UK MHRA Drug Safety Update (Volume 8, Issue 4)

Drug safety advice

• Agomelatine (Valdoxan): risk of liver toxicity—reminder to test liver function before and during treatment

Agomelatine (Valdoxan) may cause liver toxicity in some people. Test liver function before and during treatment.

 

• Colobreathe (colistimethate sodium dry powder for inhalation): risk of capsule breakage—new instructions for use

We have received reports of Colobreathe (colistimethate sodium) capsules shattering when pierced by their inhaler device. The instructions for inhaler use have been revised to reduce this risk.

 

 

Stop Press

• Boceprevir (Victrelis) and telaprevir (Incivo): baseline predictive factors for sepsis, worsening liver function, and mortality

Boceprevir and telaprevir are not recommended for patients who have a low platelet count or hypoalbuminaemia before starting either of these medicines. Boceprevir is also not recommended for patients who have coagulopathy before starting it.

 

• Ponatinib (Iclusig▼): risk of vascular occlusive events

An in-depth EU review of this risk has now been completed.

 

• Chlorhexidine solutions: reminder of the risk of chemical burns in premature infants

Use the minimum amount of chlorhexidine solution required and do not allow the solution to pool. Remove any excess solution and any soaked materials, drapes, or gowns from the skin.

 

• Desiccants in blister packs: reminder of risk of ingestion

Take care to tell people receiving blister packs containing a desiccant that the desiccant should not be swallowed.

 

 

Other information from the MHRA

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