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Telithromycin (Ketek°): a welcome market withdrawal

The company's decision to withdraw this antibiotic from the market is good news for patients, in view of the drug's negative harm-benefit balance. It is a pity that the European Medicines Agency did not muster the courage to order withdrawal of this drug long before.

In early 2018, Sanofi Aventis withdrew the macrolide antibiotic telithromycin (Ketek°) from sale worldwide, citing economic reasons.

Telithromycin was authorised in the European Union in 2001 and first marketed in France in 2002 under the brand name Ketek°. The company's objective for this antibiotic at the time was to achieve a leading position among the treatments available for respiratory infections. The promotion worked like a charm and sales soared, with over 1.3 million boxes reimbursed by France's national health insurance system in 2004.

Yet even back in 2002, despite spurious claims of a novel mechanism, telithromycin was the ninth macrolide on the French market, was no more effective than the existing eight drugs in its class, but already had a disturbing adverse effect profile. In addition to the adverse effects it shared with other macrolides, those specific to telithromycin were detectable even in the initial trials and were confirmed over time: ocular disorders, loss of consciousness, cardiac rhythm disorders as well as severe, and sometimes fatal, liver injury.

The next phase in the history of this drug was sadly typical (see for example France's recent delisting of drugs for Alzheimer's disease, details HERE). In 2007, the European Medicines Agency (EMA) reviewed the drug's harm-benefit balance. It acknowledged that telithromycin exposes patients to a greater risk of serious adverse effects than other macrolide antibiotics. It issued a warning to this effect, but took no measures to withdraw it from the European market. Then little transpired until 2018, when the company announced it was withdrawing the drug from the market for economic reasons.

Prescrire has been warning since 2002 that telithromycin is best avoided. It is high time that drug regulatory agencies mustered the strength to compel pharmaceutical companies to do their job rather than raking in profits at patients' expense.

©Prescrire 1 September 2018

"Profit and loss" Prescrire Int 2018; 27 (196): 199. (Pdf, free).

"Telithromycin: a welcome market withdrawal" Prescrire Int 2018; 27 (196): 210. (Pdf, subscribers only).

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Download the full reviews:

Profit and loss
Pdf, free

Telithromycin: a welcome
market withdrawal
Pdf, subscribers only

See also:

Drugs for Alzheimer's
disease: finally
delisted in France!
(June 2018)

Towards better patient care:
drugs to avoid in 2018
Prescrire Int 2018;
27 (192): 107-1 - 107-9.
Pdf, free

Telithromycin: too many
adverse effects
(November 2014)

Telithromycin: a needless
addition to the other
Prescrire Int 2003;
12 (63): 8-11.
Pdf, subscribers only