Safety updates for long-acting β2-agonists in the US
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Reactions 1069 - 17 Sep 2005 advisory to remind patients about appropriate long- Safety updates for long-acting acting β 2 -agonist use. 3 β 2 -agonists in the US See also Reactions 965: 2, 23 Aug 2003; 800863902 and Reactions 937: 2, 8 Feb 2003; 800863721 GlaxoSmithKline (GSK), AstraZeneca and Novartis 1. Health Canada. Updated safety information regarding the US FDA Pulmonary- have issued ‘Dear Health Care Professional’ letters to Allergy Drugs Advisory Committee meeting to review the safety of the long- advise of important Health Canada-endorsed safety acting beta agonists. Internet Document : [3 pages], 7 Sep 2005. Available from: information with regards to outcomes from the US FDA URL: http://www.hc-sc.gc.ca. 2. Health Canada. Foradil (formoterol fumarate) aerolizer dry powder capsules for Pulmonary-Allergy Drugs Advisory Committee’s inhalation safety update. Internet Document : [3 pages], 7 Sep 2005. Available (PADAC) safety review on long-acting β 2 -agonists, from: URL: http://www.hc-sc.gc.ca. including Novartis’ Foradil [formoterol], and GSK’s 3. Health Canada. Important updated safety information for SEREVENT (Rm) and reminder of its appropriate use in patients with asthma. Internet Document : [4 Serevent [salmeterol] and Advair [salmeterol/fluticasone pages], 7 Sep 2005. Available from: URL: http://www.hc-sc.gc.ca. propionate]. 1,2,3 AstraZeneca’s Oxeze [formoterol] was 800999599 not included in PADAC’s review. 1 Health risks with long-acting β 2 -agonists The three companies state that data from the US SMART study showed that salmeterol appeared to increase the risks of asthma-related death and other serious respiratory-related events, and data from a SMART post-hoc analysis suggested that these risks may be greater in African-American patients and in patients not using inhaled corticosteroids at study entry. 1,2,3 AstraZeneca and Novartis state that these risks may also apply to formoterol and other long-acting β 2 -agonists; 1,2 however, PADAC agreed that salmeterol and formoterol should remain commercially available. The companies say that Health Canada is conducting an ongoing safety review of formoterol, and that further action may be taken if needed. GSK says that it has updated the boxed warning section of Serevent to highlight the findings from SMART and the post-hoc analysis. 3 GSK has also updated the Warning section of Advair to highlight that it is unknown if the risks associated with Serevent would apply to Advair and to highlight that the dosage form prescribed should reflect the patients’ optimal inhaled corticosteroid need. Safety advice for long-acting β 2 -agonist use The following important safety advice was issued by the three companies: • Long-acting β 2 -agonists are an alternative, additional treatment for patients who have unsatisfactory symptom control despite optimal inhaled corticosteroid doses, and long-acting β 2 -agonists should be used in conjunction with and not as a substitute to inhaled corticosteroids; 3 furthermore, corticosteroids should not be stopped or reduced when long-acting β 2 -agonist treatment is added. • Long-acting β 2 -agonist doses should not exceed the maximum recommended dose, and patients should receive the lowest, most effective, dose. 1 • Long-acting β 2 -agonists, including Foradil, Serevent and Advair, should not be used to treat acute asthma symptoms, or initiated in patients with acutely deteriorating or significantly worsening asthma; 2,3 however, Oxeze Turbuhaler may be used on demand to treat acute symptoms in patients aged ≥ 12 years, but medical attention should be sought if relief bronchodilator therapy becomes less effective or if patients need more inhalations than usual. 1 Foradil recipients must also have a short-acting bronchodilator for acute symptoms. 2 • Patients should be educated to identify signs of deteriorating asthma control (increasing fast-acting bronchodilator use), and the need to seek prompt medical attention in such situations. 2,3 GSK states that Health Canada will issue a public 1 Reactions 17 Sep 2005 No. 1069 0114-9954/10/1069-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Transcript of Safety updates for long-acting β2-agonists in the US
