FDA Proposes New Drug Labeling for Women

New Guidelines Aimed at Pregnant and Breast-feeding Women

By DAN CHILDS
ABC News Medical Unit
May 28, 2008

Drugs prescribed to women may soon require new labels outlining special potential health effects for pregnant and nursing women.

A recommendation proposed by the U.S. Food and Drug Administration on Wednesday would change the current labeling system on the literature that accompanies medications, used chiefly by doctors and pharmacists but often available to patients. Some have criticized the system -- which places a drug in one of five risk categories, A, B, C, D or X -- calling it confusing.

Under the FDA's proposed system, the new label will be broken into the categories pregnancy and lactation. The pregnancy section would outline any known risks a given drug may pose to a fetus, while the lactation section would list any known details about "the drug's impact on milk production, what is known about the presence of the drug in human milk, and the effects on the breast-fed child."

"It's a population that has very, very special needs," said FDA Commissioner Dr. Andrew C. von Eschenbach during a Wednesday press conference.

"We're all well aware that not everyone likes change, and we're going to be looking at a public commentary period to get further information before we finalize this rule," he added. "But what we must do is address the needs of the patients we're here to serve."

A number of doctors said they believed the new labeling would be a boon for pregnant and lactating women, many of whom take multiple prescriptions; indeed, according to the FDA, the average pregnant woman takes three to five prescription medications.

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Group wants birth control patch pulled

Studies link Ortho-Evra to dangerous blood clots, Public Citizen says

Reuters
updated 12:56 p.m. ET, Thurs., May. 8, 2008

WASHINGTON - A U.S. advocacy group is urging the Food and Drug Administration to pull Johnson & Johnson’s birth control patch from the market after studies found an increased risk of dangerous blood clots.

In a petition filed with the FDA on Thursday, Public Citizen’s Health Research Group said the amount of estrogen released from the Ortho-Evra patch varies widely among individual women, causing up to twice as many clots and other painful side effects.

“The considerable safety concern of high-dose, variable estrogen exposure tips the balance of risks and benefits against the availability of Ortho-Evra as a contraceptive,” wrote Sidney Wolfe, head of the research group.

Ortho-Evra has seen its use slip in the wake of such data, which led to warnings on the patch’s label as recently as January, when a study of women ages 15 to 44 found blood clots known as venous thromboembolisms were about twice as likely in women using the patch versus birth control pills.

The FDA at the time said the patch was safe and effective when used as directed and urged patients to talk to their doctors about the risk.

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Alternative Medicine Attributed to Curing Child's Brain Tumor

Ella Hauschildt's tumor disappeared through natural IV treatment

Ella Hope Hauschildt was diagnosed with a brain tumor a month before she turned seven, but after natural remedies, the latest MRI was not able to detect the tumor anymore. Her family believes it was the natural treatment that helped Ella.

A month before turning 7, Ella found out she had a inoperable grape-sized brain tumor.

She went through 30 radiation treatments, but her family wanted to try an alternative therapy.

Her parents took her to Arizona for natural therapy.

After 20 IV treatments of vitamins, minerals and amino acids, the tumor was no longer detected in the MRI.

Doctors say it is almost impossible that the tumor won’t return, but Ella’s family still remains hopeful.

Ella’s family has switched to a mostly organic, natural diet.

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Infant iron deficiency may hinder emotional growth

By Joene Hendry

NEW YORK (Reuters Health) - Iron deficiency during the first year of life appears to adversely impact the social and emotional development of infants, and the presence or absence of anemia does not alter the impact, study findings suggest.

"Iron deficiency without anemia is not generally detected by current screening procedures," Dr. Betsy Lozoff told Reuters Health. The most common form of screening, the hemoglobin test, detects anemia but not iron deficiency, she explained.

If the findings of this small study are confirmed, screening might need to change from the current hemoglobin test to utilizing a complete blood count test.

"A complete blood count gives information about the red cells in addition to hemoglobin and can help diagnose iron deficiency," noted Lozoff, from the University of Michigan, in Ann Arbor.

