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Public Citizen has already petitioned the FDA for the immediate removal of Meridia weight loss pill, and on May 21, 2002, the group said they had obtained a report of an FDA inspection of Abbott facilities in Abbott Park, Illinois. This recent FDA report prompted the consumer advocacy group to urge criminal charges be brought against Abbott because the company illegally withheld information from regulators regarding eight deaths and other side effects in Meridia patients.
Required by law, all drug makers must report serious events that occur with the patients using their drugs. The report had indicated Abbott failed to report one death associated to Meridia weight loss pill and records regarding seven other deaths were inaccurate, unsupported, or incomplete. Public Citizen also stated that the FDA inspection found case files containing any documentation of follow-up investigations of Meridia associated deaths to be missing, as well as other records regarding Meridia adverse events had not been maintained for the required time period.
Public Citizen’s letter sent to Secretary Tommy Thompson at the Health and Human Services included that the FDA inspection “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.” To view the entire Public Citizen letter click here.
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