Public Citizen has written the agency to urge an outright ban, citing preliminary results from the 10,000-patient SCOUT study called that showed a slightly higher risk of heart attack, stroke and death in patients taking Meridia compared with a placebo.

At the time the study, which was conducted in patients who were older than 55, overweight with a history of heart disease or diabetes, was released last month, the FDA was “making no conclusions” about the findings. Both the FDA and the European Medicines Agency’s Committee for Medicinal Products for Human Use has started a safety review (see the FDA statement here, the EMEA statement here and the Public Citizen petition here).

“We would hope that the science behind the results seen in this study would mandate the only appropriate FDA action to protect the public health: immediate removal of ‘Meridia’ from the market,” Public Citizen wrote the FDA, which the Associated Press reminds us previously rejected a 2002 petition from the consumer watchdog to withdraw Meridia.

The FDA plans to wait for the complete SCOUT findings, but Public Citizen says there was a total of 84 deaths associated with Meridia reported to the agency as of June this year. The pill was approved in 1997 and is related to the amphetamine family of stimulants. Public Citizen pointed out that the agency’s panel of outside specialists voted 5 to 4 that the drug’s risks outweighed its benefits, the AP notes.