Date: Sat May 13, 2000 1:55pm
Subject: FDA letter

Dear group -
I wanted to let you know I finally received a response from the FDA to a
letter I wrote to Melinda Plaisier at the FDA regarding Levaquin on July
17, 1999. My response was from Celia A. DeLawter, Executive Operations
Staff (HFD-6), Center for Drug Evaluation and Research, Food and Drug
Administration, Rockville, MD 20857.
This letter really didn't say much but at least it was polite and respectful, which is a plus, considering the way most of us have been treated. And I also thought if others want to write to this same person maybe it will help. I'm not going to retype the whole thing but will hit the highlights.

She responds to my complaints after I ingested a single dose of Levaquin in March of 1998 and mentions she has been contacted by Congressman Scott McInnis, then goes on to explain they test on animals first, and then people. After it is tested on people and released to the public they sometimes find reactions in people that didn't show up in the initial test group, but they don't follow up on long term adverse
reactions on that test group so there is no information on them. The pre-approval testing reveals the most common adverse events likely to occur with a new drug perhaps down to a predicted occurrence rate of 1 in 4000. (I know Levaquin has got to be much higher than that!) She says the package info contains all of the adverse reactions I complained about. (they were loss of equilibrium, nausea, numbness on
the right side, insomnia, panic, anxiety, occipital neuralgia, visual disturbances and others.)
 

She thanks me for reporting to MedWatch and stresses how important that is. She also says they recognize that adverse reactions are underreported and that is taken into consideration when reports are received. She says the occurrence of a rare event, even a serious event, is not by itself reason to take a drug product off the market provided the benefits outweigh the risks. (And they still insist the benefits
outweigh the risks with Levaquin.) In the case of death or life threatening injury, distribution may be restricted or it may be removed from the market depending on the
frequency of the reports, the seriousness of the disease or conditions for which the drug provides a benefit, the availability of alternative therapy and the consequences of the disease left untreated. The one thing I noticed throughout this letter is that they still do not acknowledge the life ALTERING effects. We may not be dead but our
lives are permanently altered. So I will write back again trying to stress that point, and it would help if others did the same.
 

In my letter I asked FDA to investigate Levaquin and issue additional warnings to physicians. Sounds like they aren't doing that. She says considering the many millions of doses of Levaquin taken annually in the U.S. the frequency of reported reactions such as I described with long term consequences is very low. And on balance there is insufficient new information to warrant stronger warning on this
product taking into account its important for the treatment of serious infections.
She adds that this does not mean they are not taking my comments seriously or that my experience is my fault or my doctors. And my report along with others will be an important element in the continued surveillance of the effects of Levaquin and collectively these reports will ultimately determine the content of its labeling.
 

Oh - I should have noted this earlier in my post, but she also attaches this at the end. The reason long term effects aren't studied in the test group is that Levaquin is a short term therapy and does not include a requirement for long term post treatment evaluations. I thought you would all be interested in this. It's really pretty much "more of the same" as far as a runaround but if more of you write to this same person (Celia a. DeLawter - address above) it might help.

Arlene.