The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for September 2016 (PDF).
This issue contains updated advice on emergency hormonal contraception in patients taking hepatic enzyme inducers. It is now advised that women taking hepatic enzyme inducers, or who have taken them in the previous 4 weeks, are recommended to preferably use a non-hormonal emergency contraceptive - i.e. a copper intrauterine device. Where this is not possible a double dose of levonorgestrel must be used. It is also advised that a pregnancy test is performed to exclude pregnancy after use of levonorgestrel-containing emergency contraception and advice sought if they do become pregnant.
Hepatic enzyme inducers include medicines used to treat:
- epilepsy (e.g. barbiturates, primidone, phenytoin, carbamazepine)
- tuberculosis (e.g. rifampicin, rifabutin)
- HIV (e.g. ritonavir, efavirenz)
- fungal infections (e.g. griseofulvin)
- and Herbal remedies that contain St John’s wort (Hypericum perforatum)
This issue also contains additional information that posaconazole suspension and tablets are not dose equivalent as noted in the summary of letters to healthcare professionals in last month's update.
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.
Calcipotriol and Betamethasone cutaneous foam (Enstilar®) has been accepted as a topical treatment of psoriasis vulgaris in adults. It is noted that this product may be associated with a small budget impact.
Fosfomycin granules (Monuril®) have been accepted for:
- Treatment of acute lower uncomplicated urinary tract infections, caused by pathogens sensitive to fosfomycin in adult and adolescent females
- Prophylaxis in diagnostic and surgical transurethral procedures
It is noted that consideration should be given to national guidance on the appropriate use of antibacterial agents.
Liraglutide (Victoza®) has been rejected for use as monotherapy for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance or contraindications. The manufacturer has not made a submission.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The manufacturer of retigabine (Trobalt®) has written to healthcare professionals advising that this medicine is to be discontinued.
Retigabine is licensed as an adjunctive treatment of drug-resistant partial onset seizures with or without secondary generalisation in patients aged 18 years or older with epilepsy where other combinations have been inadequate or not tolerated.
The decision to discontinue this product is a commercial one based on limited use and a decline in new patients being started on this treatment. There are no safety concerns.
It is recommended that treatment is gradually withdrawn over a period of at least three weeks and safety monitoring should continue during treatment. No new patients should be started on this treatment. The manufacturer is working with regulatory authorities and suppliers to ensure that this medication remains available for the next year to allow time for alternative treatment to be identified and initiated.
Action: Clinicians should be aware of this product being discontinued. It would be prudent to run clinical system searches to identify any patients who are currently prescribed this product to allow a review and arrangements made to identify a suitable alternative.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Alirocumab (Praluent®) has been accepted for restricted use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet and other medication, if tolerated. The restriction limits use specialist lipid clinics in patients at high cardiovascular risk. This advice is also contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
Insulin degludec (Tresiba®) has been accepted for use in the treatment of diabetes mellitus in adults.
Levofloxacin (Quinsair®) has been accepted for restricted use in the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis. The restriction limits use to third line after colistimethate sodium (first line) and tobramycin (second line).
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 2016 (PDF).
Following early termination of a clinical trial it is recommended that riociguat (Adempas®) should not be used to treat patients with pulmonary hypertension associated with idiopathic interstitial pneumonias. This medication should be under specialist supervision.
There is also a summary of letters sent to healthcare professionals in July including a letter advised that posaconazole (Noxafil®) tablets and suspension are not interchangeable and that inadvertent changes between the two formulations has led to under-dosing or over-dosing.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
