The following is a list of certain drugs analysed in Prescrire in 2010 that have more potential harms than benefits and that should be avoided pending the decision by the authorities (or the drug companies) to take them off the market.

NSAIDs, antidiabetics, psychotropics, etc.
Several nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided, especially cox-2 inhibitors:

• topical ketoprofen gel because of cutaneous disorders (Prescrire Int n°109, 112). The French regulator (Afssaps) decided to withdraw these gels in late 2009, but in mid-2010, CHMP recommended that they be allowed to remain on the market;
• nimesulide because of potentially lifethreatening liver damage (Rev Prescrire n°323 and 327, coming in Prescrire Int n°116);
• celecoxib (Celebrex° in rheumatology, and Onsenal° in familial adenomatous polyposis) and etoricoxib because of an excess of cardiovascular and cutaneous disorders (see www.english.prescrire.org and Prescrire Int n°108);
• parecoxib because of life-threatening skin reactions (Prescrire Int n°109). And also:
• meprobamate because of the high risk of adverse effects with this psychotropic drug, too often misused as a “recreational” drug (see > www.english.prescrire.org);
• nicorandil because of its unproven efficacy in angina pectoris and the risk of serious ulceration (gastrointestinal, vaginal, etc.) (Prescrire Int n°110);
• quinine for cramps, because of the risk of potentially life-threatening haematological effects (Rev Prescrire n°326);
• pioglitazone, an antidiabetic drug with adverse effects that outweigh its efficacy (Rev Prescrire n°325 and > www.english.prescrire.org);
• ropinirole in restless legs syndrome: this dopamine agonist has known adverse effects but no proven efficacy in this setting. In 2010, the French authorities recommended that it no longer be reimbursed (Rev Prescrire n°325);
• telithromycin, a macrolide carrying a risk of cardiac, hepatic and visual disorders (Prescrire Int n°106 and > www.english.prescrire.org);
• trimetazidine, because of a negative risk-benefit balance in angina pectoris, dizziness, tinnitus and visual disorders, and especially a risk of extrapyramidal syndrome and thrombocytopenia Prescrire Int n°106 and > www.english.prescrire.org).

On 21 December 2010, the fixed-dose combination containing dextropropoxyphene and paracetamol was still on the market, but it is slated for European market withdrawal in 2011 (on 1 March 2011 in France) (Rev Prescrire n°323 and > www.english.prescrire.org).

Cost of inadequate regulation
In view of these few examples, how can decision-makers and health authorities be trusted, when they allow patients to be exposed to harmful drugs, letting society pick up the tab for hospitalisation, sick leave, and agree to provide reimbursement for vastly over-priced drugs.

For example, the direct cost of prescriptions for glitazones in France was about 50 million euros in 2007, for the national health insurance system alone Rev Prescrire n°317).

There is a cost for inadequate regulation. Decision-makers can start to get a grip on health spending by refusing to provide reimbursement for drugs with a negative risk-benefit balance.

©Prescrire April 2011

"New drugs and indications in 2010: inadequate assessment; patients at risk" Prescrire Int 2011: 20 (115): 105-110. (Pdf, free)