Avoiding iatrogenic complications Drugs to avoid Marketing authorisation is being grant- ed prematurely for an increasing number The following is a list of – ropinirole in restless legs syndrome: of new drugs, before their efficacy and certain drugs analysed in Pre- this dopamine agonist has known adverse particularly, their adverse effects have scrire in 2010 that have more effects but no proven efficacy in this set- been properly evaluated (Rev Prescrire potential harms than benefits ting. In 2010, the French authorities rec- n°326). and that should be avoided ommended that it no longer be reim- One would expect drug regulatory pending the decision by the bursed (Rev Prescrire n°325); agencies to be more cautious and respon- authorities (or the drug com- – telithromycin, a macrolide carrying a risk sive following scandals such as the diethyl- panies) to take them off the of cardiac, hepatic and visual disorders stilbestrol (DES) disaster and, more recent- market. (Prescrire Int n°106 and www.english. ly, the benfluorex (ex-Mediator°) affair prescrire.org); (Prescrire Int n°105, 107, 113 and Prescrire NSAIDs, antidiabetics, psychotrop- – trimetazidine, because of a negative website). ics, etc. Several nonsteroidal anti-inflam- risk-benefit balance in angina pectoris, matory drugs (NSAIDs) should be avoid- dizziness, tinnitus and visual disorders, Market withdrawal: an effective ed, especially cox-2 inhibitors: and especially a risk of extrapyramidal measure, especially when timely. – topical ketoprofen gel because of cuta- syndrome and thrombocytopenia Drug regulatory agencies often appear neous disorders (Prescrire Int n°109, 112). (Prescrire Int n°106 and www.english. reluctant to withdraw drugs with nega- The French regulator (Afssaps) decided to prescrire.org). tive risk-benefit balances, allowing sales withdraw these gels in late 2009, but in On 21 December 2010, the fixed-dose to continue unabated and needlessly mid-2010, CHMP recommended that they combination containing dextropropo - exposing patients to a risk of adverse be allowed to remain on the market; xyphene and paracetamol was still on effects. – nimesulide because of potentially life- the market, but it is slated for European The return of topical ketoprofen to the threatening liver damage (Rev Prescrire market withdrawal in 2011 (on 1 March market after initial withdrawal at the n°323); 2011 in France) (Rev Prescrire n°323 demand of the French drug agency (Afs- – celecoxib (Celebrex° in rheumatology, and www.english.prescrire.org). saps) illustrates how drug companies’ and Onsenal° in familial adenomatous financial interests are often put ahead of polyposis) and etoricoxib because of an Cost of inadequate regulation. In patient safety (Prescrire Int n°109, excess of cardiovascular and cutaneous view of these few examples, how can 112,113). disorders (see www.english.prescrire.org decision-makers and health authorities In 2010, only a small proportion of and Prescrire Int n°108); be trusted, when they allow patients to be drugs with a negative risk-benefit balance – parecoxib because of life-threatening exposed to harmful drugs, letting society were taken off the market, several years skin reactions (Prescrire Int n°109). pick up the tab for hospitalisation, sick after their dangers were first identified. And also: leave, and agree to provide reimburse- They included bufexamac, a topical non- – meprobamate because of the high risk ment for vastly over-priced drugs. steroidal antiinflammatory drug, because of adverse effects with this psychotropic For example, the direct cost of pre- of potentially serious cutaneous disor- drug, too often misused as a “recreation- scriptions for glitazones in France was ders (eczema) (Rev Prescrire n°321, 325); al” drug (see www.english.prescrire.org); about 50 million euros in 2007, for the carbocisteine and acetylcysteine (mucolytic – nicorandil because of its unproven effi- national health insurance system alone agents) in infants, because of respiratory cacy in angina pectoris and the risk of seri- (Rev Prescrire n°317). adverse effects (Rev Prescrire n°320,324); ous ulceration (gastrointestinal, vaginal, There is a cost for inadequate regula- rosiglitazone (an antidiabetic), because of etc.) (Prescrire Int n°110); tion. Decision-makers can start to get a cardiovascular adverse effects (Rev Prescrire – quinine for cramps, because of the risk grip on health spending by refusing to pro- n°325, 326); and sibutramine (an appetite of potentially life-threatening haemato- vide reimbursement for drugs with a neg- suppressant), also because of cardiovas- logical effects (Rev Prescrire n°326); ative risk-benefit balance. cular adverse effects (Prescrire Int n°107). – pioglitazone, an antidiabetic drug with ©Prescrire adverse effects that outweigh its efficacy Refusal to grant marketing autho- (Rev Prescrire n°325 and www. risation: another effective means of english.prescrire.org); protecting patients. Patients were pro- tected from exposure to unnecessary risks of certain drugs last year, after the – refusal of extension of the indications the following products (among others) in EU Committee for Medicinal Products for for two psychotropics used in fibromyal- 2010: Human Use (CHMP) refused to grant gia: pregabalin and milnacipran (in depres- – becaplermin because of infections and market approval or issued an sion) (Rev Prescrire n°320). cancer (Prescrire Int n°108); unfavourable opinion, leading the com- – fluoxetine because of cardiac malfor- pany to withdraw its application. They Adverse effects: insist on more mations in newborns exposed in early included: openness. Because marketing authori- pregnancy (Rev Prescrire n°323); – refusal of marketing authorisation for sation is increasingly granted prema- – lenalidomide because of myocardial gemifloxacin, a particularly risky fluoro- turely, the adverse effect profiles of many infarction (Prescrire Int n°109); quinolone (Rev Prescrire n°319); new drugs are not properly documented – olanzapine because of sudden death and – refusal of marketing authorisation for at the time of market release. urinary incontinence (Prescrire Int n°109); ixabepilone in breast cancer, because of Post-marketing data on adverse effects – orlistat because of interactions, pancre- serious and frequent neuropathies and are therefore crucial and must be made atitis and nephropathies (Prescrire Int haematological disorders (Rev Prescrire available to the public. The European n°107, 110); n°315); Medicines Agency (EMA) issued alerts on – angiotensin II receptor continued p. 109

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