The profile of AstraZeneca’s cholesterol-lowering agent, Crestor (rosuvastatin), took another knocking yesterday after it was linked to the death of a patient, possibly through the muscle-wasting condition, rhabdomyolysis.

In a statement, the Anglo-Swedish company confirmed that “a death possibly attributed to rhabdomyolysis associated with Crestor has been reported.” Scant details are available, but the firm did add: “The case details are complex, with clinical features more consistent with neuroleptic malignant syndrome, a condition seen with anti-psychotic agents.”

The news will no doubt serve to heighten the uncertainty surrounding the drug, which has frequently come under fire from critics claiming it is not safe. Influential US consumer group, Public Citizen, has repeatedly called for the drug to be banned, citing rates of side effects, such as muscle weakness, higher than were observed with Bayer’s Lipobay/Baycol (cerivastatin), before it was withdrawn from the market in August 2001 [[08/08/01a]], [[19/09/03a]], [[28/06/04a]]. The firm was recently taken to task by the US Food and Drug Administration over a series of Crestor advertisements, which claimed, amongst other things, that the agency had confidence in the product [[23/12/04a]]. A warning letter stated that the FDA has not publicly confirmed its confidence in the drug’s safety and efficacy and, furthermore, the agency said it “has been very concerned about Crestor since the day it was approved, and we’ve been watching it very carefully.” FDA scientist, Dr David Graham, also questioned the medicine’s safety during the US inquiry into Merck’s withdrawal of its painkiller, Vioxx (rofecoxib) [[01/10/04a]], saying it could pose a risk to human health [[22/11/04a]].

Nevertheless, Crestor remains a key drug for AstraZeneca, which has suffered a series of setbacks in recent months that could thwart future revenues. In October, US regulators recently rejected the company’s much-touted clot-buster, Exanta (ximelagatran) [[11/10/04a]], and trial data have since revealed that there was no overall survival benefit amongst patients taking its non-small cell lung cancer agent, Iressa (gefitinib) [[05/01/05a]], [[20/12/04b]].

Analysts have touted Crestor as a potential $4 billion dollar drug [[18/08/03f]], and AstraZeneca itself is counting on sales of the drug to boost its financials. Chief executive Tom McKillop has previously said that Crestor could garner some 20% of the global cholesterol market – reaping billions of dollars in return for its manufacturer [[30/01/04a]].