04.01.2008
FDA News
FOR IMMEDIATE RELEASE
January 3, 2008
Media Inquiries:
Karen Riley, 301-827-6244
Consumer Inquiries:
888-INFO-FDA
FDA Receives New Data on Risks of Anemia Drugs
Consistent With Previous Data on Tumor Growth and Death
The U.S. Food and Drug Administration (FDA) is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs. The studies show that patients with breast or advanced cervical cancers who received ESAs to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who didn’t receive the anemia drug.
These two studies were not among the six studies that were described in revised labeling approved by FDA Nov. 8, 2007, which strengthened warnings about ESAs in cancer patients.
Taken together, all eight studies show more rapid tumor growth or shortened survival when patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers received ESAs compared to patients who did not receive this treatment. In all of these recent studies, ESAs were administered in an attempt to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater, although many patients did not reach that level.
FDA plans to discuss this new data and revisit the risks and benefits of using ESAs in patients with chemotherapy-induced anemia at a public advisory committee meeting in the next few months.
“This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer, which FDA addressed in previous communications,” said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.
“FDA is reviewing these data and may take additional action. In the meantime, FDA recommends that health care providers review the risks and benefits of ESAs outlined in the product label and discuss this information with their patients.”
ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells.
Physicians determine whether a patient is anemic and decide on ESA dosing by measuring how much of the protein known as hemoglobin is present in a patient's red blood cells, typically expressed in grams per deciliter.
FDA-approved uses of ESAs are for the treatment of anemia in patients with chronic kidney failure; for cancer patients whose anemia is caused by chemotherapy; and for those infected with the human immunodeficiency virus (HIV) whose anemia is caused by the HIV drug AZT (zidovudine). ESAs are also approved to reduce the number of transfusions during and after major surgery.
On Nov. 30, Amgen, manufacturer of the three ESAs -- Aranesp, Epogen, and Procrit -- provided FDA with information from the 733-patient PREPARE study of women who received chemotherapy before undergoing surgery for breast cancer. After three years, 14 percent of the patients who received Aranesp to treat their anemia had died, compared to 9.8 percent who did not receive the drug. Tumor growth was also faster in patients receiving Aranesp.
On Dec. 4, Amgen informed FDA of the results of a study by the National Cancer Institute’s Gynecologic Oncology Group of patients receiving chemotherapy and radiation for advanced cervical cancer. The patients were administered either Procrit to maintain hemoglobin levels above 12 g/dL or blood transfusions as needed. After three years, 66 percent of the patients who did not take Procrit were alive and free of cancer growth compared to 58 percent who had received the drug.
FDA approved revised boxed warnings and other safety-related product labeling changes for ESAs in November and March 2007. Safety concerns regarding ESAs were discussed during advisory committee meetings in 2004 and 2007 and labeling was revised in 1997, 2004 and 2005 to reflect new safety information
purchase suprax overnight
suprax sale suprax overnight
400 mg suprax suprax 200 mg
purchase suprax overnight
suprax sale suprax overnight
antibiotic suprax suprax 200 mg
purchase suprax overnight
suprax sale suprax overnight
suprax suprax 200 mg
350,000 problem gamblers
teen gambling
gambling hotline council on compulsive gambling of nj, inc.
350,000 problem gamblers
teen gambling
1-800-gambler® council on compulsive gambling of nj, inc.
350,000 problem gamblers
teen gambling
1-800-gambler® council on compulsive gambling of nj, inc.
