Misodel manufacturer warns of the dangers of increased labor frequency
The prostaglandin analog misoprostol is used in gynecology to initiate births. The finished medicinal product, called Misodel, is approved for such induction. The manufacturer of Misodel now warns in a red hand letter about the occurrence of a greatly increased contraction frequency, which may not respond to a so-called tocolysis (contraction inhibition).
The manufacturer of the drug Misodel has now announced that the drug poses a risk for the occurrence of a greatly increased labor rate, which does not respond to tocolysis. The manufacturer has now published a warning in a red hand letter about the risks of Misodel.
Experts warn of excessive uterine tachysystoles
Misoprostol is used as a so-called vaginal drug delivery system. It induces contractions in women with immature cervix from the 37th week of pregnancy, for whom induction of labor is clinically indicated. However, this process can lead to excessive uterine tachysystolias, the researchers explain.
What are tachysystoles?
The experts say what are known as tachysystoles when more than five contractions occur in ten minutes over a period of 20 minutes. It is likely that misoprostol administration in women influences the tachysystoles that occur so that they no longer respond to tocolysis. This is what doctors found when reviewing case reports from the clinical trial. Similar results were also reported shortly after the market launch.
In which cases should Misodel not be used?
In order to prevent the risks arising from Misodel during pregnancy, Misodel should not be used in some special cases, the manufacturer advises. For example, if long-term or excessive uterine contractions occur, use should not be used. If there is a generally higher risk for mother and child, the drug should also not be taken. Even if active labor has started - rhythmic, fixed contractions that are suitable for triggering cervical changes - or at least after a cervical dilation of four centimeters, the intake must be avoided, the experts explain.
After stopping Misodel, tocolytic treatment may be necessary
If Misodel is no longer used, those affected and doctors should be prepared for a so-called tocolytic treatment, which can be started immediately if necessary, the experts advise. The technical and usage information will be updated immediately, the manufacturer announced. Sufficient attention should be drawn to possible measures to adequately deal with the risk.
What does misoprostol do?
Misoprostol is a synthetically produced prostaglandin E1 analog. The drug can be administered both orally and vaginally to initiate childbirth to the expectant mother. A so-called contraction (hyperactive contractions) can manifest itself, for example, in the form of uterine tachysystolia. When taking misoprostol, hyperactive labor is more common than when taking prostaglandin, the experts say. Tachysystolias caused by misoprostol more often lead to vaginal delivery within 24 hours compared to the initiation by the drug prostaglandin E2.
Misoprostol can protect against damage to the stomach lining
Misoprostol is also often used to prevent and treat medication-related (antirheumatic, acetylsalicylic acid) gastric mucosal damage, the doctors explain. The drug was approved for this task as a single substance (Cytotec) and in a combination with diclofenac (Arthotec forte). (as)