其 他 安 全 警 示
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| The United Kingdom: Pregabalin (Lyrica): reports of severe respiratory depression(English Only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines.
A recent European review of safety data considered reports of severe respiratory depression thought to be related to the action of pregabalin alone on the central nervous system (CNS). Given the available data on this risk, including spontaneous reports, and the plausible mechanism of action, the product information for medicines available in the United Kingdom will be amended to include new warnings for respiratory depression. The review identified a small number of worldwide cases of respiratory depression without an alternative cause or underlying medical conditions. In these cases, respiratory depression had a temporal relationship with the initiation of pregabalin or dose increase. Other cases were noted in patients with risk factors or underlying medical history. The majority of cases reviewed were reported in elderly patients.
Adjustments in dose or dosing regimen might be necessary in patients at increased risk of experiencing this severe adverse reaction, including patients: with compromised respiratory function or respiratory disease; with neurological disease; with renal impairment; using concomitant CNS depressants; older than 65 years.
The patient information leaflet that accompanies pregabalin is being updated to include warnings about breathing problems. The leaflet advises patients to seek medical help if they experience any trouble breathing or are taking shallow breaths related to their medicine. Pregabalin clearance is directly proportional to creatinine clearance, and dose reductions in patients with compromised renal function should be individualised.
In the United Kingdom, from Jan 2014 to 31 Dec 2020, MHRA has received 122 reports of respiratory depression or dyspnoea associated with pregabalin to the Yellow Card scheme. 80 of 122 cases report a CNS depressant as either a co-suspect or concomitant medicine alongside pregabalin. Co-administered CNS depressant medicines include opioids, benzodiazepines, and gabapentin.
Advice for healthcare professionals:
- Pregabalin has been associated with reports of respiratory depression, in some cases without concomitant opioid treatment.
- Consider whether adjustments in dose or dosing regimen are necessary for patients at higher risk of respiratory depression, this includes people: with compromised respiratory function, respiratory or neurological disease, or renal impairment; taking other CNS depressants (including opioid-containing medicines); aged older than 65 years.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/pregabalin-lyrica-reports-of-severe-respiratory-depression
In Hong Kong, there are 52 registered pharmaceutical products containing pregabalin. All products are prescription-only medicines. So far, the Department of Health (DH) has received 10 cases of adverse drug reaction related to pregabalin, but these cases are not related to respiratory depression.
Related news on the risk of serious side effects (including respiratory depression) associated with the use of pregabalin in combination with opioids, and serious breathing difficulties in patients using pregabalin who have respiratory risk factors, was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 18 Sep 2019, with the latest update posted on 1 Feb 2021. Letters to inform local healthcare professionals were issued by the DH on 18 Sep 2019.
In Jun 2020, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that safety information on the risk of central nervous system depression with opioids should be included in pregabalin-containing products. The risk of respiratory depression of pregabalin in patients with various risk factors is documented in overseas reputable drug references such as the “AHFS Drug Information". The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Friday, Feb 19, 2021
Issued at HKT 17:00
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