Class 2 Medicines Recall: Esmya 5mg tablets, EU/1/12/750/001-5, (EL(20)A/16)

See full drug alert here

Gedeon Richter (UK) Ltd is recalling all unexpired stock of Esmya 5 mg tablets from patients, pharmacies and wholesalers following a new case of liver failure requiring liver transplant in a patient taking the medicine.

Advice for healthcare professionals

Contact patients who have been supplied Esmya and ask them to stop taking their medication as soon as possible and return any unused medicine to their pharmacy. All patients currently being treated with Esmya/ulipristal acetate for uterine fibroids should contact their doctor for advice about other possible treatments for uterine fibroids.

Stop supplying the above products immediately and remove from the shelves within your store. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Stop prescribing Esmya or generic ulipristal acetate for the treatment of uterine fibroids. No new patients should start treatment with the medicines, which has been suspended throughout the EU during the review. Consider other treatment options as appropriate.

Liver function testing should be performed 2- 4 weeks after treatment has stopped as described in the product information for the medicines.

Healthcare professionals should alert patients to immediately report signs and symptoms of liver injury (such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia, jaundice) which could occur after stopping treatment.

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

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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