Safety Alerts & Recalls

What does this mean?

The benefits of using Spiriva (tiotropium) Respimat and HandiHaler continue to outweigh the risks for most patients. If you have been prescribed Spiriva Respimat or Handihaler you should continue to use as directed. Both the Respimat and HandiHaler formats contain the same active ingredient, but Respimat is prescribed to patients who are unable to use the HandiHaler device. Previous studies had suggested that patients with heart rhythm disorders were at increased risk of side effects when using the Respimat compared to the HandiHaler, but a new study suggests that any risks are similar. If you have any questions about the contents of this alert or your treatment with Spiriva you should ask your doctor or pharmacist for advice.

MHRA Advises Healthcare Professionals that Spiriva Respimat and Handihaler Have Similar Benefits and Risks

The Medicines and Healthcare Products Regulatory Agency (MHRA) has advised healthcare professionals that there is no significant difference in the risk of death from any cause between Spiriva (tiotropium) Respimat and Spiriva HandiHaler. This advice has been given in light of the most recent study into the issue. Previous studies had suggested that more people died while using the Respimat than the HandiHaler. Patients with heart rhythm disorders are thought to be at an increased risk of side effects from Spiriva. Previous advice was to use Spiriva Respimat with caution in patients with heart rhythm disorders, but in light of this latest study the MHRA will add a warning to the summary of product characteristics for both Respimat and HandiHaler formats that they should be used with caution in this group of patients.

Spiriva Respimat and HandiHaler contain the medication tiotropium and are used to treat chronic obstructive pulmonary disease.

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Source: MHRA
Publication Date: 2015-02-19
Last Updated: 2015-02-19

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