The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Delafloxacin (Quofenix®) has been rejected for use in the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections. The manufacturer failed to make a submission for this indication. The SMC advised that consideration should be given to official guidance on the appropriate use of antibacterial agents.
Bempedoic acid (Nilemdo®) has been accepted for restricted use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- In combination with a statin, or a statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or
- Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contra-indicated
The restriction limits use, in combination with ezetimibe, in patients who are:
- statin intolerant or for whom a statin is contra-indicated, and
- where ezetimibe alone does not appropriately control LDL-C, and
- where proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitors are not appropriate
Furthermore, this advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) similar to existing NICE guidance that applies in England and Wales.
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 July 2021 (PDF).
This month readers are advised that, following a review of the available toxicological data, chloramphenicol eye drops can be safely administered to children aged 0 to 2 years where antibiotic eye drop treatment is indicated. Some licences for chloramphenicol eye drop products containing borax or boric acid buffers were recently updated to restrict use in children younger than 2 years of age to reflect warnings on maximum daily limits for boron exposure. The product information for affected chloramphenicol products is being updated to reflect the revised advice and remove restrictions for use in infants. In the meantime, healthcare professionals should reassure parents and carers that these products can be safely given to children aged 0 to 2 years at the time of prescribing.
Readers are also reminded to be vigilant for suspected adverse reactions to herbal and homeopathic medicines and to report them to the Yellow Card scheme. It is recommended to specifically ask patients who present with adverse reaction symptoms if they are taking a herbal or homeopathic medicines.
This issue also contains an update on COVID-19 vaccines and medicines that includes emerging information on a very small risk of myocarditis and pericarditis associated with the Modern and Pfizer/BioNTech vaccines. It seems to affect younger men after the second vaccine is administered and cases are typically mild with affected individuals tending to recover within a short time following standard treatment and rest. The advice continues to be that the benefits of getting vaccinated outweigh the risks in the majority of people.
Finally in this issue is a summary of letters to healthcare professionals sent in June that were regarding product recalls. There were also letters noting a change in appearance and formulation for the ViePax 150 XL® brand of venlafaxine and release of some Clenil® inhalers with no dose counter.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2021 (PDF).
This month readers are advised of reports of interstitial lung disease and pneumonitis associated with use of CDK4/6 inhibitors (abemaciclib▼, palbociclib▼, ribociclib▼). Patients taking these medicines should be made aware of the need to seek advice right away if they develop new or worsening respiratory symptoms at clinic reviews. Patients on these medicines who present in primary care with respiratory symptoms should be managed cautiously and should be advised to make contact with their specialist.
Readers are also advised of the risk of severe cutaneous adverse reactions (SCARs) including SJS and TEN associated with use of atezolizumab▼ (Tecentriq®) and other immune-stimulatory anti-cancer drugs. Patients on these drugs should be advised by their specialist to be vigilant for the signs of severe skin reactions and to seek urgent medical advice if they occur. In such cases continued treatment should be withheld, and patients referred to a specialist for diagnosis and treatment.
This issue also contains an update on COVID-19 vaccines and medicines that includes information on a newly licensed vaccine from Janssen and licence extension to younger age groups for the Pfizer/BioNTech vaccine.
Finally in this issue is a summary of letters to healthcare professionals sent in May that were regarding product recalls.
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.
5-aminolevulinic acid (Alacare®) has been accepted for single use treatment of mild actinic keratoses lesions with a maximum diameter of 1.8 cm on the face and scalp (hairless areas). It is noted that another licensed formulation of 5-aminolevulinic acid is available and there may be an associated small net budget impact with the use of this product.
Vigabatrin (Kigabeq®) has been accepted for restricted use in infants and children from 1 month to less than 7 years of age for:
- treatment in monotherapy of infantile spasms (West's syndrome)
- treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated
The restriction limits use to patients in whom other formulations of vigabatrin are not suitable.
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 May 2021 (PDF).
This month readers are advised that, while generic prescribing of levothyroxine remains appropriate for the majority of patients, in some patients prescribing a specific product, known to be well tolerated by the patient, should be considered if they report persistent symptoms when switching between different levothyroxine tablet formulations. It is further suggested that if symptoms or poor control of thyroid function persist despite adhering to a specific product, the levothyroxine in an oral solution formulation can be used.
This issue also contains an update on COVID-19 vaccines and medicines that includes a statement from the JCVI on the AstraZeneca COVID-19 Vaccine for people aged under 40.
Finally in this issue is a summary of letters to healthcare professionals sent in April that were regarding product recalls and imported medicine supplies.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