She and colleagues assessed the social and emotional behavior of 77 otherwise healthy African-American infants who were 9 months old. Testing confirmed 28 of these infants were iron deficient with anemia, 28 were iron deficient without anemia, and 21 had sufficient iron levels.

Regardless of iron status, all infants received a 3 month course of liquid iron sulfate (22 milligrams daily). Among infants with sufficient iron levels, the supplements were to prevent iron deficiency during their transition to being fed unmodified cow's milk, the investigators note in a report in The Journal of Pediatrics.

Follow-up social and emotional behavioral assessments revealed that infants with poorer iron status at the age of 12 months, compared with those with sufficient iron levels, were more shy, less likely to be oriented or engaged to their surroundings and other people, and were harder to soothe. These associations held regardless of anemia status.

These results "should be confirmed in larger samples and other populations," Lozoff said.

Nevertheless, these findings contribute to the growing evidence associating early iron deficiency with poor social and emotional development, the investigators conclude.

SOURCE: The Journal of Pediatrics, May 2008

Chlorinated pesticides may raise diabetes risk

By Anne Harding

NEW YORK (Reuters Health) - Using certain chlorinated pesticides puts a person at increased risk of developing type 2 diabetes, and the greater the exposure, the greater the risk, researchers from the National Institutes of Health report.

The researchers studied more than 31,000 licensed pesticide applicators participating in the Agricultural Health Study. Licensed pesticide applicators use more potent formulations of the chemicals than are found in products sold for use in the home or garden, the researchers note.

Five years after enrolling in the study, 1,176 had developed type 2 diabetes. Among the 50 different pesticides the researchers looked at, half were chlorinated, and 7 of these were tied to an increased risk of type 2 diabetes. They are: aldrin, chlordane, heptachlor, dichlorvos, trichlorfon, alachlor, and cyanazine.

Risk was higher among study participants who had ever been exposed to any of these chemicals, and increased as cumulative days of lifetime exposure increased, the team reports in the American Journal of Epidemiology.

The strongest link between exposure to the seven chemicals and type 2 diabetes was seen among obese people, possibly, the researchers say, because people with more body fat may store more of the chemicals in their bodies.

"All of the seven are chlorinated compounds," study investigator Dr. Freya Kamel of the National Institute of Environmental Health in Research Triangle Park, North Carolina noted in an interview. "We don't know yet what the implication of that is, but it can't be a coincidence. I think it's an important clue for future research."

The three organochlorine pesticides, aldrin, chlordane, and heptachlor, are no longer sold in the United States, she added, but because they accumulate in animal tissues they remain at detectable levels in individuals' bodies, as well as in some food products.

People should follow instructions when using any product containing pesticides, Kamel said. But the best way to avoid developing type 2 diabetes, she added, is to follow existing public health recommendations to maintain a healthy weight, exercise, and eat a balanced diet.

SOURCE: American Journal of Epidemiology, published online May 14, 2008.

Multivitamins Linked With Breast Density

Breast density, which is increasingly used as a marker of breast cancer risk, is associated with the use of multivitamins, a new study shows.

The report, published this month in The American Journal of Clinical Nutrition, raises questions about advice routinely given to women to take a multivitamin. However, because the study is not a randomized clinical trial, it’s not clear if multivitamin use contributes to a woman’s breast density. It may be that the type of woman who takes multivitamins is more likely to have other risks factors linked to dense breasts.

Breast density describes the relative amount of different tissues present in the breast. A dense breast has less fat than glandular and connective tissue. On a mammogram, a dense breast looks mostly white, whereas a fatty breast looks dark gray.

Numerous studies have shown that breast density is an important breast cancer risk factor, and women with extreme density may have a two- to six-fold increased risk of breast cancer. In addition to its role in breast cancer risk, breast density makes it difficult to identify cancer on a mammogram, potentially increasing the risk that cancer will be diagnosed at a later stage.

The latest study, from Quebec researchers, studied multivitamin use among nearly 1,600 women, half of whom had not yet reached menopause. About 22 percent of the women used multivitamin and mineral supplements, and use was almost evenly distributed among women who had or had not reached menopause. Premenopausal women who were currently using multivitamin and mineral supplements had, on average, about 5 percent more breast density than women who had never taken multivitamins, a finding that was statistically meaningful. There were no statistically meaningful differences among those who did or did not use multivitamins after menopause.

