Lancet study rates 21 antidepressants for acute use in major depressive disorder

Lancet study rates 21 antidepressants for acute use in major depressive disorder

February 23 2018 A meta-analysis of data on 21 antidepressants has concluded that all are more...

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

February 13 2018 Doctors should not initiate Esyma (ulipristal acetate) in women with uterine...

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

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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

February 12 2018 The European Medicines Agency has updated advice regarding the use of retinoids...

New Drug Safety Update issued on need for contraception with mycophenolate mofetil

New Drug Safety Update issued on need for contraception with mycophenolate mofetil

February 9 2018 The medicines regulator has issued a Drug Safety Update relating to mycophenolate...

  • Lancet study rates 21 antidepressants for acute use in major depressive disorder

    Lancet study rates 21 antidepressants for acute use in major depressive disorder

    Friday, 23 February 2018 10:03
  • 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 12:18
  • 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 12:11
  • 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 14:21
  • New Drug Safety Update issued on need for contraception with mycophenolate mofetil

    New Drug Safety Update issued on need for contraception with mycophenolate mofetil

    Friday, 09 February 2018 15:01

Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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a alert imageOctober 31 2017

The medicines regulator has issued four drug safety updates (DRU) relating to gabapentin methylprednisolone clozapine isotretinoin.

The MHRA’s warning on gabapentin says the people taking the drug, used in epilepsy and peripheral neuropathic pain, have “a rare risk of severe respiratory depression even without concomitant opioid medicines.” Dose adjustments may be necessary in a number of patient groups: those with compromised respiratory function; respiratory or neurological disease; renal impairment; concomitant use of central nervous system (CNS) depressants; and the elderly.

The warning around methylprednisolone relates to Solu-Medrone 40mg injection. This strength uses lactose produced from cows’ milk as an excipient and may contain trace amounts of milk proteins.

“Do not use injectable methylprednisolone medicines that contain lactose in patients with a known or suspected allergy to cows’ milk,” says the DSU. “If a patient’s symptoms worsen or any new allergic symptoms occur, allergic reaction to cows’ milk proteins should be suspected; stop administration of the product and treat the patient’s condition accordingly.”

Constipation occurring with clozapine needs to be monitored, says the third DSU. The antipsychotic has been associated with varying degrees of impairment of intestinal peristalsis, ranging from “constipation, which is very common, to very rare intestinal obstruction, faecal impaction, and paralytic ileus.”

Particular care is needed in patients who taking other drugs known to cause constipation, in patients with a history of colonic disease or lower abdominal surgery, or in patients aged 60 years and older. Clozapine should not be used in patients with paralytic ileus.

Patients who develop constipation should report it immediately, and health professionals should “actively treat any constipation that occurs.”

The isotretinoin DSU advises that there have been some reports of sexual dysfunction, especially erectile dysfunction and loss of libido, in patients taking oral isotretinoin for severe acne. “The exact incidence of these adverse reactions is unknown but considering the number of patients in the UK taking the medicine, reports are understood to be rare,” says the MHRA.

For all drugs, the MHR is asking that any suspected adverse reactions be reported using eth Yellow Card scheme.

Links:
MHRA DSU on gabapentin           
MHRA DSU on methylprednisolone          
MHRA DSU on clozapine                 
MHRA DSU on isotretinoin             
Yellow Card scheme        

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