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  • MPS advises of need for better awareness of cauda equina red flag symptoms

    MPS advises of need for better awareness of cauda equina red flag symptoms

    Wednesday, 09 May 2018 16:01
  • Anticholinergics linked to increased risk of dementia

    Anticholinergics linked to increased risk of dementia

    Monday, 30 April 2018 12:20
  • Women of childbearing potential must be on Pregnancy Prevention Programme if taking valproate

    Women of childbearing potential must be on Pregnancy Prevention Programme if taking valproate

    Friday, 27 April 2018 12:12
  • Buprenorphine may be safer than methadone in opioid substitute therapy, study suggests

    Buprenorphine may be safer than methadone in opioid substitute therapy, study suggests

    Monday, 23 April 2018 16:59
  • Class of diabetes drug linked to increased risk of irritable bowel disease

    Class of diabetes drug linked to increased risk of irritable bowel disease

    Thursday, 29 March 2018 11:49

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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