Announcements from the U.S. Food and Drug Administration state that, due to pressure from the FDA, Abbot Laboratories have agreed to withdraw from the U.S market its anti-obesity drug Meridia due to the higher danger of stroke and heart attack.
The consumer advocacy group Public Citizen say that the action is long overdue. Dr Sidney Wolfe, director of Public Citizen’s Health Research Group, said that “[t]he FDA’s decision today to ask pharmaceutical maker Abbott to withdraw the drug is commendable, but dangerously too late for all of the victims of its unacceptable risks.”
Since March 2002, Public Citizen have appealed to the FDA to ban Meridia which came onto the market in 1998.
In a March 2002 release, Wolfe remarked “[t]he FDA knew prior to approving the drug that it significantly increased blood pressure and heart rates in many people and is only minimally effective.”
In 2002 and in 2009, the community petitioned the FDA to remove the drug with several statements released in-between this period urging to remove Meridia.
In December 2009, Public Citizen calculated that 84 Americans had died from using Meridia since the drug was approved. They recently cited a study carried out in Europe, the “Sibutramine Cardiovascular Outcomes Trial” (SCOUT), in which the alarms that Public Citizen had been sounding for some time were confirmed.
The trial in question revealed a 16% higher danger of lethal heart event and even death. Those who had taken part in the study had suffered a small change in weight loss between those taking sibutramine and users of a placebo. It was this same study which the FDA cited as being the reason for them asking Abbott to remove the drug.
John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Centre for Drug Evaluation and Research, commented on this. “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke.”
Thanks to Meridian being removed from the market, the FDA are now advising their patients to discuss weight loss maintenance and alternative weight loss programs with their health care provider.
But if your physician starts to recommend Slimming Beauty Bitter Orange Slimming Capsules please be beware. A warning has been put on this diet product which you can buy over-the-counter because these capsules contain “excessive amounts of sibutramine.”
This warning notes that the prescription-only drug sibutramine is not listed on the product’s label and that taking sibutramine “may be dangerous to people who have a history of cardiovascular disease, because it can lead to elevated blood pressure, stroke and heart attack.”
FDA spokesperson Elaine Gansz Bobo said that “[t]here has been no determination made as yet whether to pursue the makers of Slimming Beauty…What we’ve done today is get a warning out to consumers as quickly as possible regarding the possible risk.”
The FDA also claims that Slimming Beauty is being sold over the internet by Beautiful Health Inc., formerly LL Health and Beauty. The distribution of slimming Beauty sample packets at community events has also taken place.
The FDA warns that the product and the sample packets are falsely labelled as “100% Herbal” because it indicates that it is a natural vitamin and calcium capsule for use in children as young as 2 years old.