Day 143: Why is the FDA investigating these drugs?

Apparently, the FDA is investigating Bristol-Myers Squibb and GlaxoSmithKline for the drugs didanosine and abacavir, respectively. Data from The DAD Study Group published in the Lancet suggests that these drugs are associated with a higher risk of myocardial infarction. One can only assume that the FDA is under increased scrutiny for these types of events considering the recent history of Vioxx. 

While the findings of the DAD group were unexpected, I think an FDA investigation is utterly ridiculous. As I am sure you are well aware, HIV is a fatal disease when untreated. These drugs are truly life saving. I am not saying they don’t have some serious side effects, but increasing an already very low rate of MI among high risk patients should not be a primary barrier to prescribing these drugs. Conducting this investigation will only serve to scare patients away from these antiretrovirals (and maybe other antiretrovirals), which would not be a good thing. 

Now, having said that, I can’t help but find myself wondering whether the abacavir hypersensitivity reactions, slight increase in MIs, and recent troubles in ACTG 5202 (among which was an increase in general adverse events) have something in common. Could there be some inflammatory effect with abacavir? I don’t know and I probably shouldn’t even write this, as there’s no data to back it up. It would be interesting if there was a common etiology, though.

M. Linde