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Pai You Guo

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  • Pai You Guo

    A weight loss dietary supplement is being recalled by the Food and Drug Administration after an FDA analysis found the supplements contain the presence of undeclared drug ingredients, including a suspected cancer-causing agent. The recalled supplement is made by GMP Herbal Products and is marketed under the name Pai You Guo.

    Pai You Guo was found to contain sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss (Meridia); and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA warning stated that the agency has not approved the Pai You Guo products as a drug, therefore safety and effectiveness of this product is unknown.

    Pai You Guo is either sold in a box of 30 capsules or a bag of 10 g powder. The affected products were sold and distributed nationwide via the Internet.

    While no illnesses or injuries have been reported to the company to date in connection with this product, the FDA advises consumers that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

    Some commonly known side effects of Meridia (sibutramine hydrocholoride monohydrate) are:
    change in appetite
    dry mouth
    back pain
    difficulty falling asleep or staying asleep
    runny nose
    flu-like symptoms
    painful menstrual periods
    Some uncommon but dangerous side effects are:
    fast or pounding heartbeat
    chest pain
    shortness of breath
    stomach pain
    extreme excitement
    uncoordinated or abnormal movement
    muscle stiffness
    shaking hands that you cannot control
    excessive sweating
    sore throat
    large pupils (black area in center of eyes)
    change in vision
    eye pain
    skin rash
    difficulty speaking, breathing, or swallowing
    swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
    unusual bleeding or bruising

    Since commonly used TCM agents are not consistently and properly measured during dispensation, it is not uncommon for people to experience the more hazardous side effects when taking these medications, sometimes at great risk to themselves.
    Experienced Community organizer. Yeah, let's choose him to run the free world. It will be historic. What could possibly go wrong...

    "You're just a jaded cynical mother****er...." Jeffpeg

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  • #2
    Meridia taken off the market

    Meridia, generic name Sibutramine, was taken off the market because of its tachycardic and hypertensive effects, which led to increased risk of heart attack and stroke in some individuals.

    Pai You Guo is known to have Sibutramine as an additive.

    The next two articles are informative, the first, from the BBC, the second, from the NYU School of Medicine.

    From the BBC:

    Herbal medicines marketed as weight loss aids have been found to include a drug withdrawn in Europe and US on safety grounds.

    Analysis of Payouji tea and Pai You Guo Slim capsules by the UK medicines watchdog revealed they contained diet drug sibutramine.

    It was taken off the market in January 2010 over fears it increased the risk of heart attack and stroke.

    Anyone taking the drug was urged to stop and consult their doctor.

    Sibutramine was first approved as an anti-obesity drug in 1997, but data from recent studies suggests a higher rate of heart attacks and strokes among people taking it.

    While it was withdrawn in Europe in January, it was only withdrawn in the US earlier this month.

    Various herbal products in the US have been recalled because they were found to contain the drug.

    The Medicines and Healthcare Regulatory Authority, which oversees medicines in the UK, said that any product containing the drug was considered "harmful to human health".

    They said that not only could it have side effects including high blood pressure, seizures, heart attacks or strokes, but could interfere with other prescription medicines.

    Its head of herbal policy, Richard Woodfield, said: "People need to be aware that Payouji tea and Pai You Guo Slim Capsules are unlicensed herbal medicines and therefore have not met assured standards." BBC News
    From Dr Henry Black, of the New York University School of Medicine, who did some of the initial studies on Meridia (before the FDA withdrew it from the market):

    One of the biggest problems we are currently facing is an epidemic of obesity. It really is epidemic. The number of individuals who are considered overweight or obese is increasing very rapidly, in all age groups. The problem is that we have very little success in reducing weight or keeping weight off once we lose it. Of course, as for everything else, there are lifestyle modifications, there are behavioral changes and there are drugs.

