- Prescribing Advice for GPs - https://www.prescriber.org.uk -

Drug Safety Update - August 2011

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2011 (PDF).

This issue contains drug safety information advising clinicians of the updated warnings and contraindications for pioglitazone after a review was conducted to review an increased risk of bladder cancer. Clinicians are also advised that the product licence for celecoxib (Onsenal®) has been voluntarily withdrawn after a trial that aimed to evaluate the drugs benefits in familial adenomatous polyposis failed to recruit sufficient patient numbers. Clinicians are reminded that celecoxib should not be used for this indication because the benefit has not been sufficiently demonstrated and is outweighed by side effects such as cardiovascular and gastrointestinal complications.

The stop press section warns clinicians that lacosamide (Vimpat®) 15mg/ml syrup is being recalled due to a quality issue that may cause the active ingredient to precipitate out. It is recommended that patients who are currently prescribed this product be switched to tablets where possible and that no new patients are initiated on the syrup.

This section also warns healthcare professionals regarding the potentially serious adverse effects of Lei Gong Teng (Tripterygium wilfordii), a traditional but unlicensed Chinese herbal medicine. Clinicians are asked to advise anyone known to be taking this product to discontinue use.

Action: Clinicians will find this publication to be a useful review of current issues in drug safety.