Many drugs that have more harms than benefits are still marketed in France, and in some cases, for several decades.

The following drugs were examined in Pres­crire in 2011, in order of publication:

• nimesulide, a nonsteroidal anti-inflammatory drug (NSAID), because of the risk of liver damage (Prescrire Int n° 116);
• antihistamine antitussives, because of their sedative and antimuscarinic effects (issue 329 p. 179);
• dronedarone, an antiarrhythmic drug, due to a risk of liver damage and cardiovascular disorders (Prescrire Int n° 122);
• terpenes, due to their neuropsychiatric adverse effects (including seizures), especially in young children. In 2011, some medicines for children, mainly suppositories, still contained terpenes. In late 2011, the French drug regulatory agency contraindicated their use in suppositories for children under 30 months (Rev Prescrire n° 340);
• trimetazidine, marketed for angina, dizziness, visual disorders and tinnitus, carries a risk of extrapyramidal disorders, falls and thrombocytopenia (Prescrire Int n° 115). In 2011, the French regulatory agency triggered a referral to the European Medicines Agency;
• pholcodine, an opioid antitussive, because of concerns over a risk of allergy to muscle relaxants used during anaesthesia (Rev Prescrire n° 331). In 2011, the French agency simply ruled that this drug should be available by prescription only, in order to limit its use (Rev Prescrire n° 333);
• oral and nasal vasoconstrictive decongestants (ephedrine, naphazoline, oxymetazoline, phenylephrine, pseudo­ephedrine and tuaminoheptane), because of a risk of life-threatening cardiovascular disorders (myocardial infarction, arrhythmia, hypertension). In 2011, the French agency simply demanded a modification in the Summary of Products Characteristics (SPC) (Rev Prescrire n° 335);
• iron dextran, due to a higher risk of hypersensitivity than with iron sucrose (Rev Prescrire n° 335);
• meprobamate is still contained in certain products in France (for gastrointestinal disorders associated with anxiety, and premenstrual syndrome), despite a risk of severe cutaneous and haematological adverse reactions, and a withdrawal syndrome (Prescrire Int n° 123);
• bupropion, an amphetamine derivative, and varenicline, an acetylcholine receptor partial agonist used for smoking cessation, mainly because of cardiovascular and neuropsychiatric disorders (Rev Prescrire n° 329, Prescrire Int n° 124);
• quinine for cramps, because of a risk of haematological disorders, cardiac arrhythmia and hypersensitivity (Prescrire Int n° 115);
• mequitazine, a “sedative” and “atropinic” antihistamine used in allergies, carries a higher risk of cardiac arrhythmia than other antihistamines. In 2011, the French agency simply placed mequitazine on the list of controlled substances (Rev Prescrire n° 337)
• ropinirole, a dopamine agonist used for restless legs syndrome (Prescrire Int n° 115);
• orlistat for weight loss: its adverse effects and interactions largely outweigh a marginal and transient weight loss (Rev Prescrire n° 338);

Since late 2011, some of these products are no longer reimbursed in France, including those based on dronedarone, nimesulide and quinine (for cramps).

While the measures limit the consumption of these drugs and, thus, the number of patients exposed, they send a mixed message to patients. Simply withdrawing them from the market is the most effective solution.

©Prescrire April 2011

"New drugs and new indications in 2011. France is better focused on patients' interests after the Mediator° scandal, but stagnation elsewhere" Prescrire Int 2012; 21 (126): 106-110. (pdf, free)