17/04/19

Labetalol tablets – supply issue

Labetalol tablets – all strengths

DHSC has been made aware of a supply issue with the following products and as a result, supplies will be very limited from April until early-mid May.

  • Labetalol 50mg tablets
  • Labetalol 100mg tablets
  • Labetalol 200mg tablets
  • Labetalol 400mg tablets

There are two suppliers of labetalol tablets in the UK, Mylan and Recipharm:

  • Mylan have had a delay in resupply due to an internal delay in serialisation of FMD packs, further stock is expected in early-mid May.
  • Recipharm have experienced an issue with the active pharmaceutical ingredient and currently unable to provide a resupply date.

Prescribers should be aware that no new patients should be commenced on labetalol during this time as there are currently very limited stocks available.

Labetalol is indicated for the management of hypertension, particularly in pregnancy. Patients who do not have sufficient supplies to last until early May and who are unable to obtain supplies of labetalol will need to be switched to an appropriate alternative treatment during this time.

The clinical management plan for pregnant patients will be different to patients who are not pregnant.

Please see a memo developed by UK Medicines Information with input from national experts at NHSE and NHSI, which advises on management options for patients affected by this supply issue, including the use of alternative anti-hypertensives during pregnancy. This is available on the SPS website.

Suppliers of the clinical alternatives are aware of the issue. Manufacturers of both nifedipine modified release and methyldopa are confident they are able to support any additional demand on their products during this time.

Different versions of modified-release preparations may not have the same clinical effect. Prescribers should liaise with their community pharmacy to determine which brands of nifedipine modified release tablets are currently available in your area.

Suppliers of alternative beta blockers have been contacted to determine if they can meet any additional demand and currently, the manufacturers of carvedilol and metoprolol have indicated they would be unable to meet demand if patients were switched to this product. Manufacturers of bisoprolol, atenolol and propranolol have indicated they have capacity to support any additional demand on their products.

Some specialist importers have identified unlicensed stock they can bring into the UK from abroad. Lead times for these products vary between 7 and 21 days. Under the medicines legislation, doctors can prescribe unlicensed products for their patients if they think it appropriate, but do so entirely on their own responsibility.