More Problems for Weight Loss Drug

UK NEWS: WARNING OVER SLIMMING PILL
Saturday March 6,2010
By Victoria Fletcher

A MAJOR health alert has been issued over an anti-obesity pill that hundreds of thousands of us are buying over the counter with no prescription.

Drug safety watchdogs fear the slimming tablet Alli could trigger a raft of issues, including pancreatitis, kidney stones, liver problems or severe fits in people with epilepsy.

New figures show there have been 31 reported cases of adverse reactions since it went on sale at high street pharmacies in January 2009.

The pills were an overnight success. The overweight could get hold of them for just £50 a month, without the humiliation of having a full consultation with their GP.

But now the evidence against Alli – generic name orlistat – appears to be growing.

The 31 adverse reactions include palpitations, tummy problems and swollen tongues.

Patients taking a common drug to treat thyroid problems are also being told to seek advice from a doctor because the medicines could interact badly.

Since diarrhoea is a common ­side-effect, women are warned it could lessen the effectiveness of the contraceptive Pill.

US health watchdogs are investigating links to liver disease, though European researchers disagree.

The UK’s drugs safety watchdog, the Medicines and Healthcare ­Regulatory Authority, is now insisting that new warnings are added to packets of Alli following a review by the EU Committee for Medicinal Products for Human Use.

Alli works by stopping the body from absorbing fat.

For every 2lb patients lose through diet and ­exercise, it can increase weight loss by another 1lb.

For over a decade the slimming “wonder pill” could only be ­prescribed to the seriously obese by GPs. But then the dosage was halved from 120mg to 60mg, allowing pharmacists to sell it.

They are required to question patients before they sell them the pills. Those already on medication for diabetes, high cholesterol and abnormal heart rhythm are told to seek advice from a GP.

But Tam Fry, from the National Obesity Forum, said there was ­concern that although most ­pharmacists would check that patients were fit to take Alli, junior staff might not.

She urged anyone taking it to consult their pharmacist or GP.

Last night the manufacturers, GlaxoSmithKline, said: “The update to the label for Alli expands the information available to consumers and healthcare professionals to help facilitate product use.

“Consumers can be reassured that orlistat, the active ingredient in Alli, is the most studied weight-loss medicine, with a safety profile established through 100 clinical studies with over 30,000 patients.”

In January, European regulators said another anti-obesity drug, Reductil, should be withdrawn over fears it could increase the risk of heart attacks and strokes.

SOURCE:http://www.express.co.uk/posts/view/161906/Warning-over-slimming-pill

Other articles regarding Alli can be found on Natural Health News.

Dual Standard at FDA

Remember SARS?

I do, and back in 2002(2003 and 2004) there was a similar campaign by the FDA to ban any information about natural products useful for respiratory illnesses including the mass marketing of SARS.

Sound familiar? Seems like another mass marketing campaign is underway on the latest version of a created respiratory illness. The same ploy seems to be apparent according to Marc Ullman's article below about Alli and competing products from the natural products industry.

This has been a repetitive behavior for decades now, includes the tryptophan / Prozac war and a few other events.

I happened to have been attacked by the FDA when the SARS controversy was raging. In typical government style due process was absent and the charge of the light brigade was in full force.

How I learned about it was from an article in the Seattle PI where reference was made to the product I offered for flu at that time (and still offer) that may be helpful. The PI staff writer quoted me yet never made any effort to contact me and speak with me directly. I tracked him down and eventually after getting to the top gun managed to get a retraction in the on-line version of the PI.

Not being alone in the number of products attacked by Mark McClellan's goons I created a web page listing the products attacked along with information about them. Most of the data on this page, except for using Echinacea, works well for the current "swine flu" issue. (Echinacea and some other natural products cause too much of a stimulation of your immune system for this created virus compound.)

The other action I took was to contact McClellan, a Harvard grad, and provide him with the clinical data about the product on my web site. This product was studied thoroughly in clinical research at Dana Farber, the well known cancer institute, a part of Harvard. The product was also proven effective.

The only data that FDA allowed to be in the news was about experimental product under development at Roche, and not proven to be effective.

The mind set is that nothing can be used or considered effective against anything unless it comes from Big PhARMA. This of course is one major reason why the mainstream "health"industry is on its self-created collision course.

Now you see another instant replay over liver damaging Alli and a weight loss/diet supplement.

Another word to the wise from Natural Health News...

GSK vs. The Supplement Industry: Who Wins? Written by: Marc Ullman 8/26/2009

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FDA receives “32 reports of liver injury including 27 requiring hospitalization” in users of GlaxoSmithKline’s Alli OTC weight loss drug. FDA receives 23 reports of liver injury including one death in users of the dietary supplement Hydroxycut. Guess which one is still on the market.

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On May 1, 2009 FDA issued an urgent alert warning consumers “to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario.” According to the Agency’s press release, it had received 23 reports of serious health problems, including one death, that appeared to be associated with the use of the dietary supplement. At the same time, Iovate issued a “voluntary recall” of 64 different Hydroxycut products, covering, according to some news reports over 9 million product units.

On June 6 and June 18, 2009 FDA updated its list of drug products it was monitoring for “potential signals of serious risks” indicating that the Agency was reviewing the status of GSK’s Alli (orlistat) OTC weight loss drug and was “continuing to evaluate this issue to determine the need for any regulatory action” Alli was, however, allowed to remain on the market. On August 24, 2009 FDA issued an “Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat” stating that the “Review includes both prescription drug Xenical and OTC drug Alli”. The “communication” stated that “FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.” Despite this, the Agency advised that “consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.”

