FDA Warns About Cancer Pain Drug Fentora
Due to recent reports of deaths and other problems associated with the cancer pain drug Fentora (fentanyl buccal) tablets, the U.S. Food and Drug Administration on Wednesday issued a warning about the drug to doctors and patients.
Fentora is a powerful opioid pain drug used only for the treatment of breakthrough pain in cancer patients who no longer respond to standard opioid pain treatment, the FDA said. Breakthrough pain refers to intense increases in pain that occur with rapid onset, even when opioid pain control drugs are being used.
The reported deaths of patients receiving Fentora were the result of improper selection of patients, dosing or improper product substitution, according to the Public Health Advisory and Health Care Professional Sheet issued by the FDA.
The agency reminded doctors and other health professionals that it is critical to follow product labeling when administering Fentora, and that it's dangerous to use Fentora for any short-term pain such as headaches or migraines. Fentora must not be used in patients who are not opioid tolerant.
Patients must be under a doctor's care and close supervision when taking Fentora and the dose should be carefully adjusted to control breakthrough pain adequately, the FDA said.
The agency told Fentora manufacturer Cephalon Inc. to strengthen warnings and improve the dosing instructions on the drug's product labeling. The company must also improve its education plan for prescribers and pharmacists on proper patient selection, dosing instructions, and restrictions on substituting Fentora for other products.
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36 Million Americans Have Never Had Cholesterol Checked
About one in six Americans age 20 and older (almost 36 million people) have never had their cholesterol levels checked, even though the link between cholesterol and heart disease has been well publicized.
That's the finding of the latest News and Numbers from the U.S. Agency for Healthcare Research and Quality.
Those who've never had their blood cholesterol levels checked include:
- more than one-third of uninsured people ages 20 to 64; 22 percent of those with public insurance; and 16 percent of those with private insurance.
- one-fourth of Hispanic adults; 16 percent of black and Asian adults; and 15 percent of white adults.
- 20 percent of males and 14 percent of females.
- about 21 percent of people who didn't graduate from high school.
- nearly 40 percent of people ages 20 to 34; 17 percent of those ages 35 to 44; six percent of those ages 45 to 64; and two percent of those 65 and older.
The report is based on 2005 data from the agency's annual Medical Expenditure Panel Survey, which gathers information from U.S households about health care use, expenses, access, health status and quality of care.
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Experimental Skin Cancer Drug Shows Promise
An experimental drug called STA-4783 may prove an effective new treatment for skin cancer, according to research presented Wednesday at a meeting of the European Cancer Organization in Barcelona, Spain.
The drug causes tumor cells to self-destruct by overloading them with oxygen. A study of 81 patients with advanced melanoma skin cancer found that the 28 who received the standard chemotherapy drug paclitaxel went an average of 1.8 months before their cancer worsened. The 53 patients who received paclitaxel plus STA-4783 went an average of 3.7 months before their cancer worsened, the Associated Press reported.
The study also found that patients who received the combination therapy survived an average of one year after diagnosis, compared with an average of 7.8 months for those who received only paclitaxel. The study was paid for by Synta Pharmaceuticals Corp. of Lexington, Mass., which developed STA-4783.
The new drug, which has no effect on normal cells, may also prove effective against other cancers, the AP reported.
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E. Coli Risk Prompts Frozen Beef Patty Recall
A cluster of e. coli cases in the U.S. Northeast has prompted a nationwide recall of 331,582 pounds of frozen beef patties distributed by New Jersey-based Topps Meat Co. At least six people in New York State became ill, and three were hospitalized. The state Health Department said all six are recovering, the Associated Press reported.
The recall includes: certain 10-lb. boxes of Butcher's Best 100% All Beef Patties; certain 10-lb. boxes of Kohler Foods burgers; certain 10-lb. boxes of Sand Castle Fine Meat; certain 2-lb. boxes of Topps 100% Pure Ground Beef Hamburgers; and certain 3-lb. boxes of Topps 100% Pure Ground Beef Hamburgers.
The U.S. Department of Agriculture said the recalled products carry the number "Est. 9748" inside the USDA mark of inspection, and were produced on June 22, July 12 or July 23, the AP reported.
Topps is "fully cooperating with the U.S. Department of Agriculture to make sure all customers are informed and the potentially contaminated products are properly disposed of," said company spokeswoman Cortney McMahon.
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U.S. House Votes to Expand Child Health Insurance Bill
The U.S. House on Tuesday voted 265-159 in favor of expanding the State Children's Health Insurance Program (SCHIP) by $35 billion over five years, but didn't get the two-thirds majority needed to override President Bush's threatened veto of the bill, the Associated Press reported.
Currently, the state-federal program covers about 6.6 million children in families that have incomes above the poverty line but have difficulty affording private health insurance. The new bill would provide coverage for an additional 4 million children.
Bush says he opposes the Democratic-led bill due to its cost, reliance on a tobacco tax increase and its potential for replacing private health insurance with government grants. In Tuesday's vote, 51 Republicans supported the bill while 151 of them voted against it, the AP reported.
Most governors and many health advocacy groups support the bill. It's expected that the Senate will pass the bill by a wide margin later this week. However, even if the Senate vote results in a two-thirds majority, the failure of the House to achieve such a majority means that Congress ca nnot override Bush's veto.
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Bone Marrow Stem Cells May Help Liver Failure Patients
Using stem cells taken from bone marrow to dampen immune response may offer a new way to treat liver failure and keep patients alive longer until an organ donor is found, say Massachusetts General Hospital researchers.
The researchers said this method may even help keep the liver -- the only organ that can regenerate -- functioning long enough to repair itself, BBC News reported. The technique has only been tested in animals.
In this study, the researchers found that delivering molecules secreted by mesenchymal stem cells (MSCs) to the liver lessened inflammation in rats with liver failure. In addition, cycling the rats' blood through an external bioreactor containing MSCs reduced signs of liver failure, and increased survival rates from 14 percent to 71 percent, BBC News reported.
The findings appear in the journal PLoS One.
Currently, transplant is the only option for patients with end-stage liver failure. However, there's a limited supply of donor organs and recipients must take powerful immune-suppressing drugs.
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