(RxWiki News) The insulin drug Levemir, whose generic name is detemir, has been moved from a riskier category of medications for pregnant women to a less risky category by the FDA.
Levemir was initially approved by the FDA in 2005 for use by diabetics to help control their glycemic levels. Though previously listed as a "Category C" medication, reported Medscape on April 2, the FDA's updated drug label now lists Levemir as a "Category B" medication for pregnancy.
"Talk to your doctor about safe drugs to take while pregnant."
The FDA has five categories to classify the relative safety of taking a drug during pregnancy. Category C is the middle risk category, including drugs for which animals studies "have shown an adverse effect on the fetus" but for which "there are no adequate and well-controlled studies in humans."
Category C medications are often given to women if a caregiver determines that the potential benefits of taking the drug are enough to take the risk of the unknown. This is where Levemir had previously been listed.
It is now listed in Category B, in which animals studies "have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women." Because of medical ethics concerns, it is often difficult to adequately conduct clinical trials for medications in pregnant women.
Categories D and X include drugs which have been shown to cause birth defects, but Category C is a medium risk group.
Category A includes drugs for which "adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy" as well as later trimesters.
According to the FDA's Levemir drug label, hyperglycemia, or increased blood sugar levels, can increase the risk of birth defects, miscarriage or other complications for pregnant women.
In a controlled clinical trial of 310 pregnant women who had type 1 diabetes, the women who took Levemir did not have children with a higher rate of birth defects.
The women who participated in the study were in their first trimester of pregnancy. Half took Levemir once or twice daily, and the other half took NPH insulin once, twice or three times a day.
There were slightly more cases of pre-eclampsia in the group that took Levemir - 10.5 percent compared to 7 percent - but women with diabetes are at a higher risk for pre-eclampsia, and these numbers were within the expected ranges. The researchers could not determine whether the higher rate of pre-eclampsia was related to Levemir.
Fewer than 5 percent of the women taking Levemir experienced side effects. The most commonly reported side effects were headache and getting a cold.
Other adverse events reported in both groups included anemia, diarrhea, urinary tract infections, gastroenteritis, upper abdominal pain and vomiting; the percentages were slightly higher for each of these in the Levemir group over the insulin group.
No difference in blood pressure rates between the two groups were reported, and an approximately similar number of miscarriages occurred in both groups (6.6 percent and 5.1 percent).