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The Pharmaceutical Journal Vol 264 No 7089 p458
March 25, 2000 Clinical

French safety agency orders withdrawal of doxycycline capsules

All capsule formulations of doxycycline have been withdrawn in France because of the risk of oesophageal damage. The Agençe Française de Securité Sanitaire des Produits de Santé (AFSSAPS), which deals with safety issues related to medicines, announced the decision to suspend the marketing authorisations on February 7. The decision was taken after a monitoring programme showed that the incidence of oesophageal damage was higher with capsules than with the tablet formulations.
The UK summary of product characteristics (SPC) says that doxycycline (Vibramycin) capsules should be taken with adequate amounts of water, with the patient in a sitting or standing position and well before retiring at night, in order to reduce the risk of oesophageal irritation and ulceration.
A spokeswoman for Invicta, the manufacturer of Vibramycin in the UK, told The Journal on March 22 that the company was aware that doxycycline capsules had been withdrawn in France. However, there had been no indication from the UK authorities that similar action was to be taken.