Ксеникал причинява тумори!!!

Petition for FDA to ban Xenical
431 words
13 April 2006
Pharma Marketletter
English
Copyright 2006. Marketletter Publications
The US consumer group Public Citizen has petitioned the Food and Drug Administration to immediately remove from the market the prescription version of Xenical (orlistat, made by Roche ) because, it says, the obesity treatment has been known to cause a significant increase in aberrant crypt foci (ACF), which are widely believed to be a precursor to colon cancer.

Earlier this month, the FDA sent an "approvable" letter concerning the over-the-counter version of orlistat to GlaxoSmithKline, which has applied to market this version. Despite safety concerns, if GSK meets the conditions set by the FDA - conditions that have not been made public - this would make the drug eligible for final approval for OTC sales, says Public Citizen.

According to the consumer body, its petition is based on findings from the pharmacology review of Roche's own data and a recent independent confirmation that orlistat causes ACF in the colon of rats. There is a large amount of scientific literature that acknowledges the importance of ACF as the earliest identifiable neoplastic colonic lesion and a putative precursor of colon cancer. The FDA's own 1997 review of orlistat indicated a concern with colonic cell proliferation, and the drug was not initially approved by the agency because of clinical trials that found a four to seven-fold increased risk of getting breast cancer while taking orlistat, it states.

Also questions efficacy

In addition to cancer concerns, adverse events for patients taking orlistat include a cluster of gastrointestinal symptoms and a loss of fat-soluble vitamins, including beta-carotene and vitamins A, D, E and K, says Public Citizen, adding that orlistat's efficacy has also been called into question because of two recently-published clinical trials that demonstrated only a 2.8% difference in weight loss after four years versus placebo.

"The failure to ban the prescription version of this drug or, worse, to make it much more widely available by allowing OTC sales, is a decision that is likely to increase cancer incidence," said Sidney Wolfe, director of Public Citizen's Health Research Group. Public Citizen is joined in the petition by two professors of pathology at Case Western Reserve School of Medicine, Theresa Pretlow and Thomas Pretlow, who are both experts on ACF's link to colorectal cancer.

"The FDA should not allow a drug...to remain on the market for the long-term treatment of a non-lethal condition when it combines so little efficacy coupled with a still unresolved potential to cause breast and colon caner," says the 12-page petition.

FDA Is Urged to Pull Diet Drug Xenical Off Market
By Jennifer Corbett Dooren
413 words
11 April 2006
The Wall Street Journal
D3
English
(Copyright (c) 2006, Dow Jones & Company, Inc.)
WASHINGTON -- The consumer group Public Citizen asked the Food and Drug Administration to take the weight-loss drug Xenical, made by Roche Pharmaceuticals, a unit of Roche Holding AG, off the market.

In a petition filed with the FDA, Public Citizen and two researchers from Case Western Reserve University School of Medicine, said the drug was linked to changes in the lining of the intestinal tract.

"This drug, which treats obesity, causes a significant increase in the incidence of aberrant cyrpt foci, which are widely believed to be a precursor of colon cancer," the petition said. It cited animal studies Roche submitted to the FDA during the Xenical approval process. In 1997, an FDA reviewer noted a dose-dependent rise in aberrant cyrpt foci in some rats exposed to Xenical.

"We take any questions regarding safety extremely seriously," said Terence Hurley, a Roche spokesman. "To date the overwhelming body of evidence indicates Xenical is safe and consumers should continue to feel confident in the product."

Xenical has been on the U.S. market since 1999. GlaxoSmithKline PLC has proposed selling a lower dose version of Xenical, known generically as orlistat, over the counter. The FDA on Friday said orlistat was "approvable" as an OTC drug, but that Glaxo needed to meet conditions before it could be approved.

The company said it would address the FDA's concerns and expected to begin marketing orlistat under the brand name Alli later this year.

Along with wanting Xenical banned as a prescription drug, Public Citizen repeated its view that the FDA shouldn't let the drug be sold over the counter.

"Orlistat is a drug that has shown minimal efficacy coupled with both known and potentially important serious and adverse events," the petition said. It cited two studies that showed those on Xenical lost about 13 pounds while those not receiving the drug lost seven pounds. Much of the weight was later regained. "The failure to ban the prescription version of this drug or, worse, to make it much more widely available by allowing OTC sales, is a decision that is likely to increase cancer incidence," said Sidney Wolfe, director of Public Citizen's Health Research Group.

The petition was also signed by Theresa Pretlow and Thomas Pretlow, both pathology professors at Case Western who have conducted research on the role of aberrant crypt foci and the link to colon cancer.

Вестник Лечител-бр.19./тази седмица/.

Когато човек реши да пие някакво лекарство, първо се консултира с лекар, чете се ЗАДЪЛЖИТЕЛНО листовката и тогава евентуално го започва. Аз лично потърсих мнения за Ксеникала във форуми единствено, за да разбера дали има резултат. Но иначе съм 98 % убедена, че лекарството не е опасно за здравето. Относно мастноразтворимите витамини А, Д и Е - блокират се едва 1/3 от приеманите мазнини, така че остават достатъчно за усвояването на тези витамини. За по-голямо успокоение, могат да се вземат допълнително. А относно изхвърлянето на мазнини - първия ден се изненадах как направо си течеше олио като ходих до тоалетната (сори, ама няма как иначе да се изразя!). После свикваш да хапваш по-малко мазно, свикваш да се контролираш и просто не обръщаш внимание. Даже ми действа благотворно на психиката като виждам как гадостта, която съм погълнала, излиза от мен. Ексцесии при мен не е имало. Виж със зеления чай САНИЕ коликите бяха по-големи, макар че и с него свикнах и болките преминаха.

 Абсолютно вярно!   

На мене ми го предписа лекар-ендокринолог. Само че преди да го купя се порових в нета и разбрах че в щатите вече е забранен защото от него изтъняват стените на дебелото черво и се образуват тумори. Освен това знам че се дебелее предимно от въглрехидратите а не от мазнините, за което ксеникала не помага.  А като казах на ендокриноложката че не мога да давам по 200 лв на месец за хапчета тя ми каза да си купя опаковка от 21 хапчета които да пия само като ям нещо мазно като си контролирам така храненето че да ми стигат за повече от месец. Ми аз като си контролирам яденето няма да има нужда от хапчета. Нали проблема е да се подтисне апетита.

Кои изследвания? На кого?