Hi,

I just read on this site about a "black box" warning that Aptivus can cause "intracranial hemmorrage". What does this mean, and is this something I should be worried about?

Thanks -- JD

The "black box" means that the FDA has issued a significant need-to-know about drug safety.

In the case of tipranavir (Aptivus), a small, but significant number of patients developed intracranial hemmorrhage (ICH, bleeding in the brain) while receiving the medication. To me, this means that patients with previous stroke, or significant risk of stroke or bleeding should use the medication with caution.

In the end analysis, the choice of tipranavir, like other medications used in rescue or salvage therapy needs to balance the potential benefit of supressing HIV viral loads to undetectable levels with the risk of having side effects or complication. For each patient, the balance point is different and individual.

For patients who haven't achieved undetectable viral loads on tipranavir, the risk of ICH might be too high; by contrast, if tipranavir is the medication that's required to get that undetecable viral load (and other meds can't replace it), then the real benefit of viral suppression and CD4 count increase may outweigh the risk of ICH.

Hope this helps. BY