October 2010 update. Abbott Pharmaceuticals has voluntarily removed Meridia from the US market at the request of the Food and Drug Administration. In its October 6, 2010 press release, the company said:
The FDA's request is based primarily on the results of the SCOUT (Sibutramine Cardiovascular OUTcome Trial) study, an approximately 10,000 patient, 6-year study requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients. The majority of these patients had underlying cardiovascular disease and were not eligible to receive sibutramine under the current labeling.
The SCOUT results are in contrast to the vast body of sibutramine data for the on-label patient population, including 46 controlled clinical trials and more than 6 million patient years of use accumulated over 13 years during which the product has been available. These data fail to confirm the excess cardiovascular risk found in the SCOUT study.
The voluntary withdrawal of sibutramine in the U.S. follows an 11-month process, beginning in November 2009, when Abbott promptly notified FDA of the SCOUT preliminary results immediately after receiving those results. The European Medicines Agency (EMA) suspended marketing authorization for all anti-obesity medicines containing sibutramine in January 2010.
Note: Outside of North America, Meridia (sibutramine) is known as Reductil.
What is Meridia?
Meridia® (sibutramine hydrochloride monohydrate) is the first FDA approved medication of its class for the treatment of weight loss and weight maintenance. Sibutramine is an equipotent serotonin and norepinephrine reuptake inhibitor (SNRI), which means it has an equal effect on serotonin (a brain neurotransmitter which generally promotes a calming feeling) and norepinephrine (a stimulant). Research indicates that these brain chemicals have an effect on appetite and satiety. Meridia® is available in 5 mg, 10 mg, and 15 mg capsules (see photo). The recommended starting dose is 10 mg which may be increased to 15 mg if the 10 mg capsule is ineffective. The 5 mg capsule can be used as an adjunct to the 10 mg dose; it is not intended to be used as a starting dose.
Studies have shown that Meridia® is moderately effective in producing weight loss in obese individuals, with 85 percent losing at least 5 percent of body weight and 57 percent at least 10 percent. In the majority of studies it has not been shown to be as effective as the combination of fenfluramine and phentermine ("phen/fen") which enhances the release of norepinephrine and serotonin. Subjects in studies by Weintraub and Wadden lost an average of 15.9 percent of body weight. However, with the withdrawal of fenfluramine from the market in 1997, the combination is no longer available.
Animals given sibutramine have shown an increase in metabolic rate, but human studies have not been conclusive. The reasons for the difference between animals and humans is not clear but may be due to the small number of subjects tested and the small effect of the drug on energy expenditure. However, even small increases in thermogenesis could be clinically significant in weight loss and weight maintenance.
For further information, see:
What does Meridia cost?
Meridia® is priced at $3 for the 5 and 10 mg capsules, and $4 for the 15 mg capsules. Dosing is once a day. The cost is $90 for one month's supply of the 5 or 10 mg capsules, and $120 for the 15 mg capsules. Many pharmacies discount the price well below the retail prices listed above, so shop around.
I have high blood pressure. Can I still take Meridia?
If your hypertension is controlled with medication, you may very well be able to take Meridia®. Like all patients taking this drug, you will need to carefully monitor your blood pressure, especially during the beginning of treatment. A recent study found that controlled hypertensives who took sibutramine have no more likelihood of increased blood pressure than those who took placebo, although in general, patients do experience a non-significant rise in diastolic and systolic pressure.
For further information, see:
How long will I have to take Meridia? Will I gain my weight back if I stop taking it?
Most patients will have to take Meridia® indefinitely, either continuously or intermittently. Some patients may eventually switch to other medications. Obesity is a chronic condition, and the elements an individual uses in a weight loss program usually need to be continued in weight maintenance.
Studies on most weight loss drugs show that weight is regained rather rapidly when medication is withdrawn. The Sibutramine Trial in Obesity Reduction and Maintenance (STORM trial) had similar results. In the study, 605 patients at a number of European centers took Meridia® for a six month weight loss period. After that time they were randomized to receive either Meridia® or placebo. The Meridia® patients kept almost all of their weight off, with a small weight regain in the last six months. Over twenty-five percent of Meridia® subjects kept the weight off for the entire two year period. On the other hand, subjects taking placebo gained almost all of their weight back.
|Weight maintenance: sibutramine vs. placebo.
For further information, see:
Can I take Meridia with Xenical?
Yes. Xenical is a drug that blocks fat absorption in the intestine, and has no systemic effects. Therefore, you will not have an adverse reaction taking these two medications together. However, studies to date have not shown that taking both drugs produces more weight loss. Women who lost weight in a year long double-blind placebo-controlled trial did not lose more weight after adding Xenical to the regimen. Subjects who took phentermine and Xenical also failed to lose more weight. The limitation of the studies are that they only used small numbers of subjects, and did not look at initial weight loss using the combination. But early studies did not look promising.
