FDA Probes Weight Loss Drug Liver Damage

The Food and Drug Administration is investigating reports of liver damage in patients taking "alli," the only nonprescription weight loss drug approved by the agency.

Regulators said Monday they have received more than 30 reports of liver damage in patients taking alli and Xenical, the prescription version of the drug. The reports, submitted between 1999 and October 2008, included 27 hospitalized patients, and six who suffered liver failure.

Alli and Xenical are both marketed by British drugmaker GlaxoSmithKline PLC, though Xenical is manufactured by Swiss firm Roche.

The FDA says it has not established a direct relationship between the weight loss treatments and liver injury, and advised patients to continue using the drugs as directed.

Appearing on The Early Show Tuesday, Dr. Holly Phillips said, "Most people shouldn't take this drug. This is only for people who are obese, meaning they have a body mass index over 30. And even though it's over the counter - you should only take it under the advice of your doctor. …It's not to lose five pounds to squeeze into your jeans - it's really for people who are obese."

"Consumers should consult their health care professional if they are experiencing symptoms," the agency said on its Web site. Signs of liver damage include fatigue, fever, nausea and vomiting.

The FDA said it's reviewing additional details about the suspected cases of liver injury submitted by manufacturers.

Roche referred questions to GlaxoSmithKline.

A spokeswoman for GlaxoSmithKline said there is no evidence the company's drug causes liver injury, noting that it primarily acts on the intestinal tract. She said alli's safety has been studied in more 30,000 patients enrolled in 100 clinical studies.

"Liver changes can have many causes," said Debbie Bolding, in a statement. "People who are overweight and obese are predisposed to liver-related disorders."

The FDA first approved Xenical in 1999 and alli in 2007. The prescription pill is twice as potent as alli, which can be bought over the counter. Glaxo reported $123 million in sales for alli last year, while Roche posted $472 million in revenue for Xenical.

In general, the FDA has started notifying the public earlier about possible safety issues with drugs, after coming under fire for acting too slowly on problems with blockbuster treatments like Merck's painkiller Vioxx.

[toldyouso21]

funny, isn't it--that in the YEARS of clinical trials preceding the release of this drug--liver problems did not show up? follow the documentation-odds are glaxo is hiding something.

[pragmatist1]

If people on cholesterol drugs have to routinely go in for blood tests to make sure their liver isn't being damaged, why aren't people on Alli doing the same thing? I would think Alli falls into the same category of drug as do cholesterol drugs. No weight loss drugs, prescription or OTC are worth the risk to organs and overall health.

[sjc_1]

Any medication that you take 3 times a day for weeks and months at a time can have side effects. Liver damage is very serious and I am surprised that it was approved for over the counter use if that is the case.

Ever since Dan Quayle got involved in genetically modified foods when he was VP, we have been heading down a path where now the people that the FDA regulates pay their expenses. I can not think of a bigger conflict of interest that endangers public health than that. But given the state of health care, I would imagine that there are bigger ones.

[lloydbest1]

If there is a take away from this article it is this:

There is no such thing as a magic bullet. Weight loss in particular requires a great deal of effort and an ongoing commitment to altering one's mindset and lifestyle. It goes far beyond merely dieting and can NOT be maintained after one "goes off" the diet. Pills ain't gonna help. There is no such thing as a quickie diet, no such thing as an "eat what you want" or "lose weight while you sleep" diet, no such thing as a painless scheme to shed those unwanted pounds and keep them off. It just isn't going to happen. Period.
The biggest stumbling block to weight reduction isn't losing the weight; it is keeping it off. This is why I harp on "mindset" and "lifestyle" adjustments; it's why I say this is a arduous and painful process. It is the lifestyle and eating habits that caused the weight gain to begin with and undoing a lifetime of those habits is damnably difficult. Failure rates are extremely high but successfully making those changes necessary and keeping to them is the only way that permanent weight management is even possible.

[debinok1]

This is the same FDA that allowed minimal studies and rushed human trials on the H1N1 flu vaccine. They are now pushing the use of that vaccine on our children. They have no idea of the long term effects, they do suspect a connection to an increased risk of Guillain Barre Syndrome and have warned Neurologists to be on alert for an increase in those cases.

[docpeter1953]

From the above article, "Alli and Xenical are both marketed by British drugmaker GlaxoSmithKline PLC, though Xenical is manufactured by Swiss firm Roche."
------------------------
So GSK doesn't manufacture the drug they market?

________________________________

Also from above, "The FDA says it has not established a direct relationship between the weight loss treatments and liver injury, and advised patients to continue using the drugs as directed."
-----------------------------------------

Isn't this sort-of-like saying we think hitting your thumb with a hammer will hurt, but don't stop doing it until you can talk to your someone else.

