Data-Médicos 
Dermagic/Express No.8-(X-16) 
30 January 2.007 /3O Enero2.007

 
                                                               

EDITORIAL ESPAÑOL                                                  
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Quieres que yo te demuestre científicamente que la molécula XENICAL (orlistat) no es muy buena, que te puede matar, que produce daño hepático, pancreático, cáncer, depresión y lesiones de piel, desordenes gastrointestinales, hipertensión y otras mas, altamente cuestionada hoy en día.

 XENICAL (orlistat) ha matado gente, (Referencia 7)....
 ".... 99 casos de pancreatitis asociadas a orlistat reporto la FDA......"

Saludos a Todos.

Dr. José Lapenta.

ENGLISH EDITORIAL
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Do you want me to demonstrate you scientifically that the molecule XENICAL (orlistat) it is not very good, ? that can kill you,  that produces hepatic and pancreatic damage, cancer, depression and skin lesions, hypertension and gastrointestinal disorders, highly questioned nowaday.
 

XENICAL (orlistat) people have killed, (reference 7).
 "......99 cases of orlistat related pancreatitis have been reported to the Food and Drug Administration..."

Greetings to all

Dr. José Lapenta

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REFERENCIAS BIBLIOGRÁFICAS/ BIBLIOGRAPHICAL REFERENCES
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1.) Severe hepatic injury caused by orlistat.
2.) Obesity Drug Xenical Should be Banned: Public Citizen.
3.) 36 year old man presenting with pancreatitis and a history of recent commencement of Orlistat case report.
4.) The anti-obesity agent Orlistat is associated to increase in colonic preneoplastic markers in rats treated with a chemical carcinogen.
5.) Constipation, polyuria, polydipsia, and edema associated with orlistat.
6.) [A case of acute cholestatic hepatitis associated with Orlistat][Article in Korean].
7.) Massive hepatocellular [correction of hepatocullular] necrosis: was it caused by Orlistat?.
8.) Additive gastrointestinal effects with concomitant use of olestra and orlistat.
9.) Bulimia nervosa and misuse of orlistat: two case reports.
10.) Lichenoid eruption associated with orlistat.
11.) Orlistat (Xenical)-induced subacute liver failure.
12.) Orlistat Side Effects.
13.) Public Citizen renews call for FDA to ban both prescription and over-the counter distribution of Xenical (Orlistat) - 6/7/06.
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1.) Severe hepatic injury caused by orlistat

.
Source:  https://www.ncbi.nlm.nih.gov

Am J Med. 2006 Aug;119(8):e7. Links

Umemura T, Ichijo T, Matsumoto A, Kiyosawa K.
PMID: 16887401 [PubMed - indexed for MEDLINE]
 

2.) Obesity Drug Xenical Should be Banned: Public Citizen

Source: https://www.hon/ch/news/

The prescription obesity drug Xenical (orlistat) should be immediately removed from the U.S. market because it may increase the risk of aberrant crypt foci (ACF), which are widely believed to be a precursor to colon cancer, the consumer advocacy group Public Citizen said in a petition filed Monday with the Food and Drug Administration.

Public Citizen, based in Washington, D.C., said its petition is based on findings from a review of data from Roche Pharmaceuticals, which makes orlistat, and recent findings that the drug causes ACF in the colon of rats.

The group also expressed concern that the FDA seems poised to approve U.S. sales of an over-the-counter version of orlistat.

"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," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a prepared statement.

Joining Public Citizen in the petition are Case Western Reserve School of Medicine pathologists -- Dr. Theresa Pretlow and Dr. Thomas Pretlow -- who are experts on ACF's link to colorectal cancer.
 

3.) 36 year old man presenting with pancreatitis and a history of recent commencement of Orlistat case report.Napier S, Thomas M.

