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When a drug does serious harm, the FDA wants to hear from you

August 24, 2017


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Diane Vliem
October 22, 2017

I was in a research study through Amgen for the use of denocimab (Prolia) to prevent breast cancer from traveling to bones.
After five years of injections every three months, my DEXA scan showed “normal” for the first time in decades. However, after two years of being off the drug, I suffered compression fractures in L3,L4, and L5, with no fall or impact. I had two months of exacerbating PT before an MRI correctly diagnosed the fractures.
I now have spinal pain with muscle spasms. I was prescribed Forteo injections for two years, and have hopes of getting my active life back.
Meanwhile, I do only sports where I am pretty safe from falls or impacts.
I would be happy to share medical reports with the researcher to help others avoid this tragedy.

Micheal Ethan
August 28, 2017

Two recent drug recalls have again put the spotlight on consumer safety and reminded us how vulnerable we are when a widely circulated medication is deemed potentially hazardous, or actually causes harm.

Barbara Jacobs
August 26, 2017

Levaquin. Taken for an upper respiratory infection.
Within three days, I couldn’t get out of bed and walk, my leg tendons were so tight and painful. It was almost impossible to walk! I immediately went to my computer to see if it could be the Levaquin, and sure enough, that is one of the side effects. Stopped immediately. In several days, my legs got better. However, one of my patients took Levaquin for an extended time, and has permanent damage throughout her body.

J. Johns
August 25, 2017

Exmestane. Breast cancer drug administered 6 months before my five years was up ( I had been on tamoxifen with no ill effects).
Within three weeks my hand and joints looked arthritic’ the pain was so excrutiating I cried’ my fingers became numb so that I couldn’t feel ( I am an artist/sculptor so important).
I made an executive decision. Sirgeons and medical advice was to continue a five year course after breast cancer to stop its recurrence, but I stopped taking Exmestane.
My fingers are still somewhat numb but I excercise regularly and can use my hands but they look like an old woman’s hands now.
I have my own campaign: I tell women about it should they ever get breast cancer to never take Exmestane. No good telling the doctors nobody listens.

Donna A. Cox
August 25, 2017

Cool Sculpting should be outlawed as criminal as it does not work. I wasted $1800.00 and did not get a threads difference of reduced fat or inches.
Donna A. Cox
Gulfport, MS.

August 25, 2017

Seven or eight years ago, I had Botox shots in my face (related to aging manifestations) administered by a well-respected plastic surgeon. Several days later, my neck began to hang forward, had difficulty raising it, my body leaned to the side, and I couldn’t straighten up. Subsequently, several specialists examined me, did tests and then a physiatrist administered a shot in my spine which helped to straighten my torso somewhat.
During the entire period, I was followed by a neurologist and then went to Duke Medical Center for a second opinion. All of the physicians who examined me reached the same conclusion. My problem was related to the Botox injections.
My posture has improved considerably with some residual involvement in my neck.

I received.

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