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Do you know how to report adverse side effects from PF medications?
The medications that pulmonary fibrosis patients must take often come with side effects. Here in the forums, I have read a number of comments asking if anyone else experienced (insert side effect) after taking (insert drug name).
You should always inform your care team of any side effects you recognize.
Did you know you should also report them to the FDA and/or the pharmaceutical manufacturer? Have you ever heard of Medwatch?
Can we do something different? I’d love to see what you all find. Come back and share one thing you learned about reporting adverse side effects with the group.
Patient reporting is here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1
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12 Replies
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One difficulty I have with reporting side effects is that I’m often unsure whether the issue is a side effect of the medication, or of some other medication, or merely of old age. That makes it difficult to decide to report the issue, in case it is from another cause rather than from my Esbriet.
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That is a good point, Jeffrey. If you suspect it is associated with one of your medications, it is worth reporting. You can also report it as a possible interaction with another medication, which is also important. Personally, I err on the side of reporting.
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Last 4 days I’ve been experiencing tachycardia, first episode was around 4-5 hours, pulse would go from 160ish down to 60, then back up sometimes. Mostly it stayed high. I started Tyvaso for PH 3 weeks ago and cardiologist started me on HCTZ around the same time since BP was running high. I was so afraid. Didn’t take either of those meds next day, much better, yesterday went back to both meds, started again. Today I’ve decided the Tyvaso is most critical so trying just it. It is weekend, can’t face ER, seeing cardiologist tomorrow. NP at pulmonology said it couldn’t be that and brushed me off.
My question, Sam, when to report and what to report? I feel like I’m in the process of figuring it out, i think the HCTZ will be changed tomorrow.
Thanks for your help!
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Hi Scherry,
Your situation is not that unusual, as different drug combinations can either amplify or mask side effects. Because you are doing your own work to narrow down which might be causing the issue, you are on the right track. Look at the link above. The FDA MedWatch form walks you through how to report the information.
I find the form to be rather straightforward. Let me know what you think.
Sam…
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With Tyvaso DPI, it can cause some diarrhea, coughing, and emotional drama, but it is helping. I talk to the pharmacist each month before reordering. Jascayd seems okay, but I have read of people getting back pain from it – need to keep an eye on that one.
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I saw a number of people reporting back pain from Jascayd here and on other social media sites, prompting me to ask the question about reporting adverse side effects.
Sam…
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Yes, I have been taking Jascayd concomitantly with Ofev and have noticed an increase in lower back pain….
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I reported severe, debilitating back pains after taking Jascayd for seven days, stopped taking it and within two days the back pain disappeared. I suspected it was pain associated with the kidneys as opposed to muscular and/or skeletal as it was on both sides in the vicinity of the kidneys.
I first reported it to my pulmonologist and then to the prescribing pharmacy at which time I cancelled further use of the prescription; I am continuing to take OFEV. The response from the pharmacy/manufacturer is that less than 5% of the users report this issue so it is “not common” and is listed last under “side effects”.
Bottom line is, “user beware” and be your own best advocate!
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Hi @SLB,
I’m so sorry to hear about your side effects with Jascayd. You did the right thing reporting adverse effects to your pulmonologist and the pharmacy but I wonder if there is a patient care or patient support program associated with the drug developer? I know Boehringer Ingelheim (BI) has OFEV but I’m not sure who developed Jascayd; however, I know BI has a contact for patients who experience adverse effects and I would imagine Jascayd would too given its a new drug. Maybe try there? I’m glad you’re tolerating one of the anti-fibrotic medications still.
Take care,
Charlene.
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Charlene…
Thank you for your comments and yes, I have talked with a representative from Jascayd. In fact I have talked with three different individuals as I think different departments want to obtain as much information as possible. As I noted in the original comment, it was in the forum that I noticed other individuals with back issues and that was what started me to investigate further…very valuable source of first-hand information!
Cheers!
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Jascayd is also made by BI and they have patient advocates for it.
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Reporting it to your pulmonologist, pharmacist, and BI advocate are all important. I also encourage you to report it to the FDA. The FDA is responsible for tracking these reports.
Sam…
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