On Friday, The Food And Drug Administration Approved A Drug Called Makena -- Which Reduces The Risk Of Preterm Birth In At-Risk Women. Keep Reading For Details.
On Friday, the Food and Drug Administration approved a drug called Makena -- which reduces the risk of preterm birth in at-risk women. Keep reading for details.
On Friday, the Food and Drug Administration approved a drug called Makena -- which reduces the risk of preterm birth in at-risk women. Specific info about Makena:
- Makena is an injectable drug
- It was designed to reduce the risk of preterm delivery in at risk women -- women who have had at least one spontaneous preterm birth
- Not intended for use in women who are carrying multiples
- Administered as a once-weekly injection into an expectant mom's hip
- Treatment begins at 16 weeks (and no later than 21 weeks)
- Most common side effects: swelling, pain or itching at injection site; nausea; hives; diarrhea
- Uncommon but serious adverse reactions: one report of a pulmonary embolism (blood clot in the lungs) and one report of an infection at the injection site
The FDA approved Makena under the agency’s accelerated approval regulations that allow promising drugs to be approved based on a surrogate endpoint benefit (here, reducing the risk of delivery before 37 weeks of pregnancy) that is reasonably likely to predict a clinical benefit. Under these regulations, the manufacturer must conduct additional studies after the product is approved to demonstrate that the drug does, in fact, have a clinical benefit. An international trial is ongoing to learn if there is also improvement in the outcome of babies born to women given Makena. Such outcomes include reducing the number of babies who do not survive or who suffer serious health problems shortly after birth.If you would like to read the full press release, please visit the FDA's press announcement for Makena. If you have had (or theoretically, if you did have) a preterm birth, would you use Makena for a future pregnancy?