June, 2008

Ethex Recalls Additional Lots of Both 30 mg and 60 mg Morphine Tablets

Ethex Corporation has expanded their voluntary recall of morphine sulfate tablets to both 30 mg and 60 mg doses and additional lots of both doses. We reported a previous recall of a single lot of 60 mg tablets on June 11, 2008. There is a potential problem that some tablets may be oversized and may contain as much as twice the dose of morphine on the label.

No oversized tablets have been found in any of the additional lots now being recalled, but because the problem discovered in one lot, Ethex is taking extra precautions to ensure patient safety.

The 60 mg tablet is a white oval with “60″ on one side and “E” on the other. The 30 mg tablets are pink with “30″ on one side and “E” on the reverse.

Although there have been no reports of serious problems due to overdoses, the possibility exists for respiratory distress and very low blood pressure if too much morphine is taken.

Posted by Kate Murphy on June 15th, 2008
Posted in: Research & Treatment News | 2 Comments »
Tags: FDA, morphine

Xelox as Effective as FOLFOX after Colorectal Cancer Progresses

XELOX, as second-line therapy, was found to be as effective as the more commonly used FOLFOX treatment for patients whose cancer had already gotten worse on treatment with Camptosar® (irinotecan).

XELOX combines an oral drug Xeloda® (capecitabine) with Eloxatin® (oxaliplatin). FOLFOX uses an infusional schedule of 5FU and leucovorin.

Researchers randomly compared XELOX to FOLFOX4 to treat 627 patients with metastatic colorectal cancer. Patients had already received initial therapy with Camptosar and either had their cancer progress or were unable to tolerate the treatments. Although outcomes were similar for the two regimens, side effects differed.

Posted by Kate Murphy on June 13th, 2008
Posted in: Research & Treatment News | No Comments »
Tags: FOLFOX, metastatic colorectal cancer, side effects, survival, XELOX

White House Asks for $275 million for the FDA – UPDATE

As I reported yesterday, the Bush administration amended the FY 09 budget to include an extra $275 million for the Food and Drug (FDA) Administration. A valid attempt to make the situation right, it seems it may be too little too late.

In a letter from Senator Arlen Specter (R-PA) to Secretary Michael Leavitt (Health and Human Services), Specter said the FDA’s request on Monday for an additional $275 million wouldn’t give them any money until March or April 2009 “at the earliest.”

Posted by Joe Arite on June 11th, 2008
Posted in: Policy & Advocacy News | No Comments »
Tags: Appropriations, Bush Administration, Congress, FDA

Ethex morphine tablets recalled

The FDA has announced a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets by Ethex Corporation. Lot No. 91762, distributed between April 16th and April 27th of 2008, contained at least one over-sized tablet that might contain up to twice the amount of morphine.

While no reports of serious effects from Ethex morphine tablets have been reported, the opioid medicines are being recalled to prevent life-threatening overdoses.

Extended release morphine is often used to manage cancer pain, particularly in patients with advanced disease. Since many of these patients are already weak, it might be difficult for them to recognize an over-sized pill.

Signs of morphine overdose include difficulty breathing and low blood pressure. If you suspect an overdose contact your doctor immediately or call 911.

Patients or caregivers with questions about the recall should

Contact their doctor or pharmacist
Call ETHEX Customer Service at 1-800-321-1705
Email customer-service@ethex.com

Ethex representatives are available Monday through Friday, 8 am to 5 pm CST.

Posted by Kate Murphy on June 11th, 2008
Posted in: Research & Treatment News | No Comments »
Tags: drug recall, FDA, morphine

White House Asks for $275 million for the FDA

We are very pleased to announce that the Administration has taken the highly unusual step of amending its FY 2009 budget to include an additional $275 million for the FDA.

Last month we let you know the Food and Drug Administration (FDA) Chief, Andrew Von Eschenbach, wrote a letter to Senator Arlen Specter (R-PA) expressing the dire need of an influx of $275 million. This was very unusual for a political appointee to go against the proposed budget of the President.

Posted by Joe Arite on June 10th, 2008
Posted in: Policy & Advocacy News | No Comments »
Tags: Appropriations, Bush Administration, Congress, FDA