Eli Lilly & Co. agreed voluntarily yesterday to suspend sales of its popular new anti-arthritis drug Oraflex in the United States after health officials in Great Britain temporarily banned the drug because it has been linked to 61 deaths there.
The abrupt announcements by company and federal health officials last night came after sales in Britain were halted early yesterday morning "on grounds of safety."
The highly unusual removal of the drug from the market here came only three months after it was approved by the Food and Drug Administration. It followed an afternoon of deliberations between FDA Commissioner Arthur Hull Hayes Jr. and officials from Lilly, in consultation with Health and Human Services Secretary Richard S. Schweiker. Consumer groups had been urging that it be banned immediately.
In a telegram to the FDA, the British Committee on the Safety of Medicines--the equivalent of the FDA--said that it has received reports of more than 3,500 adverse effects thought to be associated with the drug, including the 61 deaths, most of those among the elderly.
"There is concern about the serious toxic effects of the drug on various organ systems, particularly the gastrointestinal tract, the liver and bone marrow, in addition to the known effects on skin, eyes and nails."
In the United States, at least 11 deaths involving liver or kidney damage have been linked with Oraflex, according to Dr. Robert Temple, acting head of the FDA's office of new drug evaluation. Commissioner Hayes, appearing before a House subcommittee yesterday morning, said that he had just learned of the British decision. He told reporters that his options were to "do nothing" and await evaluation of the British data, to "concur" with the company should it voluntarily decide to suspend sales, or to recommend to Schweiker that Oraflex be declared an "imminent hazard" and taken off the market immediately.
The third course had been urged in petitions to the government from the Ralph Nader-founded Health Research Group, the American Association of Retired Persons and the American Public Health Association (APHA). The Health Research Group, the APHA and the National Council of Senior Citizens went to court on Monday to seek a ban.
Dr. Sidney Wolfe, of the Health Research Group, charged yesterday that "dozens of people have died unnecessarily from a drug that has no unique benefits but clearly has unique risks." He blamed the FDA for approving it in the first place and for not acting six weeks ago on his group's petition.
Yesterday's action was considered "highly unusual" but not unprecedented, an FDA spokesman said. In January, 1980, Smith Kline & French suspended sales of Selacryn, a high blood pressure pill, following reports of liver damage and death. The government has invoked the "imminent hazard" ban only once, in the 1977 case of Phenformin, a diabetes drug.
Lilly officials had earlier maintained that the problems associated with their drug were no different that those found with similiar arthritis medications already on the market.
A Lilly statement issued last night said that the company has advised the government of "its intention to immediately suspend the distribution and sales of Oraflex. Oraflex, a nonsteroidal, anti-inflammatory agent, was introduced in the United States on May 19, l982, after extended clinical trials involved approximately 4,000 subjects and two years of marketing experience in the United Kingdom, Germany, South Africa and Spain.
"After a careful review of all applicable scientific and clinical information, the company continues to believe that the drug is safe and effective when used as directed. During the last several weeks, the safety of Oraflex has been the subject of an unprecedented public controversy in both the United States and the United Kingdom, which culminated with the action by the United Kingdom health ministry to suspend for 90 days the product license for the drug pending a review by the Committee on Safety of Medicines."
Oraflex received U.S. approval amidst an intense marketing campaign that shot up the drug's sales. It has been sold under a separate trade name of Opren for the past two years in England.