The manufacturer of the Evorel® range of HRT patches has written healthcare professionals advising of an imminent supply shortage.
An increase in demand for the products is cited as one of the reasons for the shortage with the entire product range affected - Evorel®, Evorel® Sequi and Evorel® Conti. It is anticipated that supplies will be restored in mid-2020.
Alternative patches are available to switch from Evorel®, but alternatives to the Sequi and Conti products are going to be more complex, perhaps involving supply of oestrogen patches and progestogen tablets or a switch to tablet versions.
Action: Clinicians should be aware of this supply interruption and be prepared to supply appropriate alternatives.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2019 (PDF).
This issue advises that febuxostat should be avoided, unless no other therapy options are appropriate, in patients with pre-existing major cardiovascular disease due to an increased risks observed in a clinical trial. The study (CARES) found a higher risk for cardiovascular-related death and for all-cause mortality in patients assigned to febuxostat than in those assigned to allopurinol.
This issue also advises that tocilizumab (RoActemra®) has been linked with rare risk of serious liver injury including cases requiring transplantation. It is recommended that alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be measured before starting treatment with tocilizumab and monitored every 4–8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter. Some areas may arrange monitoring under shared care.
There is also a reminder that rivaroxaban (Xarelto®) 15 mg and 20 mg tablets should be taken with food. There have been reports of reduced efficacy when taken on an empty stomach. The lower strengths can be taken with or without food.
Finally this month, the summary of letters to healthcare professionals includes a letter regarding the risk of teratogenicity and neuropsychiatric disorders with retinoids and the pregnancy prevention programme launched last month. There is also a link to a letter regarding the febuxostat advice mentioned above.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
Public Health England has announced that the human papillomavirus (HPV) vaccination programme is to be extended to include boys from 1 September 2019.
The vaccine has been offered to girls as part of the NHS immunisation programme since 2008. Based on the advice of the Joint Committee of Vaccination and Immunisation (JCVI) the programme is being expanded and will now have universal coverage.
Action: This information is aimed at health professionals who will be responsible for implementing the new programme but may be useful for anyone who may see patients presenting following vaccination.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2019 (PDF).
This issue advises that direct-acting oral anticoagulants (DOACs) are not recommended in patients with antiphospholipid syndrome due to an increased risk of recurrent thrombotic events. A clinical trial has shown an increased risk of recurrent thrombotic events associated with rivaroxaban compared with warfarin in patients with antiphospholipid syndrome and a history of thrombosis. This particularly affects high-risk patients who test positive for all 3 antiphospholipid tests. It is also recommended to review any patients with antiphospholipid syndrome who are currently prescribed a DOAC and consider switching to a vitamin K antagonist such as warfarin.
This issue also advises of reports of diabetic ketoacidosis seen in patients on GLP-1 receptor agonists when concomitant insulin was rapidly reduced or discontinued. It is recommended that insulin reductions should be done in a step-wise manner with careful glucose self-monitoring if GLP-1 receptor agonist therapy is initiated and the insulin is dose is reduced.
New materials have been launched to support the pregnancy prevention programme including a new prescribed checklist for oral retinoid medicines. In conjunction with this, advice about the risk of neuropsychiatric reactions has been made consistent for all oral retinoid medicines.
Finally this month, the summary of letters to healthcare professionals includes a letter regarding the shortage of Epanutin (phenytoin) oral solution which contains prescribing and dispensing advice. There is also a link to a letter regarding DOAC use in patients with antiphospholipid syndrome.
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.
Fluticasone/formoterol (Flutiform®) has been accepted for use in the regular treatment of asthma in children aged 5 to 12 years where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate:
- for patients not adequately controlled with inhaled corticosteroids and 'as required' inhaled short-acting β2 agonist
- or for patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist
This product has already been accepted for use in adults and adolescents aged 12 years and above on the same basis.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
