Endocrine MHRA alerts Flashcards
Methylprednisolone injections should not be used in which allergy?
Cows milk due to the trace amount of milk protein and lactose.
Serious allergic reactions, including bronchospasm and anaphylaxis, have been reported in patients allergic to cows’ milk proteins. If a patient’s symptoms worsen or new allergic symptoms occur, administration should be stopped and the patient treated accordingly.
The marketing authorisation has been suspended for which indication for oral ketoconazole? Which indications have not been affected?
For fungal infections, the marketing authorisation has been suspended due to risk of hepatotoxicity.
Topical products or oral ketoconazole for Cushing’s syndrome have not been affected.
Which antidiabetic carries a risk of lower limb amputation?
In which patients would you exercise caution?
What advice should you give patients?
Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes.
Consider stopping canagliflozin if a patient develops a significant lower limb complication (e.g. skin ulcer, osteomyelitis, or gangrene)
Carefully monitor patients who have risk factors for amputation (e.g. previous amputations, existing peripheral vascular disease, or neuropathy)
Monitor all patients for signs and symptoms of water or salt loss; ensure patients stay sufficiently hydrated to prevent volume depletion in line with the manufacturers recommendations.
Advise patients to stay well hydrated, carry out routine preventive foot care, and seek medical advice promptly if they develop skin ulceration, discolouration or new pain or tenderness
Continue to follow standard treatment guidelines for routine preventative foot care for people with diabetes.
Which antidiabetics carry a high risk of DKA? Does this correspond to their glucose levels?
SGLT2 inhibitors. Often the glucose levels were only moderately raised.
How should you signpost patients to be aware of the risk of DKA in SGLT2 inhibitors?
Signs and symptoms of DKA – rapid weight loss, N&V, abdominal pain, fast and deep breathing, sleepiness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat( and advise them to seek immediate medical advice if the develop any of these.
Which SGLT2 inhibitor should be used with caution in patients with risk factors for DKA?
Use canagliflozin with caution in patients with risk factors for DKA, (including a low beta cell reserve, conditions leading to restricted food intake, or severe dehydration, sudden reduction in insulin, increased insulin requirements due to acute illness, surgery or alcohol abuse)
When would you interrupt SGLT-2 treatment? How would you know when to restart them?
Interrupt SGLT-2 treatment in patients who are hospitalized for major surgery or acute serious illnesses; treatment may be restarted once the patient’s condition has stabilized.
Healthcare professionals are advised to monitor ketone levels during SGLT2 inhibitor treatment interruption in patients who have been hospitalised for major surgery or acute serious illness—measurement of blood ketone levels is preferred to urine. Treatment may be restarted once ketone levels are normal and the patient’s condition has stabilised
SGLT2 inhibitors carry a risk of which type of infections? Where does this usually occur?
Reports of fournier’s gangrene (necrotising fasciitis of the genitalia or perineum)
If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and urgently start treatment (including antibiotics and surgical debridement).
Patients should be advised to seek urgent medical attention if they experience severe pain, tenderness or erythema, or swelling in the genital or perineal area. Accompanied by fever or malaise – urogenital infection or perineal abscess may precede necrotising fasciitis.
Pioglitazone carries three key risks.
- bladder cancer
Patients already receiving treatment with pioglitazone should be assessed for risk factors of bladder cancer and treatment should be reviewed after 3-6 months, as above.
- heart failure
- hepatic failure
Withdrawal of insulin pens is not permitted due to what risk?
Insulin should not be extracted from insulin pen devices. The strength of insulin in pen devices can vary by multiples of 100units/mL.
Insulin syringes have graduations only suitable for calculating doses of standard 100units/mL.
If insulin extracted from a pen or cartridge is of a higher strength, and that is not considered in determining the volume required, it can lead to a significant and potentially fatal overdose.
What are associated with insulin NEVER events?
The words ‘unit’ or ‘international units’ should not be abbreviated.
Specific insulin administration devices should always be used to measure insulin i.e. insulin syringes and pens.
Insulin should not be withdrawn from an insulin pen or pen refill and then administered using a syringe and needle.
Injecting with insulin carries a risk of what cutaneous adverse effect? How can patients avoid this occuring?
Cutaneous amyloidosis.
Patients should be reminded to rotate injection sites within the same body region.
Patients should also be advised that injecting into an affected ‘lumpy’ area may reduce the effectiveness of insulin.
Those currently injecting into a ‘lumpy’ area should contact their doctor before changing injection site due to the risk of hypoglycaemia; blood glucose should be closely monitored after changing injection site, and dose adjustment of insulin or other antidiabetic medication may be required.
Long-term treatment with bisphosphonates can cause what bone-related adverse effects?
Atypical femoral fractures.
Patients should be advised to report any thigh, hip, or groin pain during treatment with a bisphosphonate.
Discontinuation of bisphosphonate treatment in patients suspected to have an atypical femoral fracture should be considered after an assessment of the benefits and risks of continued treatment.
After how many years should the risk of bisphosphonate treatment be re-evaluated?
5 years of use
Bisphosphonates are associated with osteonecrosis of two organs.
What measures should be taken prior to initiation due to this?
Jaw and auditory canal.
All patients with cancer and patients with poor dental status should have a dental check-up (and any necessary remedial work should be performed) before bisphosphonate treatment, or as soon as possible after starting treatment.
Patients should also maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain, or swelling, non-healing sores or discharge to a doctor and dentist during treatment.
Before prescribing an intravenous bisphosphonate, patients should be given a patient reminder card and informed of the risk of osteonecrosis of the jaw.
Advise patients to tell their doctor if they have any problems with their mouth or teeth before starting treatment, and if the patient wears dentures, they should make sure their dentures fit properly. Patients should tell their doctor and dentist that they are receiving an intravenous bisphosphonate if they need dental treatment or dental surgery.
