Paxil Warning Upgraded
A stronger warning that the antidepressant Paxil may be associated with birth defects was ordered Thursday by the U.S. Food and Drug Administration in response to early findings from two studies that indicate the drug increases the risk of fetal heart defects.
The FDA instructed drug maker GlaxoSmithKline to reclassify Paxil from a Category C to D (a stronger warning) for pregnant women. Category D means studies in pregnant women have demonstrated a risk to the fetus.
One study found about a 2 percent risk of heart defects in babies born to mothers who took Paxil early in their pregnancy, compared with a 1 percent risk in the general population, the FDA said in a prepared statement.
The second study found the risk of heart defects was 1.5 percent in babies whose mothers took Paxil in the first three months of pregnancy, compared with 1 percent in babies whose mothers took other antidepressants in the first trimester.
Thursday's warning follows one issued in September by the FDA, also on possible birth defects in women who took Paxil early in their pregnancy.
Balloon Angioplasty Devices Recalled
A worldwide recall of balloon angioplasty devices meant to treat blocked coronary arteries was announced Thursday by medical device maker Boston Scientific Corp.
The recall of about 40,000 Flextome cutting angioplasty balloon devices came after the company said it has received eight reports that the end of the device detached from the catheter as it was removed from patients. In three cases, surgery was required to remove the detached tip, the Associated Press reported.
Boston Scientific said it was working with the U.S. Food and Drug Administration on the recall and is also notifying health officials in other countries.
Angioplasty balloons are used to reopen narrowed arteries and push back accumulated plaque in the arteries. The Flextome device differs from standard angioplasty balloons in having three or four microsurgical blades on its exterior.
This is the second recall of a Boston Scientific device within a week. Last week, the company announced a recall of about 18,000 devices designed to filter and dissolve blood clots in order to protect the lungs, the AP reported.
Jury Deliberations to Begin in Third Vioxx Trial
The jury in the third Vioxx trial began deliberations Thursday in Houston after hearing closing arguments in the lawsuit against drug company Merck & Co., maker of the painkiller Vioxx, the Associated Press reported.
The plaintiff's attorney, lawyer Andy Birchfield, told jurors in his closing argument that Merck knew Vioxx increased heart attack risks but misled doctors and the public because it was more concerned with profits.
But Merck's lead attorney, Phil Beck, in his closing arguments, said the pharmaceutical giant issued adequate warnings based on studies showing Vioxx was safe. He said Merck scientists put patient safety first and were not "evil" or "out to make an extra buck."
The legal action was launched by Evelyn Irvin Plunkett over the death of her husband Richard Irvin. The 53-year-old man died of a heart attack in 2001 after he'd been taking Vioxx for about a month to treat back pain.
The lawsuit alleges that Vioxx caused Irvin's death and that Merck failed to issue safety warnings about the drug, which was taken off the market in September 2004 after a study showed that long-term use of Vioxx doubled the risk of stroke or heart attack.
This is the first federal trial over Vioxx. Merck has lost one state trial and won another state trial. The company faces about 7,000 Vioxx-related lawsuits.
U.S. Recorded 37 Measles Cases in 2004
There were only 37 cases of measles in the United States in 2004, the lowest tally in more than 90 years of record keeping, the U.S. government announced Thursday, citing the country's vaccination program as the reason for the success.
Almost all of the 37 measles cases originated abroad, including 14 U.S. travelers who were infected in other countries and 13 foreign visitors who brought the disease with them, the Associated Press reported.
Many of the 2004 cases could have been prevented if people had received proper measles immunization, said Dr. Gustavo Dayan, an epidemiologist with the U.S. Centers for Disease Control and Prevention.
Before a measles vaccine became available in 1963, the United States recorded more than 500,000 measles cases and about 450 measles-related deaths each year. The current U.S. measles immunization rate is more than 90 percent.
Slow Response to New Medicare Drug Plan Subsidy
Poor people in the United States apparently aren't showing much enthusiasm for the new Medicare prescription drug benefit that begins in January.
So far, only 661,000 applications have been approved for a subsidy that makes the new drug benefit much more affordable for disabled people and low-income seniors, says the Social Security Administration.
The government sent application letters to about 19 million people and about 7 million people are believed to be eligible for the subsidy, the Associated Press reported.
About one million applications are still under review and about 100,000 new applications are arriving each week, Social Security said. At this point, the ratio of rejections to approvals is about 3-to-1.
The response is a disappointment but not unexpected, say some representatives of advocacy and research groups.
"We knew it was going to be difficult to find and enroll people. We also knew the strategy of going to 19 million people was likely to backfire," James Firman, chairman of the Access to Benefits Coalition, told the AP.
"Unfortunately, these numbers are very discouraging, and it now appears likely that many millions of low-income seniors will be without the help they need to make drugs affordable," Ron Pollack, executive director of Families USA, told the AP.
Pollack's group has criticized the new drug benefit plan as too complex.
Bone Marrow Cells Aid Cancer Spread
Cancers take advantage of bone marrow cells to spread tumors, says a Cornell University study published Thursday in the journal Nature.
The study of mice with lung cancer found that bone marrow cells assist in the creation of new blood vessels that provide nutrients and oxygen to spreading cancers, Bloomberg News reported.
The Cornell researchers injected lung cancer cells into mice and expected that the cancer cells would migrate straight to the lungs. However, they saw that bone marrow cells reached the lungs days before the cancer cells and prepared the way for the cancer cells to grow in the lungs.
It's believed the marrow cells assist the cancer cells by producing a protein called vascular endothelial growth factor receptor 1 (VEGFR1), which triggers the formation of tumor-feeding blood vessels, Bloomberg News reported.
When the Cornell team injected the mice with molecules that blocked VEGFR1, the spread of cancer was halted.
"Without the bone marrow cells, the tumors have nowhere to land," study co-author David Lynden, an associate professor in pediatrics and developmental biology, told Bloomberg News.
Food Fact:
Thrilla in vanilla
In low-fat desserts, high-quality vanilla can make you a champ. Vanilla imparts a warm, rounded flavor of its own and serves as a backdrop for other spices. Its quality is crucial in low-fat desserts, because without a lot of fat the other flavors stand out more. Avoid imitation extracts; they simply taste bad. Buy vanilla extract that is labeled "pure." Or better yet, make your own: Slit 4 whole vanilla beans lengthwise, place in a jar, cover with vodka or brandy, and let steep for at least 2 weeks.
Fitness Tip of the day:
Keep it clean.
Could your water bottle be making you sick? The gym is a great place to get fit; it is also a great place to pick up unwanted germs. If you use a water bottle during your workouts, clean it with mild detergent and water after each use. Also, be sure to wash your hands as often as possible or wear gloves when exercising.
FAQ of the day:
Are walking shoes a waste of money?
To find the right shoe, start with knowledgeable salespeople. If someone suggests a shoe designed for another sport as a walking shoe, move on. Ask a salesperson to measure your feet every time you buy new walking shoes -- foot size and width can change over time. Try on shoes after you've exercised and your feet are at their largest. Put on the socks you normally wear when you're walking. Make sure the shoe fits in the heel -- many women mistakenly choose shoes that are too small just because they feel secure in the heel as they walk. Replace walking shoes every 500 miles, or about twice a year.
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