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Home Industry News Amgen kidney drug brochure subject of FDA notice

Amgen kidney drug brochure subject of FDA notice

5th November 2008

Amgen has been rapped by the US Food and Drug Administration (FDA) for an advertising brochure for its kidney disease drug Sensipar.

The FDA described the document as “false and misleading” and left out or played down risks of taking the drug.

In the letter posted to Amgen’s website, the FDA added the patient brochure also expanded the potential uses of the drug.

Sensipar is licensed to treat secondary hyperparathyroidism in patients with chronic kidney disease (CKD).

Hyperparathyroidism is a disorder of the parathyroid glands, where too much of a hormone involved with calcium and phosphorus levels is produced.

The FDA said the patient brochure avoided the issue of potential risk of Sensipar to patients with liver problems and also left out mention of the risk of developing a type of bone disease.

Side effects including vomiting were also omitted.

The letter read: “Specifically, Sensipar is not indicated for all patients on dialysis, but only for patients on dialysis who require treatment for secondary hyperparathyroidism with CKD.”

It ordered Amgen to cease using the brochure and in response the company said it had.

It added it was working with the FDA to resolve the issue with the brochure information.

Amgen has its global headquarters in California.

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