Source:  https://www.ncbi.nlm.nih.gov

Nutr J. 2006 Aug 28;5:19.
Bristol Royal Infirmary, Marlborough Street, Bristol, BS2 8HW, UK. [email protected]

BACKGROUND: Orlistat is an anti-obesity drug licensed in the United Kingdom for 7 years. We present a case of a patient who developed pancreatitis four days after commencing orlistat. CASE PRESENTATION: A 36 year old man presented to hospital with acute severe pancreatitis four days after starting a course of Orlistat, a lipase inhibitor used in the treatment of obesity. A diagnosis of drug related pancreatitis was made by exclusion of other causes of pancreatitis; he was a teetotaller, had a normal serum calcium, had no family history of pancreatitis or hyperlipidaemia, no history of trauma and had no evidence of gallstones on Computerised Tomography scan (CT). CONCLUSION: Orlistat was the only drug that had been started recently and has been associated with pancreatitis previously. We found no case reports of similar cases, however 99 cases of orlistat related pancreatitis have been reported to the Food and Drug Administration (FDA), but no causative link has been found in clinical trials by the drug company. It is therefore not on the list of possible complications or side effects of the drug.

PMID: 16938137 [PubMed - indexed for MEDLINE]
 

4.) The anti-obesity agent Orlistat is associated to increase in colonic preneoplastic markers in rats treated with a chemical carcinogen.

Source:  https://www.ncbi.nlm.nih.gov

Cancer Lett. 2006 Aug 28;240(2):221-4. Epub 2005 Dec 27

Garcia SB,
Barros LT,
Turatti A,
Martinello F,
Modiano P,
Ribeiro-Silva A,
Vespucio MV,
Uyemura SA.

Department of Pathology, Ribeirao Preto Medical School, University of Sao Paulo, USP, Avenida Bandeirantes 3900, 14049-900 Ribeirao Preto, SP, Brazil. [email protected]

Orlistat is an anti-obesity agent that increases the fecal fat excretion, which promotes colon carcinogenesis. Therefore, the present study was designed to verify the effects of Orlistat on the formation of rat colonic aberrant crypt foci (ACF) and cell proliferation evaluated by the PCNA method. Male Wistar rats received either a standard diet or a high fat diet (HFD), supplemented or not with Orlistat (200mg/kg chow) and two doses of the carcinogen dimethyl-hydrazine (25mg/Kg). After 30 days, Orlistat was associated to a significant increase in the number of colonic ACFs and cell proliferation in DMH-treated animals, independently of the HFD.

PMID: 16377080 [PubMed - indexed for MEDLINE]

5.) Constipation, polyuria, polydipsia, and edema associated with orlistat

.Source:  https://www.ncbi.nlm.nih.gov

Packard KA, Wurdeman Ann Pharmacother. 2002 Jul-Aug;36(7-8):1168-70. 
RL, Reyes AP.
Creighton Cardiac Center, Omaha, NE 68131-2044, USA. [email protected]

OBJECTIVE: To report the occurrence of a novel group of adverse effects associated with initiation and rechallenge of orlistat. CASE SUMMARY: A 42-year-old white woman developed symptoms of constipation, polyuria, polydipsia, and increased lower-leg edema after 2 weeks of treatment with orlistat 120 mg 3 times daily. The drug was discontinued for 4 days and the symptoms resolved. On reinstitution of the orlistat treatment, the symptoms reappeared within 2 days. Thereafter, the medication was permanently discontinued. DISCUSSION: Common gastrointestinal adverse reactions associated with orlistat use include fecal urgency and abdominal pain and discomfort. Pedal edema has also been reported to occur, although less frequently. No reports were discovered documenting the occurrence of constipation, polydipsia, and polyuria associated with the use of orlistat. Despite careful consideration of other possible causes of these symptoms, the temporal association between initiation, discontinuation, and rechallenge of orlistat and the patient's symptoms suggest a medication-related adverse event. Based on the Naranjo probability scale, the likelihood that orlistat was the cause of this cluster of adverse effects is possible. CONCLUSIONS: It is important for the healthcare provider to be aware of these adverse effects to promptly evaluate and differentiate between possible causes of similar reactions.

