The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2020 (PDF).
This month clinicians are advised of a new dedicated COVID-19 Yellow Card reporting site for medicines and medical devices. The site aims to allow rapid identification of new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects for medicines taken by patients to manage long-term or pre-existing conditions.
Readers are also advised of the temporary guidance to specialists regarding the Valproate Pregnancy Prevention Programme during the coronavirus (COVID-19) pandemic and also temporary advice for management of certain immunomodulatory drugs (thalidomide, lenalidomide and pomalidomide) and the associated pregnancy prevention programme.
The summary of letters to healthcare professionals includes details of a recall of Emerade®, safety letters about change in presentation of ReQuip® and new restrictions in the use of cyproterone acetate and several letters regarding supply contrataints.
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 April 2020 (PDF).
This month clinicians are provided with a summary of the key advice and guidance issued so far on medicines safety and pharmacovigilance during the Coronavirus (COVID-19) pandemic. This includes a reminder to make use of the Yellow Card system to notify all suspected side effects. Advice on medicines use issued during COVID-19 includes:
Ibuprofen and NSAIDs
There is currently insufficient evidence to establish a link between use of ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), and susceptibility to contracting COVID-19 or the worsening of its symptoms.
Antihypertensives
The is no evidence from clinical or epidemiological studies to support the concern that treatment with angiotensin-converting-enzyme inhibitors (ACE inhibitors or ACE-i) or angiotensin-receptor blockers (ARBs) might worsen COVID-19 infection
Chloroquine and hydroxychloroquine.
It is advised that trials are underway, and until there is clear, definitive evidence that these treatments are safe and effective these agents should only be used for this purpose within a clinical trial.
Interestingly, the Journal of the American Medical Association has recently published research advising against using high-dose chloroquine due to "safety concerns regarding QTc interval prolongation and increased lethality".
The summary of letters to healthcare professionals includes information about a recall of Emerade auto-injectors as some pens to fail to activate and deliver adrenaline and a recall of Esmya 5mg tablets following a new case of liver failure requiring liver transplant in a patient taking the medicine.
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.
Fampridine (Fampyra®) has been accepted, following a resubmission, for use to aid the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). It should be noted that this advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement and is therefore expected to be supplied via hospitals. It is also noted that the current NICE Guidance recommends against using this medication in England "because it is not a cost effective treatment".
Insulin glargine / Lixisenatide (Suliqua®) has been accepted for restricted use, in combination with metformin, for the treatment of adults with type 2 diabetes mellitus, to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose-lowering medicinal product or with basal insulin. The restriction limits use to patients who are uncontrolled on basal insulin (glycosylated haemoglobin [HbA1c] > 7.5% [59mmol/mol]) and for whom a GLP-1 receptor agonist is appropriate as an add-on intensification therapy to basal insulin analogues.
Naldemedine (Rizmoic®) has been accepted for use in the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative. It is noted that compared to placebo this medication significantly improved the spontaneous bowel movement response rate in patients with opioid-induced constipation and either non-cancer or cancer pain.
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 2020 (PDF).
This month clinicians are advised that the license for ulipristal acetate 5mg (Esmya®) has been suspended to protect public health while a safety review is conducted following a further case of liver injury requiring transplant. The product is being removed from the supply chain and it is recommended that patients are contacted and advised to stop treatment as soon as possible with a liver function test performed 2–4 weeks after stopping.
This issue also advises that SGLT2 inhibitor treatment should be interrupted during hospital admissions for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine. Treatment may be restarted when the ketone values are normal and the patient's condition has stabilised.
This month there is also a reminder that benzodiazepines and opioids can both cause respiratory depression, which can be fatal if not recognised in time. It is recommend that they are only prescribed together if there is no alternative and that patients are closely monitored for signs of respiratory depression.
The summary of letters to healthcare professionals this month includes information about Typhim Vi being supplied in an export pack to meet increased demand and a recall of Emerade 150 microgram adrenaline pens due to the potential for device failure. The medical device letters include advice that Cardinal Health Genius 2 and Genius 3 tympanic thermometers should now be calibrated every 25 weeks rather than annually to assure accuracy and reduce the risk of misdiagnosis or delay in treatment.
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.
Cinacalcet granules (Mimpara®) have been rejected for use in secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism in adults. The manufacturer failed to make a submission for these indications. NICE recommends cinacalcet for refractory secondary hyperparathyroidism in patients with end-stage renal disease under specific conditions.
Mexiletine (Namuscla®) has been rejected for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders. The justification of the treatment's cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust 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.
