The Food and Drug Administration’s (FDA) Oncology Drug Advisory Committee (ODAC) is meeting today to discuss whether the labels for Erbitux (cetuximab) and Vectibix (panitumumab) should include a mention of KRAS testing. The discussion at the meeting will have implications for future development of companion diagnostics. C3 President Carlea Bauman will be testifying during the public comment section: Read the rest of this entry »

On December 11, 2008 the C.B. Fleet Company voluntarily recalled all their over-the-counter oral sodium phosphate products including Fleet Phospho-soda® and Fleet EZ-Prep™ Bowel Cleansing System.

The recall follows the Food and Drug Administration safety alert on Thursday connecting oral sodium phosphate bowel cleansers to acute phosphate nephropathy. Read the rest of this entry »

The Food and Drug Administration is reporting shortages of leucovorin calcium, used to enhance the effectiveness of 5-FU (fluorouracil) in treating colorectal cancer.  The reason the FDA gives for the shortage is “Manufacturing Delays.” Leucovorin is supplied by Teva Pharmaceuticals and Bedford Laboratories, and the FDA directs consumers to contact them for more information.

According to a bulletin from the American Society of Health System Pharmacists (ASHP), “Leucovorin calcium lyophilized powder is on back order and the company cannot estimate a release date.” In addition, ASHP has been told, “The manufacturers will not provide a reason for the shortage.” ASHP updated their information with personal communications with the manufacturers on December 8, 2008.

Calls from to the FDA, Teva, and Bedford from patient advocates on December 12 provided no new information about what was causing the problem or when it might be resolved.

The shortage not only affects thousands of colon and rectal cancer patients who are being treated with 5-FU and leucovorin, it impacts over one hundred clinical trials in the United States where leucovorin is part of treatment protocols.  Read the rest of this entry »

On November 11, 2008 the Food and Drug Commission issued an alert about the safe use of bowel cleansing products that contain oral sodium phosphate. The FDA is requiring that the manufacturers of prescription Visicol® and OsmoPrep® put Black Box warnings on the labels for these products.  In addition, the FDA intends to change labeling for over-the-counter oral sodium phosphate bowel preps including Fleet Phospho-Soda.

New FDA labeling for over-the-counter sodium phosphate products will say that they should not be used for bowel cleansing and will address their safe use as laxatives.

The alert follows more than 20 reports of acute phosphate nephropathy, a kidney injury that can cause permanent kidney damage, after the use of OsmoPrep.

Visicol, OsmoPrep and over-the-counter Fleet Phospho-soda are frequently used to clean the bowels in preparation for colonoscopy or other procedures. Read the rest of this entry »

ETHEX Corporation has recalled more lots of generic medicines because some pills may be oversized.  In addition to previous recalls of morphine sulfate and dextroamphetamine, the new recall includes two cardiac drugs and additional lots and dosages of morphine and dextroamphetamine.

There is a possibility that some tablets may be oversized and contain up to double the amount of active medicine.  Overdoses can cause serious medical problems including difficulty breathing and low blood pressure for morphine and rapid heart beat and high blood pressure for dextroamphetamine.

If you or the patient you are caring for has difficulty breathing, faints, becomes unresponsive, or has other signs of morphine overdose, call 911 and get medical help. Read the rest of this entry »