Tag Archives: FDA

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 clot in their veins while on Avastin. Changes to the Avastin label were announced on September 30, 2011.

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 FDA responds to drug shortages and what they are doing to try to prevent shortages of medically necessary drugs.

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 drugs, which are low-priced and complicated to manufacture made by a only a few companies manufactured in aging plants where quality is hard to maintain.

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 order and are shipping it as it becomes available.  A third has all dose vials on back order and estimates shipping sometime in the fourth quarter of 2011.

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 as  powdered leucovorin calcium for injection once water is added to the US product. In a Dear Healthcare Professional letter, Teva provides a chart comparing the two products and tells doctors and pharmacists that currently Teva is the only organization with regulatory discretion to import and distribute calcium folinate solution.

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 with chemotherapy, both as first-line and second-line therapy. The public hearing held on June 28 and 29 reviewed the process began  in December, 2010 to withdraw the FDA provisional approval of Avastin for metastatic, HER-2 negative breast cancer.  It did not consider or change other label indications for colorectal, kidney, or small cell lung cancers or glioblastoma. A final decision on breast cancer will be

Irinotecan Lots Recalled

APP Pharmaceuticals has voluntarily recalled five lots of irinotecan for injection. Some customers discovered small particles of foreign material in one lot of the irinotecan vials.  Further inspection found fungal microbes in the vials they sent back. It is unlikely that you as a patient would see the recalled vials or particles directly since irinotecan is diluted before your IV infusion.  However, you might develop an infection or other adverse event.  If that happens, call your doctor immediately!

Darvon Taken Off the Market

Xanodyne Pharmaceuticals has withdrawn Darvon®, Darvon-N®, and Darvocet® from the US market at the request of the FDA. Even in recommended doses, Darvon (propoxyphene) can cause changes in heart activity which can be seen on an electrocardiogram (ECG) adding to the risk of serious changes in heart rhythm. On November 19, 2010, The FDA recommended that health professionals stop prescribing any propoxyphene immediately and that patients who are using it contact their doctor about the right way to stop. If your doctor has prescribed a drug that contains Darvon for you, the doctor should contact you to discuss other ways of managing pain and safely discontinuing its use.

More Leucovorin Woes

A September 2nd update from the FDA cites manufacturing delays at Bedford Laboratories and Teva Pharmaceuticals  for leucovorin shortages. Here at the Colorectal Cancer Coalition, we’re hearing from patients who are not receiving leucovorin during their chemotherapy because it just isn’t available. Bedford says that they will be releasing some 350 mg and 200 mg vials in September and are working on other presentations.  Teva is allocating 100 mg vials and says that the 350 mg vials are on back-order with an expected release date in the fourth quarter of 2010.

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