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 Adverse Cases


Back Reported Adverse Drug Reaction Cases
Acute neuropsychiatric events with celecoxib and rofecoxib

Acute neuropsychiatric reactions are known to occur with the non-selective NSAIDs, and are mentioned in the product information for these medicines. It appears that they may also be a class effect for the selective COX-2 inhibitors, including celecoxib (Celebrex) and rofecoxib (Vioxx).

Table 2: More commonly reported acute neuropsychiatric reactions (Table gives number of reports of each event)

Adverse event

Celecoxib

Rofecoxib

Confusion

23

16

Somnolence

22

6

Insomnia

21

6

Hallucination

12

11

Depression

18

3

Abnormal thinking/ impaired concentration

15

4

Agitation

14

3

Abnormal dreaming/ nightmares

10

3

Amnesia

10

1

ADRAC has received 142 (5% of total) reports of acute neuropsychiatric reactions associated with celecoxib and 49 (8%) with rofecoxib. These report numbers have been calculated after exclusion of psychiatric events which might have been associated with other events such as a hypersensitivity reaction or hyponatraemia.

As Table 2 indicates, the most common events with celecoxib are confusion, somnolence and insomnia. As a proportion of the total reports, hallucination has been reported more commonly with rofecoxib than with celecoxib.

In many cases the onset of the reaction was dramatic. The event occurred within 24 hours of the first dose in 36 cases with celecoxib and in 14 cases with rofecoxib. In 12 and 4 cases, respectively, the reaction recurred with re-exposure to the drug. In one report marked restlessness was said to occur an hour and a half after taking celecoxib on three occasions, and in another vivid dreams developed on the nights that celecoxib was taken.

Prescribers should consider warning patients of the possibility of an acute neuropsychiatric reaction when celecoxib or rofecoxib are prescribed.

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