For further information see:
Can I take Meridia with phentermine or Prozac?
Abbott recommends against taking Meridia® with any other stimulants or antidepressants. Since Meridia® acts on norepinephrine and serotonin pathways in the brain, taking other drugs that work on these same neurotransmitters could produce adverse reactions like hypertension, serotonin syndrome, or a number of other problems.
Nonetheless, some clinicians will prescribe Meridia® in conjunction with stimulants or antidepressants if Meridia® isn't producing desired weight loss, or in patients who need to take antidepressants. However, the risk of an adverse reaction is higher. Prescribing drugs in combinations, or for purposes that they are not intended, are considered "off-label" prescriptions, and confer additional liability on the physician. Since the 1997 withdrawal of fenfluramine, which was prescribed off-label with phentermine, many physicians have been reluctant to prescribe more than one medication for weight loss. See the Obesity-news FAQ on off-label prescribing for more information.
Will Meridia work for me if I have taken other obesity medications in the past?
There are no absolutes with medication. The response can vary substantially by individual. However, clinicians report that patients who took phen/fen or phentermine alone prior to taking Meridia® seem to be less responsive. A similar response was given by patients who took the Obesity-news Meridia survey.
There are two reasons for this, first, some individuals who take medications that work on neurotransmitters develop a tolerance. In some cases this tolerance abates when the medication is discontinued, but in other cases it does not. The second reason a patient might find a milder appetite suppression with Meridia® than with phentermine or phen/fen, is that both phentermine and fenfluramine are neurotransmitter releasers while Meridia® only inhibits reuptake.
There is not a lot of data on the efficacy of Meridia® in patients who formerly took other centrally acting weight loss drugs such as, tenuate or bontril, but since the method of action is similar, it is likely that they would have a similar response. On the other hand, prior use of Xenical, which is not a systemic medication, should have no effect on the efficacy of Meridia®.
See the Obesity-news Meridia survey for more on prior obesity medication use and Meridia® efficacy.
Meridia is not approved where I live. Is it legal for me to import Meridia?
It depends on the laws of your country. If the country you live in doesn't prohibit the import of unapproved drugs, and isn't specifically prohibiting the importation of Meridia®, you may be able to import it. You should investigate the specific laws in your country. If you live in the United States it is not legal to import Meridia®.
If your country does allow drug imports, you should be able to mail order medication with a doctor's prescription from any of the prescription mail order pharmacies on the Obesity-news web site. I do not know the specific policies of any of these pharmacies regarding out of country orders. You'll have to check directly with the pharmacies. US subscribers interested in Meridia® should see a doctor and get a prescription.
If you would like to see how successful other patients have been on Meridia®, I suggest taking a look at the Obesity-news Meridia® survey which went on line in January 1999. The survey results rate the success of 339 patients who took this medication for up to 40 weeks.
What impact does Meridia's scheduling as a controlled medication have on me?
It really has very little effect on the consumer. Every doctor is issued a Drug Enforcement Administration number. That number is entered by pharmacists into a computer database when controlled substances are prescribed. Unless irregularities are found in a physician's prescribing practices, no other action is taken other than the recordkeeping. This is an overview of the schedule of drugs:
Certain drugs which are determined to have abuse potential, are controlled by the US Drug Enforcement Administration.
- Schedule 1: illegal substances with no medical use.
- Schedule 2: drugs with high abuse potential, including narcotics, amphetamines and some depressants. There are no anorectic medications controlled under schedule 2.
- Schedule 3: drugs with less abuse potential than schedule 2 medications. Phendimetrazine is controlled under schedule 3.
- Schedule 4: drugs with less abuse potential than schedule 3 medications. Most anorectic medications including phentermine, fenfluramine, dexfenfluramine, diethylpropion are schedule 4 medications.
- Schedule 5: drugs with relatively low abuse potential. Ephedrine is controlled under schedule 5 by some individual states.
The DEA uses a specific process and criteria when deciding whether or not to control a drug.
Could Meridia give me heart valve damage or other problems associated with fenfluramine?
Heart valve damage, pulmonary hypertension and neurotoxicity (the depletion of brain neurotransmitters) are linked to fenfluramine and dexfenfluramine use.
It is unlikely that Meridia® would cause these diseases, since the drug only works on clearance of serotonin. Fenfluramine and dexfenfluramine also enhance its release. Recently, a new theory has been proposed that serotonin releasing drugs, like fenfluramine and dexfenfluramine, which activate the 5-HT2B receptor, may contribute to the development of heart valve disease.
For further information see:
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