The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Melatonin prolonged-release (Slenyto®) has been rejected following a resubmission for use in the treatment of insomnia in children and adolescents aged 2 to 18 years with autism spectrum disorder and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient. The submitting company did not present a sufficiently robust clinical or economic analysis to gain acceptance by SMC.
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 January 2021 (PDF).
This month readers are advised of a review of the risks of major congenital malformations and of adverse neurodevelopmental outcomes for antiepileptic drugs conducted by the Commission on Human Medicines. It has confirmed that lamotrigine and levetiracetam are the safer of the medicines reviewed during pregnancy. It is recommended that clinicians use this information when discussing treatment options with women with epilepsy at routine recommended annual reviews and with women who are planning to become pregnant.
Readers are also signposted to the information available about the COVID-19 vaccines authorised for use in the UK, including advice for people with allergies and for women during pregnancy and breastfeeding.
This issue also highlights data from observational studies suggesting that the use of SSRI/SNRI antidepressants during the month before delivery may result in a small increased risk of postpartum haemorrhage. Prescribers should consider this risk in the context of an individual patient's bleeding and thrombotic risk assessment during the peripartum period and the benefits of antidepressants for the patient's mental health during this time.
Finally this month, aminoglycosides have been linked with an increased risk of deafness in patients with mitochondrial mutations with some reports of this happening at serum levels within the recommended ranges. Micochondrial mutations are rare but genetic testing may need to be considered especially in patients requiring recurrent or long-term treatment with aminoglycosides. Urgent treatment should not be delayed while awaiting genetic testing results.
The summary of letters to healthcare professionals were generally regarding product recalls.
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 December 2020 (PDF).
This month readers are advised that systemic and inhaled fluoroquinolones are associated with a small increased risk of heart valve regurgitation. Fluoroquinolones are only recommended for use in serious, life-threatening bacterial infections. It is recommended that other options are considered first in patients at risk of heart valve regurgitation.
Readers are also advised that erythromycin has been associated with events secondary to QT interval prolongation including cardiac arrest and ventricular fibrillation. Clinicians are reminded to be aware of reports of cardiotoxicity with macrolide antibiotics, in particular with erythromycin and clarithromycin. These drugs should be avoided in patients with a history of QT interval prolongation or ventricular cardiac arrhythmia and those with current electrolyte disturbances. It is also noted that erythromycin may interact with rivaroxaban and increase the risk of bleeding. This interaction should be considered when prescribing antibiotics and precautions in the product information followed if concomitant use is necessary.
The summary of letters to healthcare professionals were generally regarding product recalls. Of note, Solu-Medrone® (methylprednisolone as sodium succinate) has been reformulated to be lactose free and as such there is a risk of serious allergic reactions if formulations are confused.
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.
Mexiletine (Namuscla®) has been accepted for restricted use in the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders. It is noted that this advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based. As such it would be expected that prescribing would occur in secondary care.
Bempedoic acid (Nilemdo®) has been rejected for 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 LDL-C goals with the maximum tolerated dose of a statin
- Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contra-indicated.
The submitting company did not present a sufficiently robust clinical or economic analysis to gain acceptance by SMC.
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 November 2020 (PDF).
This month readers are advised that modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment and for 2 months after stopping modafinil.
Additionally, pirfenidone (Esbriet®) has been linked with an increased risk of serious liver injury. Updated advice on liver function testing has been issued that recommends monthly checks during the first 6 months of treatment and every 3 months thereafter.
Ferric carboxymaltose (Ferinject▼®) has been linked with an increased risk of symptomatic hypophosphataemia leading to osteomalacia and fractures. Additional monitoring of phosphate levels is recommended for patients requiring multiple administrations at higher doses, on long-term treatment or with pre-existing risk factors for hypophosphataemia.
Finally in drug safety news, bupropion (Zyban®) has been associated with several cases of serotonin syndrome, especially when used with other serotonergic drugs or in cases of overdose. It is recommended that patients are informed about the milder symptoms of serotonin syndrome at initiation of treatment. If serotonin syndrome is suspected the dose of bupropion should be decreased or treatment withdrawn depending on the severity of the symptoms.
The summary of letters to healthcare professionals were generally regarding product recalls or supply disruptions.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
