FDA Investigating Link between Vytorin and Cancer

The FDA released an early communication yesterday, about an investigation into the possible association between cancer and Vytorin, Zetia and Zocor.

The investigation was initiated after data from a recent study indicated a possible connection between an increased incidence of cancer and Vytorin, which is a combination of Zetia (ezetimibe) and Zocor (simvastatin).

An early communication indicates that the FDA has an ongoing review of a potential safety issue, but that no conclusion has been reached about whether there is a causal relationship between the drugs and the identified safety concern.

Vytorin was approved by the FDA in 2004 and it is marketed jointly by Merck & Co. and Schering-Plough Corporation. It combines Zetia and Zocor, which is also available as generic simvastatin, to reduce low-density lipoprotein (LDL or ‘bad’) choleterol levels and increase high-density lipoprotein (HDL or ‘good’) cholesterol levels.

Earlier this year, concerns emerged about Vytorin after a study known as ENHANCE, demonstrated that it provides no medical benefits over older, cheaper drugs used to treat cholesterol. This has caused a great deal of controversy, as Zetia and Vytorin are widely used, with about 1 million people taking one of the drugs in 2007, and generated annual sales of about $5 billion.

Last month, data was released from another trial known as SEAS (Simvastating and Ezetimibe in Aortic Stenosis), which indicated that Vytorin was no better than a placebo in lowering the risk of heart disease in patients with partially blocked heart valves. A similar result was observed in the prevalence of aortic valve disease. An unanticipated finding in the study was that patients who took Vytorin 10/40 mg had a higher incidence of cancer than those who took the placebo.

The FDA indicates that they have received the preliminary data from the SEAS trial and anticipate receiving the final study report in about three months. The early communication does point out that preliminary data from two large ongoing cardiovascular trials involving Vytorin have not demonstrated an increased risk of cancer.

The FDA anticipates that it will take approximately nine months for them to complete their safety review into the potential Vytorin cancer side effects and make any decisions about whether regulatory actions are warranted.

The early communication does indicate that individuals taking Vytorin or another cholesterol drug should not stop taking their medication. If they have any questions or concerns about Vytorin side effects and the FDA early communication, they have been asked to contact their doctors.