How can FDA use the term "safe and effective" when
Post# of 36728
Posted On: 11/11/2013 1:51:35 PM
Re: Traderboy1966 #12000
How can FDA use the term "safe and effective" when it gives approval to cancer drugs with these known side effects and warnings? "On August 3, 2012, the Food and Drug Administration approved a new cancer drug called Zaltrap as a safe and effective treatment for patients with advanced colon cancer. "
http://nymag.com/news/features/cancer-drugs-2013-10/
Does $50,000+ per month overall treatment cost with this drug have anything to do with FDA's elastic definition of "safe and effective"? Median survival time with the drug: 42 days. With such debilitating and possibly severe side effects, is that 42 days worth living?
Side Effects and Warnings
"...severe and sometimes fatal bleeding, including gastrointestinal bleeding, and the development of holes in the gastrointestinal tract. Zaltrap can also make it more difficult for wounds to heal. The most common side effects observed in patients receiving Zaltrap plus FOLFIRI were decreased white blood cell count, diarrhea, mouth ulcers, fatigue, high blood pressure, increased amount of protein in the urine, weight loss, decreased appetite, abdominal pain, and headache." -- From Zaltrap PR.
http://colon-cancer.emedtv.com/zaltrap/zaltra...tions.html
"People treated with Zaltrap are at risk for serious bleeding problems, which may be life-threatening in some cases.
Zaltrap has been reported to cause kidney problems, including damage to the small blood vessels in the kidneys that filter water and waste products from your blood.
Zaltrap may increase the risk for blood clots and strokes.
This medicine (Zaltra) may increase the risk for fistulas, which are abnormal connections between two organs or vessels that do not normally connect. For example, an anal fistula is an abnormal channel that develops between the anal glands and the skin.
Diarrhea is a common side effect of Zaltrap.
Like other anticancer medicines, Zaltrap can decrease the amount of white blood cells and platelets in your blood, which could increase the risk for infections and bleeding problems .
Zaltrap may rarely cause a serious brain condition known as reversible posterior leukoencephalopathy.
Although rare, Zaltrap may cause a hole to develop in the gastrointestinal (GI) tract, known medically as a GI perforation. A GI perforation is a medical emergency.
This medication (Zaltrap) may increase blood pressure."
http://nymag.com/news/features/cancer-drugs-2013-10/
Does $50,000+ per month overall treatment cost with this drug have anything to do with FDA's elastic definition of "safe and effective"? Median survival time with the drug: 42 days. With such debilitating and possibly severe side effects, is that 42 days worth living?
Side Effects and Warnings
"...severe and sometimes fatal bleeding, including gastrointestinal bleeding, and the development of holes in the gastrointestinal tract. Zaltrap can also make it more difficult for wounds to heal. The most common side effects observed in patients receiving Zaltrap plus FOLFIRI were decreased white blood cell count, diarrhea, mouth ulcers, fatigue, high blood pressure, increased amount of protein in the urine, weight loss, decreased appetite, abdominal pain, and headache." -- From Zaltrap PR.
http://colon-cancer.emedtv.com/zaltrap/zaltra...tions.html
"People treated with Zaltrap are at risk for serious bleeding problems, which may be life-threatening in some cases.
Zaltrap has been reported to cause kidney problems, including damage to the small blood vessels in the kidneys that filter water and waste products from your blood.
Zaltrap may increase the risk for blood clots and strokes.
This medicine (Zaltra) may increase the risk for fistulas, which are abnormal connections between two organs or vessels that do not normally connect. For example, an anal fistula is an abnormal channel that develops between the anal glands and the skin.
Diarrhea is a common side effect of Zaltrap.
Like other anticancer medicines, Zaltrap can decrease the amount of white blood cells and platelets in your blood, which could increase the risk for infections and bleeding problems .
Zaltrap may rarely cause a serious brain condition known as reversible posterior leukoencephalopathy.
Although rare, Zaltrap may cause a hole to develop in the gastrointestinal (GI) tract, known medically as a GI perforation. A GI perforation is a medical emergency.
This medication (Zaltrap) may increase blood pressure."
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