Manufacturer warns Misoprostol can cause a greatly increased labor frequency

Manufacturer of Misodel warns of the dangers of increased labor frequency

The prostaglandin analogue misoprostol is used in gynecology to induce births. For such a birth induction, the finished medicinal product called Misodel is approved. The manufacturer of Misodel now warns in a red-hand letter before the occurrence of a greatly increased labor frequency, which may not respond to a so-called tocolysis (labor-inhibition).

Misodel, the drug manufacturer, has now announced that the drug is at risk of developing a high incidence of labor that does not respond to tocolysis. The manufacturer now issued a warning in a red-hand letter on the risks of Misodel.

To initiate a birth, for example, a drug called Misodel can be used. The manufacturer of the drug now warns of the potential dangers of the occurrence of a greatly increased labor frequency after ingestion. (Image: Sondem / fotolia.com)

Experts warn against excessive uterine tachyystolias

Misoprostol is used as a so-called vaginal drug delivery system. It initiates labor in women with immature cervix from the 37th week of pregnancy, where induction of labor is clinically indicated. However, this process can lead to excessive uterine tachyystolias, explain the researchers.

What are tachyystolias?

Tachy-systoles are referred to as having more than five contractions in ten minutes over a 20-minute period, say the experts. It is likely that a misoprostol dose in women influences the occurring tachy-systoles so that they no longer respond to tocolysis. This was noted by physicians when reviewing case reports from the clinical trial. In addition, similar results were reported shortly after launch.

In which cases Misodel should not be used?

In order to prevent the risks arising from Misodel during pregnancy, Misodel should not be used in some special cases, advises the manufacturer. For example, if long-lasting or excessive uterine contractions occur, use should be avoided. If there is a general risk to mother and child, the drug should not be taken either. Even if an active labor has begun - rhythmic, firm contractions, which are likely to trigger cervical changes - or at least with a cervical dilatation of four centimeters, the intake must be avoided, explain the experts.

After discontinuing Misodel, a tocolytic treatment may be necessary

If Misodel is no longer taken, sufferers and physicians should be prepared for a so-called tocolytic treatment, which can be started immediately if necessary, advise the experts. The technical and usage information is updated immediately, the manufacturer said. Thus, sufficient attention should be drawn to possible measures for dealing adequately with the risk.

What causes misoprostol??

Misoprostol is a synthetically produced prostaglandin E1 analogue. The drug can be administered both orally and vaginally to induce delivery to the expectant mother. A so-called labor storm (hyperactive labor activity) can manifest itself, for example, in the form of uterine tachyystolias. When taking misoprostol, hyperactive labor is more common than when taking prostaglandin, say the experts. Misoprostol-induced tachy-systoles are more likely to result in vaginal delivery within 24 hours compared to initiation by the prostaglandin E2 drug.

Misoprostol can protect against gastric mucosal damage

Misoprostol is also commonly used for the prevention and treatment of drug-related (anti-inflammatory drugs, acetylsalicylic acid) gastric mucosal damage, explain the doctors. The drug is approved for this task as a single substance (Cytotec) and in combination with diclofenac (Arthotec forte). (As)