6.) [A case of acute cholestatic hepatitis associated with Orlistat][Article in Korean]

Source:  https://www.ncbi.nlm.nih.gov

Taehan Kan Hakhoe Chi. 2002 Sep;8(3):317-20.

Kim DH, Lee EH, Hwang JC, Jeung JH, Kim do H, Cheong JY, Cho SW, Kim YB.
Department of Gastroenterology, Ajou University College of Medicine, Suwon, Korea.

Orlistat(Xenical(R), Roche) is considered a safe and effective drug to treat obesity by reduced absorption of 30% digested fat. To date, no serious adverse effects affecting the liver have been published except a case of subacute hepatic failure leading to liver transplantation in a young women with moderate obesity treated with orlistat. We report a case of acute cholestatic hepatitis in a young woman with moderate obesity treated with orlistat: a 33-year-old female admitted for the evaluation of jaundice. Abdominal ultrasonography, ERCP, routine chemistry, viral markers, and a fine needle biopsy of liver were performed. Microscopic findings of the liver biopsy specimen were compatible with acute cholestatic hepatitis. After steroid therapy, liver function was improved.

PMID: 12499790 [PubMed - indexed for MEDLINE]

7.) Massive hepatocellular [correction of hepatocullular] necrosis: was it caused by Orlistat?

Source:  https://www.ncbi.nlm.nih.gov

Lau G, Chan CL.
Med Sci Law. 2002 Oct;42(4):309-12.
Health Sciences Authority, Centre for Forensic Medicine, Singapore, Republic of Singapore. [email protected]

Orlistat (tetrahydrolipostatin) is a lipase inhibitor which is used, in conjunction with appropriate dietary control, for the treatment of obesity. It is generally deemed to be a safe drug, which mainly exerts a topical action on the stomach and small bowel, with negligible systemic absorption and oral bioavailability. Consequently, its adverse effects have largely been limited to relatively mild gastrointestinal disorders. However, there have been recent, published reports of non-fatal acute hepatitis and systemic hypertension associated with its use. The present case concerns a 62-year-old male who died from massive hepatocellular necrosis, consistent with drug-induced, fulminant hepatitis, associated with the use of oral orlistat, presumably administered at the recommended daily dose of 360 mg. It is postulated that this may represent a rare idiosyncratic reaction to the drug.

PMID: 12487515 [PubMed - indexed for MEDLINE]

8.) Additive gastrointestinal effects with concomitant use of olestra and orlistat.

Source:  https://www.ncbi.nlm.nih.gov

Ann Pharmacother. 2002 Jun;36(6):1003-5.
Heck AM, Calis KA, McDuffie JR, Carobene SE, Yanovski JA.
Purdue University School of Pharmacy and Pharmacal Sciences, Indianapolis, IN 46202-2879, USA. [email protected]

OBJECTIVE: To report a case of significant additive gastrointestinal effects with concomitant use of orlistat and an olestra-containing snack food. CASE SUMMARY: A 16-year-old African American girl with type 2 diabetes, hypercholesterolemia, and hypertension was participating in a pilot study that tested the safety and efficacy of orlistat. After 2 weeks of orlistat treatment, the patient presented to the clinic with complaints of soft, fatty/oily stools, flatus with discharge, abdominal pain, increased flatus, and fecal incontinence. On further questioning, it was determined that she was also consuming approximately 5 ounces of olestra-containing potato chips on a daily basis. The patient eliminated olestra from her diet and returned to the clinic with substantially diminished gastrointestinal adverse effects, despite continuing to take orlistat. DISCUSSION: This is the first published case describing additive gastrointestinal effects after concurrent use of orlistat and olestra. Education about the potential for serious additive gastrointestinal adverse effects is important to prevent premature and unnecessary discontinuation of orlistat therapy. Awareness of this potential interaction could be especially important for patients with underlying disease states in which severe gastrointestinal symptoms could result in significant complications. CONCLUSIONS: This case illustrates that significant gastrointestinal distress may result after olestra consumption during orlistat therapy. All patients receiving orlistat for the management of obesity should be properly educated about this potential drug-food interaction.

