Merck Statement on the Safety of Highest Dose of Simvastatin

WHITEHOUSE STATION, N.J., March 19, 2010 - In response to a news release issued today by the FDA on an on-going safety review of the risk of skeletal muscle effects from high dose simvastatin, Merck & Co., Inc. provided the following statement.

"Simvastatin, when used as a supplement to a healthy diet, can help reduce LDL cholesterol and reduce the risk of death from cardiovascular disease in patients at high risk of coronary events," said Michael Rosenblatt, M.D., chief medical officer, Merck & Co., Inc. "We support the FDA's recommendation that patients continue taking their medication as prescribed by their physicians, and that patients speak to their physician if they have symptoms or questions."

Merck has continued to share data with the FDA and other regulatory agencies from completed and on-going clinical studies of simvastatin to inform the medical community's understanding of the benefits and risks of this medicine, and has been working with these regulatory agencies to update the labeling accordingly.

The "Warnings and Precautions" section of the labeling for simvastatin-containing products reflects the potential risk of skeletal muscle effects from simvastatin, including an increased risk at higher doses and when simvastatin is taken with certain medications. The labeling for simvastatin has reflected information about potential muscle effects since approval.

Additional information about simvastatin
Simvastatin, a cholesterol-lowering prescription medicine, is used along with diet to improve cholesterol levels in people with high-cholesterol, when diet alone is not enough. The medication has been proven to significantly improve LDL and HDL cholesterol levels, as well as triglyceride levels. In patients with heart disease or diabetes, simvastatin, along with a healthy diet, is also proven to reduce the risk of heart attack and stroke.

Selected cautionary information for simvastatin
Simvastatin should not be used by anyone allergic to any of its components, with liver disease, or by women who are pregnant, breast-feeding or likely to become pregnant. Muscle pain or weakness in people taking simvastatin should be reported to a doctor because these could be signs of a serious side effect. Doctors may perform blood tests before and periodically during treatment with simvastatin to check for liver problems. People taking 80 mg of simvastatin should receive an additional liver function test at three months. People should tell their doctors about other medications and foods they are taking in order to avoid possible drug interactions. In clinical trials, the most common side effects included upper respiratory infections (9.0 percent), headache (7.4 percent), abdominal pain (7.3 percent), constipation (6.6 percent), and nausea (5.4 percent).

Forward-Looking Statement
This statement includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2009 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

For prescribing information about simvastatin, click here.

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