Tagged with “FDA”

FDA Warns of Online Cancer Fraud

The FDA has developed a message for consumers warning them of fraudulent online cancer cures.

They are frequently offered as dietary supplements or natural treatments.

Medicines and devices intended to treat cancer must gain FDA approval before they are marketed. The agency’s review process helps ensure that these products are safe and effective. Without such approval, no product can be marketed as a medical treatment.

According to the FDA, many of these fraudulent cancer products may appear completely harmless, but can cause harm by delaying or interfering with proven, beneficial treatments. Continue reading…

Posted by Kate Murphy on June 23rd, 2008
Posted in: Research & Treatment News | 1 Comment »
Tags: FDA

Victory for the FDA

The fate of the FY 08 emergency supplemental appropriations bill in the House was finally decided last night. Leaders on both sides negotiated a deal and came up with a bill that will likely be signed by the President.

The Food and Drug Administration (FDA) was one of the big winners, snagging an additional $150 million. A much lower number than we had hoped for, but a victory nonetheless.

Posted by Joe Arite on June 20th, 2008
Posted in: Policy & Advocacy News | No Comments »
Tags: Bush Administration, Congress, Emergency Supplemental Appropriations bill, FDA

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 | No Comments »
Tags: FDA, morphine

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