View Full Version : FDA Warning: Primaquine

11-13-2008, 20:35
Primaquine Linked to Risk for Hemolytic Anemia in Certain Patients

On July 28, the FDA approved class safety labeling revisions for primaquine phosphate tablets (sanofi-aventis US) to warn that treatment should be discontinued in patients with signs suggestive of hemolytic anemia, such as darkened urine and a marked decrease in hemoglobin or erythrocyte count.

According to the FDA, moderate to severe hemolytic reactions may occur in individuals with glucose-6-phosphate dehydrogenase deficiency and in those with a family or personal history of favism.

Patients from areas with a high prevalence of glucose-6-phosphate dehydrogenase deficiency (Africa, Southern Europe, the Mediterranean region, Middle East, South-East Asia, and Oceania) may be at increased risk for the development of hemolytic anemia while receiving primaquine and related drugs.

Primaquine is indicated for the radical cure (prevention of relapse) of vivax malaria.

Just thought people should be aware of this...is this still a prophylaxis of choice?


11-13-2008, 23:47
Well it's nice to see that this is finally in print. I fought this fight (successfully) in 2003/2004 while in PACOM. The PACOM SGN supported me despite the panel of naysayers. Even the guy who replaced me immediately repealed my restriction of G6PD deficient folks taking primaquine.
I feel VINDICATED!:lifter

Thanks for the update SS


12-22-2008, 10:11
Primaquine is used for the last 2 weeks of the 28 day post deployment part of prophylaxis. It's used as that added "umph" to clear out anything you might have picked up that the prophylaxis you're using, (doxy or lariam), is keeping dormant. It's been protocol for awhile that G6PD deficient people are not to use it and medics have to screen their guys records for the test and ensure whoever isn't tested is, and whoever is deficient, doesn't get it.