The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Calcium carbonate and cholecalciferol (Kalcipos-D®) has been accepted for the prevention and treatment of calcium and vitamin D deficiency in the elderly and in addition to specific osteoporosis treatment of patients who are at risk of deficiency.
Darunavir (Prezista®) has been accepted for the treatment of HIV-1 infection in combination with low dose ritonavir.
Glucosamine sulphate (Dolenio®) has been rejected for symptomatic treatment of mild to moderate osteoarthritis of the knee. The manufacturer failed to make a submission.
Glucosamine sulphate (Glusartel®) has been rejected for relief of symptoms in mild to moderate osteoarthritis of the knee. The manufacturer failed to present a sufficiently robust economic case to gain acceptance.
Methotrexate 50mg/ml solution for injection (Metoject®) has been accepted for the treatment of polyarthritic forms of severe active juvenile idiopathic arthritis. It is an option for patients when the response to non-steroidal anti-inflammatory drugs has been inadequate, a disease modifying drug is indicated and parenteral administration of methotrexate is appropriate.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
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 Clinicians are also advised that the product licence for celecoxib (Onsenal®) has been voluntarily withdrawn after a trial that aimed to evaluate the drugs benefits in familial adenomatous polyposis failed to recruit sufficient patient numbers.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.