For instance, Amgen failed to note that Sensipar, which is used to treat patients undergoing dialysis for chronic kidney disease, is associated with the risk of adynamic bone disease and poses a risk to patients with hepatic impairment, the FDA letter states. And these are serious risks (here is the brochure).
For its part, Amgen says it will address FDA concerns. "We immediately ceased distribution of the brochure. Amgen is committed to responsible marketing that reflects the benefits and risks of our medicines," the company said in a statement given Reuters. [Our thought: Don't you think the marketing folks should have noticed the omissions in the first place? Or is the biotech like a teenager who feels the need to test parental limits?]