Blood and Nutrition MHRA alerts Flashcards
Recombinant EPO can cause which type of topical reactions? With which is this more prominent?
Very rare cases of severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, in patients treated with erythropoietins; some cases were fatal.
More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol – epoetin beta).
These rashes often follow fever of flu-like symptoms – discontinue treatment permanently if such reactions occur.
What is a serious consequence of using EPO to correct haemoglobin?
Overcorrection of haemoglobin concentration in patients with CKD may increase the risk of death and serious cardiovascular events, and in patients with cancer may increase the risk of thrombosis and related complications:
Patients should not be treated with erythropoietins in CKD or in thos receiving chemo unless symptoms of anaemia are present.
The haemoglobin concentration should be maintained within the range 10-12g/100ml
Haemoglobin concentration higher than 12g/100mL
The aim of treatment is to relieve symptoms of anaemia, and in patients with CKD to avoid the need for blood transfusion; the haemoglobin concentration should not be increased beyond that which provides adequate control of symptoms of anaemia (in some patients, this may be achieved at concentrations lower than the recommended range)
What is the target Hb concentration to maintain in patients with CKD to avoid overcorrection?
The haemoglobin concentration should be maintained within the range 10-12g/100ml
In patients who are on EPO for a cancer indication, what serious outcomes were observed with regards to mortality?
An unexplained excess mortality and increased risk of tumour progression in patients with anaemia associated with cancer who have been treated with erythropoietins
Which life-threatening and fatal reactions could occur with IV iron? In which patients are these risks likely to be increased?
Serious hypersensitivity reactions, including life-threatening and fatal anaphylactic reactions.
The risk of hypersensitivity is increased in patients with known allergies, immune or inflammatory conditions, or those with a history of severe asthma, eczema, or other atopic allergy
How should IV iron be given?
Patients should be closely monitored for signs of hypersensitivity during and for at least 30 minutes after every administration. In the event of a hypersensitivity reaction, treatment should be stopped immediately and appropriate management initiated.
Intravenous iron products should only be administered when appropriately trained staff and resuscitation facilities are immediately available.
Are test doses recommended with IV iron?
No, as these reactions can occur even when a previous administration has been tolerated (including a negative test dose). Test doses are no longer recommended and caution is needed with every dose of intravenous iron.
Should IV iron be given in pregnancy?
Intravenous iron should be avoided in the first trimester of pregnancy and used in the second or third trimesters only if the benefit outweighs the potential risks for both mother and foetus.
Due to it’s significant colouring (reddish-brown), which laboratory tests may be disrupted in a patient on Eltrombopag?
Creatinine and bilirubin
Why is the material of the containers that calcium gluconate is stored in particularly important? In which patient groups would you be most concerned?
MHRA has advised that repeated or prolonged administration of calcium gluconate injection packaged in 10ml glass containers in contra-indicated in children under 18 years and in patients with renal impairment owing to the risk of aluminum accumulation
In these patients the use of calcium gluconate injection packaged in plastic containers is recommended.
Which dose of pyridoxine is considered safe? Which doses are associated with serious side effects?
Prolonged use of pyridoxine in a dose of 10mg daily is considered safe but the long-term use of pyridoxine in a dose of 200mg or more daily has been associated with neuropathy.
The safety of long-term pyridoxine supplementation with doses above 10mg daily has not been established.
Parenteral thiamine can be associated with which type of reactions? Does this affect how it is given?
This potentially serious allergic adverse reactions may rarely occur during, or shortly after, parenteral administration
This should not prevent the use of parenteral thiamine in patients where this route of administration is required, particular in patients at risk of Wenicke-Korsakoff syndrome where treatment with thiamine is essential
Intravenous administration should be by infusion over 30 minutes
Facilities for treating anaphylaxis (including resuscitation facilities) should be available when parenteral thiamine is administered.
