GI system MHRA alerts

Question 1

What are the key points from the stimulant laxatives MHRA alert?

Answer 1

• only use stimulant laxatices if others are unsuitable
• not for children under 12 unless advice from a prescriber
• new restrictions on pack sizes

Question 2

What are the new GSL pack size and age restrictions associated with stimulant laxatives?

Answer 2

• large packs no longer available for GSL
• GSL pack size (two short treatment courses) - up to 20 standard strength, 20 max strength or 100ml of syrup
• GSL age restriction is 18+

Question 3

What is the P pack size and age restrictions associated with stimulant laxatives?

Answer 3

• P age restriction: 12+
• pharmacies can still have pack sizes of up to 100 for sale in children over 12 years under the supervision of a pharmacist

Question 4

Loperamide can be associated with which type of serious adverse reactions?

Answer 4

• reports of serious cardiac adverse reactions with high doses of loperamide associated with abuse or misuse
• naloxone can be given as an antidote
• loperamide duration is longer than naloxone so repeated doses may be needed, monitor for 48hours for signs of CNS depression

Question 5

PPI’s are associated with a type of skin-conditions. What is this skin condition and what advice would you give?

Answer 5

• very low risk of subacute cutaneous lupus erythematosus (can occur after weeks, months or years after exposure to drug)
• if a patient treated with a PPI develops lesions – especially in sun-exposed areas of the skin and it is accompanied by the arthralgia:
• Advise them to avoid exposing the skin to sunlight
• Discontinue PPI unless it is imperative
• The risk may be the same for other PPIS

Symptoms usually disappear on withdrawal but topical or systemic steroids might be necessary if no signs of remission after a few weeks or months.

Question 6

Hysocine butylbromide injection (Buscopan) carries a serious risk of which adverse affects? 2 cardiac and 1 anaphylaxis

Answer 6

• injection can cause serious adverse effects including tachycardia, hypotension, and anaphylaxis
• this can be fatal in patients with underlying cardiac disease
• use with caution in these patients, ensure appropriate monitoring and resus equipment
• CONTRAINDICATED IN TACHYCARDIA

Question 7

Obeticholic acid (Ocaliva) is associated with injury of which main organ system?

Answer 7

• risk of serious liver injury in patients with pre-existing moderate or severe hepatic impairment
• adjust dosing according to liver function monitoring

Question 8

What is obeticholic acid usually used for?

Answer 8

Primary biliary cholangitis in combination with ursodeoxycholic acid when response to ursodeoxycholic acid has been inadequate or if patients intolerant to ursodeoxycholic acid