Abstract
Background: While dopamine agonists (DA) are effective in the control of Parkinson's disease, their use has recently decreased in Australia. This may be a consequence of unusual adverse events reported with ergot DAs being more widely appreciated.
Objectives: To examine the pattern of adverse event (AE) reporting of DAs in Australia over two decades and to determine if there is a class difference in the spectrum of AEs with ergot and non‐ergot DAs.
Methods: In Australia, there is voluntary reporting of suspected AEs of therapeutic medicines by health professionals and consumers. We analysed the case listings of AEs obtained from the Australian Committee on the Safety of Medicines (ACSOM) for bromocriptine, cabergoline, pergolide, pramipexole and ropinirole; and related them to drug utilisation as dispensed prescriptions (1992‐2012). The main outcome measures were nature, frequency, onset, novelty, severity and outcome of AEs.
Results: The 220 suspected AEs reported fell into five categories: (i) syncopal/ pre‐syncopal, (ii) fibrotic, (iii) psychotic, (iv) obsessive‐compulsive behaviours (OCB) and (v) increased sleep. Of note were differential lag times between initial individual drug registration and reporting of these suspected AEs. There was a lag of at least one year for fibrotic reactions and OCB compared to more contemporaneous reporting of other AEs. Fibrotic reactions appear to be class‐type AEs of ergot DAs, whereas symptomatic hypotensive reactions, psychosis and OCB occurred in both ergot and non‐ergot DAs, cabergoline and pramipexole, respectively. Reports of syncopal and pre‐syncopal reactions seemed to diminish as ergot DA use declined. Sleep pattern abnormalities were reported too infrequently to permit conclusions.
Conclusions: Consistent with published literature, the ACSOM data showed that ergot DAs share fibrotic reactions as a class AE. The remaining categories of AEs relate to individual medicines rather than a subclass.
Objectives: To examine the pattern of adverse event (AE) reporting of DAs in Australia over two decades and to determine if there is a class difference in the spectrum of AEs with ergot and non‐ergot DAs.
Methods: In Australia, there is voluntary reporting of suspected AEs of therapeutic medicines by health professionals and consumers. We analysed the case listings of AEs obtained from the Australian Committee on the Safety of Medicines (ACSOM) for bromocriptine, cabergoline, pergolide, pramipexole and ropinirole; and related them to drug utilisation as dispensed prescriptions (1992‐2012). The main outcome measures were nature, frequency, onset, novelty, severity and outcome of AEs.
Results: The 220 suspected AEs reported fell into five categories: (i) syncopal/ pre‐syncopal, (ii) fibrotic, (iii) psychotic, (iv) obsessive‐compulsive behaviours (OCB) and (v) increased sleep. Of note were differential lag times between initial individual drug registration and reporting of these suspected AEs. There was a lag of at least one year for fibrotic reactions and OCB compared to more contemporaneous reporting of other AEs. Fibrotic reactions appear to be class‐type AEs of ergot DAs, whereas symptomatic hypotensive reactions, psychosis and OCB occurred in both ergot and non‐ergot DAs, cabergoline and pramipexole, respectively. Reports of syncopal and pre‐syncopal reactions seemed to diminish as ergot DA use declined. Sleep pattern abnormalities were reported too infrequently to permit conclusions.
Conclusions: Consistent with published literature, the ACSOM data showed that ergot DAs share fibrotic reactions as a class AE. The remaining categories of AEs relate to individual medicines rather than a subclass.
| Original language | English |
|---|---|
| Article number | 536 |
| Pages (from-to) | 283-284 |
| Number of pages | 2 |
| Journal | Pharmacoepidemiology and Drug Safety |
| Volume | 23 |
| Issue number | S1 |
| DOIs | |
| Publication status | Published - Oct 2014 |
| Externally published | Yes |
| Event | 30th International Conference on Pharmacoepidemiology and Therapeutic Risk Management - Taipei International Convention Center, Taipei, Taiwan, Province of China Duration: 24 Oct 2014 → 27 Oct 2014 Conference number: 30th |