Other safety alerts
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| The United Kingdom: Braltus (tiotropium): risk of inhalation of capsule if placed in the mouthpiece of the inhaler |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that it has received reports of patients who have inhaled a Braltus capsule from the mouthpiece into the back of the throat, resulting in coughing and risking aspiration or airway obstruction. Patients should be trained to place the Braltus capsule in the correct chamber of the Zonda inhaler
Braltus tiotropium 10 µg per delivered dose inhalation powder is a once-a-day maintenance bronchodilator treatment authorised to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). The inhalation powder is provided in capsules for inhalation using the Zonda inhaler device.
MHRA has received 2 Yellow Card reports of patients who have inhaled a Braltus capsule from the mouthpiece into the back of the throat. Both patients coughed up the capsule and recovered from the event. Health professionals have also observed that some patients have placed the capsule into the mouthpiece during training to use the inhaler device. It is essential that patients know never to place a capsule directly into the mouthpiece.
Healthcare professionals are advised:
- Train patients in the correct use of their inhaler; a placebo device is available for training purposes and instructions for patients are provided in the patient information leaflet and on the carton.
- Tell patients to store capsules in the screw-cap bottle provided (never in the inhaler) and to always check the mouthpiece is clear before inhaling.
- Pharmacists dispensing Braltus capsules should remind patients to always read the instructions for use in the package leaflet and that they must never place a capsule directly into the mouthpiece.
- Please continue to report adverse incidents during use of the inhaler as well as suspected adverse reactions to the medicine on a Yellow Card.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/braltus-tiotropium-risk-of-inhalation-of-capsule-if-placed-in-the-mouthpiece-of-the-inhaler
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, May 25, 2018
Issued at HKT 15:00
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