Reactions 1069 - 17 Sep 2005
advisory to remind patients about appropriate long-Safety updates for long-actingacting β2-agonist use.3β2-agonists in the US See also Reactions 965: 2, 23 Aug 2003; 800863902and Reactions 937: 2, 8 Feb 2003; 800863721GlaxoSmithKline (GSK), AstraZeneca and Novartis1. Health Canada. Updated safety information regarding the US FDA Pulmonary-have issued ‘Dear Health Care Professional’ letters to
Allergy Drugs Advisory Committee meeting to review the safety of the long-advise of important Health Canada-endorsed safetyacting beta agonists. Internet Document : [3 pages], 7 Sep 2005. Available from:
information with regards to outcomes from the US FDA URL: http://www.hc-sc.gc.ca.2. Health Canada. Foradil (formoterol fumarate) aerolizer dry powder capsules forPulmonary-Allergy Drugs Advisory Committee’s
inhalation safety update. Internet Document : [3 pages], 7 Sep 2005. Available(PADAC) safety review on long-acting β2-agonists, from: URL: http://www.hc-sc.gc.ca.including Novartis’ Foradil [formoterol], and GSK’s 3. Health Canada. Important updated safety information for SEREVENT (Rm) and
reminder of its appropriate use in patients with asthma. Internet Document : [4Serevent [salmeterol] and Advair [salmeterol/fluticasonepages], 7 Sep 2005. Available from: URL: http://www.hc-sc.gc.ca.propionate].1,2,3 AstraZeneca’s Oxeze [formoterol] was 800999599
not included in PADAC’s review.1
Health risks with long-acting β2-agonistsThe three companies state that data from the US
SMART study showed that salmeterol appeared toincrease the risks of asthma-related death and otherserious respiratory-related events, and data from aSMART post-hoc analysis suggested that these risks maybe greater in African-American patients and in patientsnot using inhaled corticosteroids at study entry.1,2,3
AstraZeneca and Novartis state that these risks may alsoapply to formoterol and other long-acting β2-agonists;1,2
however, PADAC agreed that salmeterol and formoterolshould remain commercially available. The companiessay that Health Canada is conducting an ongoing safetyreview of formoterol, and that further action may betaken if needed.
GSK says that it has updated the boxed warningsection of Serevent to highlight the findings from SMARTand the post-hoc analysis.3 GSK has also updated theWarning section of Advair to highlight that it is unknownif the risks associated with Serevent would apply toAdvair and to highlight that the dosage form prescribedshould reflect the patients’ optimal inhaledcorticosteroid need.
Safety advice for long-acting β2-agonist useThe following important safety advice was issued by
the three companies:• Long-acting β2-agonists are an alternative, additional
treatment for patients who have unsatisfactorysymptom control despite optimal inhaledcorticosteroid doses, and long-acting β2-agonistsshould be used in conjunction with and not as asubstitute to inhaled corticosteroids;3 furthermore,corticosteroids should not be stopped or reducedwhen long-acting β2-agonist treatment is added.
• Long-acting β2-agonist doses should not exceed themaximum recommended dose, and patients shouldreceive the lowest, most effective, dose.1
• Long-acting β2-agonists, including Foradil, Sereventand Advair, should not be used to treat acute asthmasymptoms, or initiated in patients with acutelydeteriorating or significantly worseningasthma;2,3however, Oxeze Turbuhaler may be usedon demand to treat acute symptoms in patients aged≥ 12 years, but medical attention should be sought ifrelief bronchodilator therapy becomes less effectiveor if patients need more inhalations than usual.1Foradil recipients must also have a short-actingbronchodilator for acute symptoms.2
• Patients should be educated to identify signs ofdeteriorating asthma control (increasing fast-actingbronchodilator use), and the need to seek promptmedical attention in such situations.2,3
GSK states that Health Canada will issue a public
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Reactions 17 Sep 2005 No. 10690114-9954/10/1069-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
