Under Reporting on Side Effects

[PJBinMI]

Earlier this week, I read an article on Medscape (a good resource for medical info) about pharmaceutical companies not adequately reporting side effects of drugs in clinical trails and newly FDA approved. If I understood the article accurately, side effects are grouped in ways that can obscure just how difficult/dangerous some side effects really are. This did not surprise me one bit! A friend of mine died when neither her oncologist or pulmonologist realized a connection between the "acute pulmonary collapse' that put her in ICU and the Afinitor that had recently become FDA approved and that she had been on for a few weeks. They kept administrating it to her and she died after about a month in the hospital. Then, in 2016, I was on Ibrance for almost ten cycles and developed breathing problems that were diagnosed as Interstitial Lung Disease, which has not lessened in the two years I've been off Ibrance, and which makes me get out of breath easily and especially in the kind of humid weather we had this summer. Both my oncologist and my pulmonologist believe that Ibrance caused the ILD. Another thing I learned through this experience of mine is that doctors are not required to report side effects (or deaths!) to the FDA or drug companies and many find it too time consuming. I have been wondering if either the FDA or the drug companies are required to give patients information about reported side effects when they ask for that info. I'd like to know how many others have had serious lung issues from Ibrance or Afinitor, for example. I have been living with mbc for over 14 years and my biggest day to day issues with my health have been unrelated to cancer until this breathing thing came up. I am now on 2 breathing meds and developed atrial fibrillation, which can be caused by ILD! Talk about multiplying problems............

We can report side effects ourselves, on line, to the FDA and some drug companies and I encourage anybody who has side effects, even minor ones, so the data becomes more well known.

[Barbteeth]

Hi

This is a bit scary

When I was practicing as a mere dentist we would get forms sent to us occasionally about a drug and would be required to report any side effects

However if the patients don’t tell us about these then how can we report it?..Obviously I’m talking about normal drugs here not these horrid ones we have to take with possible serious side effects

I think the patient..I.e us ladies should definitely be proactive and report any adverse effects to our oncologist or GP..I’m sure this information will be passed on to the FDA..if that isn’t happening then definitely report directly ourselves..so terrible that a life was wasted and you’re still suffering from reacting to Ibrance

Barb xx

[Jerseygirl45]

I agree! I went on Afinitor Aug 5,2018. Started having side effects bad taste, no appetite, loss of weight, mouth sores, acne, finger nail fell off, toe fungus, shortness of breath, fever, chills, UTI. I tried to take it as long as I could since it seem to be helping my back and arm. But I was so sick by thenI went to the ER and was admitted with pneumonia. They said the Afinitor had infiltrated my lungs. One of the doctors had me sign a release form so she could write an article warning of my side effects. I still get lung scans to be sure it is better. I was only on it for 7 weeks.Yet other people have no side effects. But we are told the side effects we may have before we take it. That is why I am waiting for my petscan from last week. I want to see if my. Suffering did any damage to my cancer cells. Let's hope it did.

[mariootsi in reply to Jerseygirl45]

Here's hoping!

[Rhwright12]

Thanks for the reminder to report!

I think they Infusion rooms should give us the fact sheets with each new drug. I got them in the beginning. But when I switched to Xgeva from Zometa I didn’t. Then I got a rash and was looking on the internet for something else and discovered the rash should have been reported as it’s a sign of a severe reaction...oops 😱 who knew! I knew it was a reaction but didn’t think it could have been a sign of something worse!

[diamags]

Side effects are printed on (or inside) the boxes the drugs come in ie. Faslodex -- you can ask for the piece of paper. There's a lot of scary information on those forms including data on length of survival as well as chemistry that goes well above my college chemistry classes! You can also find the information on line. During clinical trials, they do have to report all side effects, so that's why sometimes you'll see some that 2 people out of 2000 have had.

[PJBinMI in reply to diamags]

But what this article was saying is that the drug companies do not fully disclose the severity of side effects--they often assess something that a patient finds intolerable as a mild side effect or not even list it. And doctors are not required to report, so some side effects are not brought to their attention. Those listings that come with our meds are often very incomplete compared to what patients experience in the real world of living with mbc.

[hdhonda]

We all should probably report side effects to our doctor and to the FDA. Making sure the FDA gets the information is so important to everyone. Blessings, Hannah