This unnecessary new drug puts men at much greater risk of embolism, heart attack and stroke
The FDA’s newest drug approved for men with “low T” will now put them at an even greater risk for “high D” — as in death.
Drug maker Endo had tried three times to get this dangerous drug approved.
And three times the FDA rejected it.
But now, in the midst of serious concerns about all testosterone drugs, the FDA goes ahead and gives us another one.
This drug is so dangerous that men who get the shot need to be observed for 30 minutes to make sure they don’t die in their doctor’s office!
So if your doctor mentions a new shot to up your “T,” here’s what you need to know right away…
“Reverse this unsafe and unreasonable decision.”
That’s what Dr. Sidney Wolfe of Public Citizen wrote to the FDA about Aveed. And this newest testosterone drug on the market not only puts men at risk for heart attacks and strokes, but for severe allergic reactions and a deadly type of embolism.
And it comes as a shot that’s given several times a year.
The first application Endo sent in for Aveed in 2007 was given a big thumbs down by the FDA. It was just too dangerous. Same answer when they tried again in 2009. The FDA had big concerns with the drug’s “risk-benefit profile.”
But in 2013 Endo gave it another try.
They were turned down again that year — only this time they saw a chance.
Did they do something to make the drug any safer? Of course not! It’s the same dangerous drug the FDA gave three strikes to. But, it seems Big Pharma is never “out” with the FDA.
Wait ’til you see what happened…
The FDA didn’t ask for any more safety studies, they already knew how dangerous Aveed was. But they did ask for a better way to calculate that risk after it’s already on the market!
Endo said at the time that they appreciated the FDA’s “clarity” for the “path forward for Aveed.”
To get the drug out of pending status and into doctor’s offices, the drug maker developed what it calls REMS — a risk evaluation and mitigation strategy. They also added a black box warning about the serious risk of allergies and embolisms.
Now even before a doctor can give a shot of Aveed, they need to register for REMS certification. The program requires healthcare providers to get training and certification for “safe use strategies.” So every office that administers Aveed must be certified before they can even order the drug!
Let me get this straight. Aveed is so dangerous that a trained, experienced doctor needs additional training to be sure he can recognize if his patient is going to have a life-threatening reaction?
And the FDA couldn’t bring itself to say “No!” one more time?
To help up sales, Endo also produced a two-minute commercial for doctors to show their patients.
It starts out with “Billy” at the piano. He’s a patient with low T, who “loves performing music.” Billy always “took care of himself,” but now he’s not quite as energetic after a performance.
You have to tell your doctor, says Billy, “I need to be checked for low T.”
A doctor also explains in the video (while Billy plays “Let’s Fall in Love” in the background) to watch out for those “clinical signs and symptoms of testosterone deficiency.”
What Billy doesn’t bother to mention are the serious concerns about heart risks with all these low T drugs. Risks that even the FDA has acknowledged!
But as Dr. Wolfe notes in his letter, the FDA didn’t even discuss those heart risks when it finally approved Aveed.
It certainly doesn’t take any extra training to assess the level of risk of trusting the FDA.
Sources:
“Letter to the FDA protesting Aveed” Sidney M. Wolfe MD, March 6, 2014, Public Citizen, citizen.org
“FDA approves Aveed testosterone jab, with restrictions” Miriam E. Tucker, March 7, 2014, Medscape, medscape.com
“FDA nixes testosterone shot again” Kristina Fiore, 5/31/2013, MedPage Today, medpagetoday.com