________________________________

[toldyouso21]

Pharmaceutical companies routinely use other companies to make a product for them. this is because another company may have a license to make of sell a product but the new owner of that product does not maintain the license.

for instance, If Glaxo bought a company which can sell the product alli or Xenical, but Glaxo does not have a site which is approved* to make or package Xenical, then they approach a company that does have that license and shares the profits with them in return for that other company making the product for them.

It is called CONTRACT mfg and almost all companies either do it or have someone paying them to do it. Happens all the time.

The reason companies do this is because they often buy a company with a product license but to get a license for their main plants in the home country costs hundreds of millions to build and takes years to approve.

This is why there is so much gobbling up of Pharm companies by other companies--often for each COUNTRY one wants to market the product in--one either has to wait years (and lose market share and money) to get the product in their own name or make sure when they buy the company, they buy the licenses.

In fact, when companies are bought and sold for Big Pharm, what the buying company is really after is a state of the art already FDA and EU approved site and products already licensed to sell in certain countries. the people, the business itself is not really relevant to them--it is a way of having a ready made profit stream and it is what most larger companies do. Without the license or a viable R &D facility there is nothing and a mfg site that has already been approved is a huge plus.

[toldyouso21]

forgot to add: A license is ONLY good in the country that gave it and for a certain mfg site--if the site changes (like moves to another country) or where the product is sent, changes--then the company has to go through the entire process again for EACH country that granted the license.

Just because a company owns the rights to make a drug does not mean they can make it anywhere. they can only make it in an approved facility specifically challenged and tested for THAT product and then they can only send it to countries whose governments have already been out for YEARS, challenging and testing that facility.

As for OTC drugs and liver damage--Tylenol causes so much liver damage it can lead to death. Almost all metabolic drugs cause liver damage--to what degree depends on what is in the drug. The liver is the last stop for wastes so they get concentrated there--if these drugs cause hepatic toxicity' with normal use, then this would have been known in the clinical trials. If it is true, then Glaxo and the FDA got some 'splainin' to do.

[imprisoncheney]

Gotta love it . . .

Over the counter meds destroy livers . . . while the FDA refuses to even conduct tests on marijuana . . . b/c it's "too dangerous" . . .

Meanwhile, Big Pharma markets marijuana everyday -- as a pain-killer nasal spray (Savitex).

What's wrong with this picture?

[toldyouso21]

What's wrong is that you see the FDA as the reason that reefer is not legal? Reefer still remains primarily a recreational drug. The FDA was not formed to ferret out or challenge recreational use of chemicals or drugs--it was formed to keep companies from introducing drugs onto the market of bogus health reasons or introducing dangerous products onto the market.

The FDA is a policing org for Pharmaceutical companies. they do not write either law or policies which is why you do not see them in the headlines about smoking or liquor use. They are just enforcers--and what they enforce and to what degree depends on who is in office and what they are told to do.

No matter what, the FDA cannot take a stand on Marijuana or any other recreational drug--they can only enforce federal laws when drugs are manufactured by so called legitimate companies. The primary reason Marijuana is not a legal drug is that there is no way to control its use, how it is grown or even who gets to use it--not to mention the loss in revenue if one company cannot own it and make money off of it.

If Marijuana was legal, most would not pay pharm companies to synthesize it for them. They'd grow their own and if it got laced with something, who could enforce the laws? What standard could the FDA possibly hold a street dealer to? Or anyone else to?

It is not legal because it cannot be controlled, monitored, enforced or profited from like OTC and Parenteral drugs.

And--drugs are not meant to be for entertainment or for "fun" they are meant to augment health in some way.

As for deleterious effects from MJ--there are MANY but the one that comes to mind most frequently is loss of cognitive ability and memory over time as well as inability to pay attention which is sort of hazardous when one is on the road with a dope smoker (or liquor drinker) (or cell phone user) (or car tv watcher).

[tincup356]

Funny the way the government says drugs kill.....I think they made a mistake when they decided which drugs kill....the ones from big pharma are much more dangerous than the Evil weed, Marijuana when it comes to bad.....Big pharma drugs kill, maim, and cause misery on a daily basis,,,,marijuana , has attributed to zero deaths.The FDA receives influence to approve drugs, political influence and lobby dollars.,,,,,,its ALL about the money....NOT what is safe .

[estabwary]

when are people going to learn that pills cannot replace healthy behaviors

[billpl-2009]

....took the words from my mouth

i guess they also forget about all those old ads on TV that said

"Drugs Kill"

[nextgenman09]

When are people going to learn that healthy behaviors don't stop or prolong death either.