PMID: 12022901 [PubMed - indexed for MEDLINE]
 

9.) Bulimia nervosa and misuse of orlistat: two case reports.

Source:  https://www.ncbi.nlm.nih.gov

Fernandez-Aranda F, Amor A, Jimenez-Murcia S, Gimenez-Martinez L,
Int J Eat Disord. 2001 Dec;30(4):458-61.
Turon-Gil V,Vallejo-Ruiloba J.
Department of Psychiatry, University Hospital of Bellvitge, Barcelona, Spain. [email protected]

OBJECTIVE: Orlistat (tetrahydrolipstatin) is an intestinal lipase inhibitor that was approved recently for the management and treatment of obesity. This is the first report of the misuse of orlistat in two normal-weight purging bulimia nervosa (BN) patients. METHOD AND RESULTS We report two diagnosed cases of BN in two Spanish women who used orlistat as a purging mechanism after binge episodes. In both cases, the onset of the eating disorder was in adolescence. From the beginning, a restrictive diet, binging, and purging behavior (vomiting and using laxatives) were present. Both patients misused this substance as their only purging mechanism after every binge episode. CONCLUSION: BN patients have used many substances and bizarre behaviors as purging mechanisms. Nevertheless, to the authors' knowledge, these are the first reported cases of orlistat misuse as the only purging mechanism in two BN patients. Copyright 2001 by John Wiley & Sons, Inc.

10.) Lichenoid eruption associated with orlistat.

Source:  https://www.ncbi.nlm.nih.gov

Sergeant A, Milne G, Shaffrali F.
Br J Dermatol. 2006 May;154(5):1020-1. Links
PMID: 16634924 [PubMed - indexed for MEDLINE]
 

11.) Orlistat (Xenical)-induced subacute liver failure.

Source:  https://www.ncbi.nlm.nih.gov

Eur J Gastroenterol Hepatol. 2005 Dec;17(12):1437-8. 

Thurairajah PH, Syn WK, Neil DA, Stell D, Haydon G.

PMID: 16292105 [PubMed - indexed for MEDLINE]
 

Related Links[A case of acute cholestatic hepatitis associated with Orlistat]
[Taehan Kan Hakhoe Chi. 2002] PMID: 12499790
Depression induced by orlistat (Xenical) [Can J Psychiatry. 2000]
PMID: 10696499 Orlistat associated subacute hepatic failure. [J Hepatol. 2001]
PMID: 11211898 Over-the-counter orlistat. A weight loss "Alli" or adversary on the horizon. [AWHONN Lifelines. 2006] PMID: 17069574
[Is xenical hepatotoxic?] [Gastroenterol Clin Biol. 2000] PMID: 10804353
 

12.) Orlistat Side Effects

Source: https://www.gunzburglaw.com/

Orlistat (also referred to as Xenical) is a lipase-inhibitor drug designed by Hoffman La-Roche Laboratories to help obese individuals lose and maintain their body weight. The drug works by preventing fat from being absorbed by the body but can cause excess gas, oily discharge and other gastrointestinal problems. Although this may sound like a miracle weight loss drug, it has hidden cancer risks which are emerging that clearly outweigh any possible benefit the drug may have. According to research studies, people who use it have a higher risk of developing both colon cancer and breast cancer.

Have you or someone you know suffered from Orlistat Side Effects? Contact us for a free consultation on your potential case against Orlistat Side Effects today!

