October 4, 2016

No Reproductive Safety Signal Raised by Immunosuppressant Use in Fathers

By Jenny Powers

VIENNA, Austria -- October 4, 2016 -- A large data analysis revealed that paternal exposure to azathioprine, cyclosporine or methotrexate for chronic inflammatory diseases prior to conception is not linked to congenital abnormalities, low birth weight, or premature birth in newborns, according to a study presented here at the 25th European Academy of Dermatology and Venereology (EADV) Congress.

However, risk may be affected by paternal use of cyclosporine within 3 months of conception, reported Alexander Egeberg, MD, Copenhagen University Hospital Gentofte, Helleaek, Denmark.

“Nearly half or 45% of pregnancies are unplanned,” said Dr. Egeberg. “Data on the reproductive safety of immunosuppressant drugs regarding parental use are scarce and yield conflicting results.”

The researchers reviewed records of all 31,238 children born between January 1, 2004, and December 31, 2010, in Denmark having available information of the biological father contained in the population-based Danish Birth Registry.

The study included all fathers that had claimed a prescription for azathioprine, cyclosporine or methotrexate at any time before conception and controls were fathers who had not claimed these prescriptions.

The relative risk of congenital abnormalities, low birth weight, and premature birth in fathers using immunosuppressant therapy compared with no paternal use prior to conception was assessed by logistic regression analyses that were adjusted for maternal age, parity, maternal smoking, and gender of the child.

Prescriptions for azathioprine were claimed by 1,246 fathers, cyclosporine by 141 fathers, and methotrexate by 848 fathers prior to conception.

The analysis evaluated the possible risk of immunosuppressant use by the fathers of the 634 children born prematurely or with congenital abnormalities or low birth weight.

“Paternal use of azathioprine, cyclosporine, and methotrexate prior to conception appears to be safe,” said Dr. Egeberg.

Paternal exposure (ever) to cyclosporine was not associated with risk of congenital abnormalities or premature birth, but a non-significant trend of increased risk for low birth weight was observed (adjusted odds ratio [OR], 1.62).

Use of cyclosporine within the 3 months prior to conception was associated with an increased risk of congenital abnormalities. Of 18 fathers claiming prescriptions for cyclosporine, 4 (22.2%) fathers had children with congenital abnormalities (adjusted OR, 3.68).

Parental use of methotrexate was not associated with increased risk save for a discrete non-significant trend towards premature birth that was observed with an increasing number of methotrexate prescriptions.

“Our data indicate no risk for the paternal risk of azathioprine or methotrexate, but the risk of congenital abnormalities may be affected by use of cyclosporine within 3 months of conception,” said Dr. Egeberg.

[Presentation title: Outcomes in Children Fathered by Men Treated With Immunosuppressant Drugs Before Conception. Abstract D3T01.1A]

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