FDA Black Box warning

I called the FDA today: 1-888-463-6332. I asked about the Black Box warning for quinolones. I told the lady at the FDA that the Black Box warning was issued over 6 months ago. I asked when will it be put on the prescribing literature at the pharmacy. I said it was outrageous that it has taken so long and there is still no Black Box warning yet. She actually agreed with me that this is an outrage. The FDA is agreeing with me that this is an outrage. Wow! She told me the reason why the Black Box warning isn’t out on the prescribing literature is that congress hasn’t given the FDA juristiction to regulate the content of the prescribing literature at the pharmacy. She said that the Black Box warning is on the Package insert only. The package insert is the tiny little fold out that is attached to the Levaquin or Cipro medicine bottle in the pharmacy. Each medicine bottle in the pharmacy has a package insert attached to it. This package insert is not given to patients. Many people don’t even know that there is a package insert. Patients never get the package insert. The prescribing literature is what is only given to the patients. So in effect, patients never recieve the Black Box warning. This is unbelievable! A Black Box warning was issued over six months ago for quinolones and it will never reach anyone at pharmacy when they pick up their prescription for Levaquin, Cipro or Avelox. This is terrible. If anyone would like to call the FDA at the number above to express their outrage at this please do so.

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One Response to “FDA Black Box warning”

  1. bob says:

    Given that you were in the quinolone film with Sidney Wolfe and he is obviously aware of the FQ Syndrome, maybe you, Bob Groz and Paul Cahan ought to write up a letter to him. This may bring the matter to the front of his agenda. If I thought it was worth it It I would write myself but as I live in the UK I am not sure what credibility it would have.
    BOB

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