Levaquin off label use and misleading promotion.

My family has been contacting some government oversight places such as the Department of Justice, Health & Human Services, Government Accountability Office, and elected official offices. Surprisingly, I got an email from one of the offices dealing with Criminal Investigations. I have an appointment to meet with a government official in late January regarding Levaquin safety and promotion. The government official stated the meeting would last the better part of the day. He was willing to come to my house due to my medical condition. 
 
I was on an FDA Webinar last month called the FDA Bad Ad Program. This FDA program deals with deceptive and misleading promotion of drugs. I have placed a link to Bad Ad Program below. 
 
It would be great to have a copy of the visual aid/detail piece that was used for promoting Levaquin to doctors. This would be very valuable to show to the government investigator for the meeting. If there is any current or former Johnson & Johnson or Ortho McNeil sales representative that has any information to disclose on Levaquin off-label use or deceptive marketing, I would greatly appreciate being contacted. My email address is listed below. 
 
I realize that Levaquin has helped save people from life threatening infections. However, it has ruined many lives as well. Levaquin is a drug of last resort. It is not meant for simple routine infections which is how it has been prescribed for many people. Doctors need to be educated to avoid prescribing Levaquin for these routine infections. 
 
The Johnson & Johnson Credo states that patients of their products come first. There are a significant number of people suffering from devastating long term injuries from Levaquin. Familes have been ruined emotionally and financially. Jenn Wilcox’s story on the PBS national news segment is a powerful illustration of this.  Bedridden for over a year after taking Levaquin, Jenn Wilcox lost her job as a school teacher. Unable to work, the Wilcox family lost their home.  It is hard to understand the suffering unless its happened to you or a family member.        
 
So many people injured by Levaquin state that their doctors are not aware of the potential long term injuries caused by this drug. I feel part of the problem is that doctors have not been properly informed of the inherent  risks of this drug by the Johnson & Johnson sales representatives. Perhaps upper management did not fully disclose to the sales force the true side effect profile of Levaquin. Here is a good article by Dr. Jay Cohen that talks about how doctors are in denial over Levaquin and other fluoroquinolone drugs.   http://medicationsense.com/articles/2011/FQreactions042011.html
 
It is my opinion that the manufacturer of Levaquin has engaged in deceptive marketing practices regarding the safety of their antibiotic Levaquin. I feel that Johnson & Johnson sales representatives have downplayed safety information, failed to provide fair balance on Levaquin in their presentations to doctors, and misinformed physicians about the true risk/benefit profile. I know when I was a drug representative, the vast majority of pharmaceutical sales representatives rarely gave fair balance. Just about every pharmaceutical sales representative that I partnered with, and I have worked with many, downplayed or failed to mention important drug safety information during their lunch presentations with physicians. 
 
Many pharmaceutical companies are paying large fines for off-label marketing and other forms of deceptive marketing practices. Consumers deserve to have proper knowledge and more adequate information on potential serious drug safety issues. I very much appreciate any assistance on this matter.        
 
John Fratti
 
 
FDA Bad Ad links:
 
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9 Responses to “Levaquin off label use and misleading promotion.”

  1. JJ says:

    I was checking on this medication they gave to my husband when he was released from the hospital on Tuesday (03/06/12). Levofloxacin, I have now stopped him from taking the rest of it. He has Multiple Sclerosis, diabetes, wears a pacemaker and has a torn valve in his heart. He surely does not need this medication. My biggest concern is are doctors not informed or are they just not paying attention to what the side affects are? I as a rule always check out medication on-line and if the side effects are bad I refuse for any of my family to use these drugs. What I always ask is, what has happened to the old stand-by’s? I don’t believe in taking any new medications that are out there because I don’t believe the FDA is doing their job for the good of the people. I believe they are taking bribes to pass these drugs onto the public because it’s all about the profit and not if people will die. After all by the time the bad reactions get out these companies have already made their billions. Things have got to change to make our medications safe again. Does anyone have or know how long the FDA has been allowing these bad drugs to be put on the market?

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