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important announcement from FDA

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Forum Name: TNBC Metastasis/Recurrence Users
Forum Description: A place to discuss metastatic disease
Printed Date: Apr 16 2021 at 9:40pm
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Topic: important announcement from FDA
Posted By: SagePatientAdvocates
Subject: important announcement from FDA
Date Posted: Sep 16 2019 at 8:40am
Dear Beloved TNBC Family,

I have been crazy busy helping folks, so I rarely post; but this email, received from MedPage, this morning, hit my eye. 

I am currently helping a woman with a miserable cough (that she has had for months) and I asked her yesterday on the phone what her oncologist said about it and she said "they told me it has nothing to do with my metastatic breast cancer." I have sent her this article to her this morning and ask her to check with her Breast Medical Oncologist to see if this pertains to her.

I also just went to my PMs and saw that I have received some PMs that I was unaware of and, therefore, had not responded. My apologies to those who wrote. I will try to reply in the next few days, And also will speak to the powers that be on TNBC Foundation to find out why I have not received certain messages.

In any event, my heart remains with all of you.

with love to all here,


Donna, can you help please...I will write you separately. Having trouble posting this link. Didn't see anyone posting it but maybe a duplicate" rel="nofollow -

Reports of ILD, pneumonitis in patients on CDK4/6 inhibitors
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  • mailto:?subject=MedPage%20Today%20News:%20FDA:%20Novel%20Breast%20Ca%20Drugs%20Linked%20to%20Severe%20Lung%20Illness&body=I%20thought%20you%20would%20like%20to%20read%20the%20attached%20article:DADAFDA:%20Novel%20Breast%20Ca%20Drugs%20Linked%20to%20Severe%20Lung%20IllnessDADAClick%20,%20once-daily,%20Medical%20News%20Daily%20Headlines%20Email.DADAMedPage%20Today%28R%29%20provides%20physicians%20and%20other%20healthcare%20professionals%20real-time%20coverage%20of%20breaking%20medical%20news,%20the%20top%20stories%20in%20health%20and%20medicine,%20and%20interesting%20and%20illuminating%20opinion%20pieces%20from%20those%20working%20all%20over%20the%20medical%20map." rel="nofollow -
  • by  Deputy Managing Editor, MedPage Today

WASHINGTON -- The" rel="nofollow - FDA issued a warning  Friday that CDK4/6 inhibitors for advanced breast cancer may cause rare but severe lung inflammation, and said fatalities had been reported.

Package warnings have been added to the three approved agents in the class -- palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio) -- and breast cancer patients taking these agents should be monitored for pulmonary symptoms indicative of either pneumonitis or interstitial lung disease (ILD).

"The overall benefit of CDK4/6 inhibitors is still greater than the risks when used as prescribed," the agency said in the statement announcing the move. But clinicians should suspend treatment in patients "who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe ILD and/or pneumonitis."

Data from completed and ongoing postmarketing trials involving CDK4/6 inhibitors were reviewed and revealed the connection, the FDA said, but factors to identify at-risk patients have not been found.

Signs and symptoms of ILD and pneumonitis can include "hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded."

I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates

Posted By: Kellyless
Date Posted: Sep 16 2019 at 10:30am
So wonderful to see you post Heart Stephen and I think of you often. I'm at 2 1/2 years NED, I'm very grateful to be one of the many lives you helped save. I'd really like to catch up with you when we're thru moving, I'd love to bounce a few things off of you. Hope you and yours are well! Hug

This FDA warning is terrifying. Thanks for posting. 

(Yes, we are just now moving...tomorrow..It's been a process. Never ever ever moving again. Never.)

IDC, 2.2 cm, Stage IIb,lumpectomy 1/30/09 ACx4,Tx4 36 rads
6/1/16 Local recurrence same breast, same spot 1.8cm Carb.4x every 3 wks, Taxol 12x once wk. Dbl Mast. PCR!! Reconstruction fail, NED!

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