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Why is Alvesco prescribed for children under 12 ?

On their website it says do not use for children under 12 but than on the Canadian Fact sheet it sees that practitioners can prescribe it for kids age 6 and up?

  1. Great question! I will attempt to answer your question. The difference in age recommendations often comes down to the way medications are studied and approved in different countries. In the U.S., the FDA label for Alvesco specifies it for children 12 and older, likely because the initial studies submitted for approval didn’t include younger children. In Canada, additional clinical experience or studies may have allowed practitioners to safely prescribe it for children as young as six.

    Doctors sometimes prescribe medications 'off-label'—meaning outside the approved age range—when there's sufficient evidence from clinical practice or studies to suggest it’s safe and effective. Alvesco is an inhaled corticosteroid (ICS), a class of medications that has been used safely and effectively to treat asthma since the 1980s. Over time, physicians have gained confidence in its safety for younger patients with asthma, even though regulatory labels may not always reflect this broader experience. Do you find this brief response helpful? John. community moderator.

    1. Thank you for your reply, your explanation makes a lot of sense. I wonder if there are any legal risks this sort of practice brings if it was not tested on patients for that age range and something happens to the patient that has been perscribed the medication but does not fall within that age range, who resumes responsibility for the patients suffering? Would it be the doctor who decided to perscribe the medication, or the parent who decided to give the medication to the child despite the packaging stating that it is not suitable for patients that fall outside of that age category. Thank you again for answering my question it is very helpful.

      1. Your concern for the well-being of patients is quite valid. From what I understand it should be a collaboration. Each party - the parent and the doctor - has their roles when considering the safety of a prescribed medication and its legal risks depending upon the specific circumstances involved. I would think it is such a complex issue that having continued open communication between doctor and parent is paramount when exploring options necessary to manage a child's chronic health condition. I truly understand your concern on this topic. My daughter has been asthmatic since birth and weeding through the recommendations and options was quite difficult. I didn't want to create more issues than what we were treating. Eventually agreeing on a treatment plan - we moved forward. I hope this helps. thoughtfully, Rebecca (team member)

    2. Thank you Rebecca for providing me with your experience, knowledge and perspective. I think your approach also makes sense. I will discuss the right treatment plan for my daughter with our doctor. It sure is a difficult journey for my daughter and myself but I have heard of many adults who were on inhalers as children only needed the inhalers occasionally as adults and some not needing them at all. It makes me hopeful that there is a good chance for a great outcome in the end. Thank you for your insights.

      1. It’s quite encouraging to know that many children outgrow asthma or find it easier to manage as adults. As I've transitioned to using my inhaler only occasionally and on managed asthma treatment, I appreciate your hopeful perspective. Your strength and support will be crucial in guiding your daughter through this journey. Sending strength your way - Rebecca (team member)

      2. Thank you for sending me and my daughter strength. May this year give us all continued strength and knowledge. Wishing you a year full of health.

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