Eye, ENT and Skin MHRA alerts

Question 1

What is a consequence of the reformulation of Latanoprost?

Answer 1

Increased reporting of eye irritation since reformulation to allow it to be stored at room temperature.

Question 2

When would you consider stopping treatment due to the side effects of latanoprost?

Answer 2

Patients should e advised to tell their health professional promptly (within a week) if they experience eye irritation (e.g. excessive watering) severe enough to make them consider stopping treatment. Review treatment and prescribe a different formulation if necessary.

Question 3

Which formulation of hydrocortisone should not be used off-label for adrenal insufficency in children? Why?

Answer 3

Muco-adhesive buccal tablets.

Substitution of licensed hydrocortisone formulations with muco-adhesive buccal tablets can result in insufficient cortisol absorption and in stress situations, life-threatening adrenal crisis

Question 4

What are hydrocortisone muco-adhesive buccal tablets licensed for?

Answer 4

Hydrocortisone muco-adhesive buccal tablets are indicated only for local use in the mouth for aphthous ulceration and should not be used to treat adrenal insufficiency

Question 5

What are the safety risks associated with use of emollients?

Answer 5

Risk of severe and fatal burns with paraffin-containing and paraffin-free emollients.

There’s a fire risk associated with the build-up of residue on clothing and bedding.

Question 6

What should patients/carers be advised about emollients?

Answer 6

Healthcare professionals should advise patients not to smoke or go near naked flames because clothing, bedding, dressings, and other fabrics that have been in contact with an emollient or emollient-treated skin can rapidly ignite.

Washing these materials at high temperature may reduce emollient build-up but not totally remove it.

Question 7

What safety risks are associated with head lice products? What should be avoided when using these products?

Answer 7

Head lice eradication products: risk of serious burns if treated hair is exposed to open flames or other sources of ignition

Patients and carers should be advised on the safe and correct use of head lice eradication treatments and if appropriate, should be advised that they should not smoke around treated hair and that it should be kept away from open flames or other sources of ignition, including in the morning after overnight application until hair is washed.

Question 8

What sexual side effects may be seen with isotretinoin?

Answer 8

Erectile dysfunction and decreased libido

Question 9

What neurological side effects may be seen with isotretinoin?

Answer 9

Neuropsychiatric reactions have been reported in patients taking oral retinoids.

Healthcare professionals are advised to monitor patients for signs of depression or suicidal ideation and refer for appropriate treatment, if necessary; particular care is needed in those with a history of depression. Patients should be advised to speak to their doctor if they experience any changes in mood or behaviour, and encouraged to ask family and friends to look out for any change in mood

Question 10

Women should be under which programme when taking oral retinoids?

Answer 10

PPP

Question 11

Which oral retinoids requires patients to be on the PPP?

Answer 11

Acitretin, alitretinoin, or isotretinoin

Question 12

What is the conctraception advice associated with isotretinoin?

Answer 12

Effective contraception must be used.

Females must practise effective contraception for at least 1 month before starting treatment, during treatment, and for at least 1 month after stopping treatment.

Question 13

What should patients do if they become pregnant during treatment with isotretinoin?

Answer 13

Females should be advised to discontinue treatment and to seek prompt medical attention if they become pregnant during treatment or within 1 month of stopping treatment.

Pregnancies occurring during treatment and within 1 month following discontinuation of
treatment should be reported to the MHRA

Question 14

When should a pregnancy test be done with isotretinoin ?

Answer 14

In females of childbearing potential, exclude pregnancy a few days before treatment, every month during treatment (unless there are compelling reasons to indicate that there is no risk of pregnancy), and 4 weeks after stopping treatment.

Question 15

What type of contraception should not be used as it is not considered effective enough?

Answer 15

Oral progestogen-only contraceptives are not considered effective.

Barrier methods should not be used alone, but can be used in conjunction with other contraceptive methods.

Question 16

How long must a patient on isotretinoin wait before donating blood?

Answer 16

Not to donate blood during Isotretinoin therapy and for one month after discontinuation due to the potential risk to the foetus of a pregnant transfusion recipient.

Question 17

When should isotretinoin be used in the treatment of acne?

Answer 17

Severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy

Question 18

In the context of oral retinoids, what is classed as a woman who has the potential for pregnancy?

Answer 18

A woman has a potential for pregnancy if one of the following applies:

Is a sexually mature woman who:

1. has not had a hysterectomy or bilateral oophorectomy
2. is not in a natural postmenopause for a minimum of 24 consecutive months (i.e., menstruated at a certain point in the last 24 consecutive months).

Question 19

Brimonidine gel carries what cardiovascular risk?

Answer 19

Systemic cardiovascular effects including bradycardia, hypotension and dizziness have been reported after application of brimonidine gel.

To minimise the possibility of systemic absorption, it is important to avoid application to irritated or damaged skin, including after laser therapy.

Question 20

How should brimonidine gel be applied?

Answer 20

Treatment should be initiated with a small amount of gel (less than the maximum dose) for at least 1 week, then increased gradually, based on tolerability and response.

Patients should be counselled on the importance of not exceeding the maximum daily dose, and advised to stop treatment and seek medical advice if symptoms worsen during treatment.