ketotifen undergoes postmarketing surveillance

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Ketotifen Undergoes Postmarketing Surveillance But 8291 patients show up nothing new 19,252 patients were enrolled in a postmarketing surveillance study, the objectives of which were to study 10 ,000 patients treated with ketotifen for 1 year recording efficacy and adverse effects, and to provide prescribers with such information. In addition to initial information at the time of registering, record forms were completed at 3, 6, 9 and 12 months during ketotifen treatment. 8291 patients completed record forms for the full 12 months. For all study patients the average age was 42 years; 36% of patients were more than 50 years old Consideration of the distribution of asthma type showed extrinsic asthma falling to 28%, and intrinsic asthma rising to 65%, at 70 years of age. Adverse events occurred with an incidence of 27% at 3 months and 7% at 12 months Most commonly occurring were sedation, dizziness, nausea, headache, dry mouth, weight gain, worsening of asthma, bronchospasm and status asthmaticus. No deaths were attributed to the agent. At 3 months 76% of patients reported ketotifen to be efficacious, while at 12 months 94% found it to be efficacious (non-responders and those experiencing adverse events having been excluded). The main information from this study was already known. 'It remains to be seen whether this expensive type of surveillance is of value in the continuing search for control and safety in prescribing.' Mac/ay Vol P et at British Medical Journal 288. 911 (24 Mar 1984) 10 INPHARMA@ 5 May 1984 0156-2703/84/ 0505-0010/0$01.00/0 © ADIS Press

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Ketotifen Undergoes Postmarketing Surveillance But 8291 patients show up nothing new

19,252 patients were enrolled in a postmarketing surveillance study, the objectives of which were to study 10,000 patients treated with ketotifen for 1 year recording efficacy and adverse effects, and to provide prescribers with such information. In addition to initial information at the time of registering, record forms were completed at 3, 6, 9 and 12 months during ketotifen treatment. 8291 patients completed record forms for the full 12 months. For all study patients the average age was 42 years; 36% of patients were more than 50 years old Consideration of the distribution of asthma type showed extrinsic asthma falling to 28%, and intrinsic asthma rising to 65%, at 70 years of age.

Adverse events occurred with an incidence of 27% at 3 months and 7% at 12 months Most commonly occurring were sedation , dizziness, nausea, headache, dry mouth , weight gain, worsening of asthma, bronchospasm and status asthmaticus. No deaths were attributed to the agent. At 3 months 76% of patients reported ketotifen to be efficacious, while at 12 months 94% found it to be efficacious (non-responders and those experiencing adverse events having been excluded).

The main information from this study was already known. 'It remains to be seen whether this expensive type of surveillance is of value in the continuing search for control and safety in prescribing.' Mac/ay Vol P et at British Medical Journal 288. 911 (24 Mar 1984)

10 INPHARMA@ 5 May 1984 0156-2703/84 / 0505-0010/0$01.00/ 0 © ADIS Press