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  1. #1
    TXCharlie's Avatar
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    Is Ordering This New Diet Drug From Europe Illegal?

    There is a new diet drug called Rimonabant which blocks hunger without the normal "speed high" and addictive profile of other diet drugs that I cannot take, because of my heart problems.

    The problem is that the FDA has not approved it yet, even though they issued an "approvable letter" last year (what the hell does that mean for me, legally???), and may not at all, because in a few cases it is believed to have caused depression - However it was approved in Europe as a prescription drug, and it can be purchased online after filling out a medical profile, which under UK law, supposedly gives you a valid prescription.

    The question is, how illegal is that for me if I ordered it with a valid UK prescription, or from a country where it's OTC??? I've read some very contradictory statements from legitimate sources. In Police Academy of course, we were told that smuggling in OTC drugs from Mexico is a violation if you don't have a US prescription, but I am told that if I order it, it will go through U.S. Customs with proper labeling and declarations - So if Customs passes it through, does that make it legal for me to accept the shipment???

    Example literature:
    http://en.wikipedia.org/wiki/Rimonabant
    Rimonabant
    From Wikipedia, the free encyclopedia

    Rimonabant (also known as SR141716, Acomplia, Riobant, Slimona, Rimoslim, and Zimulti)[1] is an anorectic anti-obesity drug. It is a CB1 cannabinoid receptor antagonist. Its main avenue of effect is reduction in appetite.

    Rimonabant is the first selective CB1 receptor blocker to be approved for use anywhere in the world. In Europe, it is indicated for use in conjunction with diet and exercise for patients with a body mass index greater than 30 kg/m², or patients wih a BMI greater than 27 kg/m² with associated risk factors, such as type 2 diabetes or dyslipidaemia. In the UK, it has been available since the end of July 2006. As of 2007, the drug was available in 38 countries.

    Approval
    Despite the FDA issuing an approvable letter in February 2006 for the obesity indication and a non-approvable letter for smoking cessation, the drug did not enter the market in the United States in 2006. The French pharma firm Sanofi-Aventis disclosed that a complete response to the FDA's approvable letter was submitted on October 26, 2006, triggering a Class I (two-month) or Class II (six-month) review process. On June 13, 2007, FDA's Endocrine and Metabolic Drugs Advisory Committee (EMDAC) concluded that the French manufacturer Sanofi-Aventis failed to demonstrate the safety of rimonabant and voted against recommending the anti-obesity treatment for approval.[2] Subsequently, Sanofi-Aventis announced that it was withdrawing the new drug application (NDA) for rimonabant and that it would resubmit an application at some point in the future.

    On 21 June 2006, the European Commission approved the sale of rimonabant in the then 25-member European Union. Sanofi announced that the first country in which Acomplia will be sold is the United Kingdom. Sales began in July 2006. Sanofi also announced that it projects that the drug will be sold shortly thereafter in Denmark, Ireland, Germany, Finland and Norway. It is expected in Belgium[3] and Sweden in 2007. Ordinary obesity will, according to official medical recommendations, not be enough to acquire the prescription in Sweden; there are additional requirements concerning abnormal blood lipid levels.[4]

    The EU's approval was not a blanket approval, nor did it approve Acomplia for non-obesity related problems such as smoking cessation, although off-label use of the drug is still possible. The approval is in combination with diet and exercise for the treatment of obese patients (BMI greater than or equal to 30), or overweight patients (BMI greater than 27) with associated risk factors, such as type 2 diabetes or dyslipidaemia.


    Side effects
    Shortly after market introduction, press reports and independent studies suggest that side effects occur stronger and more commonly than shown by the manufacturer in their clinical studies. Reports of severe depression are frequent. This is deemed to result from the drug being active in the central nervous system, an area of human physiology so complex that drug effects are highly difficult to determine reliably.[5] The reported development of previously clinically silent multiple sclerosis in one patient taking Rimonabant suggests that any patients with an underlying neurological condition should not take Rimonabant, given the neuroprotective role of the endocannabinoid system in many experimental paradigms of neurological disease.

