MHRA issues DRUs covering gabapentin, methylprednisolone, clozapine and isotretinoin

MHRA issues DRUs covering gabapentin, methylprednisolone, clozapine and isotretinoin

October 31 2017 The medicines regulator has issued four drug safety updates (DRU) relating to...

PPIs may add to liver disease problems in people with alcohol dependency, suggests study

PPIs may add to liver disease problems in people with alcohol dependency, suggests study

October 17 2017 Protein pump inhibitors could supress stomach acid secretion to the extent it...

Pregnant women are not always informed of risks associated with sodium valproate

Pregnant women are not always informed of risks associated with sodium valproate

September 26 2017 Almost a fifth of women with epilepsy (18%) who take sodium valproate are not...

Study finds ibuprofen is linked to blood pressure rise in arthritis patients at cardiovascular risk

Study finds ibuprofen is linked to blood pressure rise in arthritis patients at cardiovascular risk

September 4 2017 Ibuprofen is associated with increased blood pressure and hypertension compared...

Steroids are not effective for chest infection, new study finds

Steroids are not effective for chest infection, new study finds

August 31 2017 Oral corticosteroids do not reduce the symptom duration or severity of acute lower...

  • MHRA issues DRUs covering gabapentin, methylprednisolone, clozapine and isotretinoin

    MHRA issues DRUs covering gabapentin, methylprednisolone, clozapine and isotretinoin

    Tuesday, 31 October 2017 20:03
  • PPIs may add to liver disease problems in people with alcohol dependency, suggests study

    PPIs may add to liver disease problems in people with alcohol dependency, suggests study

    Tuesday, 17 October 2017 14:27
  • Pregnant women are not always informed of risks associated with sodium valproate

    Pregnant women are not always informed of risks associated with sodium valproate

    Tuesday, 26 September 2017 14:14
  • Study finds ibuprofen is linked to blood pressure rise in arthritis patients at cardiovascular risk

    Study finds ibuprofen is linked to blood pressure rise in arthritis patients at cardiovascular risk

    Monday, 04 September 2017 15:12
  • Steroids are not effective for chest infection, new study finds

    Steroids are not effective for chest infection, new study finds

    Thursday, 31 August 2017 12:57

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
More inWhite Papers  

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        

Clinical News

November 21 2017 Community pharmacy is campaigning today in Westminster, to promote the role that community pharmacies can play in helping people to stay healthy through the winter.
December 7 2015 Pharmacists in Scotland have been asked to share their views on what politicians need to be made aware of ahead of the Scottish Parliament elections in 2016. The Royal Pharmaceutical Society...