The manufacturer of exenatide once weekly (Bydureon®) has written to healthcare providers advising that the original 'vial and syringe' kit is being replaced by a pre-filled pen.
The pen has been available for several months and is designed to make administration easier for patients. According to the letter, the older formulation will be phased out later this year. Any patient who is starting this treatment should be supplied with the pen device. This is indicated as 'pre-filled pen' or 'pre-filled disposable device' in the item description on clinical systems. Patients who are currently prescribed the vials should be moved to the new device.
Patient information about the switch is available at talkingtype2.co.uk [acceptance of legal, privacy and cookie terms required] and the Patient Information Leaflet describes how to use the new device.
Action: Clinicians should be aware that the vial and syringe kit is being replaced. It would be prudent to run clinical system searches to identify any patients who are currently prescribed the vials so prescriptions can be updated.
The manufacturer of canagliflozin has written to healthcare professionals, in agreement with the European Medicines Agency, advising of an increased risk of lower limb amputations seen in the CANVAS study.
Canagliflozin (Invokana®, Vokanamet®) is licensed for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control. The CANVAS study is a long-term study investigating cardiovascular outcomes. Adverse event monitoring in this study has observed a two-fold increase in the risk of a lower limb amputation, primarily the toe.
The risk rate in study participants taking canagliflozin is 6 lower limb amputations per 1,000 patient years compared to a risk of 3 per 1,000 patient years in patients taking placebo. No dose response had been noted.
Healthcare professionals are advised that:
- Routine preventative foot care management remains important
- Patients with other risk factors for amputation, such as peripheral vascular disease or peripheral neuropathy should be carefully monitored
- Consideration should be given to suspending treatment in patients who develop significant lower limb complications such as ulcers, osteomyelitis or gangrene
- Patients should be advised to maintain adequate hydration and monitored for signs or symptoms of volume depletion, especially those who are also taking diuretics
Regulatory agencies will continue to monitor and investigate this issue.
Action: Clinicians should be aware of this new safety information. Risk factors for amputation should be considered before starting new treatment and consideration given to stopping treatment if complications develop during treatment.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2016 (PDF).
This issue reminds clinicians that they should test for raised ketones in diabetic patients taking a sodium-glucose co-transporter 2 (SGLT2) inhibitor with ketoacidosis symptoms, even if plasma glucose levels are near-normal. It is further recommended that treatment with an SGLT2 is stopped when ketoacidosis is suspected or during acute episodes of serious illnesses.
Clinicians are also reminded that live attenuated vaccine use should be avoided those who are clinically immunosuppressed. Recent Yellow Card adverse reaction reports have been submitted regarding immunosuppressed patients who have received a live attenuated vaccine, some of which resulted in severe infection and death.
The product license for meprobamate will be cancelled by the end of 2016 and UK manufacturing has ceased. This was recommended by the European Medicines Agency in 2012. Any patient who is currently receiving a meprobamate-containing medicine should be reviewed with a view to switching them to an alternative treatment.
Clinicians are reminded that paraffin-based emollients are a fire hazard. A recent fatal incident reported to the NHS England National Reporting and Learning System.
Finally this month there is a summary of letters sent to healthcare professionals in March.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The FDA has issued a safety alert regarding saxagliptin (Onglyza®) and alogliptin (Vipidia®). More information is available in the FDA safety announcement. The Summary of Products Characteristics for saxagliptin and alogliptin for the UK market already contain cautionary information about using these medicines in patients with heart failure.
A safety review found that type 2 diabetes medicines containing saxagliptin and alogliptin (including combinations containing metformin) may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. The FDA alert advises that healthcare professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control.
The review included data from two large clinical trials (SAVOR and EXAMINE). In the saxagliptin trial, 3.5% of patients who received the drug were admitted to hospital for heart failure versus 2.8% of patients who received a placebo. In the alogliptin trial, 3.9% of alogliptin treated patients were admitted to hospital for heart failure versus 3.3% in the placebo group. The trials ran for different durations but these data indicate that for approximately 1 in every 150 patients treated with either of these drugs for around 2 years would be expected to be admitted to hospital with heart failure.
Patients taking these medicines should be advised contact a healthcare professional if they develop signs and symptoms of heart failure such as:
- Unusual shortness of breath during daily activities
- Trouble breathing when lying down
- Tiredness, weakness, or fatigue
- Weight gain with swelling in the ankles, feet, legs, or stomach
Action: Clinicians should be aware of this recent safety development. Patients who are prescribed these medicines should be monitored for signs of heart failure and these medicines stopped should signs develop.
The manufacturer of nadolol (Corgard®) has confirmed that this product has been discontinued. The product has been discontinued for commercial reasons.
Nadolol, a beta blocker, is licensed for use in hypertension, angina, arrhythmias, migraine prophylaxis and adjunctive treatment of thyrotoxicosis. Supply chain stock will be limited and there is no generic alternative. Treatment should not be stopped abruptly and therefore patients who are currently being prescribed nadolol should be identified, reviewed offered an appropriate alternative.
Action: Clinicians should be aware of this product being discontinued. It would be prudent to run clinical system searches to identify any patients who are currently prescribed this product to allow a review and an alternative to be arranged.