    On 15 June 2007 the BBC News reported [6] that a committee advising the US FDA has voted not to recommend the drug's approval because of concerns over suicidality, depression and other related side effects associated with use of the drug.


    Smoking cessation
    Rimonabant may also be found to be effective in assisting some smokers to quit smoking. Sanofi-Aventis is currently conducting studies to determine the possible value of rimonabant in smoking-cessation therapy. The Studies with Rimonabant and Tobacco Use (STRATUS) Program involves more than 6,000 subjects. STRATUS is designed to explore two smoking-related therapies. First, to use rimonabant directly to aid in smoking cessation. Second, to help prevent weight gain in former smokers. Initial results apparently suggest that rimonabant is effective for both uses. However, the FDA has explicitly stated to Sanofi-Aventis that without additional studies rimonabant cannot be approved in the United States for smoking cessation therapy.
    Of course I wouldn't do it unless my doctor researched it and couldn't come up with a reason that I couldn't take it - But from all the literature I've read, that is about the only known serious side effect, which should be easy to deal with since I'd know what caused it.

    I have a feeling it would screw up a few drug polygraph questions for sure, and I know this is trying to take the "easy way" out, but I just can't seem to loose any quantity of weight (2 pounds here, 5 pounds there), and then I wind up snacking too much sitting at the damn computer all day at work, or at home and gaining it all back. I need to loose 100 pounds.

    I know, I need to get off my ass, but I have this damn pacemaker because I did get off my ass mowing the yard, and almost had a damn heart attack in the process

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  2. #2
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    BEK
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    I dont know the answer without further research but I cant wait to try it...why .......... just look at these cool side effects


    Nausea, dizziness, mood changes, infections and infestations, metabolism and nutrition disorders: anorexia, decreased appetite, nervous system disorders disturbance in attention, gastrointestinal disorders, dry mouth, vomiting, trouble with sleeping, depression, irritability, diarrhea, anxiety, itching, excessive sweating, muscle cramps or spasm, fatigue, bruising, tendon pain and inflammation (tendonitis), memory loss, back pain (sciatica), altered sensitivity of the hands and feet, hot flush, fall, influenza, and joint sprain.


  3. #3
    k-9max's Avatar
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    cool, thems all the problem, we all have in life, go figure!
    YEAH, IM THE BERRIES, AND CHERRIES IN YOUR REAR VIEW MIRROR.

    Handle every stressful situation like a dog.
    Eat it, Play with it, or piss on it, and walk away!

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  4. #4
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    Your answer will require some research on your part. Here are some places to look for answers. If you need legal advice to make a decision, see a lawyer.

    DEA Pharmaceutical Regulations, Diversion, or Laboratories.
    your State Board of Pharmacy
    your State Health Dept.
    US Postal Inspectors
    US Customs
    Physician Desk Reference PDR
    Pharmacist or Univ. School of Pharmacy

    Wikipedia may be quick, but you might question the accuracy.

    Know before you order.
    Is this a legend drug (requires Rx) or controlled (scheduled and requires Rx) drug? What is it under Federal Code and Rules? Can it be imported? Does your State regulate it? Does it require a Rx to simply possess it? What is the generic chemical name? Look it up under Scheduiles - Uniiform Controlled Substances Act" for all trade and generic IDs..Check the PDR.

    Watch for: Is there any hint of the seller or shipper concealing or misrepresenting the origin or contents from Customs or Postal Inspectors? Do they "guarantee" discounts or replacement if Customs seizes your order? If so, there is big trouble ahead, and you should report them.

    A case where a person ordered steroids on-line from Europe. Felony - Federal and State. Schedule III VUCSA. The seller was outside of the US but assured the buyer it was "legal", yeah "legal" until the payment cleared, then the parcel was seized.

    Do you want to ingest this? Safe? Pure?
    Where does the order actually come from? Does the firm actually exist? Where is the drug actually made? Is it a fake? Is it pure? Is it made in China? Example: some steroids shipped from EU western Europe were made in a middle-east country or unknown factory in Bulgaria or Romania. Some were re-labelled, color of contents varied from vial to vial. These were packaged for injection.....

