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 as sulphasalazine during pregnancy’, say Professor Philippe Marteau and colleagues from France. They add that their findings are also reassuring for dosages ≥ 3 g/day given during pregnancy. The researchers investigated pregnancy and fetal outcomes of 123 pregnancies in which women were taking 1–4 g/day of mesalazine microgranules for inflammatory bowel disease. 96 women received mesalazine during the first trimester, 85 during the second trimester, and 83 during the third trimester of pregnancy. 37 women took ≥ 3 g/day of mesalazine (high-dose group) and 86 received < 3 g/day (low-dose group). The study findings showed that mesalazine at dosages of < 3 g/day during pregnancy did not influence pregnancy outcomes, and that dosages of 3 g/day did not increase the risk of fetal malformations. Such malformations occurred in 4/126 (3.1%) fetuses. This percentage is similar to that observed in the general population in France (1.7–3.4%), say Dr Marteau and colleagues. Despite their reassuring findings, the researchers say that further information on high doses of mesalazine during pregnancy is needed as it is currently uncertain whether high blood concentrations of the agent constitute a risk for the fetal kidneys. They suggest that at the present time, alternative treatments are preferred over high doses of mesalazine during pregnancy. However, if high doses of the agent are used, they recommend that the echogenicity of fetal kidneys should be regularly monitored. Marteau P, et al. Foetal outcome in women with inflammatory bowel disease treated during pregnancy with oral mesalazine microgranules. Alimentary Pharmacology and Therapeutics 12: 1101-1108, Nov 1998 800727044 1 Reactions 12 Dec 1998 No. 731 0114-9954/10/0731-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Oral mesalazine microgranules `safe' during pregnancy

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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