Oral mesalazine microgranules `safe' during pregnancy

Reactions 731 - 12 Dec 1998

Oral mesalazine microgranules‘safe’ during pregnancy

The use of oral mesalazine microgranules [‘Pentasa’]at dosages of ≤ 2 g/day ‘is probably as safe assulphasalazine during pregnancy’, say Professor PhilippeMarteau and colleagues from France. They add that theirfindings are also reassuring for dosages ≥ 3 g/day givenduring pregnancy.

The researchers investigated pregnancy and fetaloutcomes of 123 pregnancies in which women weretaking 1–4 g/day of mesalazine microgranules forinflammatory bowel disease. 96 women receivedmesalazine during the first trimester, 85 during thesecond trimester, and 83 during the third trimester ofpregnancy. 37 women took ≥ 3 g/day of mesalazine(high-dose group) and 86 received < 3 g/day (low-dosegroup).

The study findings showed that mesalazine at dosagesof < 3 g/day during pregnancy did not influencepregnancy outcomes, and that dosages of 3 g/day didnot increase the risk of fetal malformations. Suchmalformations occurred in 4/126 (3.1%) fetuses. Thispercentage is similar to that observed in the generalpopulation in France (1.7–3.4%), say Dr Marteau andcolleagues.

Despite their reassuring findings, the researchers saythat further information on high doses of mesalazineduring pregnancy is needed as it is currently uncertainwhether high blood concentrations of the agentconstitute a risk for the fetal kidneys. They suggest thatat the present time, alternative treatments are preferredover high doses of mesalazine during pregnancy.However, if high doses of the agent are used, theyrecommend that the echogenicity of fetal kidneysshould be regularly monitored.Marteau P, et al. Foetal outcome in women with inflammatory bowel diseasetreated during pregnancy with oral mesalazine microgranules. AlimentaryPharmacology and Therapeutics 12: 1101-1108, Nov 1998 800727044

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Reactions 12 Dec 1998 No. 7310114-9954/10/0731-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved