Reactions 1329 - 27 Nov 2010

Pramipexole/ropinirole

Nasal congestion: 5 case reportsFive women aged within the range of 51-70 years

experienced nasal congestion during treatment withpramipexole or ropinirole [routes and frequencies notstated]. These cases were reported to the NetherlandsPharmacovigilance Centre Lareb.

Three women received ropinirole at 0.5-5mg for restlesslegs, sleep disorders or Parkinson’s disease, and twowomen received pramipexole 0.125mg for restless legs. Alldeveloped nasal congestion, beginning 1 day to 3 monthsafter either initiation or dosage increase. Two patientsdeveloped additional symptoms, including somnolence,insomnia and "tearing eyes". In one patient, who wasreceiving ropinirole tablets, congestion occurred every30 minutes after evening administration, initially lasting for2 hours, but later continuing for the whole night. Inanother, congestion developed "shortly after"administration, recovering within the night. Her congestionrecurred with the following dose.

The implicated drug was discontinued in two women;one recovered, and the other received xylometazoline andwas recovering at last follow-up. The woman who had nochange in her pramipexole recovered. In the two whocontinued receiving ropinirole, one had not recovered atlast observation, and the outcome for the other isunknown.

Author comment: "The relation between nasal congestionand pramipexole or ropinirole use is supported by the reportsin the Lareb database and a possible mechanism. However,we cannot exclude that other factors, such as the underlyingdisease or allergy, may have played a role in the occurrenceof the reactions."Lareb. Ropinirole, pramipexole and nasal congestion. Internet Document : [4pages], 2010. Available from: URL: http://www.lareb.nl - Netherlands 801108839

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Reactions 27 Nov 2010 No. 13290114-9954/10/1329-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved