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31 July 2014

Epilepsy drug Buccolam - update

Following fears of potential contamination, the pharmaceutical company Viropharma has reassured people with epilepsy that they can continue to use their supplies of the emergency medication Buccolam and do not need to return them to the pharmacy.

During a routine review of the drug company's UK production site earlier this year, the MHRA (Medicines and Healthcare Products Regulatory Agency) felt that there was a very low ‘theoretical risk of contamination’ of Buccolam by another drug at the manufacturing site. It is important to note that no contamination was found in any of the batches tested, only that there was a theoretical potential risk.

In response to this, stocks of  Buccolam oromucosal solution (a form of buccal midazolam used to treat convulsive seizures in children and adolescents) were recalled by Viropharma.  To ensure no contamination could occur, Viropharma relocated its manufacturing process to a new site that produces only Buccolam.

The recall of supplies only applies to certain batches of the drug, only to stocks held by pharmacists (not any supplies that individuals with epilepsy might have), and only as a precautionary measure. As good practice and to reassure both pharmacies and individuals with epilepsy, Viropharma has produced replacement stocks of the medication which are available to pharmacies immediately.

Viropharma stresses that no contamination has been found in any supply of Buccolam, and that this recall and replacement is a purely precautionary measure to reassure everyone that there is no risk to product quality or patient safety from using this product.

Important Information if you use Buccolam 

If you have a supply of Buccolam you do not need to return this to your pharmacy, and you can continue to use it.

Information for pharmacists

Although there has been concern expressed by some pharmacies that there are problems with replacement stocks of Buccolam, Viropharma assures us that this is not the case and that there are no problems with supplies of stock. Stocks of Buccolam are available immediately to wholesalers. Any pharmacies experiencing difficulties ordering stock from their usual wholesaler are advised to contact the distributor UDG directly, who will be able to supply them with stocks.

For more background information on this issue please visit the Health Products Regulatory Authority or the Medicines and Healthcare Products Regulatory Agency.