Drugmaker Johnson & Johnson negotiated with the Food and Drug Administration to keep a lucrative drug on the market and to weaken potential warnings even amid growing reports of deaths and heart problems by patients taking the drug, according to a published report.
The New York Times reported Friday that the drug, Propulsid, a treatment for heartburn and acid reflux, was pulled from the market in 2000 after five years of reported problems. The drug had seen sales of above $1 billion annually while it remained on the market, according to the Times. It reported the company pulled the drug as the government prepared to hold a hearing that could have drawn attention to the drug’s long, largely hidden, record of trouble.
By the time the drug was pulled from the market the federal government had reports of 80 heart-related deaths and 341 injuries, according to the paper.
The paper said its report was based on company and government documents filed under seal in lawsuits related to the drug.
The company defended the safety of the drug in a written statement given to the paper, and said it pulled the drug because physicians continued to prescribe it inappropriately despite repeated attempts by the company to warn them against that.
The company and FDA also did not reveal studies that questioned if it was effective, especially when used by children, according to the report.
The company’s own pediatric studies failed to demonstrate it was effective, according to the paper, and in January 1995, the FDA told the company that without studies showing it worked in children, it would not receive approval for pediatric sales. J&J never applied for such approval and the label did not recommend it for use in children.
But without a warning that the about the limit of the drug’s effectiveness for children Propulsid became popular among pediatricians, with half a million prescriptions a year for children and infants. The company claims a cherry flavored version of the drug was designed for elderly patients, but its own documents showed that 90 percent was going to children.