The FDA has been given more options on half of the 16 members in the FDA on Wednesday that the agency needs to take off the weight-loss drug (Meridia) off the market.
Six panelists went’s to keep the drug on the market, but the only two conditions were met:
•Giving the warning label to the Wight Loss Pills. These pills can cause an increased risk for major heart problems and you need to monitor your blood pressure, pulse and body weight.
•Restricting its use, but only the specially trained doctors can prescribe it. Two panelists to allow continued, unrestricted use as long as the boxed warnings were added.
The FDA, approved the wight Loss Pills (Meridia) in 1997, and follows the expert panels, but it is unclear what the agency will do because the voting was split.
A study, about Two weeks ago, by maker Abbott Laboratories reported the Meridia wight loss pills raised heart attack and the by stroke risk by 16% in patients with heart disease and it was associated with only a modest weight loss. In the study in The New England Journal concluded "it is difficult to discern a credible rationale for keeping this medication on the market."
Based on preliminary study of data, from the European Union that suspended Meridia's marketing license in January but The FDA, however, has only added a stronger label of information about the use by the heart disease patients.
In a review from the studys in the advisory committee meeting with the FDA scientists Simone Pinheiro and Vicky Borders-Hemphill, from the same office that monitors the safety drugs after they come in to the market. They both say "currently available data ... indicating a potential increase in the cardiovascular risk ... does not preclude the agency from taking a regulatory action at this time."
At the committee meeting with the Abbott representatives proposed a "risk management plan." Its including a label for the boxed wight loss pills to say a history of cardiovascular disease and those who have cardiovascular disease should not take the drug. Among the plains to other components was with voluntary physician training via the Web and the nine-question patient screening form. A "yes" answer to any of the questions, which were related to heart disease history and risk factors, would exclude a patient from using Meridia.
