About a dozen young women died last year from blood clots believed to be related to the birth-control patch Ortho Evra, and dozens more survived strokes and other clot-related problems, safety reports reveal.
The federal drug safety reports obtained by The Associated Press under a Freedom of Information Act request appear to indicate that in 2004 -- when 800,000 women were on the patch -- the risk of dying or suffering a survivable blood clot while using the device was about three times higher than while using birth control pills.
The Food and Drug Administration and patch-maker Ortho McNeil both maintain that the patch is as safe as the pill, but they both saw warning signs of possible problems with the patch well before it reached the market, AP reports.
Ortho McNeil, a subsidiary of Johnson & Johnson, says none of the deaths can be directly attributed to the patch.
"Although we are investigating each and every one of the reports that we get, we have not drawn any causal relationships to the medication," said Dr. Katherine LaGuardia, Ortho McNeil's director of women's health care, told AP.
Several lawsuits have already been filed by families of women who died or suffered blood clots while using the patch, and lawyers said more are planned.
U.S. Regulators Approve Brain Stimulator for Depression
U.S. health officials approved on Friday an implantable electronic device designed to help treat severe depression in patients who have failed to respond to all other treatments.
Houston-based Cyberonics said the Food and Drug Administration had signed off on its Vagus Nerve Stimulation Therapy System. The pacemaker-like device sends electrical impulses to the brain, which can apparently result in improvement in those suffering from severe depression. The system was originally designed to treat epilepsy, according to MarketWatch.
The FDA approved the VNS system with the caveat that it be used with more traditional psychiatric therapies. The device costs about $15,000, MarketWatch said.
The company, which estimates that about 4 million Americans suffer from intractable depression, said the market for the device could reach $1.2 billion by the end of the decade, MarketWatch said.
The system has already been approved to treat depression by regulators in Europe and Canada.
Critics said there has been a lack of rigorous scientific research to prove the VNS system really works, according to the Associated Press.
But FDA medical device chief Dr. Daniel Schultz said he was persuaded by Cyberonics' research, despite initial skepticism within his agency. "These are patients pretty much at the end of the line in terms of what treatment options are available to them," he said.
FDA to Rule on 'Morning-After Pill' by September
The U.S. Food and Drug Administration will decide by Sept. 1 whether the controversial "morning-after" contraceptive pill can be sold without a prescription.
The announcement was contained in a letter from Department of Health and Human Services Secretary Michael Leavitt to high-ranking senators. The news led two Democratic senators, Patty Murray of Washington and Hillary Rodham Clinton of New York, to say they'd allow a vote on the confirmation of Lester Crawford as commissioner of the FDA, the Associated Press reported.
The two lawmakers had held up a vote on Crawford's nomination because of a decision delay on the pill, also known as "Plan B."
"After more than two years of waiting, American consumers and American women will finally get an answer," the two Democrats said.
In December 2003, an FDA advisory panel recommended in a 24-3 vote that the pill be approved for over-the-counter sales. But the FDA ignored that recommendation, citing concerns that the pill could lead young teens to have sex, leaving them susceptible to sexually transmitted diseases. The pill's manufacturer, Barr Laboratories, filed a second application with the agency to address those concerns, the AP said.
Supporters of over-the-counter Plan B said the pill would help women prevent unintended pregnancies and reduce the need for abortions, the news service said.
FDA Investigating Pain Patch Deaths
The U.S. Food and Drug Administration is investigating 120 deaths among users of patches that emit the painkiller fentanyl. The agency also warned patients Friday to be sure to use the potent narcotic properly to avoid accidental overdose, the Associated Press reported.
The FDA is reviewing whether any of the deaths were related to inappropriate use of the painkiller or factors related to the product's quality.
Fentanyl is a strong narcotic painkiller that could cause death from overdose if the product's directions aren't strictly followed, the agency said in issuing Friday's public health advisory. The patch is available under the brand name Duragesic, and as a generic version.
The agency said Fentanyl skin patches should be used only when chronic pain isn't controlled with shorter-acting painkillers, and should not be used to treat short-term pain, pain that isn't constant, or for post-surgical pain.
The agency also reminded users to properly dispose of used, unneeded or defective patches by folding the sticky sides together and flushing them down the toilet, to prevent possible abuse by children.
Friday's warning followed by two days the FDA's ban on sales of the narcotic painkiller Palladone, citing the potential for deadly reactions if the drug was used with alcohol.
In a separate action, a healthcare accrediting group is warning about the potential misuse of a cancer drug the could kill or permanently paralyze patients.
The drug vincristine is supposed to be injected into a vein, but on rare occasions has been added to spinal catheters used by leukemia and lymphoma patients, the Joint Commission on Accreditation of Healthcare Organizations said.
The group noted some 49 cases of vincristine mix-ups worldwide since 1968, killing about 90 percent of these patients, the Associated Press reported.
Food Fact: Slice of heaven?
Is pizza healthy any way you slice it? No, but you can make it so... To make healthy pizza, you've got to attack the fat. Instead of full-fat mozzarella, sausage and pepperoni, increase the variety and quantity of vegetables and use a small amount of flavorful cheese, such as feta or Parmesan. Given the amount of pizza Americans eat, any choice to cut calories helps; collectively, we eat about 100 acres of pizza each day, which works out to 46 slices of pizza for every man, woman and child over the course of a year.
Fitness Tip of the day: Knock down cholesterol.
It's not just about diet -- physical activity makes a huge difference, too. Exercise improves your blood cholesterol profile by lowering your levels of LDL (bad) cholesterol and, more important, boosting your levels of HDL (protective) cholesterol. It also reduces your overall risk of dying prematurely and helps you control your weight; significantly reduces your risk of dying from coronary artery disease or a heart attack; helps your heart pump more blood with each contraction; reduces your risk of developing high blood pressure and helps lower existing high blood pressure; and improves blood circulation throughout your body.
FAQ of the day: Can soy save me from prostate cancer?
Soy's isoflavones exhibit several cancer-protective effects, but one relates directly to reducing prostate cancer risk. Isoflavones inhibit an enzyme that converts testosterone into an active form (dehydrosterone) associated with prostate cancer risk. Dehydrotestosterone, made primarily in the prostate, regulates the prostate cell's growth. Soy isoflavones have little effect on testosterone itself.