The US Regulators have warned of taking genetic tests for AIDS patients before undergoing treatment GlaxoSmithKline Plc’s drug Ziagen.
The Food and Drug Administration in its Web site has cautioned that patients who test positive for a specific gene variation should not go for Ziagen. It should only be considered when the potential benefit outweighs the risk, it added.
The agency points out that studies have found that a specific version of the immune system gene showed fatal reaction to Ziagen.
Fever, nausea, rash, vomiting and fatigue are the symptoms of the reaction and in some cases it could even lead to respiratory problems and death. Generically known as abacavir, the Ziagen had global sales of $218 million in 2007.
Meanwhile, the drug makers themselves have included the recommendation for the screening in the black box warning, which is the strongest warning for any drug. The instructions also have information on heart risk factors. It notes that a study has found that Zoiagen treated patients have higher risks of heart attacks. However, the label also says that the clinical trials have shown no excess risk. the label also asks doctors to be cautious when prescribing the drug to patients with heart diseases.
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