BTS issues new guideline on pleural mesothelioma

BTS issues new guideline on pleural mesothelioma

February 20 2018 New British Thoracic Society guidelines on pleural mesothelioma include some key...

EMA says no new patients should be started on Esyma for uterine fibroids

EMA says no new patients should be started on Esyma for uterine fibroids

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New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

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EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

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New Drug Safety Updates issued for mycophenolate mofetil and misoprostol

New Drug Safety Updates issued for mycophenolate mofetil and misoprostol

February 9 2018 The medicines regulator has issued two Drug Safety Updates relating to...

  • BTS issues new guideline on pleural mesothelioma

    BTS issues new guideline on pleural mesothelioma

    Tuesday, 20 February 2018 17:21
  • EMA says no new patients should be started on Esyma for uterine fibroids

    EMA says no new patients should be started on Esyma for uterine fibroids

    Tuesday, 13 February 2018 12:44
  • New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

    New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

    Tuesday, 13 February 2018 12:40
  • EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

    EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

    Monday, 12 February 2018 14:44
  • New Drug Safety Updates issued for mycophenolate mofetil and misoprostol

    New Drug Safety Updates issued for mycophenolate mofetil and misoprostol

    Friday, 09 February 2018 15:24

a alert imageFebruary 9 2018

The medicines regulator has issued two Drug Safety Updates relating to mycophenolate medicines and contraception, and on the Mysodelle misoprostol vaginal delivery system.

The first relates to the use of mycophenolate mofetil and its active metabolite mycophenolic acid to prevent transplant rejection. The compounds are teratogenic and genotoxic, but clinical evidence so far does not indicate an increased risk of malformations or miscarriage in pregnancies where the father was taking mycophenolate medicines.

However, the MHRA is advising that “there is insufficient evidence to rule out any risk.” As such, it says that “as a precautionary measure for male patients, it is now recommended that either the patient or their female partner use reliable contraception during treatment with mycophenolate medicines and for at least 90 days after stopping.”

In addition, “female patients of childbearing potential receiving mycophenolate should always use contraception,” and that two forms of contraception are preferred.

The second DSU advises that women who have been given the misoprostol vaginal delivery system need to be monitored carefully, due to reports of it causing excessive uterine contractions (tachysystole) unresponsive to tocolytic treatment.

“Misoprostol (Mysodelle) vaginal delivery system is authorised for induction of labour in women with an unfavourable cervix, from 36 weeks’ gestation, in whom induction is clinically indicated,” says the DSU.

“Monitor patients closely and remove the vaginal delivery system immediately in cases of excessive or prolonged uterine contractions, at the onset of labour, or if there is clinical concern for mother or baby.”

Links:
MHRA DSU on mycophenolate mofetil, mycophenolic acid        
MHRA DSU on misoprostol       

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