Friday, May 13, 2016

Update on Cipro

I initially started this blog as way to communicate information to patients concerned about certain medical topics, specifically those that hit the media.  With our 24/7 news cycle, multiple TV and cable channels, as well as blogs, social media, etc. there is always some new study or finding about a disease or drug.  However, patients or family members with that disease or who take that drug are often confused, because reporting on these topics tends to be confusing.  
Unfortunately, with new job responsibilities over the past several years, I have been unable to keep up with this blog.  While I have greatly enjoyed sharing information with patients, it takes a tremendous amount of time to write the type of posts on this blog, which cite multiple sources and attempt to interpret data.
However, despite not writing posts for three years, I have kept the blog active on the web.  I still get many hits, so I assume the information is still useful to some.  I continue to get inquires about popular topics.  In addition, for some posts, patients have used my blog as a forum to share experiences.
By far, the most popular post on my blog was written in July of 2008, called Tendon rupture with Cipro? FDA caves to Public Citizen.  The post has 163 comments and has over 46,000 views. Clearly, I stumbled on to something with this post.

The initial post was in response to media reports about a boxed warning placed on Cipro and other flouroquinolone antibiotics by the FDA in response to a letter by watchdog group Public Citizen.  My opinion at the time was that while Cipro was probably overused, the safety data from Public Citizen's report was actually not so bad, and came from a flawed event reporting system. Thus, I felt that the FDA was probably "caving" to public pressure. I saw this as a problem because there are many examples of FDA "warnings" that scare patients and the public unnecessarily, as well as lead to TV commercials from lawyers that scare patients from taking almost any treatment.    Most importantly, I stated that "the FDA stated it had recently done its own "new" analysis, which is why it added the boxed warning. However, they do not present the details of their findings. To me, this implies that they simply caved from public pressure and/or from law suit threats."  As a physician, it is hard to make decisions without looking at the data.  I thought it wasn't very responsible of the FDA to make such a warning without releasing any data.

The response to this post was overwhelming.  Patient after patient, commented on my post with horror story after horror story about problems they had with Cipro.  While this contrasted my experience with patients I had prescribed Cipro to, the sheer volume of posts told me that there really must be more to this flouroquinolone issue.  One affected patient who responded to my post actually obtained some of the aforementioned FDA "new" data through the Freedom of Information Act. He shared some of this data with me, confirming my suspicion.  Thus, I reversed my opinion.  Cipro is clearly not the safe drug I thought it was.  I stopped prescribing it for my patients, and I had indicated my position change in comments section of the post.  (I probably should have written a new post, since I would occasionally get angry responses to the original post and would need to indicate that the post was old and my position had changed).

Finally, yesterday, three years later after the boxed warning, the FDA states that these drugs are indeed dangerous.  Specifically, " The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options."  While it again would have been nice for the FDA to present more of the data (which was discussed in a meeting back in November, which eventually led to this announcement), I am glad to see that the FDA continued to pursue the issue and has communicated this issue to the public.

I want to thank all of the respondents to my original post who correctly challenged my viewpoint.  In doing so, you:
1. Changed my opinion and my practice.  While I never prescribed a lot of quinolones before, by stopping their use, I am sure I spared someone potentially dangerous side effects.
2. You created a forum for patients to share their stories
3. You kept the conversation going and my have helped keep pressure on the FDA to continue to focus on this issue.

I do hope that my schedule allows me to blog again in the future.