FDA: Test before giving GSK med

Personalized medicine, here we come--at least that's the message in two genetic-testing developments today. First, the FDA is advising docs to screen HIV patients for a particular genetic variant before prescribing abacavir, a GlaxoSmithKline anti-AIDS med sold under the brand name Ziagen and as part of the combo treatments Trizivir and Epzicom. That's because people with that genetic variation are at a far higher risk of a severe allergic reaction.

Though that risk was first reported several years ago, it was only recently quantified in a clinical trial. The genetic test will be recommended in a "black box" warning on abacavir labeling. With this move, abacavir becomes one of only a handful of meds for which the FDA has recommended genetic screening--but we can expect more to come.

Second, a new study tagged a particular variant with statins' most serious side effect. People who have that genetic variation were five to 17 times more likely to develop muscle pain and weakness--which can lead to muscle breakdown, kidney failure and death--when taking the cholesterol-lowering meds. The finding could lead to a predictive genetic test, which could help doctors know which patients can tolerate the higher doses that are increasingly common amongst statin-users.

- read the abacavir news from the New York Times
- check out the Washington Post statin story

Related Articles:
Did GSK ignore early abacavir warning?
Lancet: Glaxo HIV med boosts cardiac risk
Personalized medicine will drive restrictions by health plans