    There is a reason the FDA is holding back, see if you can find it. The manufacturer, distributor, or seller is not the best source of accurate info.

    If you need it, ask your physician to order it for you, or ask the doc to find an effective substiitute.
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  5. #5
    TXCharlie's Avatar
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    Quote Originally Posted by BEK View Post
    I dont know the answer without further research but I cant wait to try it...why .......... just look at these cool side effects


    Nausea, dizziness, mood changes, infections and infestations, metabolism and nutrition disorders: anorexia, decreased appetite, nervous system disorders disturbance in attention, gastrointestinal disorders, dry mouth, vomiting, trouble with sleeping, depression, irritability, diarrhea, anxiety, itching, excessive sweating, muscle cramps or spasm, fatigue, bruising, tendon pain and inflammation (tendonitis), memory loss, back pain (sciatica), altered sensitivity of the hands and feet, hot flush, fall, influenza, and joint sprain.
    Virtually all drugs have side effects like that listed in the fine print of the little booklet that the pharmacist gives you - LOL - how could this drug cause the flu or joint sprain?

    The reason is that in the studies, if even one person gets a muscle cramp or the flu, for example, they have to list it as a possible side effect, regardless of whether the drug actually caused it or not... So you have to look at the percentages of people who had those problems.

    There's always a possibility that the drug may have weakened people's immune system or something that made them catch the flu, but if only a small number of people caught the flu, for example, then they probably would have caught it anyway.

    But yeah, sgtbear111, the purity, fraud & legal issues seem too risky to overcome - I could deal with the actual side effects I think

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  6. #6
    TXCharlie's Avatar
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    Oh BTW... I forgot to mention, I did ask my doctor about it on my last visit. He said he couldn't recommend or write a prescription for it unless the FDA approves it, but here's the interesting part:

    It works on the same brain receptors that marijuana works on to cause the "munchies" - except it blocks the receptors instead of exciting them like marijuana does.

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  7. #7
    Lazy Fed's Avatar
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    Non FDA approved drug, means easy seizure stat for me
    dulce et decorum est pro patria mori


    Quote Originally Posted by Resident Smart Ass
    Life is to short not to experience Lazy Fed
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    The incoherent statements given in my posts DO NOT reflect the opinions, views, policies, and/or procedures of my employing agency or any other person for that matter. They are MY PERSONAL DELUSIONAL FANTASIES and I accept sole responsibility as such as I am either drunk or stressed out of my mind.

  8. #8
    TXCharlie's Avatar
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    Quote Originally Posted by Lazy Fed View Post
    Non FDA approved drug, means easy seizure stat for me
    Thanks, but is that a criminal act for the recipient, or just a seizure of the pills?

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  9. #9
    Lazy Fed's Avatar
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    No for diet pills, if it is a controlled substance then yes it is illegal and charges may be pursued. If a person is importing large quanties of (insert any non-fda drug) and providing false invoices and manifests, then yes major criminal charges may be pursued. However by drugs online from overseas is VERY FUCKING RISKY. You have to remember quality control issues and stuff like that. Here is a link to the FDA website for more questions you might have, however the site reads like crap. http://www.fda.gov/cder/consumerinfo...de_US_text.htm
    dulce et decorum est pro patria mori


    Quote Originally Posted by Resident Smart Ass
    Life is to short not to experience Lazy Fed
    ___ ___ ___
    {o,o} {-.-} {0,0}
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    O RLY?? YA RLY NO WAI!!!!

    The incoherent statements given in my posts DO NOT reflect the opinions, views, policies, and/or procedures of my employing agency or any other person for that matter. They are MY PERSONAL DELUSIONAL FANTASIES and I accept sole responsibility as such as I am either drunk or stressed out of my mind.

  10. #10
    TXCharlie's Avatar
    TXCharlie is offline Former & Future Reserve Officer
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    Thanks Lazy Fed... Yeah, I've read some real horror stories about people getting narcotics, sugar pills, or even veterinary pills when they order blood pressure medicine or antibiotics and stuff like that online. Gives me cause to re-think it.

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