Class 2 Medicines Recall: LEO Laboratories Ltd, Picato 150 mcg/g gel

See full drug alert here

LEO Laboratories Ltd (T/A LEO Pharma) is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy. The recall is a precautionary measure following the suspension of the marketing authorisation of Picato (ingenol mebutate), while investigations are ongoing.

Advice for healthcare professionals

• Stop supplying the above products immediately. Quarantine all remaining stock and return it to your supplier using your supplier's approved process.

• Stop prescribing Picato and consider other treatment options as appropriate. For patients who have recently been prescribed Picato, advise patients to be vigilant for any skin lesions developing and to seek medical advice promptly should any occur.

Magnesium Hydroxide Mixture Shortage

Due to difficulties obtaining raw materials, there are currently no stocks of magnesium hydroxide mixture. The earliest anticipated return date is Feb 2020. Alternative laxatives will be required in the interim (lactulose and macrogol being alternative osmotic laxatives). 

03/12/2019 - We are now in Flu Season 

Surveillance data indicates an increase in influenza cases in the community. Prescribers may now prescribe and pharmacists may now supply antiviral medicines for the prophylaxis and treatment of influenza at NHS expense.  

Please see here for further information 

Shortages update - 28th October

Opicapone 50mg capsules will be out of stock from mid-November to mid-January 2020 - see CAS alert for details.

Fluoxetine 10mg capsules are now available therefore the SSP has been withdrawn.  The SSPs for 30mg and 40mg capsules are still in place.

Paroxetine oral solution is out of stock from the end of October to January 2020.  Unlicensed imports are available; the tablets can also be crushed and mixed with water (note this is off-label and the tablets are bitter with slight local anaesthetic effects).

Nifedipine 5mg and 10mg capsules

Adalat brand was discontinued earlier in the year.

Generic brand is now available from Relonchem

16th October - Ranitidine supply issue 

• All oral formulations of ranitidine are anticipated to be out of stock, with no date for resupply until further notice.

• An investigation by the Swiss and German regulatory agencies and the US Food and Drug Administration (FDA), has identified a contaminant, N-nitrosodimethylamine (NDMA), in samples of ranitidine active substance.

• All stock manufactured for the UK using the affected ranitidine active substance has been quarantined, whilst Medicines and Healthcare products Regulatory Agency (MHRA) investigations are ongoing.
• Although all oral formulations are expected to be out of stock, very limited supplies of unaffected oral ranitidine products may remain available and should be reserved for those patients in whom alternatives are not clinically appropriate.
• All other patients should be reviewed as repeat prescriptions are requested, and if ongoing treatment is required, be switched to clinical alternatives.
• Please see the CAS alert for details about actions required and alternatives