I have actualyl read the Danish study that started all the controversy over the 6-mp and male fertility debate. The study focused on men who had been taking the drug for at least nine months, and had had a pregnancy withing nine months of the drug. Out of the 26,000 pregnancies during the trial period, only 54 males met the criteria (took 6-mp, had a pregnancy, and took the drug close to the conception date). The study showed that 4 of these preganancies had abnormalities, which is a rate of 7.4%. The average of the remaining 26,000 pregnancies of males who were NOT on 6-mp was around 4%, so they thought they had a higher rate, therefore caution was expressed.
Here are some criticisms of the study:
1) Of the four males, none were auto-immune disease patients. Three were organ tranplant recipients, and the fourth had a rare form of luekemia. There is no telling really what other medications they were on or what complications they had.
2) This is entirely too small of a number to judge anything on. For what was supposed to be a wide spread test, only 54 viable subjects were found. If there had been one more abnormality, then it would have been more than twice the average, one less abnormality, then it's the same as the population.
3) The time periods of what dosage and how long they were taking that dosage was never clearely defined. Was one man taking it for five years, another just one? These distinctions weren't made.
In all, I think the study has fallen by the wayside, but when a Pharm Rep goes to see a dr. with a new expensive biologic to help crohns patients, they might still use this study to bash the cheaper drugs like 6-mp. Some doctors will listen. My last gi was against it, by new gi is not, and now I'm getting better. I hope this helps. I'm young and married, and we hope to have kids in the next three to four years, and after what I've studied, I'm not too worried about
I am a pre-30yr. old who has been diagnosed with Crohn's for 14 years. Symptoms change from cramping and weight loss to severe anemia with fatigue and diarrhea.
100mg mecaptopurine, 40mg Prednisone, Darvocet for dessert. Starting Cimzia this week (fingers crossed).