Bacteria found in recalled kids' Tylenol

Risk to consumers is ‘remote,’ FDA director says

Ingredients used by Johnson & Johnson in some of the 40 varieties of children's cold medicines recalled last week in the U.S. and 11 other countries were contaminated with bacteria, according to a report by the Food and Drug Administration.

Agency officials said Tuesday none of the company's finished products tested positive for the contaminants, though such testing is not definitive.

"We think the risk to consumers at this point is remote," said Deborah Autor, director of FDA's drug compliance office, on a call with reporters.

Last week's sweeping recall is the latest quality issue to taint J&J's over-the-counter medicine franchise. In January, the company recalled a line of adult Tylenol pain relievers due to complaints of a moldy smell associated with wooden pallets used to transport the drugs.

The FDA report, which was posted online, lists more than 20 manufacturing problems found at the McNeil Consumer Healthcare plant in Fort Washington, Pennsylvania, where the formulas were made. The recalled products include children and infant formulations of Tylenol, Motrin, Zyrtec and Benadryl.

FDA inspectors visited the plant in mid-April and wrapped up their inspection Friday. J&J issued its "voluntary" recall later that night.

Among other problems, FDA inspectors said the company did not have laboratory facilities to test drug ingredients and failed to follow up on customer complaints.

J&J did not investigate more than 46 complaints received in the last year about "black or dark specks" in Tylenol products, according to the FDA's report.

Additionally, inspectors found some pieces of equipment covered with thick layers of dust, while others were held together with duct tape.

In a statement Tuesday, J&J called the problems cited by the FDA "unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate." The health conglomerate, which is based in New Brunswick, New Jersey, said production at the plant won't resume until the problems have been fixed.

The FDA reiterated that serious medical problems with the products are unlikely, but advised consumers to stop using the medicine as a precaution. Parents are instructed to use generic alternatives instead.

J&J's McNeil Consumer Healthcare unit has said some of the recalled medicines may have a higher concentration of the active ingredient than listed on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet testing requirements.

FDA leadership told reporters Tuesday that they first met with J&J in February to discuss manufacturing problems identified in a warning letter about another J&J plant. The agency decided to step up inspections of the company's facilities based on those problems.

"That warning letter brought us to the point where we thought it was necessary to sit down with management and discuss our concerns," Autor said.

 

Flashy fruits entice kids to chow down

Want young ones to eat healthy? Turn food into a spectacle

Here's a potential tip for getting kids to eat their fruit: Make it look flashy.

That's the conclusion of Dutch researchers who examined ways to boost fruit consumption in 94 children 4 to 7 years old. If the fruit was presented in a visually appealing way, kids ate almost twice as much of the juicy produce than if it was presented in a more run-of-the-mill manner.

In the study, "visually attractive" strawberries, grapes and apples were skewered with flagged cocktail sticks and stuck into a watermelon. The "regular" fruit was still skewered, but just laid out on a white plate. 

In contrast, the study found no evidence to support the idea that prohibiting children from eating fruit makes them want to eat more of it (similar to the way sweets are made all the more tantalizing if your mother says you can't have any.)

The researchers don't know why the kids preferred to chow down on the more visually attractive fruit, since the children knew both presentations would taste the same.

"Perhaps, it was not about taste, but about fun," the researchers, from Maastricht University in the Netherlands, write in the current issue of the journal Appetite.

"Parents, schools, supermarkets and food producers should take advantage of these results and offer children fruit and vegetables that are presented in a visually appealing manner," they write.

Food presentation Researchers divided children into three groups, which were all presented with the two plates of fruit. In the first session, one group was told not to eat from the plate of visually appealing fruit, while another was told not to eat from the plate of regular fruit, and a third group was told they could eat from any plate. In a second session, all children were told they could eat from any plate of fruit.

 The kids ate on average 4.8 ounces (135 grams) of the visually appealing fruit and about 2.6 ounces (73 grams) of the regular fruit.

Although the researchers also expected children in the other two groups to favor the fruit that was restricted during the first session, they saw no such effect. Future research will be needed to gauge the role of restriction in kids' eating behavior, the researcher say.

Get creative The authors admit they don't actually know whether the kids found the fruit sticking out of the watermelon more visually appealing or they were drawn to its unusual presentation.

They also don't know how a certain presentation of fruit will fare over the long term. After seeing the presentation multiple times, kids might start to lose interest.

"In the long term, it is probably necessary for parents and food producers to remain innovative," they suggest. 

That innovation could help to boost kids' fruit consumption. Kids are recommended to eat about 1 to 2 cups of fruit a day, according to the U.S. Department of Agriculture. Currently, most Americans don't get enough fruit — only around 6 percent of adolescents aged 12 to 18 eat the recommended amount of fruit, according to a 2009 study by the CDC.

 

New Pampers trigger safety concerns

The U.S. Consumer Product Safety Commission has launched an investigation into Pampers diapers with Dry Max after some parents complained that the new Procter & Gamble Co diapers appear to be the cause of rashes and chemical burns on their children.

Pampers recently updated its Swaddlers and Cruisers diapers with a thinner, more absorbent technology in what the company has called its biggest diaper innovation in 25 years.

Several parents have said that their children developed diaper rashes and some claim to have seen chemical burns on their children after they started using the products, which P&G said went through extensive testing.

The staff of the CPSC is looking into complaints being made by parents and is in discussions with P&G about the product, said Scott Wolfson, the agency's director of public affairs.

P&G said it has shared its safety data with the agency and stands by its product.

"There's no evidence that a single baby has experienced a serious skin safety issue as a result of Dry Max," said Bryan McCleary, a spokesman for P&G's baby care division.

Every day, about 2.5 million babies in the United States have diaper rash. About 10 percent of those cases are severe, with deep red coloring, blisters and/or breaks in the skin, he said.

Many parents, including members of a Facebook group called "Pampers bring back the OLD CRUISERS/SWADDLERS," say they have seen similar issues with their children after using Pampers with Dry Max. They assert the problems started only when they used the new diapers and had not happened before with other diapers, including the old versions of Cruisers and Swaddlers.

The investigation is the latest issue related to a major brand that parents of young children are facing. Last week, Johnson & Johnson recalled Children's Tylenol and other products after an investigation of a manufacturing plant [ID:nN04255618].

The updated, premium-priced diapers had their major debut in the United States in March, but Pampers also put some of the diapers into packages in 2009 without letting consumers know that the new products were included instead of the old versions.

Among most successful product launches
McCleary said Pampers with Dry Max are among the most successful product introductions the brand has ever had and that the company is seeing a level of complaints in line with what it anticipated.

"It's one severe rash complaint for every 6 million diaper changes," McCleary said.

Pediatric dermatologists contacted by Pampers confirmed the company's findings that the product is as safe as the previous version. Among them are Dr. Loraine Stern, Clinical Professor of Pediatrics at the UCLA School of Medicine.

"I have seen absolutely no increase in rashes since the introduction of the newer model," Stern wrote in a statement provided to Reuters by Pampers. "The pictures on the Internet show what looks like classical rashes, not chemical burns. I have full confidence in recommending that my patients continue to use Pampers with Dry Max."

Still, many parents remain convinced that the new Pampers are the cause of their children's problems and have switched to other products, such as Kimberly-Clark Corp's Huggies. The Facebook group, which had about 1,000 members in mid-April, had nearly 3,700 members as of Wednesday afternoon.

Younger women 'face work stress risk'

Stress at work raises the risk of heart disease for women under 50, a study of more than 12,000 nurses suggests.

Danish research in Occupational and Environmental Medicine concludes work pressure has a greater effect on young women than those in their 50s and 60s.

It suggests other risk factors may play a bigger role in the development of heart disease for older women.

The British Heart Foundation says people facing stress at work should try to tackle it in a positive way.

There is a lot of evidence indicating that stress at work raises the risk of heart disease in men, but there has been much less research examining the impact on women.

Risk profile

In this study, the researchers asked more than 12,000 female nurses aged between 45 and 64 about pressure at work and tracked their health for 15 years up to 2008.

By then 580 nurses had been admitted to hospital with ischaemic heart disease, including 369 cases of angina and 138 heart attacks.

After accounting for risk factors such as smoking and diabetes, the researchers found that those who described pressure at work as "much too high" were 35% more likely to have developed heart disease than those who were comfortable with the pressure.

But when they broke the results down by age, they found it was only the women aged 50 and under who were affected significantly.

The researchers from Glostrup University Hospital, in Denmark, say this could be down to a changing risk-profile in different age groups.

"It seems as if the effect of work pressure has a greater impact on younger women," they said.

"This is in agreement with findings from previous studies looking at age-specific effects in both men and women.

"The lower risk among the older nurses may be due to other risk factors that become relatively more important with increasing age."

'Worrying'

June Davison, a cardiac nurse with the British Heart Foundation, said people who were stressed at work should talk to colleagues or managers about how to manage the pressures.

"If you feel under pressure you should try and tackle it in a positive way and get active during work hours," she said.

"Using the stairs and walking some of the way to work could help act as a stress buster and boost heart health too."

Josie Irwin, head of employment relations at the Royal College of Nursing, said the paper raised important concerns.

"Our latest employment survey found that 55% of nurses feel they are under too much pressure at work, making this research worrying reading," she said.

"We know that safe staffing levels are key to providing the best quality care for patients - this research also suggests under-staffing and excess pressure can have a damaging effect on nurses' health."

