Published: 8 April 2024
Updated: 16 October 2024
Safety Information
Monitoring communication
Calcium channel blockers and the possible risk of new-onset eczema
Update to original communication
16 October 2024
During the monitoring period (8 April 2024 to 8 October 2024), Medsafe and the Centre for Adverse Reactions Monitoring (CARM) received 2 reports for eczematous dermatitis/rash with amlodipine and felodipine (NZ-Medsafe-157700, NZ-Medsafe-158888).
Currently, there is not enough information to confirm the risk of new-onset eczema with CCBs. Medsafe will re-investigate this concern if more information becomes available.
The data sheets of CCBs list known adverse reactions such as urticaria, rash, pruritis and erythema, and this is sufficient at this time.
The balance of benefits and risks of harm for calcium channel blockers remains positive and no further action is required at this time.
Original Communication
8 April 2024
Monitoring closes 8 October 2024
Medsafe is highlighting a possible risk of new-onset eczema with the use of calcium channel blockers (CCBs). The aim of this communication is to encourage further reporting to obtain more information on this potential safety concern.
This potential safety concern was triggered by a report received by the Centre for Adverse Reactions Monitoring (CARM). The report (CARM ID 148006) describes a 69-year-old male patient who was prescribed felodipine for hypertension. Several years after initiating treatment he was diagnosed with adult-onset eczema associated with calcium channel blocker use.
Products affected
More information
Medsafe's actions
Reporting adverse events
Products affected
Table 1: Calcium channel blockers – products and sponsors
| Product name* | Sponsor |
|---|---|
| Amlodipine | |
| Vasorex | REX Medical Limited |
| Diltiazem | |
| Cardizem CD | Pharmacy Retailing NZ Ltd |
| Diltiazem CD | Clinect NZ Pty Limited |
| Dilzem | Douglas Pharmaceuticals Limited |
| Felodipine | |
| Plendil ER | AstraZeneca Limited |
| Felo ER | Viatris Limited |
| Nifedipine | |
| Nyefax Retard | Douglas Pharmaceuticals Limited |
| Nimodipine | |
| Nimotop | Bayer New Zealand Limited |
| Verapamil | |
| Isoptin | Viatris Limited |
* The table only lists approved CCB products that currently have a published data sheet . However, this monitoring communication applies to all CCBs.
CCBs are used to treat hypertension (high blood pressure) and angina (tightness or pain in the chest). Verapamil is also used to treat arrhythmia (irregular heartbeat).1
More information
Eczema, also called dermatitis, is an itchy inflammatory condition of the epidermis (the outer layer of the skin). The clinical features of new-onset eczema include redness, swelling, the formation of bumps or blisters, oozing and weeping of the skin.2
Currently, the CCB data sheets list some signs and symptoms associated with eczema (itching, redness) but not eczema.
As of 18 March 2024, CARM has received six reports of eczema where the suspect medicine was a CCB. Of these reports, five were associated with felodipine and one with diltiazem.
See the consumer medicine information (CMI) and data sheet for advice on how to take these medicines and the known side effects.
Search for consumer medicine information and data sheets
Medsafe’s actions
We are placing this safety concern on the Medicines Monitoring ()
scheme to encourage reporting of new-onset eczema with calcium channel
blockers.
Reporting adverse events
Please report adverse events to medicines (side effects) to CARM. Anyone can submit a report.
References
- New Zealand Formulary (NZF). 2023. NZF v141: Calcium-channel blockers 1 March 2024. URL: https://nzf.org.nz/nzf_1340 (accessed 20 March 2024).
- Coulson I. 2022. Dermatitis. In: DermNet April 2022. URL: https://dermnetnz.org/topics/dermatitis (accessed 20 March 2024).
