admin December 11th, 2007
The UK’s NPC have issued guidance on the use of NSAIDs, and specifically have singled out diclofenac prescribing for attention. Pulse Magazine reports:
GPs should review use of the most widely prescribed NSAID diclofenac and switch to ibuprofen or naproxen, says an NHS review into the safety profile of anti-inflammatory treatments.
Diclofenac accounts for 46% of all NSAID prescriptions in primary care.
But the National Prescribing Centre’s review of cardiovascular risks associated with traditional NSAIDs and cox-2 inhibitors has said this high level of prescribing should be ‘reconsidered’.
The report claims as many as 2,000 additional or premature cardiovascular events per year could be caused by diclofenac prescribing.
It goes on to say patients on diclofenac should be reviewed and switched to low-dose ibuprofen or naproxen if possible, to reduce their CV thrombotic risk.
Background to this story can be found at MEREC 30 and the NPC blog, and additional support materials are available from the NPC.
Currently the MHRA are conducting a consultation on an application for the reclassification of a low dose diclofenac preparation from prescription only medicine status to an over-the-counter medicine for sale in pharmacies. Comments should be submitted by 4 January 2008.
admin December 10th, 2007
Readers may be interested in the FDA’s new Drug Safety Newsletter.
Rituximab (marketed as Rituxan): Progressive Multifocal Leukoencephalopathy (PML)
Modafinil (marketed as Provigil): Serious Skin Reactions
Temozolomide (marketed as Temodar): Aplastic Anemia
Deferasirox (marketed as Exjade): Early safety findings.
[PDF here]
admin December 6th, 2007
The FDA have requested that manufacturers update prescribing information for desmopressin to include warnings about severe hyponatremia and seizures. Children treated with desmopressin intranasal formulations for primary nocturnal enuresis (PNE) are particularly susceptible, and for that reason such formulations are no longer indicated for the treatment of primary nocturnal enuresis.
Bottom line: The indication of primary nocturnal enuresis (PNE) was removed from all desmopressin nasal spray products in the UK in April of this year and the risk of hyponatremia was discussed in Drug Safety Update (Vol 1: Issue 2) in September 2007. This news acts as a reminder of the risk of hyponatraemia and the need to monitor therapy appropriately.
admin December 4th, 2007
The MHRA have made available the public assessments summarising the evidence for the safety of recombinant human erythropoietins in patients with cancer and in patients with chronic kidney disease
Recombinant human erythropoietins stimulate erythropoiesis. They are indicated for the treatment of anaemia in patients with chronic kidney disease. Some recombinant human erythropoietins are also authorised for the treatment of patients with non-myeloid cancer who develop anaemia after chemotherapy.
Overcorrection of haemoglobin concentration in patients with chronic kidney disease may increase the risk of death and serious cardiovascular events, and in patients with cancer may increase the risk of thrombosis and related complications. Recombinant human erythropoietins should not be given to patients with cancer who do not fulfil the criteria in the authorised cancer indications.
admin December 4th, 2007
Following review, The European Medicines Agency has concluded that the benefits of the thiazolidinediones rosiglitazone (Avandia) and pioglitazone (Actos) continue to outweigh their risks in the approved indications. They have also suggested that further studies should be carried out in order to increase the amount of information about the safety of these agents. [PDF Press Release].
The MHRA has also put up a page of material related to this decision, cardiovascular disorders, eye disorders and fracture risks. The issue is also covered in this month’s Drug Safety Update.
admin December 4th, 2007
The MHRA’s Drug Safety Update is out: Volume 1, Issue 5, December 2007 [PDF here]
This month:
Recombinant human erythropoietins: new prescribing advice
Rosiglitazone and pioglitazone: cardiovascular safety
Dosulepin: measures to reduce risk of fatal overdose
ACE inhibitors and angiotensin II receptor antagonists: not for use in pregnancy
Short-acting β agonists: myocardial ischaemia
Yellow Card scheme update: electronic reporting
Varenicline: possible effects on driving, and psychiatric illness
NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks
Aprotinin: suspension of Marketing Authorisations
Lumiracoxib: suspension of Marketing Authorisations
Strontium ranelate: risk of severe allergic reactions
Talc for pleurodesis: risk of adverse events
Recent letters to healthcare professionals
Other information from the MHRA
New sections on the MHRA website