'Very Low' Risk From Statin Cholesterol Drugs
Study Says Kidney and Muscle Damage Seen Mostly in People Vulnerable to Those Problems
May 23, 2005 -- Statin drugs, which lower dangerous cholesterol levels, have "very low risk" of kidney and severe muscle side effects, says Richard Karas, MD, PhD.
However, among available statins -- Crestor, Lipitor, Pravachol, and Zocor -- the FDA received more reports of those problems with Crestor during the drug's first year on the market, says Karas and colleagues in the online edition of Circulation.
Karas, who directs the Preventive Cardiology Center and the Women's Heart Center at Boston's Tufts-New England Medical Center, talked about the study at a news conference.
The news needs a big dose of perspective, he and other doctors said at the news conference. Those side effects were extremely rare and people should not stop taking their statin drugs without first consulting their physicians, they said.
'Very Safe' Drugs
High cholesterol is a major heart hazard, and heart disease is a leading cause of death for U.S. men and women. There are many steps to take to lower cholesterol, including a healthy diet and exercise. Millions of people also take medications to curb their cholesterol.
"Statins in general are very safe," said Scott Grundy, MD, PhD, at the news conference. "These can be lifesaving to high-risk patients."
Grundy works at the Center for Human Nutrition and the departments of clinical nutrition and internal medicine at the University of Texas Southwestern Medical Center in Dallas. He wrote an editorial for Circulation about the study.
"Statins are among our best drugs for treating individuals who have elevated cholesterol," says American Heart Association president Alice Jacobs, MD, in a news release. "This study should reassure the public that the drugs are safe. Overwhelmingly, the majority of individuals tolerate statins very well and the absolute risk of side effects is low, including for [Crestor]."
Crestor's Maker Reacts
AstraZeneca, the maker of Crestor (and a WebMD sponsor) issued a press release on Monday night about the study.
The release says the study's conclusions are "misleading, and unfortunately create unnecessary alarm for patients who need this medication to lower their cholesterol."
AstraZeneca says the study "attempts to draw conclusions that simply cannot be drawn from adverse event reporting data," and that the company stands "fully" behind Crestor's safety and effectiveness when the drug is used according to prescription information. Crestor has been prescribed almost 22 million times for more than 4.7 million patients, says AstraZeneca.
Screening Recommended Before Prescription
Most of the muscle and kidney side effects occurred in people who were particularly vulnerable to those problems and generally went away when the medications were stopped, said Grundy. He encourages doctors to screen for risk factors before prescribing any statin.
Patients should also talk to their doctors about any issues that come up, such as brown urine, an indication that muscle damage or liver problems may be occurring. Also, "very dramatic [muscle pain] that doesn't go away" is something Karas recommends that patients should discuss with their doctors. Those may be symptoms of a severe and potentially fatal condition called rhabdomyolysis, in which massive muscle damage occurs.