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Aptivus: black box warning update

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newt:
FDA Updates Black Box Warning on Boehringer Ingelheim's Protease Inhibitor Aptivus To Treat Drug-Resistant HIV

In short, the warning is amended to include a caution on use of this drug for people at greater risk  of bleeding after 13 out of 6,840 people on the clinical trials had brain hemorrhages (8 fatal). According to the FDA, many of these people had other medical conditions or were taking other drugs that could have contributed to the bleeding.

- matt

Cliff:
This drug has been in clinical studies since 2001 (probably even earlier), I wonder why it takes so long for this sort of potential danger to be exposed (determined) and the public notified?

Tim Horn:
Here is a news story I posted on the subject yesterday:

http://www.aidsmeds.com/news/am20060703.html

This drug was only approved a year ago (June 2005).  In turn, the largest clinical trials (including the U.S. and European expanded access program) -- where we learn about a drug's "minutiae," if you will -- have only been closed for a year.  It can definitely take this long to go over all of the safety data and conduct any additional studies -- such as the coagulation test tube studies conducted by Boehringer Ingelhim -- to make sense of any noted adverse events.  The ICH seen in clinical trials of Aptivus actually occurred, on average, a year and a half after Aptivus was started. 

For me, this simply goes to show that even when a drug is approved, there is still quite a bit more to learn about its safety and efficacy in the subsequent months and years of use.  A number of the "Black Box" warnings that have been issued for available antiretroviral drugs were put into place based on observations seen AFTER the completed of clinical trials and the approval of the drug.  This is definitely the case with hepatotoxicity... its definititely the case with things like lactic acidosis... and lipid abnormalities... and diabetes.  Much of what we learned about these side effects -- and how serious they can be -- came from "post-marketing" experience. 

The 14 ICH cases -- out of all participants in clinical trials of Aptivus -- represents an incidence rate of 0.2%.  Apparently, this is not much higher than the incidence rate seen in HIV-positive (or age-matched HIV-negative) people not taking Aptivus.  In turn, there's still a bit more to learn about this potential adverse effect... but, fortunately, some Black Box Warnings (and recommendations) are now in place in an effort to reduce the risk of this happening in people who use Aptivus.

Tim Horn

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