For Immediate Release: June 17, 2010
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Approves New Treatment for Advanced Prostate Cancer
The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.
In prostate cancer, the male sex hormone testosterone can cause prostate tumors to grow. Drugs, surgery, or other hormones are used to reduce testosterone production or to block it. Some men have hormone refractory prostate cancer, meaning the prostate cancer cells continue to grow, despite testosterone suppression. Different treatments are needed for men with this type of cancer.
Jevtana was reviewed under the FDA’s priority review program, which provides for an expedited six-month review for drugs that may offer major advances in treatment, or provide a treatment when no adequate therapy exists. Jevtana received approval ahead of the product’s Sept. 30, 2010, goal date.
“Patients have few therapeutic options in this disease setting,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, part of the FDA’s Center for Drug Evaluation and Research. “FDA was able to review and approve the application for Jevtana in 11 weeks, expediting the availability of this drug to men with prostate cancer.”
Jevtana’s safety and effectiveness was established in a single, 755-patient study. All study participants had previously received docetaxel. The study was designed to measure overall survival (the length of time before death) in men who received Jevtana in combination with prednisone compared with those who received the chemotherapy drug, mitoxantrone, in combination with prednisone. The median overall survival for patients receiving the Jevtana regimen was 15.1 months compared with 12.7 months for those who received the mitoxantrone regimen.
Side effects in those treated with Jevtana included decrease in infection-fighting white blood cells (neutropenia), anemia, decrease in the number of white blood cells (leukopenia), low level of platelets in the blood (thrombocytopenia), diarrhea, fatigue, nausea, vomiting, constipation, weakness (asthenia), and renal failure.
Prostate cancer, which usually occurs in older men, is the second most common cancer among men in the United States, behind skin cancer. In 2006, the most recent year for which numbers were available, 203,415 men developed prostate cancer and 28,372 men died from the disease, according to the Centers for Disease Control and Prevention.
Jevtana is marketed by Bridgewater, N.J.-based Sanofi-Aventis.
For more information:
Thursday, June 17, 2010
American RED CROSS Fined 16Million For Failure To Meet Blood Safety Laws.
For Immediate Release: June 17, 2010
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Despite the compliance failures, FDA found no evidence that the Red Cross violations endangered any patients and the blood supply is believed to be safe. Multiple layers of safeguards are in place to protect and enhance the safety of blood products. However, these types of violations decrease the assurance that blood products manufactured by American Red Cross will continue to be safe and have the potential to compromise the safety of the blood supply.
The FDA assessed fines totaling $16.18 million – $9.79 million for violations related to mismanagement of certain blood products and $6.39 million for Good Manufacturing Practice violations. Blood products include red cells, plasma and platelets.
FDA is encouraged by recent efforts made by the Red Cross leadership and will work closely with them to achieve full compliance. The FDA is hopeful these fines will encourage the Red Cross to act more quickly to take the actions necessary to address and correct the issues that have contributed to these violations.
In October 2009, the agency notified the American Red Cross that FDA inspections conducted during fiscal years 2008 and 2009 revealed violations that included failure to identify problems that occur during manufacturing and failure to adequately investigate identified problems.
The fines announced today were assessed under an amended 2003 consent decree that outlines requirements for the American Red Cross to ensure safety of the nation’s blood supply.
The original 1993 decree was amended in 2003 to allow the FDA to impose significant fines for failure to comply with agency regulations and provisions designed to ensure the safety of the nation’s blood supply.
Since 2003, the American Red Cross has made progress addressing some of its quality issues, including standardizing procedures, upgrading its National Testing Laboratories, and increasing oversight of the organization. However, to fully comply with federal regulations and consent decree provisions, the American Red Cross must make swift, additional progress on all of the issues the FDA has identified.
The agency has previously sent 12 similar letters to the American Red Cross and imposed a total of more than $21 million in fines under terms of the amended 2003 consent decree.
The American Red Cross is one of several organizations that is responsible for the nation’s blood supply.
For more information:
To access the adverse determination letters
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Fines American Red Cross $16 Million for Prior Failures to Meet Blood Safety Laws
The FDA announced today that the American Red Cross has been fined $16 million for prior failures to comply with Federal laws and regulations related to the collection and manufacture of blood products.Despite the compliance failures, FDA found no evidence that the Red Cross violations endangered any patients and the blood supply is believed to be safe. Multiple layers of safeguards are in place to protect and enhance the safety of blood products. However, these types of violations decrease the assurance that blood products manufactured by American Red Cross will continue to be safe and have the potential to compromise the safety of the blood supply.
The FDA assessed fines totaling $16.18 million – $9.79 million for violations related to mismanagement of certain blood products and $6.39 million for Good Manufacturing Practice violations. Blood products include red cells, plasma and platelets.
FDA is encouraged by recent efforts made by the Red Cross leadership and will work closely with them to achieve full compliance. The FDA is hopeful these fines will encourage the Red Cross to act more quickly to take the actions necessary to address and correct the issues that have contributed to these violations.
In October 2009, the agency notified the American Red Cross that FDA inspections conducted during fiscal years 2008 and 2009 revealed violations that included failure to identify problems that occur during manufacturing and failure to adequately investigate identified problems.
The fines announced today were assessed under an amended 2003 consent decree that outlines requirements for the American Red Cross to ensure safety of the nation’s blood supply.
The original 1993 decree was amended in 2003 to allow the FDA to impose significant fines for failure to comply with agency regulations and provisions designed to ensure the safety of the nation’s blood supply.
Since 2003, the American Red Cross has made progress addressing some of its quality issues, including standardizing procedures, upgrading its National Testing Laboratories, and increasing oversight of the organization. However, to fully comply with federal regulations and consent decree provisions, the American Red Cross must make swift, additional progress on all of the issues the FDA has identified.
The agency has previously sent 12 similar letters to the American Red Cross and imposed a total of more than $21 million in fines under terms of the amended 2003 consent decree.
The American Red Cross is one of several organizations that is responsible for the nation’s blood supply.
For more information:
To access the adverse determination letters
Counterfeit Tamiflu Sold On Internet! And Is Dangerous To Patients Allergic To Penicillin.
Tamiflu: Counterfeit ( “Generic Tamiflu” ) Product Sold on Internet
product is dangerous to patients allergic to penicillin.
Audience: Consumers, Pharmacists
[Posted 06/17/2010]
Issue: FDA notified consumers and healthcare professionals about a potentially harmful product represented as “Generic Tamiflu” sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu’s active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin. Patients who are allergic to penicillin products are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse.
Background: The FDA bought the fraudulent “Generic Tamiflu” without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations. Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements. Legitimate pharmacies that carry the VIPPS seal are listed at www.vipps.info
Recommendation: The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by visiting the OCI website (http://www.fda.gov/OCI).
Consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
product is dangerous to patients allergic to penicillin.
Audience: Consumers, Pharmacists
[Posted 06/17/2010]
Issue: FDA notified consumers and healthcare professionals about a potentially harmful product represented as “Generic Tamiflu” sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu’s active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin. Patients who are allergic to penicillin products are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse.
Background: The FDA bought the fraudulent “Generic Tamiflu” without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations. Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements. Legitimate pharmacies that carry the VIPPS seal are listed at www.vipps.info
Recommendation: The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by visiting the OCI website (http://www.fda.gov/OCI).
Consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Online: www.fda.gov/MedWatch/report.htm
- Phone: 1-800-332-1088
- Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
- Fax: 1-800-FDA-0178
- 06/17/2010] News Release - FDA]