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From North Carolina, USA:

My wife is 30 years old and we just learned that we have lost our first baby. She had been prescribed to use Humalog by an endocrinologist seven days ago. The first vial of Humalog was given to use without the vial warnings, as it was prescribed one would think it would be safe to use.

We have since read the warnings and see that under the pregnancy section the following comment "Humalog has not been tested in pregnant or nursing women." Do you know of any other cases of this untested insulin being used by pregnant women? This would be helpful in trying to help us cope with the lost of our child, and understand what happened.

My wife has not had a DNC yet, but we will ask our OB to try and see if the cause of death can be associated with Humalog. The baby was visible at 6.5 weeks, and had a normal heart beat. Now a week later only the sac can be seen by ultrasound, and to my knowledge no heartbeat.

My wife has been diagnosed for 2 years with diabetes. She was fighting to keep her blood sugars below 140, hence the referral by her OB to a endocrinologists. I realize this is a specific incident, but if you could provide any other references to see if this problem has occurred before or such an error has been made in prescribing untested drugs I would be grateful.


I am sorry about your loss. Unfortunately, miscarriages are common. Probably half of all conceptions are lost, but most happen so early that a woman may not even know she was pregnant. Knowing this probably will not make your situation any easier, but perhaps give you some understanding of problems in reproduction.

It is difficult to say if lispro insulin [Humalog®] contributed to the miscarriage. Lilly does not recommend the use of Lispro in pregnancy. There has been some case reports of fetal abnormalities in mothers using Lispro, but this has not been substantiated by any studies at this time. My guess is that Lispro did not have anything to do with your wife's miscarriage. However, if you try to conceive again, I would suggest switching to Regular insulin prior to conception and during the first 9-10 weeks of pregnancy.


Original posting 21 Feb 1998
Posted to Family Planning and Insulin Analogs


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