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More Bad News for Vytorin as FDA Researches Possible Cancer Link
August 22, 2008 01:56 PM
The FDA said it has begun researching whether Vytorin increases cancer risk, but patients should not stop taking the cholesterol-lowering drug.
30-Second Summary
Federal drug safety regulators said that the risk of cancer from taking Vytorin, a combination of Merck drug Zocor and Schering-Plough drug Zetia, is still unclear, and so those taking the drug should not stop.
Clinical trial results released in July showed that in a study of more than 1,800 people, 93 people who took Vytorin developed cancer, compared with 65 in a control group. But two studies currently underway have shown no increased risk, according to the FDA.
Some researchers were quick to say the original cancer finding was most likely an anomaly. Richard Peto, a statistician at Oxford University, said the idea that Vytorin could cause cancer was “a bizarre hypothesis.”
The possible cancer link, however, comes on the heels of another recent clinical trial that showed that the drug failed to improve a heart valve condition called aortic stenosis, which, left untreated, can lead to serious heart problems.
Studies also found that the drug was no better at lowering cholestoral than the much cheaper generic drug, Zocor, a finding that contributed to the debate over brand-name versus generic drugs.
Clinical trial results released in July showed that in a study of more than 1,800 people, 93 people who took Vytorin developed cancer, compared with 65 in a control group. But two studies currently underway have shown no increased risk, according to the FDA.
Some researchers were quick to say the original cancer finding was most likely an anomaly. Richard Peto, a statistician at Oxford University, said the idea that Vytorin could cause cancer was “a bizarre hypothesis.”
The possible cancer link, however, comes on the heels of another recent clinical trial that showed that the drug failed to improve a heart valve condition called aortic stenosis, which, left untreated, can lead to serious heart problems.
Studies also found that the drug was no better at lowering cholestoral than the much cheaper generic drug, Zocor, a finding that contributed to the debate over brand-name versus generic drugs.
Headline Link: Vytorin gets closer look
Lawmakers have become involved in the reported cancer findings. Leaders of the leaders of the House Energy and Commerce Committees have asked Merck and Schering-Plough for “extensive data” on the clinical trials that indicated a cancer increase in patients who take Vytorin, the Associated Press reports.
Source: ABC (AP)
Background: Original cancer findings; study shows Vytorin no better than older drugs
The SEAS study, released in July, showed that Vytorin not only failed to imrprove the rare heart valve condition aortic stenosis, but that it may increase rates of cancer. However, some experts quickly said that the cancer results were a fluke.
Source: Forbes
Researchers predicted that a study conducted in January would show that Vytorin, a combination of Zetia and Zocor, would clear plaque from arteries better than Zocor alone. However, the study, which consisted of 720 patients and lasted for two years, found that Vytorin is not more effective than Zocor.
Source: findingDulcinea
Related Topics: Generic vs. brand-name; FDA pushes new drug rules
The Los Angeles Times questions whether generic drugs are “just as good” as their brand-name counterparts. According to the story, generics cost less than one-third of the corresponding brand names and the FDA ensures generic drugs are equal to brand name drugs, with the “same dose of the same active ingredient, delivered in the same way, and manufactured according to the same standards of quality.”
Source: Los Angeles Times (free registration may be required)
The Food and Drug Administration is researching whether moving away from measuring traditional benchmarks—like lowering blood sugar and bad cholesterol—may make drugs more effective overall. Currently, companies need to prove only that diabetes drugs regulate blood sugar levels. But two major recent studies show that even aggressively lowering patients’ blood sugar levels doesn’t prevent them from having heart attacks.
Source: findingDulcinea
Reference: Aortic valve stenosis
According to the Mayo Clinic, “Aortic valve stenosis—or aortic stenosis—is a condition in which the heart's aortic valve narrows. This narrowing prevents the valve from opening fully, obstructing blood flow from your heart into your aorta and onward to the rest of your body.” The condition can lead to serious heart problems.
Source: The Mayo Clinic
© 2009 Dulcinea Media, Inc.
