Smithkline Faces Suit Over Drug Side Effect

The U.S. Justice Department is considering bringing criminal charges against SmithKline Corporation because of the company's delay in reporting adverse reactions to the anti-hypertension drug Selacryn. SmithKline has also been bombarded with more than 50 product-liability cases by people claiming injuries or death attributable to Selacryn, which causes liver damage in some patients.

SmithKline officials failed to report twelve cases of liver damage they knew to have been linked to use of the drug within the 15-day period specified in U.S. Food and Drug Administration (FDA) regulations, and therefore could be punishable as a result of a Justice Department suit "by a maximum fine of $10,000, a maximum of 3 years in jail, or both if there is intent to defraud or mislead," according to Dr. Sidney Wolfe of the Public Citizen Health Research Group. When the firm did inform the FDA of the cases-up to 4 months late-the information appeared buried in volume three of a seven-volume routine submission to the FDA.

Not only did SmithKline fail to notify the FDA of Selacryn's harmful side effects, but the firm actively continued to promote the drug, distributing 230,000 prescriptions from the time of the first reports of adverse reactions until the report to the FDA in November, 1979. According to a report by Dr. Wolfe; "As of November 1980, the FDA had received approximately 1,100 adverse reports, including 600 cases of liver toxicity and over 60 deaths, as a result of Selacryn's eight-month tenure on the US market."

Selacryn was first sold in the U.S. in May, 1979, but was hastily withdrawn on January 15,1980, after the FDA learned of 52 cases of liver damage, including 5 deaths, among American users. Selacryn has since been banned in West Germany, Mexico, the Philippines, and Switzerland.

The drug is still being sold in France by the French pharmaceutical firm Lipha Albert Rolland, from whom SmithKline acquired the rights to market it in the U.S.-despite warnings from the Health Research Group about previous reports of side effects.

A brief news release from SmithKline states that "the company continues to believe that no further action is necessary." A spokesperson for the Justice Department declined to comment on the case, since it is under investigation.