a variety of non - prescription slimming products are now readily available on the market , which are often advertised to contain purely natural ingredients , hence assumed to be harmless .
however , these products may contain prescription weight - loss agents or banned pharmaceutical analogues that are not mentioned on the pack or in the patient information leaflet , and therefore may result in significant toxicities and even mortality.1)2 ) sibutramine , which has now been banned due to cardiovascular adverse effects , is one of the most commonly encountered illicit adulterants in non - prescription slimming pills.2 ) we describe a rare case of dilated cardiomyopathy with massive left ventricular ( lv ) thrombus in an otherwise healthy 32-year - old man who was taking sibutramine - containing slimming products .
a 32-year - old man was admitted with progressively worsening dyspnea on exertion of 1 month duration .
the patient was not known to have hypertension , diabetes or any other medical illness .
he reported having taken the unauthorized health product , " slim-30 " , for the last 7 months and had stopped taking it 2 weeks ago .
several medicines regulatory authorities are warning that this product contains an undeclared pharmaceutical ingredient , n - desmethyl sibutramine , an analogue of sibutramine , which has now been banned because of cardiovascular adverse effects .
when the drug was first started , his body mass index was 26.3 . from the outset the patient presented higher blood pressure and palpitation ,
on admission , initial vital signs were as follows : blood pressure of 110/80 mm hg , pulse rate of 130 beats / min , respiration rate of 20 breaths / min , and body temperature of 36.5. upon physical examination , pitting edema in both lower extremities was noted and a s3 gallop sound was audible .
chest x - ray showed cardiomegaly ( cardiothoracic ratio was 0.60 ) and no pulmonary edema ( fig .
the cardiac enzymes were within the normal range with a troponin - t level of 0.023 ng / ml ( normal 0.100 ) and creatine kinase - mb level of 1.86 ng / ml ( normal 4.94 ) .
however , pro - b - type natriuretic peptide level was elevated to 5404 pg / ml ( normal 88 ) .
a complete blood cell count , coagulation profile , and thyroid function test were within normal limits .
liver enzymes were elevated with an aspartate aminotransferase level of 80 iu / l and alanine transaminase level of 120 iu / l .
the transthoracic and transesophageal echocardiogram revealed dilated lv ( end - diastolic diameter of 6.5 cm ) with severely impaired systolic function { ejection fraction ( ef ) of 23% } and multiple hyperechoic , pedunculated masses attached to the lv apical wall , of which the largest measured 4.61.5 cm in size ( fig .
severe lv systolic dysfunction , the mass - like lesions were suspected of thrombi . the patient was started on diuretics , angiotensin - converting - enzyme inhibitor ( acei ) and parenteral unfractionated heparin .
he had a good clinical response to treatment and subsequent echocardiogram performed 10 days later showed that lv thrombi had nearly dissolved , although there was only a slight improvement in lv dilatation and contractility .
multi - detector computed tomographic coronary angiography , which was performed before discharge , showed normal a coronary artery ( fig .
he was discharged in a stable condition and prescribed a beta blocker , acei , and oral warfarin . at 1 month
follow - up , echocardiogram demonstrated complete resolution of lv thrombi and markedly improved lv systolic function ( ef of 45% ) and dilatation ( end - diastolic diameter of 5.6 cm ) ( fig .
the patient is currently doing well and is being followed up via the outpatient department .
sibutramine ( meridia , reductil , ectiva , abbott laboratories , abbott park , il , usa ) was approved by the u.s .
food and drug administration in 1997 and was approved for use in the european union ( eu ) in 1999 for the long - term ( 12 months ) management of obesity .
sibutramine and its two active metabolites , n - desmethyl and n - bisdesmethyl sibutramine , act centrally to inhibit serotonin and noradrenaline ( norepinephrine ) reuptake leading to satiety and act peripherally to increase metabolic rate , thermogenesis , and energy expenditure by stimulating 3-adrenergic receptors.3 ) such sympathomimetic activity of sibutramine causes a modest increase in heart rate and blood pressure,4)5 ) which can potentially increase the risk of adverse cardiovascular outcome in susceptible patients . since 2002 , serious adverse events including cardiac arrhythmia ( qt interval prolongation ) , myocardial infarction ( mi ) , and death had been reported in sibutramine - treated patients.6 - 12 ) this led to a contraindication of the use of this drug in patients with established coronary heart disease , previous stroke , heart failure , or cardiac arrhythmias . in the sibutramine cardiovascular outcomes trial , subjects with pre - existing cardiovascular disease who were receiving long - term sibutramine treatment ( 5 years ) had an increased risk of nonfatal mi and nonfatal stroke but not of cardiovascular death or death from any cause.5)13 ) on the basis of this trial , sibutramine was withdrawn from the eu in january 2010 and subsequently withdrawn from parts of asia and the u.s .
market in october 2010.14 - 16 ) however , sibutramine has still been found in adulterated non - prescription slimming products or natural herbal products.1)17 ) these products , of which ingredients are not declared , are usually found to contain n - desmethyl sibutramine in concentrations far above the maximum daily dose ( 5 to 15 mg).1)17 ) the unperceived use of this substance may be even more hazardous and lead to unpredictable complications and even mortality for individuals without any cardiovascular risk factor . therefore , more effective and proactive measures are required to guard against illicit use of slimming products containing n - desmethyl sibutramine or other banned pharmaceutical analogues such as n - nitrosofenfluramine .
one case has been reported of reversible cardiomyopathy possibly associated with sibutramine.18 ) however , cases of patients who presented with dilated cardiomyopathy with massive intracardiac thrombus secondary to sibutramine use have not been reported . in our case
, the patient did not have any attendant cardiovascular risk factors and another culpable agent was not identified .
we excluded other etiologic causes of reversible cardiomyopathy such as alcohol abuse , abnormal thyroid function , and coronary heart disease .
the chance of myocarditis seemed to be very low due to cardiac enzymes within the normal range and no history of viral infection .
this strongly suggested that sibutramine use was responsible for his dilated lv with severely impaired contractility , thereby causing intracardiac thrombus formation .
we report a rare case of an otherwise healthy man who presented with dilated cardiomyopathy with massive lv thrombus secondary to the use of sibutramine - containing slimming pills .
this case highlights the emerging threat posed by adulteration of non - prescription slimming products with undeclared , banned pharmaceutical analogues .
when investigating the secondary cause of dilated cardiomyopathy with unknown etiology , physicians should be vigilant to the possibility of over - the - counter weight - loss agents or dietary supplements with undeclared ingredients .
 sibutramine , which acts as an anti - obesity drug by inhibiting reuptake of serotonin and norepinephrine , has now been banned due to cardiovascular adverse effects . however , despite being banned , it is not uncommon for people to purchase products with sibutramine or its analogues used as adulterants in non - prescription slimming products or health foods available on the internet . 
 sibutramine has been associated with rare but serious adverse reactions such as cardiac arrhythmia including qt interval prolongation , myocardial infarction , and cardiomyopathy , as well as increases in blood pressure and pulse rate . here 
 , we report a case of a 32-year - old male who presented with dilated cardiomyopathy with massive left ventricular thrombus after taking unauthorized sibutramine - containing slimming pills sold over the internet . 