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. Read the rest of this entry »

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recommendation by the FDA’s Oncology Drug Advisory Committee (ODAC) that approval of Avastin for breast cancer be withdrawn will not affect colorectal cancer treatment.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 made by the FDA Commissioner Margaret Hamburg, MD.  Until then the indication for breast cancer will remain on the FDA-approved label. Read the rest of this entry »

By a vote of 217-203 the House approved the fiscal year 2012 agriculture appropriations bill (H.R. 2112). The bill includes funding for the FDA.

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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! Read the rest of this entry »

Xanodyne Pharmaceuticals has withdrawn Darvon®, Darvon-N®, and Darvocet® from the US market at the request of the FDA.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. Read the rest of this entry »