FDA Takes Action on Two Critical Cancer Drugs in Shortage

FDA LogoFDA 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 should be enough to meet needs for Doxil treatment.  FDA has inspected and approved the foreign plants that manufacture Lipodox.

APP Pharmaceuticals and Hospira both have ramped up production of methotrexate. Together they expect to be able to ship the drug immediately and have enough to meet future needs.  Methotrexate is especially needed by children with leukemia where it can produce remissions rapidly and cure most children with acute lymphoblastic leukemia (ALL).

Unfortunately, fluorouracil (5-FU) and leucovorin are still in shortage.

The FDA now has an 11 person Drug Shortage Team working to help resolve shortages. Other FDA staff are cooperating in getting information about potential inspection problems to the team or speeding up approvals for new manufacturing providers.

In addition, there has been a significant increase in voluntary reporting of potential supply problems to FDA, with a six-fold increase since the President’s Executive Order in October 2012.

As for drugs important in colorectal cancer treatment, the latest information from the American Society of Health-System Pharmacists says:

  • Fluorouracil is back order by one manufacturer, who is releasing it on allocation to avoid excessive purchasing. A second company has supplies but is having difficulty meeting increased market demand. It also is allocating supplies through wholesalers. The third company has manufacturing delays and cannot estimate when the drug will be available.
  • Irinotecan shortage has been resolved and is now available from all manufacturers.
  • Leucovorin from Bedford Laboratories has been affected by suspension of all manufacturing at Ben Venue and cannot estimate when new supplies will be available. Teva has exhausted the supplies being imported from Europe, but expects to release more in mid-February.  APP has leucovorin on back order but expects to be able to release some in late first quarter 2012.  Spectrum has Fusilev (levoleucovorin) readily available.
  • The Xeloda (capecitabine) issue has been resolved. Imported blister packs are no longer being shipped by Genentech. Tablets in bottles are available again.

During the February 21 teleconference, advocates pushed for speedy approval of legislation that would improve reporting — the Senate Preserving Access to Lifesaving Medications Act. and its companion bill in the House.


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