Published: 2 March 2017

Gathering Knowledge from Adverse Reaction Reports

Prescriber Update 38(1): 9
March 2017

Adverse reaction reporting is an important component of medicine safety monitoring. Case reports can highlight significant safety issues concerning therapeutic products and their use.

In this new section of Prescriber Update, a selection of informative cases from the Centre for Adverse Reactions Monitoring (CARM) database is presented.

CARM ID: 121331
Age: 26
Gender: Female
Medicine(s): Cyproterone + ethinylestradiol
Pulmonary embolism
The pulmonary embolism occurred more than 5 years after starting cyproterone + ethinylestradiol, which was being used for contraception.
The Ginet data sheet ( states that it is not recommended in women solely for contraception. It is indicated as oral contraception in women requiring treatment for androgen-dependent diseases including acne. In general, treatment should be continued over several months. The length of use depends on the severity of the treated condition and the patient's response. It is recommended to take Ginet for at least another three to four cycles after the signs have subsided.
CARM ID: 117663
Age: 63
Gender: Male
Medicine(s): Betamethasone + calcipotriol
The patient experienced an increase in blood sugar levels and a loss of diabetes control after using a betamethasone-containing product (Daivobet). This case highlights the possibility that systemic effects can occur with topical administration of corticosteroids.
The Daivobet data sheet ( states that adverse impact on the metabolic control of diabetes mellitus may also occur during topical corticosteroid treatment due to systemic absorption. Be aware of systemic effects in patients using topical corticosteroids.