FDA: New Package Labeling over Increased Risk of Blood Clots with Ortho Evra Patch

A new study showing an increased risk of blood clots among women using a contraceptive skin patch has prompted the Food and Drug Administration to add that finding to the drug’s label.  The agency said that the label on the Ortho Evra Contraceptive Transdermal Patch would include the results of a study in women ages 15 to 44 indicating a higher risk of clots than for women using birth control pills.  The blood clots could potentially lead to a lung embolism, the agency said.  The agency said it believed the patch was a safe and effective method of contraception, but recommended that women with concerns or risk factors for serious blood clots talk with their physicians and health care providers about contraceptive options.

To read the entire New York Times article, please click on the following link:

http://www.nytimes.com/2008/01/20/us/20patch.html?_r=1&ref=health&oref=slogin

For more information on defending medical malpractice, nursing home and general liability matters in Florida contact Howard Citron at Citron & Associates, P.A. – www.citronlegal.com.

Study Says: Too Much Caffeine During Pregnancy Causes Increased Risk of Miscarriage

Too much caffeine during pregnancy may increase the risk of miscarriage, a new study says, and the authors suggest that pregnant women may want to reduce their intake or cut it out entirely.  Many obstetricians already advise women to limit caffeine, though the subject has long been contentious, with conflicting studies, fuzzy data and various recommendations given over the years.  The new study, published in the Journal of Obstetrics and Gynecology, finds that pregnant women who consume 200 milligrams or more of caffeine a day — the amount in 10 ounces of coffee or 25 ounces of tea — may double their risk of miscarriage.  Pregnant women should try to give up caffeine for at least the first three or four months, said the lead author of the study, Dr. De-Kun Li, a reproductive and perinatal epidemiologist at the Kaiser Permanente Division of Research in Oakland, Calif.  “If, for whatever reason, they really can’t do it, think of cutting to one cup or switching to decaf,” Dr. Li said. “Stopping caffeine really doesn’t have any downside.”  Professional groups like the American College of Obstetricians and Gynecologists and the American Society for Reproductive Medicine have not taken official positions on caffeine, representatives said.  

To read the entire New York Times article, please click on the link below:

http://www.nytimes.com/2008/01/21/health/21caffeine.html?_r=1&ref=health&oref=slogin

For more information on defending medical malpractice, nursing home and general liability matters in Florida contact Howard Citron at Citron & Associates, P.A. – www.citronlegal.com.

Makers Say Drug, Zetia, Has No Clinical Benefits Following Trial

A recent clinical trial of Zetia, a cholesterol lowering drug prescribed by physicians to about 1 million people a week, failed to show that the drug has any medical benefits.  The results will add to the growing concern over Zetia and Vytorin, a drug that combines Zetia with another cholesterol medicine in a single pill.  About 60 percent of patients who take Zetia do so in the form of Vytorin, which combines Zetia with the cholesterol drug Zocor.  While Zetia lowers cholesterol in 15 percent to 20 percent in most patients, no trial has ever shown that it can reduce heart attacks and strokes – or even that it reduces the growth of the fatty plaques in arteries that can cause heart problems. 

To read the entire New York Times article, please click on the following link:

http://www.nytimes.com/2008/01/14/business/14cnd-drug.html?_r=2&hp&oref=slogin&oref=slogin

For more information on defending medical malpractice, nursing home and general liability matters in Florida contact Howard Citron at Citron & Associates, P.A. – www.citronlegal.com.