Colon cancer concerns have spurred the consumer advocate group, Public Citizen, to petition the FDA asking it to withdraw the prescription diet drug from the market; the group also wants the FDA to refuse approval for the weight-loss pill to be made widely available over the counter. Public Citizen has a strong track record of identifying dangerous drugs well before federal regulators take action to ban or put warnings on these drugs. For example, Public Citizen warned consumers about the dangers of Vioxx, Ephedra, Bextra, Rezulin, Baycol, Propulsid and many other drugs years before the drugs were pulled from the market. Public Citizen, representing over 100,000 consumers in this petition, has moved forward with the petition based on research that shows people taking Orlistat have a significant risk of developing aberrant crypt foci. Aberrant crypt foci has been found to be a precursor to colon cancer.

Orlistat side effects has also been determined to be associated with higher risks of developing breast cancer. According to research data submitted by Hoffman La-Roche in its application to the FDA requesting approval, that it has a higher risk of developing breast cancer. Data from Hoffman La-Roche’s clinical studies showed that It accelerated the development of breast cancer in women over 45 years of age or older when given the medication orally at a dose of 120 milligrams three times per day. This data initially gave the FDA concern and it held off on approving the drug. In the seven randomized, controlled clinical trials, there were 10 cases of breast cancer in the treated group with only one in the control group. The relative risk of getting breast cancer while taking Orlistat (compared to those taking a placebo) was calculated several times by both the FDA and the sponsor and found to vary between 4 and 7 fold, depending on the analysis. These results caused the FDA Medical Officer to rescind his original approval. However, the FDA recommended that the warning labels contain information related to this risk, also asked for post marketing surveys be conducted. No such warnings were included in the products labels, and to the present date no post marketing surveys have been performed.

Have you or someone you know suffered from Orlistat Side Effects? Contact us for a free consultation on your potential case against Orlistat Side Effects today!


13.) Public Citizen renews call for FDA to ban both prescription and over-the counter distribution of Xenical (Orlistat) - 6/7/06

Source: Public Citizen

In a letter published in the Cancer Letter, a weekly newsletter that publishes news and items related to cancer research, the consumer group Public Citizen renewed its call upon the acting commissioner of the FDA to ban both prescription and over-the-counter distribution of orlistat. Xenical is the prescription version of orlistat, an obesity-fighting drug which Roche Laboratories and GlaxoSmithKline hope to sell over-the-counter to the public. GSK announced on April 7 that it had learned the FDA would soon approve its over-the-counter version of orlistat, to be called Alli, once the company answered some remaining questions. If approved, Alli would be the first over-the-counter version of orlistat. The FDA has still not granted Alli full approval for sale in the U.S.

Orlistat has been found to cause a marked increase in the incidence of aberrant intestinal crypts, or crypt foci, widely believed to be a precursor of colon cancer. These aberrant crypt foci, or ACF, are considered pre-cancerous changes; lesions that serve as "biomarkers" or signs of cancer growing in the body.

Public Citizen testified before an FDA advisory panel on January 23rd to oppose the approval of orlistat for over-the-counter sales. Four researchers on the panel who were subsequently interviewed by the Cancer Letter were not informed at or prior to the January 23rd meeting about the studies that found orlistat induced ACF in animal colons, an outcome Public Citizen said is documented in two studies.

University of Chicago gastroenterologist Marc Bissonnette, a panel researcher, said in the June 5 Public Citizen statement that the FDA’s apparent decision not to consult researchers on the ACF question appears consistent with the recent failures by the FDA to detect dangers in the toxicity of drugs. "It reminds me of the Vioxx story, unfortunately, and lots of other stories like it," Bissonnette said.

Sources: Ed Silverman, "Advocacy group objects to weight-loss drug," New Jersey Star-Ledger, June 6, 2006, accessed June 7, 2007; Sidney M. Wolfe, MD; Elizabeth Barbehenn, PhD; Peter Lurie, MD, MPH; "Supplement to petition to ban diet drug orlistat (XENICAL). Additional information provided about pre-cancerous changes to the colon (HRG Publication #1771)," Public Citizen, June 5, 2006, accessed June 7, 2006.


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DATA-MÉDICOS/DERMAGIC-EXPRESS No 8-(X-16)  30/01/2.007 DR. JOSÉ LAPENTA R. 
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