The Justice Department has issued a subpoena to Merck & Co. for the way it researched, marketed and sold Vioxx, the drugmaker said in a regulatory filing.
Merck, which pulled Vioxx from the shelves in September, also said it faces an informal investigation by the Securities and Exchange Commission, the Wall Street Journal reported.
The company took Vioxx off the market after it conducted a study
that showed a doubled risk of heart attack or stroke in patients who took the once-a-day painkiller for longer than 18 months.
Although Merck has steadfastly defended its actions, it said it will cooperate with the SEC and the Justice Department. Justice's inquiry is connected to a federal health-care investigation under criminal statutes, the company said in its filing.
The company said it "cannot predict the outcome of these inquiries, however, it is possible that highly unfavorable outcomes, including a potential civil disposition from the SEC and/or potential civil or criminal dispositions from the Justice Department, could have a material adverse effect" on its finances, liquidity and results.
Some medical experts are saying that Vioxx should have been withdrawn years ago. According to the British medical journal Lancet, which published an analysis of public clinical-trial data, clinical evidence of harmful side effects would have justified the withdrawal. A Lancet editorial characterized the approval of Vioxx by regulators and its subsequent sale as "public health catastrophes."
Merck said last week that it “acted responsibly and appropriately as it developed and marketed Vioxx, and made decisions based on all available data at the time.” The company said the Lancet study was not based on new data and that the company's own analyses were more comprehensive.
Merck's stock prices have not recovered from the Vioxx controversy, as shares sold Monday at $26.57, compared with a high of about $50 set in February.