PROCRIT NEWS
GENE MAY POINT TO RISK FOR ANEMIA DRUGS
Posted by Jacob Goldstein
Anemia drugs sold by Amgen and J&J have been under the safety spotlight for awhile now, with some research suggesting the drugs may stimulate the growth of tumors in cancer patients. A study presented at this year’s American Society of Clinical Oncology conference points to a possible method for figuring out which patients are more (and less) likely to be harmed by the drugs. (Read more…)
Source: The Wall Street Journal health blog
Posted June 1, 2008
ANEMIA DRUGS MAY INCREASE THE RISK OF DEATH
By Cindy L. Nations
A new study published in the Journal of the American Medical Association found increased mortality rates and increased risks of blood clots associated with the administration of ESAs (erythropoiesis-stimulating agents). ESAs are a class of medications used to treat certain types of anemia and to reduce blood transfusions during some surgeries. Procrit, Aranesp, and Epogen are the top-selling ESAs with nearly one million Americans receiving the drugs every year. This is not the first time these drugs have been plagued with safety issues. In 2007, the FDA ordered that a black box warning be added to the ESA labels to warn of the serious, often life-threatening risks associated with the drugs. (pdf format 8.9Kb)
Source:
Law Offices of Howard L. Nations
February 29, 2008
A BAD YEAR FOR PHARMACEUTICAL ERYTHROPOIETINS
By Paul S. Mueller, M.D., M.P.H., F.A.C.P
Pharmaceutical erythropoietins, such as epoetin {alpha}(Epogen and Procrit) and darbepoetin {alpha}(Aranesp), are FDA approved to treat symptomatic anemia caused by chronic kidney disease (CKD) and cancer chemotherapy. However, several recent trials have heightened concerns about the safety of these agents, particularly when they are used to induce hemoglobin (Hb) levels >12 g/dL. (pdf format 50.5Kb)
Source: Journal Watch General Medicine
http://general-medicine.jwatch.org
Published December 28, 2007
DOCTORS AND DRUG COMPANIES: PROFITING MILLIONS AT PATIENTS EXPENSE
By Cindy L. Nations
The fact that pharmaceutical companies are billion-dollar businesses is common knowledge. But what many people don’t know is that some doctors are also bringing in millions of dollars each year just for prescribing certain medications. (pdf format 11.6Kb)
Source:
Law Offices of Howard L. Nations
May 9, 2007
DOCTORS REAP MILLIONS FOR ANEMIA DRUGS
By Alex Berenson and Andrew Pollock
Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses. (pdf format 37.9Kb)
Source: New York Times
May 9, 2007
FDA SAYS MAY NEED TO LIMIT USE OF ANEMIA DRUGS
By Peter Loftus
Amgen Inc. ... and Johnson & Johnson ... may have to further limit the targeted patient population and dosing levels for popular anti-anemia drugs to reduce risks to cancer patients, U.S. regulators said Tuesday. (pdf format 27.9Kb)
Source: Market Watch from Dow Jones
May 9, 2007
AMGEN UNDER FIRE FROM CONGRESS
Kerry A. Dolan
Biotechnology superstar Amgen has taken yet another blow, this time from Congress. [pdf format 286Kb]
Source: Forbes Magazine Online
March 21, 2007
ANEMIA DRUG MAY HARM SOME PATIENTS, FDA SAYS
By David Brown
The Food and Drug Administration warned yesterday that anemia-fighting drugs called erythropoietins, which had $10 billion in U.S. sales last year, are being used so aggressively that they may be harming some patients. (pdf format 92.1Kb)
Source: Washington Post
March 10, 2007
FDA Strengthens Safety Information for Erythropoiesis Stimulating Agents (ESAs)
(PDF file 17.3Kb)
FDA Press Release
March 9, 2007
FDA Public Health Advisory
(PDF file 22.8Kb)
Erythropoiesis Stimulating Agents (ESAs)
March 9, 2007 (updated March 14, 2007)
FDA Questions and Answers on Erythropoiesis stimulating Agents (ESAs)
(PDF file 26.3Kb)
March 9, 2007
STUDIES SHOW ANEMIA DRUGS MAY HARM CANCER PATIENTS
By Andrew Pollack
New studies are raising questions about whether drugs that have been used by millions of cancer patients might actually be harming them. The drugs, sold by Amgen, Roche and Johnson & Johnson, are used to treat anemia caused by chemotherapy and meant to reduce the need for blood transfusions and give patients more energy. But the new results suggest that the drugs may make the cancer itself worse. (pdf format 58Kb)
Source: New York Times
Published February 27, 2007
TREATMENT OF ANEMIA QUESTIONED
By Alex Berenson
An expert panel of doctors for the National Kidney Foundation plans to assess whether hundreds of thousands of patients with kidney disease are being dangerously overtreated with drugs for anemia. The decision to convene the panel comes two weeks after studies in The New England Journal of Medicine suggested that kidney patients whose anemia was more aggressively treated were more likely to die or suffer heart problems than those who were allowed to remain more anemic. (pdf format 50.6Kb)
Source: New York Times
Published November 30,2006
FDA Alert
Information on Erythropoiesis Stimulating Agents (ESA)
(marketed as Procrit, Epogen, and Aranesp)
(PDF file 31.3Kb)
November 16, 2006 (updated February 16, 2007 and March 9, 2007)
FDA Public Health Advisory
(PDF file 21.8Kb)
Epoetin alfa (marketed as Procrit, Epogen)
Darbepoetin alfa (marketed as Aranesp)
November 16, 2006
ONCOLOGISTS REBEL AGAINST AMGEN'S MARKETING TACTICS
Last spring, the nine physicians at Marin County’s California Cancer Care received an offer they wanted to refuse. Amgen, which sells Aranesp, Neupogen and Neulasta for chemotherapy‑related anemia, told the oncologists that unless they purchased a quarter of its red cell stimulator from Amgen, the goliath of the biotech world would cut off their discounts on white blood cell products. After much internal grumbling, they agreed. [more...]
Source: Gooz News Archives
Reprinted from Bay Area Oncology News
March 02, 2006
JOHNSON & JOHNSON SUES AMGEN OVER SALES TACTICS
By Andrew Pollack
The New York Times
In the latest skirmish over the best-selling drug ever created by biotechnology, Johnson & Johnson has filed an anti-trust suit accusing a rival, Amgen, of using illegal leverage to try to drive its drug, Procrit, out of the market. (pdf format 16.4Kb)
Source: International Herald Tribune
Published October 13, 2005
Originally published in New York Times
NEW WARNING FOR ANEMIA DRUG ARANESP
FDA Urges Doctors Not to Exceed Approved Doses of Drug That Treats Side Effect of Chemotherapy. (pdf format 133.5Kb)
Source: WebMD from FDA / Amgen
Published January 14, 2005
Violative Advertising and Promotional Labeling Letter
(Letter from FDA to AMGen about false advertising of Procrit)
... You should immediately cease any further dissemination of all advertising and promotional materials that contain these claims and similar presentations. (pdf format 26.2Kb)
Source: U.S. Food & Drug Administration
June 20, 2003
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