The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2020 (PDF).
This month clinicians are advised that the licence for ingenol mebutate gel (Picato®) has been suspended as precautionary measure due to risk of skin malignancy. The European Medicines Agency (EMA) continues to investigate these concerns.
This issue also advises of the distribution last month of updated educational materials to support the valproate pregnancy prevention programme. Valproate is contraindicated in girls and women of childbearing potential, unless the conditions of the pregnancy prevention programme are met.
The insertion site and method for etonogestrel (Nexplanon®) contraceptive implants has been amended to avoid this risk of deep insertion. This is following concerns regarding reports of neurovascular injury and implants migrating to the vasculature.
Readers are also encouraged to support ADR awareness week between 17–23 February 2020 by sharing material on social media and discussing with colleagues and patients the importance of reporting suspected side effects.
The summary of letters to healthcare professionals includes this month includes links to letters warning of the risks of congenital malformation with modafinil and potentially fatal dosing errors with methotrexate as well as letters regarding some of the items above. The medical device letters highlights a risk of stoma injury, bleeding and leakage under the skin barrier with specific batches of convex two-piece skin barriers that have been incorrectly manufactured with off-centre starter/stoma hole. Identification and return of affected devices is recommended.
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.
Sodium zirconium cyclosilicate (Lokelma®) has been rejected for use in the treatment of hyperkalaemia in adult patients. The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC.
Update: Thanks to an observant reader (see comments below), I must clarify that NICE guidance exists that applies to England and Wales for this medicine which should be followed in those member countries.
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 2020 (PDF).
This month clinicians are invited to report suspected adverse reactions associated with use of e-cigarettes or vaping (including lung injury) to the MHRA via the Yellow Card Scheme. More than 2,600 cases of lung injury have been reported to the US Centers for Disease Control and Prevention (CDC) with 60 fatal cases. Clinicians should have a high index of suspicion in patients presenting with respiratory symptoms where there is a history of e-cigarette use or vaping in the past 30 days.
Clinicians are also notified of a small increased risk of oral clefts following use of ondansetron in the first 12 weeks of pregnancy. This information comes from epidemiological studies in the USA which have some limitations but are sufficiently robust to indicate an increased risk. Ondansetron is not usually used as a first line treatment in hyperemesis gravidarum. Where it is offered, women must be counselled on the potential benefits and risks of use, both to her and to her unborn baby and the final decision should be made jointly.
The summary of letters to healthcare professionals this month includes a further group of letters recalling ranitidine, a letter advising that three presentations of Insuman® are being discontinued and an update on the valproate Pregnancy Prevention Programme.
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.
Abiraterone (Zytiga®) has been accepted for use in combination with prednisone or prednisolone for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer in adult men in combination with androgen deprivation therapy. 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 normally be prescribed by a specialist.
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 December 2019 (PDF).
This month clinicians are advice that domperidone is no longer licensed for use in children younger than 12 years or those weighing less than 35 kg. Results from a placebo-controlled study in children younger than 12 years with acute gastroenteritis failed to demonstrate any difference in efficacy at relieving nausea and vomiting compared with placebo. It is recommended that alternative treatments to domperidone are used in children younger than 12 years of age who need relief of symptoms of nausea and vomiting.
The summary of letters to healthcare professionals this month includes further links to letters recalling ranitidine, Emerade® adrenaline auto-injectors and several other pharmacy level drug recalls.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
