Vytorin cancer side effects evaluated by FDA
The FDA released an early communication yesterday about an ongoing safety review of Vytorin, Zetia and Zocor, and a possible association with the development of cancer. Vytorin users were found to have a higher incidence of cancer in a small study that was recently released, and the FDA indicates that they will be reviewing data from this study over the next nine months before reaching any formal conclusions about whether there is a causal relationship between the drugs and this emerging safety issue.
>>FDA LINK: Vytorin, Zetia and Zocor Early Communication
An early communication is the FDA’s method of notifying the public about a potential drug side effect or safety concern that they are investigating. It does not mean that the FDA is advising doctors or patients to change their medications and it does not mean that any conclusions have been reached about whether any regulatory actions will be needed.
However, this is the latest in a series of concerns which have emerged about Vytorin this year. Studies have raised questions about whether the once-popular cholesterol drug, which combines Zetia (ezetimibe) and generic Zocor (simvastatin), provides any medical benefits over older, cheaper cholesterol drugs.
In January, data was released from a clinical trial (known as ENHANCE), which indicated that Zetia and Vytorin provide no benefits over high doses of generic Zocor alone. The release of data from that study was delayed for months, raising serious questions about the motives of the drug makers, Merck & Co. and Schering-Plough Corp, who generated annual sales of about $5 billion off of the drugs.
Last month, data from another study (known as SEAS) was released, involving nearly 1,900 participants, which indicated that Vytorin was no better than a placebo in lowering the risk of heart disease in patients with partially blocked heart valves, or in the prevalence of aortic valve disease events.
An additional observation from the SEAS trial was that a larger percentage of the participants treated with Vytorin were diagnosed with and died from all types of cancer when compared to those taking a placebo over the course of the five year study.
After the release of this data, Merck and Schering Plough sent a letter to healthcare providers dismissing the potential for a Vytorin cancer risk, stating that the higher incidence of cancer was likely attributed to chance.
The FDA indicates that they anticipate receiving the final data from the SEAS trial in about three months, and they expect that it will take about 6 more months after that to fully evaluate the data. Once their evaluation is complete, they will release their conclusions and any recommendations to the public.
In the early communication, the FDA did point out that preliminary data from two other large trials of Vytorin which are still ongoing, have not demonstrated any Vytorin cancer side effects. The FDA has advised patients that they should not stop taking Vytorin or any other cholesterol lowering medication, and they should talk to their doctor if they have questions or concerns.
1 Comment • Add Your Comments
Ellen says:
My father was on Vytorin for a number of years and had some major health issues possibly as a result. How do we find out about the current class action suit against Merck?
Posted on November 12, 2009 at 11:03 am