Zetia and Vytorin Side Effects Not Linked to Cancer According to Study
Despite reports that emerged last year linking side effects of Vytorin and Zetia to an increased incidence of cancer, a new study suggests that the cholesterol drugs are not associated with an increased risk of cancer.
Zetia (ezetimibe) is a prescription drug which decreases cholesterol delivery to the liver by inhibiting its intestinal absorption. Vytorin is a combination drug that contains both Zetia and an older cholesterol drug, Zocor (simvastatin).
After it was introduced in 2004, Vytorin was heavily marketed by the drug’s makers, Merck & Co. and Schering-Plough Corp., quickly becoming a blockbuster, best-selling medication, with annual sales of around $5 billion.
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Learn MoreSince last year, sales have dropped significantly after studies emerged that suggest Vytorin provides no medical benefits over taking Zocor alone, which is available as a cheaper generic.
In July 2008, a clinical study known as SEAS (Simvastatin and Ezetimibe in Aortic Stenosis), indicated that Vytorin was no better than a placebo in lowering the risk of heart disease in patients with partially blocked heart valves. However, an unexpected finding from the study suggested that patients who took Vytorin had a higher incidence of cancer than those who took the placebo.
In response to the SEAS study, the FDA released an early communication on August 21, 2008, indicating that they were investigating the possible association between cancer and Vytorin, Zetia and Zocor.
Although Merck and Schering Plough dismissed the potential increased risk of cancer as an anomaly, an editorial posted in the New England Journal of Medicine indicated that there was not yet enough data to rule out a Vytorin cancer side effect.
According to a new study published this month in the Journal of Clinical Lipidology, findings from a new large-scale study involving an analysis of all cancer reports filed with the FDA between July 2004 and March 2008 among users of Zetia and Vytorin, indicates that the cholesterol drugs do not increase the risk of cancer.
The researchers report that 2,334 cases of cancer were filed from among the 559 million prescriptions written for the drugs during the 4-year evaluation period. The findings indicate that the risk of cancer associated with use of Vytorin (1.3 per million) and Zetia (2.9 per million) is no more than the risk observed with other cholesterol reducing drugs (ranging from 3.1 to 5.1 per million).
Merck and Schering-Plough currently face Vytorin class action lawsuits which allege that the drug provides no additional medical benefits over cheaper alternatives. In addition, an investigation by the U.S. Department of Justice is looking into their marketing of the drugs and whether they made false or misleading representations that led to payments by Medicare and Medicaid.
3 Comments
ChrisNovember 19, 2009 at 6:15 am
I was taking Vytorin for about a month and I started to have some knee pain. Then my right knee and ankle swelled up to a point the I could not bend my knee very much. I still have trouble with both my knees and its about two months since i stop taking vytorin10 40. I'm taking a pain killer and anti inflamitory medician just to get through the day. When am I going to see an inprovement in my a[Show More]I was taking Vytorin for about a month and I started to have some knee pain. Then my right knee and ankle swelled up to a point the I could not bend my knee very much. I still have trouble with both my knees and its about two months since i stop taking vytorin10 40. I'm taking a pain killer and anti inflamitory medician just to get through the day. When am I going to see an inprovement in my ability to walk or get up out of a chair????
LoriNovember 14, 2009 at 6:26 pm
The study referenced in the Journal of Clinical Lipidology is a post marketing analysis of adverse events reported to the FDA which list "cancer" or "malignancy" among Zocor, Zetia or Vytorin users. This can be a very effective way for a manufacturer to "prove" what it wants: that there is not enough "evidence" to support a definitive and causative link between a particular drug and an adverse eve[Show More]The study referenced in the Journal of Clinical Lipidology is a post marketing analysis of adverse events reported to the FDA which list "cancer" or "malignancy" among Zocor, Zetia or Vytorin users. This can be a very effective way for a manufacturer to "prove" what it wants: that there is not enough "evidence" to support a definitive and causative link between a particular drug and an adverse event or outcome. However, this type of "study" can be extremely flawed. The reality is that the "average" person/patient and even most health care providers have neither the time nor resources to readily access "gold standard" clinical trials (randomized, double blinded, placebo-controlled) in which previously unknown adverse events or side effects can be uncovered. Therefore, why would a patient or healthcare provider expect a cholesterol lowering agent to impact the immune system to the level that cancer cells could multiply, or that there could be direct causative effect on cancer cell growth? Therefore, why would new cancer diagnoses routinely be reported to the FDA listing Zocor, Zetia,or Vytorin as suspicious agents? The reality is that the current FDA process for adverse event/outcome reports is rife with inaccuracies and unreliability: anyone can make a report, even anonymously - documented with supporting evidence or not, factual or claimed by an entity that has an ulterior motive. The original reporting process set forth by the FDA is known by physicians to create stacks of time-consuming paperwork to adequately document adverse events. Therefore, such reports have evolved into an almost completely voluntary system and grossly under-reports the actual events as already over-worked physicians avoid reporting adverse events at all costs unless there is a blatant and definite link. Therefore a postmarketing review, such as the one published in the Journal of Clinical Lipidology will almost always be skewed towards a favorable report for Zocor, Zetia, Vytorin ... and the drug companies which stands to lose/gain millions of dollars. The only exception to such favorable skewing: if mainstream media outlets pick up on reports of an adverse event and make it more widely known. Therefore the public - both medical and private - will think to make the connection between what might be thought a random medical condition/event as an actual adverse effect of a drug that taken concomitantly. Why would I, a self-professed "average" person, state the above? Because I am an "average" wife of an "average" husband who took Zocor to lower his high cholesterol. My "average" husband, who endured triple bypass surgery at age 49, changed to Vytorin after it came to market in an effort to do all he could to prevent further heart problems because we believed the marketing "that addressing the 'two sources of cholesterol' made sense". Now, my "average" husband has not only suffered another blockage requiring cardiac stent placement and irreversible damage, but has also endured numerous painful surgeries to remove basal cell carcinomas. Our "average" days are now spent wondering what will/could happen next? Is it possible or even probable that such events could have occurred while taking a cholesterol lowering agent other than Zocor, Zetia or Vytorin? We will never know as it is quite apparent that the manufacturer of the aforementioned drugs are using media and medical headlines - and even the FDA itself - as a tool to keep these adverse events under-reported.
LeoSeptember 28, 2009 at 6:56 pm
I took Vytorin for 2 years, had a session of muscle myopathy(unbekownst that that was what it was) after 1 year. Then at the end of the 2nd year i lost all motor ability, turned yellow and was quite ill. I was diagnosed with myopathy and lost all my muscle mass along with 40 lbs. Physical therapy helped me to regain my motor skills. I was pulled off Vytorin. At the same time a diagnosis of panc[Show More]I took Vytorin for 2 years, had a session of muscle myopathy(unbekownst that that was what it was) after 1 year. Then at the end of the 2nd year i lost all motor ability, turned yellow and was quite ill. I was diagnosed with myopathy and lost all my muscle mass along with 40 lbs. Physical therapy helped me to regain my motor skills. I was pulled off Vytorin. At the same time a diagnosis of pancreatic tumor with metastasis was made, non-operable.My bile duct was obstructed and a stent had to be put in place. I have been on chemo since Jan 2008.