Anemia Drug Aranesp Considered Safe Before Dialysis

Amgen's anemia drug Aranesp was linked to an increase in strokes in a study of kidney patients last year, prompting the company to include a warning in its prescription notes. This badly affected its sales and general use, as you can imagine. But recently the USA's Food and Drug Administration had a panel of outside advisers vote on whether or not it should continue to be used, and decided that it can be used after all. Many news sites reported on this, including Bloomberg's

It seems that while the FDA acknowledges the possibility of risks being associated with the drug, they feel it can be used in kidney patients who are not yet on dialysis, and that more work needs to be done on the possible problem. The panel which recommended this is now looking into what the recommended dose should be.

With anemia a common side effect in kidney disease sufferers, some drugs such as Aranesp are used to boost production of hemoglobin.

Fresenius gets another warning

America's Food and Drug Administration (FDA) has issued a warning to the well-known provider of dialysis care and treatment Fresenius about problems with two of its products - Liberty Cycler sets and Naturalyte Acid Concentrate products. The warning is over a claimed failure to deal with products already in the hands of dialysis patients. Apparently the units can leak and although the company is said to have identified the problem and sorted it, units out in the field, so to speak are not having the problem resolved.

If you regularly browse medical news sites, you may have seen this reported in the last few days.

The full warning notice can be viewed at the FDA website. It lists five points that they want corrected within 15 working days.

This is not the first warning that the FDA has issued to Fresenius - there were complaints about their Phoslo gelcaps product three times in the last 18 months.