A consumer group Tuesday urged U.S. officials to bring criminal charges against Abbott Laboratories, saying the company withheld information from regulators regarding eight deaths in patients who took the diet drug Meridia.
Abbott said the allegations had no merit and said it remained confident about Meridia's safety and effectiveness.
Consumer group Public Citizen, which wants Meridia pulled from the market, said it had obtained a report of a recent Food and Drug Administration inspection of Abbott facilities in Abbott Park, Ill.
The document indicated Abbott did not report one death associated with Meridia and that records regarding seven other deaths were inaccurate, unsupported or incomplete, according to Public Citizen. Drug makers are required by law to report to the FDA serious events in patients taking their products.
The consumer group said portions of the FDA report were redacted and that it was interpreting certain sections based on information elsewhere in the report.
Public Citizen's charges "are without merit, are not factual and have been intentionally written to alarm and mislead physicians and patients," Dr. Eugene Sun, an Abbott vice president, said.
Meridia, a prescription drug known generically as sibutramine, was launched in the United States in 1998 to treat obesity. More than 8.5 million patients in more than 70 countries have used the drug, Abbott said.
The company said it remained confident in the safety and effectiveness of Meridia, which Sun called an "important and safe option for the treatment of obesity."
An FDA spokeswoman acknowledged that the agency had inspected Abbott facilities. "We have inspected and if there are problems we will take the appropriate action," the spokeswoman said.
John Wolfinger, an Abbott vice president for pharmaceutical quality assurance, said, "The FDA's observations have been addressed and do not impact the product's safety."
The firm's statement said it was confident that all confirmed deaths it was aware of were reported to proper authorities. Abbott said the unreported death alleged by Public Citizen was described as a "rumor" by the person who contacted the company. An Abbott investigation was unable to substantiate the rumor, the company said.
But Public Citizen said the FDA inspection, conducted in March and April, "reveals an Abbott scheme to conceal important information that could establish the causal role of sibutramine in the deaths of specific patients using the drug."
"Unless this and all other companies engaging in such activity are promptly and vigorously criminally prosecuted, patients in this country will be harmed by not having access to the full scope of information about Meridia and other drugs," the group wrote in a letter to Health and Human Services Secretary Tommy Thompson.
Public Citizen has linked Meridia to 29 U.S. deaths and has called for the drug to be pulled from the market. The group said clinical trials showed some Meridia patients had elevated blood pressure and experienced abnormal heart rhythms.
Meridia had global sales of $200million in 2001, a small fraction of Abbott's total sales last year of $16.2 billion.
Abbott shares fell 38 cents to close at $46.63 on the New York Stock Exchange.