In yet another setback for the company, American Home Products Corp. said Friday it was withdrawing its diarrhea vaccine from the market after 100 infants who received it suffered obstructed bowels.
It was the first time in nearly 45 years that a vaccine was withdrawn because of safety concerns.
An estimated 1-million children were given at least one of the three recommended doses of the rotavirus vaccine, RotaShield, after it was approved by the Food and Drug Administration in August 1998. Officials estimate that 100 babies have been reported ill from intussusception, a type of obstruction in which the bowel folds in on itself.
Among those reported cases, some children required surgery and one died, according to Douglas Petkus, a spokesman for American Home's Wyeth Lederle Vaccines unit.
Rotavirus is the most common cause of severe diarrhea and dehydration in children in the United States, according to the Centers for Disease Control and Prevention in Atlanta. About 40 U.S. children die from it each year; in poor countries, it kills as many as 600,000 children per year.
In studies done before Rota-Shield was licensed, intussusceptions occurred in five of 10,090 vaccine recipients, a rate not significantly higher than in unvaccinated children, according to the CDC.
Use of RotaShield had been suspended since July on the recommendation of the CDC. The CDC, the Food and Drug Administration and Wyeth said then that while no firm link had been drawn between the vaccine and the children's illnesses, they needed more time to study it. The company said it would try to reach a conclusion before November, the start of the rotavirus season.
Friday, Wyeth said it did not have the final data and thought the best course was to withdraw the product and recall all remaining doses. Interim data, however, "continue to suggest" an association between RotaShield and intussusception, the company said.
"It is important to note that available data do not indicate an ongoing risk to children given RotaShield in the past," American Home added.
In the last two years, American Home has withdrawn from the market two obesity drugs, one of which was used in the fen-phen diet-drug combination, and a pain reliever. It also has withdrawn an application for FDA approval of a new blood-pressure medicine and recalled injection kits used to fight allergic reactions.
Last week the Madison, N.J., company announced it would pay $3.75-billion to settle lawsuits related to its diet drugs.