Some of the medications used for weight loss in the management of obesity have been associated with unacceptable morbidity and mortality. Safety concerns have led to the withdrawal of aminorex, followed by the fenfluramines in 1997, and phenylpropanolamine (norephedrine) in 2000. Aminorex was associated with an increased prevalence of primary pulmonary hypertension (PPH), fenfluramines with an increased prevalence of PPH and valvulopathy, and phenylpropanolamine with an increased risk of haemorrhagic stroke. Several studies have investigated the safety of the fenfluramines, yet the benefit-risk profile has not been conclusively quantified. This is due to several deficiencies in the published studies, including a lack of data on the baseline prevalences of comorbid conditions in obese subjects, and potential confounders and biases in the study designs. Although several studies and systematic reviews support an increased risk of PPH and valvulopathy in patients who have taken fenfluramines, without knowledge of the background prevalence it is not possible to determine if the exposure preceded the outcome. The population at higher risk of these adverse effects includes those taking higher doses or with a longer duration of exposure to fenfluramines and those with pre-existing cardiac disease or a genetic predisposition. Patients exposed to fenfluramines continue to be monitored, with some follow-up studies indicating no overall worsening in valvulopathy over time. There are limited efficacy and safety data for amfepramone (diethylpropion) and phentermine and their approval for the management of obesity is limited to short-term use. Orlistat and sibutramine are the only currently approved medications for long-term management of obesity. Although the benefit-risk profiles of sibutramine and orlistat appear positive, sibutramine continues to be monitored because of long-term safety concerns. The safety and efficacy of currently approved drug therapies have not been evaluated in children and elderly patient populations and there is limited information in adolescents, whilst the long-term safety of current and potential new drug therapies in adults will require several years of postmarketing surveillance to fully elucidate their adverse effect profiles.

Safety of Drug Therapies Used for Weight Loss and Treatment of Obesity

Obesity is a frequent complication following liver transplantation and is insufficiently responsive to dietary and life style advice. We studied the safety of orlistat treatment in obese and overweight liver transplant recipients (n = 15) on a stable tacrolimus-based immunosuppressive regimen. For safety reasons, the treatment period was restricted (6 months 120 mg t.i.d., 3 months 120 mg daily). Three patients dropped out, tacrolimus dose was adjusted in six of 12 remaining patients (dose reduction in 4, increase in 2, P = N.S.). All dose adjustments occurred during the 6 months of orlistat 120 mg t.i.d. therapy. No drug intolerance, adverse events or episodes of rejection occurred during the study. Efficacy of orlistat treatment in this population could not be shown, because a formal control population was not included in this safety trial. Moreover, only a significant decrease of waist circumference (P < 0.01 versus start of the study), but not of weight or body mass index, was achieved in the treated group. Orlistat treatment is well tolerated in liver transplant recipients and can be started safely, provided immunosuppressive drug levels and dietary adherence are closely monitored.

Orlistat treatment is safe in overweight and obese liver transplant recipients: a prospective, open label trial

Background: Obesity has become a global epidemic with recent estimates of > 400 million obese adults. Despite this, there are few safe and effective pharmacological interventions for obesity. Sibutramine is a weight loss agent, for use as an adjuvant to a comprehensive program of calorie restriction, exercise and behavioral therapy. Objective: The goal of this article is to review the available literature of pharmacological interventions for obesity and specifically to examine data with sibutramine for the short term on safety and efficacy for weight loss. Methods: The literature on sibutramine was reviewed after a PubMed and Medline search in March 2008. All randomized clinical trails were reviewed. Results/conclusions: Sibutramine appears to be safe and effective in producing clinically significant weight loss for up to 1 year. Longer prospective clinical studies with sibutramine are needed to evaluate its safety (effect on blood pressure) and ability to maintain weight loss, improve metabolic profiles ...

Sibutramine: current status as an anti-obesity drug and its future perspectives.

............................................................................................................................. I ACKNOWLEDGMENTS ........................................................................................................... IV TABLE OF CONTENTS ............................................................................................................ VI LIST OF TABLES ..................................................................................................................... IX LIST OF FIGURES .................................................................................................................... X LIST OF ABBREVIATIONS ....................................................................................................... X

Risk of Acute Liver Injury Associated with the Use of Orlistat: Cohort and Self-Controlled Case Series Studies Using the MarketScan® Commercial Claims Database

SUMMARY Introduction. There are altogether four reported cases in the literature about psychotic episodes associated with sibutramine, which has been reg- istered as an appetite suppressant for 10 years. Objective. Authors review the case of a patient who, after being on sibutramine for three weeks, passed gradually into a psychotic state. Case summary. A 39-year-old white woman started to take sibutramine to lose weight at a dosage of 10mg/day. After taking the pill for two weeks her behavior changed basically, she ne- glected her tasks and irrealistic thoughts ap- peared in her mind. Later, she recalled these weeks as if they had been a dream. In two weeks time after spontaneous abrupt of sibutramine in- take symptoms disappeared without any treat- ment. The examination did not reveal organic disturbances or psychiatric illnesses. Discussion. The result of the psychological ex- amination rendered it probable, that the multi- tude of severe difficulties the patient had experi- enced in her life before she developed a patho- logical condition had weakened her psychic de- fense mechanism, making her vulnerable to the drug's psychosis-inducing properties. The corre- lation between the symptoms and sibutramine intake according to the Naranjo ADR scale is "probable".

Sibutramine-associated psychosis (case report).

Sibutramine Use Associated with Reversible Hepatotoxicity

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Sibutramine Use Associated with Reversible Hepatotoxicity