clarithromycin reviews
buy clarithromycin 250mg
buy biaxin online clarithromycin online
buy clarithromycin canada
buy biaxin 500mg
order biaxin buy biaxin canada
buy clarithromycin canada
buy biaxin 500mg
clarithromycin buy biaxin canada
buy discount clarithromycin
clarithromycin online
buy biaxin uk cheapest biaxin
buy discount clarithromycin
clarithromycin online
buy biaxin uk cheapest biaxin
buy clarithromycin no prescription
buy cheap biaxin
cheap biaxin buy generic clarithromycin
buy clarithromycin no prescription
buy cheap biaxin
buy clarithromycin buy generic clarithromycin
where to buy abortion pills online
where can i buy abortion pills
abortion pill buy the abortion pill online
online purchase abortion pill
where can i buy abortion pills
abortion pill order abortion pill online
online purchase abortion pill
where can i buy abortion pills
abortion pill order abortion pill online
online purchase abortion pill
where can i buy abortion pills
abortion pills order abortion pill online
how to order the abortion pill online
abortion pill online purchase
abortion pill how to order the abortion pill online
how to order the abortion pill online
abortion pill online purchase
order abortion pill online how to order the abortion pill online
how to order the abortion pill online
abortion pill online purchase
abortion pill how to order the abortion pill online
buy viagra online safe
alternative to viagra
viagra kaufen get viagra
buy viagra online safe
alternative to viagra
viagra kaufen get viagra
buy viagra online safe
alternative to viagra
viagra kaufen get viagra
buy viagra online safe
alternative to viagra
free viagra get viagra
buy viagra online safe
alternative to viagra
viagra online get viagra
female uk kamagra
cialis vs kamagra
kamagra order kamagra online
problems with kamagra jelly
buy kamagra jelly in london england
kamagra jelly kamagra jelly side effects
problems with kamagra jelly
buy kamagra jelly in london england
kamagra jelly sale kamagra jelly side effects
problems with kamagra jelly
buy kamagra jelly in london england
kamagra jelly sale kamagra jelly side effects
problems with kamagra jelly
buy kamagra jelly in london england
kamagra jelly kamagra jelly side effects
generic amoxil
buy cheap amoxil online uk
amoxicillin amoxil for sale
generic amoxil
buy cheap amoxil online uk
amoxicillin amoxil for sale
free synthroid sample
women does synthroid work
synthroid synthroid dosage
free synthroid sample
women does synthroid work
synthroid synthroid dosage
women does bisacodyl work
natural bisacodyl alternatives
laxative get bisacodyl online
buy ampicillin online safe
female herbal principen
ampicillin principen for sale
buy ampicillin online safe
female herbal principen
ampicillin principen for sale
buy ampicillin online safe
female herbal principen
ampicillin principen for sale
buy abortion pill online
pill for abortion online
abortion pills order abortion pill
buy clarithromycin australia
discount clarithromycin
clarithromycin cheap clarithromycin
buy clarithromycin australia
discount clarithromycin
clarithromycin cheap clarithromycin
buy clarithromycin australia
discount clarithromycin
clarithromycin cheap clarithromycin
generic cipro
natural ciprofloxacin
ciprofloxacin buy ciprofloxacin online a href
cheap duricef tablets
duricef prescription buy
cefadroxil generic Cefadroxil
cheap duricef tablets
duricef prescription buy
duricef samples generic Cefadroxil
cheap duricef tablets
duricef prescription buy
duricef samples generic Cefadroxil
buy vantin
photos cefpodoxime
cefpodoxime cefpodoxime equivalent
buy vantin
photos cefpodoxime
cefpodoxime cefpodoxime equivalent
buy ceftin online
generic cefuroxime sale
cefuroxime cheap ceftin
ordering abortion pills to be shipped to house
abortion pill online purchase
abortion pill buy abortion pills online
ordering abortion pills to be shipped to house
abortion pill online purchase
abortion pill buy abortion pills online
ordering abortion pills to be shipped to house
abortion pill online purchase
abortion pill buy abortion pills online
ordering abortion pills to be shipped to house
abortion pill online purchase
pill for abortion online buy abortion pills online
cheap cephalexin
buy cheap keflex online uk
cephalexin cephalexin for sale
cheap cephalexin
buy cheap keflex online uk
keflex for sale cephalexin for sale
cheap cephalexin
buy cheap keflex online uk
cephalexin cephalexin for sale
cheap cephalexin
buy cheap keflex online uk
cephalexin cephalexin for sale
buy chloromycetin on the internet
photos chloromycetin
chloramphenicol chloromycetin samples
buy chloromycetin on the internet
photos chloromycetin
chloramphenicol chloromycetin samples
buy chloromycetin on the internet
photos chloromycetin
chloramphenicol chloromycetin samples
buy abortion pills online
buy abortion pill online
abortion pill ordering abortion pills to be shipped to house
buy abortion pills online
buy abortion pill online
abortion pill ordering abortion pills to be shipped to house
where to buy clavulanate online
alternative to augmentin
augmentin generic augmentin online
where to buy clavulanate online
alternative to augmentin
get augmentin online generic augmentin online
where to buy clavulanate online
alternative to augmentin
get augmentin online generic augmentin online