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Friday, April 24, 2009

Pregnant and Older May Mean More Complications

CDC finds some problems on the rise, with no clear explanations.



Although the rate of complications during pregnancy has remained unchanged since 1993, the percentage of pregnant women with preexisting conditions, such as high blood pressure and diabetes, has increased, a new study finds.

The scientists speculated that the increase was driven by more obese women and more older women having babies. Both obesity and the mother's age have been linked to increased complications during pregnancy and delivery, according to researchers from the U.S. Centers for Disease Control and Prevention.

"There's the good news and the bad news," said study co-author Dr. William Callaghan, a senior scientist in the CDC's Maternal and Infant Health Branch in the Division of Reproductive Health. "The good news is that we are seeing some improvements. The bad news is that some of the traditional complications of pregnancy -- hemorrhage and hypertension -- are increasing."

Why these problems are on the rise is not clear, Callaghan said. "It would be great to understand why and, to the extent they are preventable, prevent them," he said.

The report is published in the May issue of Obstetrics & Gynecology.

For the study, Callaghan and his CDC colleagues used data from the National Hospital Discharge Survey to estimate the rate of pregnancy and delivery complications, including preexisting medical conditions and cesarean delivery. They compared data from 2001 to 2005 with data from 1993 to 1997.

They found that the overall rate of delivery complications held steady at 28.6 percent. However, the prevalence of preexisting medical conditions among women delivering infants increased, from 4.1 percent to 4.9 percent.

High blood pressure, preeclampsia, diabetes, asthma and bleeding after delivery all increased, raising concern among the researchers. "This is something we are not going to see go away," Callaghan said.

"There is no question hypertension is increasing," he said. "Again, it is unclear exactly why. We know it is associated with older women, we know it is associated with first pregnancy and we know that there are more older women having first pregnancies."

But obesity, which is also associated with high blood pressure, is increasing and may be a reason as well, he said.

At the same time, the rate of lacerations from episiotomy decreased, the study found. This may have something to do with the increasing number of cesarean deliveries, Callaghan said.

The rate of cesarean delivery increased, from 21.8 percent from 1993 to 1997 to 28.3 percent from 2001 to 2005, the researchers reported. The reason for this increase is also unknown, Callaghan said.

"It may reflect an increase in the risk status of women who are getting pregnant, especially older women and women who are coming into pregnancy with chronic diseases," he said. "It also reflects changes in practice patterns and how physicians make decisions about when a cesarean is warranted."

Dr. Edmund F. Funai, chief of obstetrics at Yale University School of Medicine, said he thinks the authors were "spot-on in their conclusions."

"While studies derived from administrative data must be interpreted with caution, it is very true that more births are occurring in older women than ever before," Funai said. "One natural byproduct of aging is the likelihood of accruing chronic disease diagnoses, such as hypertension. Compounding this fact is the rise in the prevalence of obesity, which itself is associated with morbidities such as hypertension and diabetes. The effect of aging and obesity is also likely synergistic."

However, classifying cesarean delivery as morbidity does not seem to be seem relevant any longer, Funai said.

"Many patients and providers are more interested in being able to schedule a birth, rather than awaiting spontaneous labor," he said. "Also, an increasing number of women seem to be most interested in maximizing fetal safety via cesarean, even if it means a disproportionate maternal risk as a trade-off. This is a cultural shift among patients that is still evolving."

Scientists Find New Way to Create Stem Cells

'Chemical' programming avoids problems genetic manipulation poses, study finds.
Scientists have converted adult cells into embryonic-like stem cells by using chemical programming instead of genetic manipulation.

Gene manipulation is an older method that has posed the risk of serious health problems such as cancer, the researchers explained.

The ability to make stem cells without genetically altering them could lead to the development of many new types of therapies for a wide range of diseases, including type 1 diabetes and Parkinson's disease, the team noted.

"We are very excited about this breakthrough in generating embryonic-like cells from fibroblasts [cells that give rise to connective tissue] without using any genetic material. Scientists have been dreaming about this for years," research leader Sheng Ding, an associate professor at the Scripps Research Institute in La Jolla, Calif., said in a Scripps news release.

Ding and his colleagues reprogrammed adult cells by engineering and using recombinant proteins, which are proteins made from the recombination of fragments of DNA from different organisms. They experimented with these proteins until they found the exact mix that enabled them to gradually reprogram the adult cells.

The reprogrammed embryonic-like cells from fibroblasts behaved the same as embryonic stem cells in terms of molecular and functional features, including differentiation into various cell types, such as neurons, pancreatic cells and beating cardiac muscle cells.

The study, published online April 23 in the journal Cell Stem Cell, was supported by Fate Therapeutics.

Friday, April 3, 2009

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Thursday, April 2, 2009

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Wednesday, April 1, 2009

Labels on OTC Painkillers Need Improvement

Study found safety warnings for kids were missed, could be more prominent.



When Laura Bix brought home a bottle of over-the-counter pain relievers recently, she was surprised to find that the bottle did not have a child-resistant cap on it.

Bix, the mother of three small children and an assistant professor in the School of Packaging at Michigan State University, knew that one size of any product line can be exempted from the federal requirement for child-resistant closure as long as the warning is "conspicuous" and "prominent" on the label. However, this was not the case with the painkillers Bix had bought.

"I thought, 'I'm bringing it into my house, so probably others are bringing it in as well,' " she said.

