The Value Of Clinical Appraisal

Personal examination of all events resulted in the identification of a new adverse reaction to sumatriptan. Aggravation or activation of pain was noted at sites of trauma or inflammation in 22 reports. The varied descriptions did not link them with any particular body system or organ and there was no reaction or event term in use which could be used to identify these events. Recall of the various events by the reviewer resulted in linking

Table 27.5. Titles of articles in Prescriber Update (First issue 1993).

Adverse respiratory reactions to long-acting beta-agonists. 1999

Top 10 adverse events to sumatriptan in the IMMP. 1998 Top 10 adverse reactions with Multiload Cu375 in the IMMP. 1997

Top 10 adverse reactions to omeprazole in the IMMP. 1997

Interactions with fluoxetine and other SSRIs. 1997 Top 10 adverse reactions to fluoxetine in the IMMP. 1996

Top 10 adverse reactions to moclobemide in the IMMP. 1996

Sumatriptan in the media. 1996

Interactions with moclobemide and serotonergic antidepressants. 1996

Omeprazole and bacterial overgrowth in the gut. 1995 Selective serotonin reuptake inhibitors and hyponatraemia. 1994

Chest pain and sumatriptan in the IMMP. 1994 Adverse effects of omeprazole. 1993

Table 27.6. Titles of recent articles in the New Zealand Family Physician.

Specialist only drug snags may present to CPs first (nefazodone, olanzapine, tolcapone and Mirena). 1999 Salmeterol and eformoterol monitoring: progress report. 1999

Reactions to omeprazole obscured by ageing process. 1998

Psychiatric and behavioural responses to sumatriptan (Imigran). 1997

Interim results of Multiload Cu375 monitoring reassuring. 1997

Moclobemide and fluoxetine compared. 1996

Beta2 agonists under scrutiny. 1996

Sumatriptan and possible autonomic imbalance. 1995

Monitoring of omeprazole. 1995

Further experience with monitoring sumatriptan

(Imigran). 1995

Lipid lowering agents and reasons for cessation of therapy. 1994

Fluoxetine interactions. 1993 Early experience with sumatriptan. 1993 Bezafibrate, gemfibrozil and simvastatin. 1992 Early results from moclobemide. 1991 A review of reactions to ACE inhibitors. 1990 ACE inhibitors and pancreatitis. 1990 Experience with aciclovir. 1990

Table 27.7. Signals arising

from the sumatriptan cohort.

Amnesia

Muscle weakness

Angioedema

Myalgia

Anxiety

Pain inflammation

Apnoea

activated

Autonomic disturbance

Pain trauma activated

Chest pain

Panic

Confusion/disorientation

Rebound headache

Depersonalisation

Rigors

Depression

Sensory disturbance

Dry mouth

Somnolence

''Flight or fight'' reaction

Sweating

Hallucinations

Tachycardia

Ischaemic optic

Tachyphylaxis/tolerance

neuropathy

Throat tightness

them to a common syndrome which was named "pain activation syndrome'' (Coulter, DM, presentation at the 19th Annual Meeting of National Centres Participating in the WHO International Drug Monitoring Programme, Switzerland, 1997). "Pain trauma activated'' and "pain inflammation activated'' were terms adopted in WHOART. With the varied presentation and absence of specific terms for the events, it is unlikely that this syndrome could have been identified by automated signal generation.

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