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

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

April 23 2018 Buprenorphine has been found to have lower rates of overdose death than methadone...

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

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

March 29 2018 A study has shown that dipeptidylpeptidase-4 inhibitors may increase the risk of...

Cochrane review indicates mefloquine is safe in pregnancy, but adverse effects are a barrier to use

Cochrane review indicates mefloquine is safe in pregnancy, but adverse effects are a barrier to use

March 29 2018 Mefloquine is safe to use for malaria prevention during pregnancy, a Cochrane...

Anti-epilepsy drugs exposure in womb associated with poor school performance years later

Anti-epilepsy drugs exposure in womb associated with poor school performance years later

March 27 2018 Exposure to anti-epilepsy drugs in the womb has been linked to significantly poorer...

COPD flare-ups may only need 5 days of systemic steroids

COPD flare-ups may only need 5 days of systemic steroids

March 26 2018 A new study has suggested that shorter doses of systemic corticosteroids may be as...

  • 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
  • Cochrane review indicates mefloquine is safe in pregnancy, but adverse effects are a barrier to use

    Cochrane review indicates mefloquine is safe in pregnancy, but adverse effects are a barrier to use

    Thursday, 29 March 2018 11:46
  • Anti-epilepsy drugs exposure in womb associated with poor school performance years later

    Anti-epilepsy drugs exposure in womb associated with poor school performance years later

    Tuesday, 27 March 2018 10:08
  • COPD flare-ups may only need 5 days of systemic steroids

    COPD flare-ups may only need 5 days of systemic steroids

    Monday, 26 March 2018 12:53

a dispensary shelves imageDecember 19 2017

The MHRA’s latest Drug Safety Update includes information about two black triangle drugs, eluxadoline and fingolimod.

The MHRA says there have been a number of reports of pancreatitis in people taking eluxadoline (Truberzi), used in treating irritable bowel syndrome with diarrhoea (IBS-D). This has led to people being admitted to hospital and has also been implicated in some deaths, primarily in people who have undergone a cholecystectomy.

The MHRA is advising that:

  • eluxadoline should only be initiated by specialists;
  • eluxadoline should not be used in patients without a gallbladder or where there is a known or suspected biliary tree or pancreatic duct obstruction;
  • patients should avoid consuming alcohol;
  • patients should be advised about symptoms which could indicate pancreatitis, so they can quickly access appropriate help.

Fingolimod (Gilenya) is indicated for use in certain patient groups with highly active relapsing remitting multiple sclerosis. Two Drug Safety Updates relating to fingolimod have been issued, the first relating to the drug having the potential to cause persistent bradycardia, increasing the risk of serious cardiac arrhythmias.

The DUS warns that fingolimod can cause serious ventricular arrhythmias, particularly in the first year of use. In addition, the drug is now contraindicated in:

  • myocardial infarction or unstable angina;
  • cerebrovascular disease;
  • certain categories of heart failure;
  • certain categories of severe cardiac arrhythmias;
  • certain types of atrioventricular (AV) block or sick‐sinus syndrome;
  • pre-treatment QT intervals ≥500 milliseconds.

The second DSU advisory for fingolimod relates to its immunosuppressant activity, its potential to increase the risk of skin cancers, lymphoma and serious opportunistic infections. Patients should be monitored closely for skin cancers, and should be advised to seek urgent attention if they develop signs or symptoms of serious infections, says the DSU. Patients should also avoid exposure to UV light, including sunlight and phototherapy.

In all cases of suspected adverse reactions to the drugs, the MHRA is asking that any suspected adverse reactions be reported via the Yellow Card scheme.

Links:
MHRA eluxadoline DSU                   
MHRA fingolimod cardio effects DSU 
MHRA fingolimod immunosuppressant activity DSU         
MHRA Drug Safety Update. December 2017. Vol. 11; issue 5                 

Clinical News

April 23 2018 A pilot scheme is highlighting anticipated waiting times for a hospital referral, using an ‘e-traffic light’ system. When a GP is wanting to make the referral, a green light on the...
April 23 2018 Buprenorphine has been found to have lower rates of overdose death than methadone when used in opioid substitute therapy. The impact was particularly seen in the first four weeks of...