The findings don’t mean that women using multivitamins should stop taking them, particularly if their doctors have prescribed the supplements. However, women with dense breasts should be aware of it and seek regular mammograms and possibly additional ultrasound scans. A recent study showed that using ultrasound with mammography helped doctors spot significantly more breast cancers in high-risk women with dense breasts but also resulted in four times as many false alarms.

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Preventing Diabetes With Diet And Exercise

In a Diabetes Special Issue of The Lancet, researchers demonstrate that group-based lifestyle interventions of diet and exercise for a period of six years may prevent or delay diabetes for up to 14 years following the intervention. It is not clear, however, that lifestyle interventions also reduce the incidence of cardiovascular disease (CVD) and mortality.

There have been several major clinical trials in various countries that have demonstrated how people with impaired glucose tolerances can reduce their likelihood of diabetes due to lifestyle interventions. Researchers, though, still have questions regarding the length of time after intervention that the strategies remain effective. To investigate this issue, Professor Guangwei Li, (China-Japan Friendship Hospital, Beijing, China), Dr Ping Zhang (Centers for Disease Control and Prevention, Atlanta, Georgia, USA), and colleagues conducted the China Da Qing Diabetes Prevention Outcome Study (CDQDPOS) - analyzing 20 years of patient follow-up data.

The patients who participated in the study all had impaired glucose tolerance and came from 33 clinics in China. In 1986, the researchers randomly assigned the patients to one of three lifestyle intervention groups (diet, exercise, or diet and exercise) or to the control group. Over a period of six years (until 1992), the patients experienced active intervention, and a 2006 follow-up provided data that would be used to assess the interventions' long-term effects on main outcomes such as diabetes incidence, CVD incidence and mortality, and all-cause mortality.

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Research Suggests Limiting Food Additives in Diet May Help Kids With ADHD

By Salynn Boyles
WebMD Medical News

May 22, 2008 -- The notion that artificial colors and preservatives in foods may play a role in hyperactivity has been largely dismissed within conventional medicine, but there are signs that this is beginning to change.

In a newly published editorial appearing in BMJ, pediatrics professor Andrew Kemp, MD, of the University of Sydney, called for removal of food additives from the diet to be part of standard initial treatment for kids with attention deficit hyperactivity disorder (ADHD).

Kemp cited a recent controlled trial showing an increase in hyperactivity among children without ADHD who were fed a diet high in food colorings and the preservative sodium benzoate.

Last February, editors of the American Academy of Pediatrics publication AAP Grand Rounds cited the same study as evidence that it is time to revisit the issue.

"The overall findings of the study are clear and require that even we skeptics, who have long doubted parental claims of the effects of various foods on the behavior of their children, admit we might have been wrong," the editors wrote.

Kemp tells WebMD that practitioners have largely ignored the clinical evidence suggesting that dietary modification improves ADHD symptoms in some children.

"Clearly it doesn't work for everybody, but very few treatments do," he says. "(Dietary modification) is certainly something that parents who want to avoid drugs could try for a month or six weeks."

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New research shows avoiding rays may lead to a vitamin D deficiency

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Get your vitamins from small amounts of sun: New research shows that people who regularly use sunscreen and avoiding sunlight may be sacrificing important vitamin D, which is made by the skin when it's exposed to sunlight. Now, the recommendation is to get 15 minutes of sun at the peak of the day three times a week to help avoid a vitamin D deficiency.

Once thought of as helping only to develop strong bones, vitamin D is now believed to serve many purposes in the human body. A deficiency of the vitamin has been linked to several diseases and disorders.

Yet most people don't get enough of the so-called sunshine vitamin.

For years, Americans have been taught that as summer approaches, they should reach for sunscreen to protect themselves from a scorching burn - and the skin cancer it might trigger. But new research shows that by covering up, they may be sacrificing important vitamin D, which is made by the skin when it's exposed to sunlight.
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