JFDA & US FDA pulls weight-loss drug off market!
January 26, 2010 in Drug Information
The Jordan Food and Drug Administration (JFDA) is pulling Reductil (chemical name Sibutramine) off the market due to a higher risk of heart complications.
I am extremely happy with this decision and I hope that all countries remove this product from their pharmacy shelves. The FDA in the states has still not recalled this medication, but I am sure many outside groups will start putting the pressure. Reductil has already been banned across Europe following a six-year study that showed an increased risk of serious cardiovascular events in those taking Reductil compared to people not taking the drug.
Be aware that Sibutramine is also marketed under other brand names such as Meridia and Sibutrex. JFDA also urges those taking similar products (not legally registered), such as Reduct to stop taking them for their own safety.
Another final warning, there are many different weight loss products marketed as “dietary supplements” that illegally contain undisclosed amounts of sibutramine, and similar cases pointing to Chinese “herbal supplements.” Many of these products do not accurately list the ingredients and are not forced to meet the strict codes for medicine approval.
Sibutramine withdrawn from U.S. market
Abbott agrees to take Meridia off the market due to increased risk of heart attack and stroke.
Abbott Laboratories agreed last week to a voluntary withdrawal of Meridia (sibutramine) in the United States. The weight-loss drug has been linked to increased risk of heart attack and stroke, according to FDA.
FDA requested this withdrawal based on results from SCOUT (Sibutramine Cardiovascular Outcomes Trial), which was initiated after the European approval of the drug. Results from SCOUT indicated a 16% increase in the risk of serious heart events, including nonfatal myocardial infarction, nonfatal stroke, resuscitated cardiac arrest, and cardiovascular death, in patients given sibutramine compared with those given placebo.
“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,” said John Jenkins, MD, Director of the Office of New Drugs in the FDA Center for Drug Evaluation and Research Office, in a news release. Jenkins advised physicians to stop prescribing Meridia and patient to stop taking the drug and consult with a health professional about alternative weight loss and weight loss maintenance programs.
Meridia was approved in 1997 for weight loss and maintenance of weight loss in obese people and in certain overweight people with other risks for heart disease. FDA’s decision was based on an analysis of SCOUT results during a FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 15.
Posted by Alex Egervary (aegervary@aphanet.org)
October 14, 2010, 5:00 pm
hi dr.sandy
thanks for this information , I’m thinking to have an weight loss products but i don’t know which one i choose as you know there are many different weight loss products , i complaining from Hypothyroidism and i take 100 mg thyroxine tablet per day , it’s hard to lose wight by Dieting so please Advise me to find Suitable Medicine .
Hi Suha,
If you are taking thyroxine then your thyroid should function normally and your metabolism will not be slower so losing weight should not be as difficult as when you were not taking the thyroxine. With that being said, the best way to lose weight and increase metabolism is not through pills because they frankly do not work. A balanced diet and exercise (which I know is easier said than done) but it is the most proven method. The only drug approved for weight loss is Orlistat (xenical), it is not as good for people who like to snack and eat throughout the day; it really is better for those who eat big meals. Before resorting though to drugs, you should try diet and exercise for 6 months. Also, drug therapy use depends on your Body Mass Index (BMI).
thaaaaaaaaaaaaaanx dr.sandy
i really start Dieting and walking one hour evrey day i hope i can lose some wight . the proplem that i dont have Enough Patience to Continues
thanx again
hello dr
im very uppset ..i used the medecine not mounthly but whenever i felt i put on weigth n it is garanteed effect but as a side effect i didnt notice something urgent ..for me no depression ..but my mood was always a bit nurvise n i have used it since april- 2008 ..till last mounth but from time tto time
n i was always worry about if its dangerous or it may cause cancer??tell me pls if i need to make check up to know if im safe or not n what kind of check up? thanx
The reason they took Reductil off the market is not because of cancer; it is because this medicine can increase the chances of having a heart attack or stroke for certain people. This medication increases blood pressure so that can put some people at risk for heart attacks and stroke. They decided that it is hard to figure out who is at risk so, in order to be on the safe side, they removed it from the market. There is no need to worry if you stopped using the medicine. The risk is only there if you are currently using the medicine, once you stop, you are not exposed to the side effects of the medicine anymore. Hope I eased your concerns.
thanx doctor sandy …but do you have any other kind maybe more natural to help me to loose weigth so that i can find it in paris?
i saw many types of them n felt confusied to decide which one i may take!!
