콜레스테롤 약의 부작용 경고 Safety Alerts Cite Cholesterol Drugs’ Side Effects

Federal health officials said these widely prescribed drugs could cause elevated blood sugar and problems with memory.

연방 식품 의약국이 콜레스테롤 수치를 줄이는 처방약의 새로운 부작용을 경고했습니다.
콜레스테롤 수치를 낮추는 약은 세계에서 가장 많이 복용되는 약입니다.

연방 식품 의약국은 드믈기는 하지만 콜레스테롤 약이 기억력 감퇴, 당뇨, 근육통증을 일으킬 수 있다고 경고했습니다. 약을 복용한 사람 가운데는 이 같은 부작용 증상이 있다고 호소한 사람이 있었지만 FDA가 콜레스테롤 약이 건망증, 혼돈이라는 부작용을 일으킬 수 있다고 경고한 것은 처음입니다.

이번에 경고를 받은 약은 Statin 성분이 있는 Lipitor, Zocor, Crestor, Vytorin과 같은 처방약입니다.
그러나 동시에 경고를 했다고 환자들이 복용해선 안되는 약이라는 뜻은 아니라고 강조했습니다.
Statin 성분이 심장질환을 막아준다는 것도 분명히 증명됐다고 지적하고, 다만 부작용에 대한 지식을 더한 것이라고 했습니다. 당뇨환자도 스테이틴스를 계속 복용해야 한다고 강조했습니다.

지난해 미국에서는 2천 백 만 명이 콜레스테롤 수치를 낮춰주는 스테이틴스를 복용했습니다.
콜레스테롤 수치를 낮추는 약은 보통 나이나 가족의 고혈압 병력 등을 감안해 콜레스테롤 전체 수치가 약 200 정도이면 약을 복용하는 게 도움이 된다고 보는 전문가가 많습니다.
건강한 사람이라면 콜레스테롤 수치가 240 미만이면 약을 먹어서는 안된다고 경고하는 전문가도 있습니다.

식품의약국은 건망증과 기억력 감퇴는 스테이틴스을 복용하는 모든 나이 그룹의 환자에게 나타났다고 밝히고, 어떤 환자는 집중력이 떨어지고 또 다른 환자는 생각이 정리되지 않는다고 밝혔습니다.

스테이틴스는 일부환자에게는 작은 양으로도 혈당량을 높여서 오래 복용할 경우 당뇨가 될 확률도 있습니다.
식품의약국은 당뇨위험은 베스트셀러 약인 크레스토, Crestor에 이미 경고했고, 이번에 모든 종류의 콜레스테롤 약에 추가로 경고했는데 오래된 약 하나는 제외됐습니다. Bristol-Myers Squibb에서 만든 Pravachol입니다. 부작용이 없다고 파정받은 프라바콜은 심장질환을 줄이는 효과는 다른 약에 비해 작습니다.

전문가들은 약의 부작용도 환자의 체질과 건강상태에 따라 다르므로 의사가 콜레스테롤 약을 복용하는 환자의 혈당량 등 여러 징후를 채크하는 것이 중요하다는 데 동의합니다.

Safety Alerts Cite Cholesterol Drugs’ Side Effects

Safety Alerts Cite Cholesterol Drugs’ Side Effects – NYTimes.com

Federal health officials on Tuesday added new safety alerts to the prescribing information for statins, the cholesterol-reducing medications that are among the most widely prescribed drugs in the world, citing rare risks of memory loss, diabetes and muscle pain

It is the first time that the Food and Drug Administration has officially linked statin use with cognitive problems like forgetfulness and confusion, although some patients have reported such problems for years. Among the drugs affected are huge sellers like Lipitor, Zocor, Crestor and Vytorin.

But federal officials and some medical experts said the new alerts should not scare people away from statins. “The value of statins in preventing heart disease has been clearly established,” said Dr. Amy G. Egan, deputy director for safety in the F.D.A.’s division of metabolism and endocrinology products. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

Diabetes patients and even those who develop diabetes while taking statins should continue taking the medicines, said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, who has studied the medicines extensively.

“These are not major issues, and they really do not alter the decision-making process with regard to statins,” Dr. Nissen said.

Last year, nearly 21 million patients in the United States were prescribed statins. Whether that number of users is too high or too low has been debated for years. While advice on whether to take statins involves a complex mix of factors like age, family history and blood pressure, some experts have suggested that those with total cholesterol levels around 200 would benefit from treatment. Others have argued that treatment should not start until a cholesterol level of 240 or higher, all other factors being equal.

Dr. Sidney M. Wolfe, director of Public Citizen’s health research group, is among those who contend statins are overused. He said the new alerts about risks provided more reasons that otherwise healthy people with cholesterol levels less than 240 “should not be taking these drugs.”

The F.D.A. said that routine monitoring of liver enzymes in the blood, once considered standard procedure for statin users, was no longer needed because the liver injury associated with statin therapy was so rare.

Reports about memory loss, forgetfulness and confusion span all statin drugs and all age groups of patients, the F.D.A. said. Dozens of well-controlled trials of statins have offered few hints that the drugs cause any kind of cognitive impairment, Dr. Egan said. Still, the F.D.A. has received many reports over the years that some patients felt unfocused or “fuzzy” in their thinking after taking the medicines.

Officials in the F.D.A. debated whether such reports were truly worrisome, Dr. Egan said. But in recent years, the F.D.A. — criticized for waiting too long to issue some safety alerts — has become more willing to be public about possible drug risks, even when the evidence is uncertain

“We are trying to be as transparent as possible with our alerts and labeling,” Dr. Egan said, even though the alert on the possibility of fuzzy thinking “is not overly helpful.”

Statins seem to increase blood sugar levels in some patients by small amounts, and when millions are treated, that change leads to a diagnosis of diabetes for more people.

The F.D.A. had already placed an alert about diabetes risks on the label of Crestor, a big-selling statin made by AstraZeneca, because a Crestor trial showed an increased risk. The agency decided to extend that alert to all drugs in the class with the exception of Pravachol, an older medicine manufactured by Bristol-Myers Squibb.

A well-controlled trial of Pravachol previously showed that it reduced the risks of developing diabetes by 30 percent, but other trials have found Pravachol less effective in reducing cardiac risks.

Dr. Egan suggested that doctors check the blood sugar levels of patients after starting them on statin therapy.

That statins can cause muscle pain, particularly at high doses, has long been known, but in its new alert the F.D.A. reminded doctors that some other medications increase the likelihood that statins linger in the body longer than normal and increase the risk of muscle pain. Among the drugs that conflict with statins are hepatitis Cprotease inhibitors like telaprevir and boceprevir and the antibiotics erythromycin and clarithromycin.