So, Bix conducted a study, published in this week's issue of the Proceedings of the National Academy of Sciences, to see if consumers were seeing and/or remembering these warnings.

"Child-resistant labeling is really important, because children sometimes feel that medicine is candy, and they run the risk of taking medication and overdosing," explained Amber Watts, an assistant professor of pharmacy practice at Texas A&M Health Science Center Irma Lerma Rangel College of Pharmacy in Kingsville, Texas. "A lot of times, medication should not be consumed by children, especially those less than 6."

In fact, manufacturers of over-the-counter cough-and-cold medicines recently agreed to stop marketing these products to children under 4.

In the Michigan State study, 61 participants were asked to look at the packages of five over-the-counter pain relievers and were monitored with eye-tracking devices to pinpoint what they were looking at and for how long. Individuals were given 10 seconds to review the label.

"Most people spend five to seven seconds viewing things before making purchasing decisions, so we felt that this was conservative," Bix explained.

Participants spent the most time scanning the brand name.

More than 80 percent of volunteers didn't look at the tamper-evident warning. More than 50 percent didn't view the child-resistant section.

Warning labels were recalled the least, from 0 percent to 18 percent (tamper-evident information was not mentioned by any one). Brand name, indications and package color were the most likely to be recalled. Two-thirds remembered the brand name, and 40 percent could remember the color.

The child-resistant and tamper-evident warnings were also found to be less legible than other sections of the packaging. There was some indication that people with children found the labels less legible, although this may be because those with children were older than those without (average age of participants was 25).

"This basically points out that labels may not be conveying the information that we would like them to," Bix said. "Are there things we could do to make them more noticeable or is the consumer just not taking this information seriously and not taking the time to think it out. Depending on where the failure occurs, I think the solutions are very different."

Although the likelihood that anything would happen by having a non-child-resistant bottle in a household with children is slim, Bix nevertheless took the bottle she had purchased to her office.

"The doom-and-gloom scenario is that somebody's not aware that they're receiving the same level of safety that they are with child-resistant packaging, and they leave it in that environment, and the child gets into it," Bix said. "As for tampering, in the vast majority of cases, tampering hasn't occurred, and it's not going to have an effect. But in the rare instance when a feature is missing, and the person is not aware that it's supposed to be there, and they take the drug, then you could have potentially what we had in 1982 in Chicago. Seven people died when they took Tylenol laced with cyanide. For the most part, I think products are very secure, but if something does occur, it can be very serious."

"I feel that other information on the label is more important, drug facts, for instance," Watts said. "I do think that the [newer] drug fact label is a lot better; however, I feel that the tamper feature and child-resistant feature should be a little more distinguished on the label."

The Consumer Healthcare Products Association stated that "the safe and appropriate use of OTC medicines is a top priority for the makers of OTC medicines" but that the "study's design and conclusions cannot be supported."

"Many OTC medicines have been part of numerous scientific studies on label comprehension and actual use, which inform best practices for labeling. . . . Finally, as the paper itself notes, the study is limited by the fact that we do not know participants' history with the medicine labels selected. It may well be that the consumers in the review were already familiar with the labels and product features based on use on previous occasions," the association statement said.

Statins May Help Before Artery-Opening Surgery

Italian studies report fewer heart attacks after procedures.

Giving statins just before artery-opening angioplasty procedures reduces the incidence of heart attacks and other problems, even for people who already have been taking the cholesterol-lowering drugs, Italian trials show.

It's not the effect that statins have on cholesterol that is responsible for the benefits but rather their ability to reduce inflammation and other problems associated with heart disease, said Dr. Carlo Briguori, a cardiologist at the Clinica Mediterranea in Naples, who was to report the findings Monday at the American College of Cardiology annual meeting, in Orlando, Fla.

His study included 688 people who were having the procedure that cardiologists formally call percutaneous coronary intervention (PCI), in which angioplasty is performed and a stent is then placed in the artery. None had been taking statins before PCI was scheduled. About half of them were give 40 milligrams of atorvastatin (Lipitor) in the 24 hours before the procedure, and the others did not take the drug.

Within 12 hours of the procedure, 15.8 percent of those who were not given a statin had a heart attack, compared with 9.5 percent of those given atorvastatin, Briguori reported.

"This supports the concept that a high loading dose of a statin a day before PCI can have a beneficial effect," he said.

But that trial included only people who had not been taking a statin, and "this patient population is disappearing," said Dr. Germano Di Sciascio, chairman of cardiology at the University of Rome, who reported on a second trial at the meeting. "The vast majority of people who come to the catheterization laboratory are on statins," he said. "In our group, it was 70 percent of patients."

His study included 352 people with heart problems such as stable angina -- chest pain caused by narrowed cardiac arteries -- who had been taking statins. Half of them took 80 milligrams of atorvastatin 12 hours before PCI, with an additional 40 milligrams just before the procedure. The other half took a placebo.

The incidence of major cardiac problems, such as heart attacks, was 48 percent lower in those who took the statin before their procedure, Di Sciascio reported. Blood levels of C-reactive protein, a molecule associated with inflammation, were significantly lower in those who got the statin, he noted, and the drug also acts on clot-forming blood platelet cells and improves the function of the endothelium, the sensitive layer of cells that lines the arteries.

"These findings have the potential to change current clinical practice," Di Sciascio said. "They may support the routine use of statin reloading."

But the trial was relatively small, and its results would have to be repeated in larger studies to justify the routine use of statins before PCI, he said.