Statement

IMI ConcePTION recommendations published on the data fields needed for pregnancy pharmacovigilance

Researchers from the Innovative Medicines Initiative (IMI) ConcePTION project have released a set of guidelines about the core data elements recommended for research on medication use during pregnancy. These guidelines cover essential variables necessary for evaluating immediate pregnancy and infant outcomes, as well as the long-term effects on children following maternal medication use during pregnancy. Each data element included in the reference framework is accompanied by a clinical definition, recommended data format, expected source, and purpose. The guidelines are available online through the ENTIS website and were initially published in Drug Safety after undergoing a peer-review process.

Paracetamol use during pregnancy

STIS supports the position statement published by ENTIS concerning paracetamol use during pregnancy.

For the full position statement, click here, 5.10.2021.

Depressed feelings during pregnancy affect baby

STIS has participated in a study published in Obstetrics & Gynecology that shows relationship between depression and negative birth outcome.

COVID-19 vaccines in pregnancy and lactation

STIS supports the position statement published by ENTIS concerning the use of COVID-19 vaccines in pregnant and lactating women. In summary, ENTIS holds the position that vaccination is the currently the most effective measure to reduce the risks associated with COVID-19 disease in pregnant women. Current safety data are reassuring, and ENTIS endorses a favourable benefit-risk ratio for COVID-19 vaccination in pregnancy. For the full position statement, click here.

Ondansetron

Concerns regarding birth defects following in-utero exposure during the first trimester of pregnancy.

Dolutegravir and risk of neural tube defects

WHO, the European Medicines Agency, the US Food and Drug Administration, and Swissmedic issue a warning about the possible risk of neural tube defects after exposure to dolutegravir (Tivicay®, Triumeq®) during early pregnancy.

A study questions the safety of pregabalin during pregnancy

Treatment with pregabalin (Lyrica® or generica) in pregnant women could put the fetus at serious risk. A study led by the STIS and published in Neurology found an increased frequency of major malformations following exposure to pregabalin during the first trimester of pregnancy.

Valproate: new measures aimed to limit exposure during pregnancy and to inform health professionals and patients

Paracetamol remains the analgesic of choice during pregnancy

Topiramate and risk of clef lip or palate

FDA issues a warning about the risk of cleft lip or cleft palate after exposure to topiramate (Topamax® and generics) during early pregnancy.

Influenza a H1N1 flu: antiviral drugs and vaccines

The Swiss Teratogen Information Service (STIS) commits itself to the follow-up of prospective exposures to antiviral treatments and the Celtura® vaccine.

Mycophenolate mofetil/mycophenolate sodium and congenital malformation

The FDA has issued an alert regarding mycophenolate mofetil (MFM, CellCept®) and mycophenolate sodium (Myfortic®) following reports on outcomes of pregnancies suggesting an increased risk of pregnancy loss and congenital malformation in association with maternal use of these drugs during pregnancy. Mycophenolate mofetil and mycophenolate sodium must be considered as associated with an increased risk of pregnancy loss and congenital malformation with regards to attitudes of prescription and information to patients.

NSAIDs and pregnancy: new elements to prefer paracetamol

Two studies suggest an increased risk of miscarriage after nonsteroidal anti-inflammatory drugs (NSAID) use during the first trimester of pregnancy. The NSAID exposure during the first trimester of pregnancy could also be related to an increased risk in congenital anomalies (specifically cardiac defects). However, this teratogenic potential remains uncertain. In practice, a benefit/risk evaluation on a case-by-case basis should always be undertaken before prescribing NSAIDs during the first trimester of pregnancy and paracetamol should, whenever possible, be used instead.

Association of lamotrigine with an increased risk of non-syndromic oral clefts

New data from the North American Antiepilectic Drug Pregnancy Registry (NAAED) suggest a possible association between exposure to lamotrigine monotherapy during the first trimester of pregnancy and cleft lip and/or cleft palate.

ACEI could be associated with an increased risk of congenital malformations

Exposure to ACEI during the first trimester of pregnancy could be associated with an increase in the risk of congenital anomalies among newborns.