Meet the 'sabre-toothed sausage'

The mole rat could help us to answer many questions

"They look a bit like a sabre-toothed sausage," says Dr Chris Faulkes, as we enter the naked mole rat laboratory at Queen Mary, University of London.

Scuttling around in a maze of tubes are dozens of small rodents. They appear to be hairless, covered with wrinkly, pink skin and they have beady, black eyes. But the thing that really catches your attention is their enormous, protruding teeth.

At first glance, it's clear that Dr Faulkes' description is spot on.

"It's a really, really bizarre looking animal," admits the scientist, who has spent the past 20 years studying naked mole rats.

These rodents, which belong to the African mole rat family, are found in parts of Kenya, Ethiopia and Somalia.

They live in huge underground burrows, which goes some way to explaining why these creatures look like they do - they use their giant teeth to help them dig.

Dr Faulkes says: "They are amazingly well adapted to living underground."

Busy as a bee

But it isn't just their unusual appearance that attracts attention: their behaviour is about as strange as it gets in the mammalian world.

For a start, these little creatures live in huge groups. On average, you will find colonies made up of 80-100 individuals, but sometimes they can grow to a 300-strong group.

More bizarre still is their social structure.

They behave like the mammalian equivalent of a social insect.

Dr Faulkes points to a mole rat that looks almost twice as large as any nearby. And it is clearly pushing around some of its punier companions.

"That's the queen," he says. "Even in these really huge colonies, there is only a single female that breeds. And she mates with one or two, or sometimes three, breeding males.

"And then the rest of the colony, of both sexes, have their reproduction suppressed and never ever breed."

But the sex-free mole rats have another job, he explains.

"The small ones tend to act as workers, so they carry out colony maintenance activities," says Dr Faulkes.

The larger animals seem to adopt a more defensive role, he adds, keeping predators, such as snakes, at bay.

And if this kind of set up sounds rather familiar, that's because it is.

Dr Faulkes explains: "They behave like the mammalian equivalent of a social insect - they have many, many similarities with bees, ants, wasps and termites."

Throw in on top of this the fact that naked mole rats also live for an unfeasibly long time for a small rodent - 30 years in captivity - and that they also seem to be resistant to cancer, so it is easy to see why scientists are so interested in them.

Could mole rats give us clues about monogamy?

"There are so many aspects of their biology that are extreme," says Dr Faulkes.

The scientist and his colleagues in Pretoria and at King's College London have used this as the basis to find out what lies behind the naked mole rats' behaviour, and in turn, to start to look at how this might relate to other mammals - including humans.

And one way that they have been doing this is to compare naked mole rats with another member of the African mole rat family, the Cape mole rat.

Where the naked mole rat is a highly social animal and forms long-term social bonds, especially between the queen and her select suitors, the Cape mole rat is solitary and aggressive, and sexually, rather promiscuous.

Dr Faulkes says: "They represent both ends of the spectrum in sociability."

Earlier research carried out on voles had suggested that differences in the way that two hormones, oxytocin and vasopressin, were expressed could make a huge impact on social behaviour, including determining whether a species was likely to be monogamous or promiscuous.

So the team decided to look at whether these hormones could also be linked to the differences in behaviour between the two mole rat species.

The Cape mole rat is a solitary animal

Dr Faulkes explains: "We found that the naked mole rats and the Cape mole rats had substantially different patterns.

"The solitary, highly aggressive Cape mole rats had their oxytocin receptors distributed in a different part of the brain to the naked mole rats, while the naked mole rats' oxytocin receptors were found in the same region as monogamous voles."

He added: "This is really telling us that these kinds of systems of differing patterns of distribution for the oxytocin receptors are an important part of what underlies different kinds of social behaviour across mammals."

And while this research has focussed on mole rats, other research groups have been looking at the effects of these hormones on humans, including a recent study that suggested men who inhaled oxytocin became as empathetic as women.

Dr Faulkes says: "It seems even in humans that such changes can actually alter human reproductive behaviour, such as how stable relationships are.

"Some people have even linked mutations in the oxytocin receptor gene to certain types of autism."

Big questions

But scientists are not just looking at social behaviour. They also think that naked mole rats could help us to sniff out answers to a whole host of questions linked to the human condition.

Some researchers are trying to find out whether the animals hold the key to longevity; others are looking at the clues they might give us in the fight against cancer; while some scientists want to see if they can help us to answer questions about reproduction and fertility.

Dr Faulkes says: "Although it might seem a bit of a stretch of the imagination to go from a naked mole rat to humans, the underlying biology is very, very similar.

"And they are just so unusual and there are so many aspects of their biology that are extreme that they could help us to extend our knowledge across so many species and disciplines."