Power-Alley: If You Are A Male And A Type-II Diabetic, And Trying To Have Children... Talk To Your Doctor.

[In yet another narrative arc spanning over a decade here, back in early November 2010, I noted a Merck stock price decline occasioned by the lunch-time FDA approval of Bristol-Myers-Squibb and AstraZeneca's Kombiglyze^® XR, which was approved by FDA for Type II diabetes. That novel combination is an extended-release version of the metformin diabetes drug (also in Merck's Janumet^®) with the companies’ Onglyza^® (Saxagliptin). Onglyza was, in turn, cleared for U.S. sales in July 2010. Kombiglyze was then approved by the FDA to treat patients with Type II diabetes.

By the end of 2012, Merck had secured an approval for a competing once-a-day regimen for Type II diabetes. Both combinations contain metformin. And to be fair, so do a wide array of ensuing competitors, as the updated graphic at right indicates. There were (in the ensuing years) other off-target effects noted in some studies, but nothing of this magnitude, below. More backgrounders, here, and here.]

Now over a decade later, we are learning that if a man/hopeful father is taking a metformin-containing diabetes medication directly around, or at the time of conception, the couple's child has an elevated risk of certain birth defects. This latest post-hoc analysis found a 40 per cent elevated risk -- but only if the father was actively taking metformin right around time of conception.

So, if you know you take a metformin-containing medication for your diabetes, and you are planning to start a family, talk to your doctor, first. A medication switch is likely advisable. Here's the latest -- quite somber -- warning:

. . .A large cohort study found that babies born to men who took metformin during the period of sperm development were at increased risk for birth defects, specifically genital defects in boys. These finding suggest that men with diabetes who are taking metformin should talk to their doctors about whether they should switch to another treatment when trying to conceive a child. . . .

Babies whose fathers took metformin had an increased risk for birth defects. There were too few babies whose fathers took sulfonylureas to determine risks for birth defects with any certainty. Taking metformin before or after sperm development did not increase the risk for birth defects. Unexposed siblings were also not at increased risk.

According to the authors, the size of the diabetes pandemic suggests that treatment of prospective fathers with diabetes, including pharmacologic management and counseling on diet, physical exercise, and weight loss, should be subject to further study. . . .

Sadly, Type II diabetes is -- in the last half-century, in the US -- a far more commonly-seen disease, at younger age in men, due in no small part to decreased exercise, and less rigorously healthy diets. So, the burden of this potential birth defect could reach epidemic proportions, if family-bearing age couples are not made aware, promptly. So, to check in on your friends with Type II diabetes, that may be contemplating having kids.

When you know better, you do better.

नमस्ते