and by the way i was suffering from law pressure but now i feel better than before {maybe cuz of reductil?}
n to be honest with you i cant say i stopped thinking of taking it forever cuz i just bougth a baket 4 days ago n it contains 28 tablets SO?? im realy wondering …..pls give the rigth advice and i ll be thankfull ..n i find it hard to stop eating after 6pm without this tablet
thank you and my best regards
The right advice is NOT to take Reductil. This medicine has a known risk for causing heart attacks. It is removed from the market in Europe and Jordan which, I think, is the right decision. It sounds like you are stressed out in your studies. Overeating is definitely triggered by stress and fatigue. Try to find ways to manage your stress and this can control your overeating, thus keeping your weight in control (I know easier said than done). Eating high bran foods, whole wheat and more fiber will keep you from getting hungry. Read my tips on the blog and message boards, I think controlling food intake is about skill power which can be learned and practiced, not will power. I hope this helps.
of course it helps doctor n i will ….my over weigth is 7 killos ….not more n im a mother with 39 years old my tall is 172cm..my weigth is 84
So you found something right for yourself. Keep up the good work of spreding awareness ….
Thank you Dr Manoj.
Excellent blog! I can’t believe this isn’t outlawed in the states yet. If it’s too good to be true then it is. People want to bypass a healthy diet and exercise for a quick fix, but exchanging weight problems for heart problems is foolish!
There is a lot of pressure for the FDA to pull it off the market, I am sure they will follow suit.
Thanks for your support !
I have tried the product myself for more than 7 months, the predicted weight loss results are guaranteed 100%. It does cause anxiety, depression and affects psychological health indeed, still for overweight people desperation and suffering of being abnormal in a country that is full of (3asa3ees) it leaves the same effect if you know what I mean, frustration and depression is guaranteed when your overweight, and also CHD because of the greasy kinds of foods. it’s a circle and the victims are still suffering, 34JDs a month is similar to the 40JDs people spend on dietitians I guess.
Thank you for your advice and interesting blog
Regards
Your point is very well taken and I am sure many people in Jordan will be able to relate to you. Your post even made me chuckle because you really eloquently put things into perspective. I found your comments interesting and informative. I can understand where you are coming from especially that I helped edit a book about a woman battling compulsive eating disorder which is due to be out in Jordan bookstores soon. I learned a lot about the issues surrounding obesity.
I also took a peek at your blog and you are talented yourself. Keep up the good work.
Thank you for your feedback and I look forward to blogging with you.
You know.. I have always thought about eating disorders as another step the American society is taking ahead toward a “healthy” trend to generalize within pop culture. Still taking a deeper look into it as a psychological disorder.. there are way more behind it. And of course spreading awareness about such sensitive subjects has to be postulated the right way; Obese women – even those who received a fair share of education – knowing that there is such a magical successful prescribed medicine as the mentioned above causes serious diseases will still look seductive, and with each moment of pain they go through (socially and physically).. The medicine’s name will pop louder in their heads… WHAT A DELIMA!
Still it is a very very interesting subject. And yes I am commenting here again and populating the page to increase your traffic!
Would love to get a copy of the book as soon as it’s out. and a lot will be interested too.
Great job doc!
Cheers.
Hi Dr. Sandy
in my opinion, Reductil withdrawal is a wise step. i love the blog, congratulations!!!
I completely agree with you !!! Glad you liked the blog
okay what about ROYAL SLIM they say its all herbals so if it didnt give the desired results it wont at least hurt !!?! thanxx
I am really happy that you posted this question because the issue concerning herbals should be addressed. The biggest misconception that people have is that it does not hurt to take herbals. This is completely wrong. Just because the herbal companies claim that their stuff is natural does not mean that it is safe. Herbal products like Royal Slim do not need to go through the strict approval process that drugs have to go through. Herbals bypass the stringent rules that is required of drugs because they are considered food. This means that they are not tested for safety and efficacy (whether it is effective or not) like drugs are. Another problem is that herbal products do not always list all the ingredients on the label (which means unsafe substances may be added without the consumer’s knowledge). Also, herbals may have too much or too little of the ingredients causing potential harm to the person; in addition, the herbs must be extracted from plants and the like so they might not be pure. There is not enough scientific literature regarding the use of these Chinese weight loss herbals, so people are advised not to take them for safety reasons.
Please look at this link to see how many herbal products have been deemed unsafe and why: http://www.medicalnewstoday.com/articles/133954.php