Just in case you’re still wondering who wins as between the supplement industry and GSK, consider the following:

● In April 2004 FDA banned the sale of ephedra containing dietary supplements based upon the Agency’s conclusion that such products constituted an unreasonable risk to public health. As part of the basis for its action FDA cited a 2003 Rand Corporation study that concluded, in part, “Over the short term (four to six months), ephedrine, ephedrine plus caffeine, and supplements containing ephedra or ephedra plus caffeine promoted modest increases in weight loss, about 2 pounds per month more than the weight loss of persons taking the placebo.” This level of weight loss was found to offer no benefit to public health.

● On February 7, 2007 FDA approved the sale of Alli as an OTC weight loss remedy. The Agency took this action despite reports of severe side effects including “incontinence” (uncontrollable diarrhea) and “oily spotting” (anal leakage). Among the factors cited by FDA in support of its decision was evidence that Alli users lost 5-10 pounds over 6 months, about a 50% increase compared with diet and exercise alone. Unless FDA uses some kind of “new math” that I have yet to hear of, this amounts to slightly less than the 2 pounds a month it found insignificant for ephedra.

9 million units of recalled Hydroxycut and one ban of ephedra later, it seems that as between the supplement industry and GSK there is little doubt who wins at FDA.

TV Drug Ads, Celebrities and FDA Propaganda

UPDATE: May 27, 2010 - FDA Adds Liver Injury Warning to Diet Drug

WASHINGTON -- The weight-loss medication orlistat, marketed both by prescription as Xenical (120 mg) and over-the-counter as Alli (60 mg), will carry a warning about the potential for severe liver injury, the FDA announced ... full story http://www.medpagetoday.com/InfectiousDisease/PublicHealth/tb/20310

UPDATE: August 25 - FDA probes liver damage with weight loss pill alli
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Originally posted 2/13/09
As we shall see over comings months the stimulus package is not going to be all you think it is because of smoke, mirrors and an ever expanding bureaucracy.

Not too far removed from the stimulus issue is how TV ads for drugs push up profits for Big Pharma.

One example of just how thick as thieves things are between drug companies and their PR programs is a recent story about how Wyeth promoted risky HRT through a media program aimed at increasing prescription writing for their well know hormone product just as they moved to be bought out by Pfizer.

Now, as if this $12 million isn't enough of a tax write off for the drug industry, GSK is leading us all down the pike to fairy land with its ad featuring Wynonna for its over-the-counter weight loss drug 'alli'.

During the commercial featuring Wynonna, whom we all know has had some serious weight problems, is shown serving herself some vegetables during a family meal. Then the camera moves to a tight head shot where we learn that she could not erccomend anything that sin't safe but she is gald that alli is FDA approved.

These days FDA approval and a quarter don't get you a cup of coffee.

And here is probably a fairly reliable take on what the glossy ad that cost plenty of money alone, not including air time fees, might be what GSK doesn't want you to know.

Alli Weight Loss Pill: Expectations Vs. Reality
January 02, 2008 by Big Momma
It's the time of year when our thoughts focus on shedding a few pounds. We are inundated with commercial advertisements promoting the best, easiest or fastest way to lose weight.

Alli is the newest over the counter weight loss pill that promises hope to the masses by blocking fat absorption in the body. Alli is FDA approved, is not absorbed into your body and works only in the digestive track.

My first red flag regarding Alli was the product statement that Alli is to be used together with a reduced calorie diet to promote weight loss. A reduced calorie diet by itself will promote weight loss, but let's see the results that one Alli user has had.

An acquaintance of mine has been using Alli for several months, her expectations from the Alli pills were to help her jump start a weight loss program that she could stick with and ultimately help her reach her goal weight.

The Alli usage pamphlet warns users of 'treatment effects', which include greasy/oily leakage in undergarments, gas with discharge, change in stool color and/or fatty deposits in stools, inability to control bowel movements, stomach pain, rectal pain, teeth/gum problems or flu like symptoms. Alli users are advised to wear dark clothing and pads to protect against the leakage.

This is the reality she got from using Alli: Large amounts of uncontrollable leakage of a greasy substance that permanently stained her clothing. Dark clothing and pads could not contain or hide the leakage most of the time. She had a significant increase in gas and odor, with gas bubbles being expelled along with the greasy substance. She had no control over this.

Abdominal cramping became a part of her daily life, she likened the feeling to a gall stone attack. She felt tired all the time, even though she was taking the additional vitamins that are recommended by Alli. She also experienced hair loss while taking Alli.

After using Alli for six months, she had lost a total of 15 pounds. Yes, 15 pounds.

Another 'treatment effect' of Alli is that even after you stop taking it, you experience the greasy leakage and abdominal pains for up to two months, until the product works it's way completely out ofyour system.

A new wardrobe is eagerly anticipated at the end of a diet, but having to buy new clothing during the diet due to your body leaking grease, is altogether different.

Six months and 15 pounds later, the expectations from the weight loss pill Alli and the reality of it did not even come close.

NB: Natural Health News posted this information in 2008.  It took Mike Adams another 2 years to inform you, yet his backers are continually continually monitoring this website, now for 6 years, to get their story ideas. 1 June,10.