Fake Drugs are a Global Problem

The counterfeit drug trade has reached global proportions, and solving the problem needs a global approach. So says an editorial in this week’s The Lancet. While the Avastin announcement last week raised lots of concern and media attention, the issue of counterfeit drugs isn’t new….

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FDA Takes Action on Two Critical Cancer Drugs in Shortage

FDA Commissioner Margaret Hamburg announced yesterday during a teleconference that the FDA has arranged to meet critical needs for methotrexate and Doxil® (doxorubicin). FDA has approved temporarily importing Lipodox, which has the same active ingredient — doxorubicin — and the same concentration as Doxil. There…

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The White House Addresses the Drug Shortage Issue

President Barack Obama signed an Executive Order yesterday addressing the drug shortage issue. As we have reported extensively on www.FightColorectalCancer.org, the current drug shortages have impacted colorectal cancer patients who have been unable to get 5-FU, leucovorin or on occasion, irinotecan. The Executive Order does…

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FDA: Avastin Can Cause Ovarian Failure

The FDA has changed the package insert for Avastin® (bevacizumab) to include information about newly identified risks for the drug including Loss of ovarian function (ovarian failure). Bone death in the jaw (osteonecrosis). Bleeding and additional blood clots in patients who have already had a…

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How the FDA Is Addressing Drug Shortages

If you missed the FDA Webinar on Drug Shortages last Friday, you can Watch a video of the entire presentation, including questions. Download the webinar slides. The webinar, led by Captain Valerie Jensen, R.Ph., Associate Director for the FDA’s Drug Shortage Program, discusses how the…

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Congress Probes Drug Shortages

Drug shortages in the US are a growing crisis, members of Congress were told last Friday, September 23.  And there is no single reason why this is happening and no easy solutions to the problem. Problems lie mostly in older generic versions of sterile injectable…

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5-FU Added to Drug Shortage List

This morning the FDA added fluorouracil to its drug shortage list. The American Society of Healthcare Pharmacists (ASHP) has also reported a shortage of fluorouracil (5-FU), a common backbone drug for colorectal cancer chemotherapy. Two manufacturers have some doses of the drug on intermittent back…

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Leucovorin Shortage Update: Imported Supplies Available

The FDA issued a shortage update for leucovorin on July 21, 2011. While leucovorin remains in shortage from all three US manufacturers, the FDA is temporarily allowing Teva Pharmaceuticals to import calcium folinate solution for injection from Europe. The imported solution is the same strength…

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Avastin Still Approved for Advanced Colorectal Cancer

Yesterday’s recommendation by the FDA’s Oncology Drug Advisory Committee (ODAC) that approval of Avastin for breast cancer be withdrawn will not affect colorectal cancer treatment. Avastin® (bevacizumab) remains on the market in the US and is FDA-approved  for advanced colon and rectal cancer in combination…

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