    In general, when we look at hypertension or dyslipidemias, we always start on a platform of lifestyle modifications. We have many very effective drugs for both of those conditions. What we have with obesity reminds me of what happened with hypertension back in the 1940s when the only way we could lower blood pressure was to actually do sympathectomies. This was a successful operation and people would probably have died from the consequences of hypertension without it. In 1947 with the advent of reserpine, and certainly by 1957 when we had thiazide diuretics available, the need for surgery was modestly reduced, and then significantly reduced, and is now almost nonexistent.

    The same thing happened with lipids. Before we had statins available and the only thing we had were resins, it was very hard to get cholesterol down to ranges that were safe and effective, and so we did ilial bypasses and eventually transpositions. Then when statins came along, those procedures were no longer necessary.

    Now when it comes to weight loss, I think we are in the same position. We now know with lap band surgery and other gastric bypass surgeries that not only can we reduce weight, but we can also actually reduce morbidity and mortality -- something we have no drug to do. So, where is the next hydrochlorothiazide? Where is the next statin for obesity? Because we're probably not going to get anywhere with behavior modification alone. Although it has certainly been tried.

    In the United States now, there are 2 agents that have been approved for use for weight loss. One is orlistat (Xenical®), and the other is sibutramine (Meridia®). Orlistat causes fat malabsorption. It's now available over-the-counter, but it's not terribly well-tolerated by the patients who take it, nor is it terribly effective. If we get 5% weight loss, we're happy. Sibutramine is somewhat more effective than orlistat, but it's a sympathomimetic, and the likelihood of increasing blood pressure and heart rate could be a problem. So it was decided to test sibutramine against placebo for a longer time.[1] The interesting thing about this study, and something that kind of bothers me a bit, is (we're talking about 10,000 people now) that there was a run-in period (6 weeks long) where everybody got 10mg of sibutramine. During that 1-month period, there were 340 clinical events that weren't counted in the analysis of the clinical trial. There was also weight loss in that first month.

    By the time the randomization occurred, when the patients received either 10 mg sibutramine increased to 15 mg if needed or placebo, a lot of the high-risk individuals actually had been screened out already. So were the nonresponders theoretically, but it's a question of 340 events that would have been counted had the trial begun at that moment. In any case, at the end of the trial period, what you saw was pretty much what you expected. There was a steady weight loss after the randomization began, down to about a 5-kg loss. A loss of 2.8 kg came during the run-in period, and another 1.7 kg during the first year of the trial. The placebo group lost weight during the run-in period when they received active drug and then their weights stabilized. Over the next 4 years of observation, which actually extended out to 6 years altogether, what we saw were a lot of dropouts -- 40% of each group discontinued the trial, making it very suspicious that this would be something we can really use. However, there was no question that there was no benefit from sibutramine. In fact, there was increased risk. The way the investigators designed this trial was to have a diabetes-only group, a cardiovascular disease-only group, and a group with both. When further analysis was done, the group that had diabetes only at randomization showed no risk. The groups with cardiovascular disease or cardiovascular disease and diabetes were where all the risk was seen. So, I think we can conclude a few things from this long and important trial.

    First, there doesn't seem to be any long-term benefit from the weight loss that was achieved in this study. There was a modest increase in blood pressure in the group that got the active drug relative to the placebo group. However, in both cases, blood pressure was lower than when they began. So, lowered blood pressure wasn't necessarily associated with reduced risk for either group. There was an increase in heart rate also. These are both probably related to the sympathetic stimulation from a drug like sibutramine, but this also tells us that we need to be very careful in making selections of patients for an agent like this. It may work well in people with diabetes who have gained weight, without increased risk. However, it is probably too much risk for people with cardiovascular disease or with cardiovascular disease and diabetes -- very similar to what the label says. In my opinion right now, we've got to keep searching. The European authorities and the British have both suspended marketing of this agent. The US Food and Drug Administration has this drug under observation and it's very likely that we're not going to have this drug around much longer. MEDSCAPE
    Experienced Community organizer. Yeah, let's choose him to run the free world. It will be historic. What could possibly go wrong...

    "You're just a jaded cynical mother****er...." Jeffpeg

    (more comments in my User Profile)


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