturer of Levaquin. I filed a Freedom of Information Request to the FDA for adverse event information on Levaquin, Cipro, and Avelox. The Freedom of Information Report that I have from the FDA lists 1,015 Total Death Outcomes from Levaquin and 14,796 Individual Safety Reports that have been filed for this drug from 11/1997 to 1/2010. Prolonged disability can occur from as little as a few pills according to the Freedom of Information Report. In my opinion, this is far more serious than the recent Johnson and Johnson recall that is currently in the news. 

I purchased shares of Johnson and Johnson stock and made a difficult trip to the annual shareholder convention. I was able to speak to the CEO, Mr. William Weldon, the Board of Directors, and the shareholders. I kept my speech very civil. I asked for improved safety warnings for Levaquin. I received loud applause by the Johnson and Johnson shareholders. Another shareholder that has been injured for over a decade gave a speech the year before. He received a standing ovation by the Johnson and Johnson shareholders for his presentation on this antibiotic safety issue. Johnson and Johnson executives continue to ignore pleas for improved safety measures for Levaquin. It is a matter of profits over people.
 
I can provide my FDA credentials and documentation concerning the Freedom of Information Report for Levaquin. I can also provide documentation concerning my July 13th meeting with the FDA on fluoroquinolone antibiotics. I was filmed several weeks ago by a national news organization concerning fluoroquinolone antibiotic toxicity. The news segment is scheduled to be aired in November. I would like very much to find out how I can provide the documentation I have to be reviewed by members of Congress on this very important safety issue. There is a significant number of disabled victims from these widely prescribed antibiotics. This antibiotic toxicity creates an incredible burden on family members that have to care for their loved one that has been injured or disabled. It also costs taxpayers in the form of social security disability. If anyone can offer any assistance or advice I would greatly appreciate it. Thank you very much for your time and consideration. 

Here is an informative article on fluoroquinolone antibiotic toxicity by Dr. Jay Cohen.
http://www.medicationsense.com/articles/jan_mar_04/congress_ltr.html


Sincerely,
John Fratti
Jfratti@comcast.net
717-566-2433

Press Release: http://www.cbs8.com/Global/story.asp?S=12937513

No comments: