PRAC recommendations on signals
PRAC recommendations on signals
On 8 February 2021, Pharmacovigilance Risk Assessment Committee (PRAC) provided recommendations on the signals discussed during the meeting of 11-14 January 2021.
The timeline recommended by PRAC for submission of variations following signal assessment is applicable to both innovator and generic medicinal products, unless otherwise specified.
PRAC recommendations on signals: Recommendations for update of the product information
- Adalimumab – Abnormal weight gain
Summary of product characteristics
4.8. Undesirable effects
Investigations
Frequency ‘Not known’: Weight increased
Package leaflet
- Possible side effects
Not known (frequency cannot be estimated from available data)
worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).
weight gain (for most patients, the weight gain was small)
2. Anastrozole – Depressed mood disorders
Summary of product characteristics
4.8. Undesirable effects
Tabulated list of adverse reactions
SOC Psychiatric disorders
Frequency ‘Very common’: Depression
Package leaflet
4 – Possible side effects
Very common side effects (affect more than 1 in 10 people)
Depression
3. Hydrocortisone – Adrenal crisis
Summary of product characteristics
4.2. Posology and method of administration
Changing from conventional oral glucocorticoid treatment to Alkindi
When changing patients from conventional oral hydrocortisone replacement therapy, crushed or compounded, to Alkindi, an identical total daily dose may be given. Alkindi is therapeutically equivalent to conventional oral hydrocortisone tablets formulations. Where a patient is changed from other oral hydrocortisone formulations to Alkindi, inaccuracy in the dosing possible with other oral hydrocortisone formulations can lead to a relative fall in hydrocortisone exposure on the same nominal dose, leading to symptoms of adrenal insufficiency or crisis (see section 4.4).
4.4. Special warnings and precautions for use
Adrenal crisis
Adrenal crisis can occur when switching from conventional oral hydrocortisone formulations, crushed or compounded, to Alkindi. Close monitoring of patients is recommended in the first week after switch.
Healthcare professionals should inform carers and patients that extra doses of Alkindi should be given if symptoms of adrenal insufficiency are seen. If this is required, then an increase in the total daily dose of Alkindi should be considered and immediate medical advice should be sought.
Package leaflet
2 – What you need to know before you give Alkindi
Warnings and precautions
– When your child is changing to Alkindi from another hydrocortisone preparation.
Differences between hydrocortisone preparations when changing to Alkindi may mean your child could be at risk of receiving an incorrect dose of hydrocortisone in the first week after switching to Alkindi. This may lead to a risk of adrenal crisis. You should watch your child carefully in the week after changing to Alkindi and give extra doses of Alkindi if there are symptoms of adrenal crisis such as unusual tiredness, headache, a raised or low temperature or vomiting. If this happens medical attention should be sought right away.
Recommendations for submission of supplementary information
| Product | Signal | Action for MAH | MAH |
| Alemtuzumab | Sarcoidosis | Requested Supplementary information
|
Sanofi Belgium |
| Clindamycin | Acute renal failure | Requested Supplementary
information
|
Pfizer |
| Eliglustat | Erectile dysfunction | Requested Supplementary
information
|
Genzyme Europe BV |
| Labetalol | Nipple pain and suppressed lactation | Requested Supplementary
information
|
Aspen Pharma |
| Rituximab | Sarcoidosis | Assess in the ongoing PSUSA (submission of response by 11 February 2021) | Roche Registration GmbH |
| Romosozumab | Cardiac arrhythmia | Requested Supplementary
information |
UCB Pharma S.A. |
| Secukinumab | Facial paralysis | Assess in the next PSUR (submission by 5 March 2021) | Novartis Europharm Limited |
| Secukinumab | Henoch-Schonlein purpura | Requested Supplementary
information
|
Novartis Europharm Limited |
| Sulfamethoxazol e, trimethoprim (co-trimoxazole) | Acute respiratory distress syndrome | Requested Supplementary
information
|
Roche, Eumedica Pharmaceuticals, Aspen Pharma, Teva |
| Sulfamethoxazol e, trimethoprim (co-trimoxazole) | Haemophagocytic lymphohistiocytosis | Requested Supplementary
information
|
Roche, Eumedica Pharmaceuticals, Aspen Pharma, Teva |
| Tramadol | Serotonin syndrome | Requested Supplementary
information
|
All MAHs for tramadol as single ingredient with the obligation to submit PSURs (The version of the EURD list published on 14 January 2021 should be used to determine the submission.) |
| Warfarin | Anticoagulant-related nephropathy | Requested Supplementary
information
|
Bristol-Myers Squibb |
Other recommendations
Hydrocortisone – Adrenal crisis
Action for MAH: Distribute a Direct Healthcare Professional Communication (DHPC) according to the text and communication plan agreed with the CHMP
Pembrolizumab – Systemic scleroderma
Action for MAH: Routine pharmacovigilance
PRAC recommendations on signals: To know more@ Click Here
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