The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2017 (PDF).
This issue contains information about an association between finasteride 1mg and depression and, in rare cases, suicidal thoughts. Finasteride is used for male pattern baldness at a dose of 1mg daily and for benign prostatic hyperplasia at 5mg daily. It is therefore recommended that patients taking finasteride 1 mg are advised to stop this medication and inform a healthcare professional should they develop symptoms of depression.
This issue also signposts a new set of free e-learning modules to find out more about how and when to report suspected adverse drug reactions. Doctors completing these modules will also earn CPD credits.
There is also a summary of letters sent to healthcare professionals in April including a reminder that retigabine (Trobalt®) has been withdrawn and will not be available from the end of June 2017. Other letters include a warning of the risk of medication errors with oral solution presentations of levetiracetam and a change to dosing recommendations for Amoxil® in patients undergoing haemodialysis.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Liraglutide (Saxenda®) has been rejected for use as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index of:
- ≥30kg/m2 (obese)
- ≥27kg/m2 and <30kg/m2 (overweight) with at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea
The manufacturer failed to make a submission.
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 April 2017 (PDF).
This issue contains updated information about the risk of developmental disorders seen in babies born to mothers who take valproate medicines. It is estimated that there is a 30–40% risk of developmental disability and a 10% risk of birth defects. Despite previous communications there is evidence that women are still not aware of the risk. The following new recommendations are therefore being made:
- Do not prescribe valproate medicines for epilepsy or bipolar disorder in women and girls unless other treatments are ineffective or not tolerated; migraine is not a licensed indication
- Ensure women and girls taking valproate medicines understand the 30–40% risk of neurodevelopmental disorders and 10% risk of birth defects and are using effective contraception
- Valproate use in women and girls of childbearing potential must be initiated and supervised by specialists in the treatment of epilepsy or bipolar disorder
There is also a summary of letters sent to healthcare professionals in March including a letter noting the reintroduction of a paediatric carbocisteine liquid that is double the strength of the same presentation discontinued in January 2015. Clinicians should ensure an appropriate dose volume is prescribed when using this product.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Emtricitabine / Tenofovir (Truvada®) has been accepted for use in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. It should denoted that NHS Boards in Scotland will make it available within the next three months when systems are in place.
Insulin aspart (Fiasp®) has been accepted for the treatment of diabetes mellitus in adults. It is noted that this is a new formulation with a faster onset of action than another formulation of insulin aspart and is available at an equivalent cost.
Ticagrelor (Brilique®) has been rejected for use when co-administered with acetylsalicylic acid for the prevention of atherothrombotic events in adult patients with a history of myocardial infarction and a high risk of developing an atherothrombotic event. The manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance.
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 March 2017 (PDF).
This issue contains updated advice on the increased risk of lower-limb amputation (mainly toes) associated with use of the SGLT2 inhibitor canagliflozin. The updated advice notes that the current evidence does not show an increased risk for dapagliflozin and empagliflozin, but warns the risk may be a class effect. As previously suggested, patients receiving canagliflozin should be monitored for risk factors for amputation such as poor diabetes control and vascular disease. Treatment should be stopped if foot complications such as infection, skin ulcers, osteomyelitis or gangrene develop. It is also noted that preventive foot care is important for all patients with diabetes and especially in those being treated with an SGLT2 inhibitor.
The issue also announces a year long pilot of a reporting scheme for healthcare professionals to report suspected adverse reactions to illicit drugs, particularly new psychoactive substances (or 'legal highs'). A new site is available containing the Report Illegal Drug Reaction form that also collects information about licensed medicine that may help identify common issues arising from combinations of specific licensed medicines and psychoactive substances.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
