1) How long has doxycycline monohydrate been marketed in Sweden?/n2) What dosage forms of doxycycli

Fråga: 1) How long has doxycycline monohydrate been marketed in Sweden?

2) What dosage forms of doxycycline monohydrate are available in Sweden?

3) Are there any ADR reports of oesophagitis/oesophageal ulcerations associated with doxycycline monohydrate in Sweden?

4) What is the total number of ADR reports on oesophagitis/oesophageal ulcerations associated with other doxycycline formulations (hyclate injection and others excluding monohydrate) in Sweden and globally?

Sammanfattning: Based on sales and ADR´s, more reports were found with doxycyline hydrochloride than with doxycycline monohydrate concerning gastrointestinal complications such as oesophagitis/oesophageal ulcerations in Sweden.

Svar: The following doxycycline monohydrate speciality is registered in Sweden: Doxyferm tablets 100 mg, registered March 19, 1993.

Two other doxycycline monohydrate specialities have been registered but recently withdrawn from the market on the manufacturers own request, probably due to low sales: Doxycyclin Enapharm tablets 100 mg, registered May 22, 1995, withdrawn December 31, 1996 and Idocyklin tablets 100 mg, registered November 12, 1976, withdrawn November 30, 1996.

ADR reports in Sweden from 1972 to 1997: In all, there are 505 reports associated with doxycycline treatment. Of these, 112 reports concerned the gastrointestinal system, 20 concerned oesophageal ulcerations and 19 concerned oesophagitis.

Only five of the 20 reports of oesophageal ulceration appeared during treatment with doxycycline monohydrate, and all five were during the years 1978 to 1982. The other 15 reports concerned treatment with doxycycline hydrochloride or carragenate.

Only four of the 19 reports of oesophagitis appeared during treatment with doxycycline monohydrate, and all four were during the years 1981 to 1982. The other 15 reports concerned treatment with doxycycline hydrochloride or carragenate.

The adverse effect profile, in Sweden, of doxycycline monohydrate covers only 60 reports during 1972 to 1997. This figure could be compared with doxycycline carragenate (247 reports), doxycycline hydrochloride (199 reports) during the same period (1).

Enclosed are the Swedish sales figures for doxycycline monohydrate and doxycycline hydrochloride (2).

The WHO center located in Uppsala, Sweden (3), has received 308 reports of oesophageal ulcerations and 260 reports of oesophagitis in connection to treatment with doxycycline. However, in these reports it is impossible to clarify which salt of doxycycline has been used. 1 SADRAC, Swedish Adverse Drug Reactions Advisory Committee 2 Swedis 3 WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden