Posted On: December 30, 2010

French study prompts FDA concern about growth hormone

The Food and Drug Administration (FDA) has undertaken a review of recombinant human growth hormone (somatropin) after a French study determined that some kids who take it because they are abnormally short may be at a small increased risk of death.

The FDA does not recommend that patients stop taking recombinant human growth hormone before talking to their physicians, as it believes the benefit of the hormone still outweighs its potential risks. However, the FDA is now reviewing all available information on this potential risk and plans to issue new recommendations, if necessary, once the review is completed.

Meanwhile, healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program here.

Recombinant human growth hormone, a manufactured protein that is nearly identical to the main form of the naturally occurring human growth hormone, can stimulate tissue growth, protein, carbohydrate, lipid and mineral metabolism, and increases in height and weight.

In the U.S., it is used to treat children with short stature due to growth hormone deficiency (including idiopathic growth hormone deficiency), Turner syndrome, Noonan syndrome, Prader-Willi syndrome, short stature homeobox-containing gene (SHOX) deficiency, chronic renal insufficiency, and idiopathic short stature, as well as children small for gestational age. Recombinant human growth hormone is marketed under the following brand names: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin.

Source: Food and Drug Administration

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Posted On: December 23, 2010

Feds finally ban drop-side cribs

The federal government has finally banned the traditional drop-side crib. In a unanimous vote, the Consumer Product Safety Commission (CPSC) voted to ban the manufacture, sale and resale of the cribs.

Drop-side cribs, so-called because they have a side rail so that the side of the crib can move up and down, making it easier for parents to lift their babies out of the crib, are believed to have caused the deaths of more than 30 children over the past decade. During the same period, millions were recalled over safety concerns.

Effective June 1, a new standard takes effect that requires cribs to have fixed sides. Hotels and childcare centers have 2 years to purchase new cribs. The new rules also mandate more stringent safety tests that mimic how children of different ages behave in cribs. Older children typically apply more force to the crib by shaking, running around and jumping in it. The new tests will ensure cribs can take the additional pressure. In addition, better labeling on crib pieces will also be required.

CPSC Chairman Inez Tenenbaum called the new rules some of the strongest in the world and predicted they will significantly cut crib-related accidents.

Anticipating the ban, crib makers have been phasing out drop-side cribs for the past few years. Last year, ASTM International, the organization that sets voluntary industry standards, approved a drop-side ban.

However, many parents still have drop-sides in their homes. They also can be found in secondhand stores.

Source: Associated Press

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Posted On: December 22, 2010

Dosing directions in children’s medications found wanting

Given the importance of correct dosing of over-the-counter pediatric medicines, you would think that the labeling on the package and the dosing information would be clear and understandable for parents. Unfortunately, a recent study published in the Journal of the American Medical Association (JAMA) says that is usually not the case, with potentially deadly results.

The study examined the directions and measuring devices in 200 non-prescription pediatric liquid medicines for allergy, cough and cold, pain and gastrointestinal problems, as well as some combination medicines, over one year ending Nov. 1, 2009. The sample represented 99% of over-the-counter liquid pediatric medicines sold in the United States.

Researchers found that 52 medicines did not include a measuring device, and that 146 of the other 148 had inconsistencies between the dosing directions and the devices, including missing or superfluous markings, unfamiliar units of measurement (for example, drams or cubic centimeters), or undefined or nonstandard abbreviations. More than 24% of the medications that did include measuring devices had missing markings, while 120 had superfluous markings. Meanwhile, 11 of the 200 medications used little-known units of measurement, such as drams and cc, for doses listed.

The Food and Drug Administration (FDA) published voluntary guidelines for labeling of dosing directions and measuring devices for over-the-counter liquid medicines in November 2009 and expects to see changes by next winter, according to the study’s lead author, Dr. Shonna Yin. At that time, Yin says, the study will be redone to determine if the voluntary guidelines work.

Source: The New York Times

You can view the JAMA abstract here.

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Posted On: December 17, 2010

CPSC "recalls" its recall of lead-laced drinking glasses

The Consumer Product Safety Commission has reversed an earlier decision and now says lead-laced drinking glasses with images of superheroes and characters from the Wizard of Oz are intended for adults, not children.

Previously, the CPSC had said the glasses were children’s products and therefore had to meet strict federal lead limits. Independent lab testing by the Associated Press had determined that the amount of lead in the colored decorations was as much as 1,000 times the federal maximum for children's products. There are, however, no limits on lead content for adult drinking glasses.

The main danger of lead ingestion is to the developing brains of small children.

According to agency spokesman Scott Wolfson, “a premature statement was made regarding two sets of glasses . . . that has now been determined to be inaccurate." Ironically, it was Wolfson himself who had announced that the glasses were children’s products and that CPSC would launch an investigation into their lead content. After Wolfson’s initial statement, the company that imported the glasses from China announced it was pulling them from the market and would recall those already sold.

Wolfson now says that CPSC staff weren’t in possession of the glasses when they were declared children’s products. “After thoughtful analysis by child behavior experts at CPSC, it has been determined that the glasses are not children's products [because] the size, weight, packaging and price of the glasses sampled by CPSC are consistent with glasses more commonly used for consumption of adult beverages."

Jim Therrell, a professor at Central Michigan University who wrote the guidelines used by CPSC to determine what items children of different ages use, disagrees. “"Kids would choose this glass over a plain glass. If you consider that they are all movie based, they're all fantasy based, the fantasies would probably range in appeal to ages 4 to 5 at the low end up through 11, 12."

Under federal law, an item is a "children's product" if it is "primarily intended" for those 12 and under.

Source: Bloomberg BusinessWeek

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Posted On: December 16, 2010

Firefighters rescue 2-year-old trapped in vending machine

The mother of a Pittsburgh-area toddler who became trapped inside a toy crane vending machine and had to be rescued by firefighters is calling for changes to how the machines are manufactured.

The woman’s 2-year-old daughter managed to crawl through the hole where the toys exit to get a closer look at the stuffed animals and other toys inside the machine. Once inside, however, she was unable to crawl back out.

The child remained calm during the 15 minutes she was stuck in the machine before firefighters pulled her out uninjured, but her mother now says the holes in these machines need to be made much smaller. Meanwhile, the vending machine has been removed from the mall.

It’s not the first time a small child has become stuck inside a vending machine. In October, a 9-year-old boy became trapped in a similar machine, and over the past decade, there have been several such stories, leading to calls for vending machine manufacturers to make design changes to ensure these incidents no longer happen.

Source: Gather Blog

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Posted On: December 6, 2010

Rear-view cameras in cars may be mandated to protect kids from being backed over

The Department of Transportation plans to make rear-view cameras standard for all vehicles by 2014 to prevent children being backed over. Each year, hundreds of children are hospitalized after being hit by cars backing up, and every week at least 50 children are reportedly backed over by vehicles in the U.S.

The regulation, which was proposed by the National Highway Traffic Safety Administration (NHTSA), would expand the required field of view for all passenger cars, pickup trucks, minivans, buses and low-speed vehicles with a gross vehicle weight rating of up to 10,000 pounds so that drivers can see directly behind the vehicle when the vehicle’s transmission is in reverse. NHTSA believes automobile manufacturers will install rear mounted video cameras and in-vehicle displays to meet the proposed standards.

The cost of adding the cameras will probably be borne by consumers. According to NHTSA estimates, it will add as much as $200 to the price of a new car. If the law passes, it would be phased in over the next four years, starting with 10% of new cars sold by September 2012, 40% by September 2013 and 100% by September 2014.

The proposed rule was required by Congress as part of the Cameron Gulbransen Kids Transportation Safety Act of 2007. Two-year-old Cameron Gulbransen, for whom the Act is named, was killed when his father accidentally backed over him in the family’s driveway.

NHTSA estimates that, on average, 292 fatalities and 18,000 injuries occur each year as a result of back-over crashes involving all vehicles. Children and the elderly are most affected, with approximately 44% of fatalities being children under 5 years of age.


Click here to view a press release with more information from the NHTSA about the proposed legislation.

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Posted On: December 4, 2010

Feds probe lead-tainted drinking glasses for kids

The U.S. Consumer Product Safety Commision (CPSC) has launched an investigation into lead levels in themed drinking glasses depicting comic book and movie characters. CPSC ruled that the glasses were children’s products, and therefore subject to stricter standards than those intended for adults.

The CPSC said it was collecting samples of all glasses cited in a continuing Associated Press probe into dangerous metals – cadmium,in particular – in children's merchandise.

After CPSC announced that it considers the glasses children's products, Warner Bros. said it would stop selling them, and the importer, Utah-based Vandor LLC, said it would pull them from the broader market, despite its insistence that the products were marketed to adults, not children. The Chinese-made glasses depict the likes of Superman, Wonder Woman and characters from "The Wizard of Oz" such as Dorothy and the Tin Man.

About 160,000 glasses have been recalled since AP disclosed that laboratory tests it commissioned showed that colored designs in a range of glasses contain high levels of lead or were made in such a way that lead or cadmium could escape and contaminate the hands of someone handling them.

The CPSC said its own inquiry would extend beyond the superhero and Oz glasses to include others cited by AP "that have decorations that children would be attracted to."

Child safety advocates worry that that toxic metals rubbing onto children's hands can get into their mouths and cause cumulative damage over time. Testing performed so far revealed that the enamel used to color the glasses contained 1,000 times the the amount of lead (i.e. the enamel was 30% lead, whereas the federal limit is 0.03%).

Had the regulators decided the glasses weren’t children’s products, they wouldn’t be subject to the strict federal limits.

Both Vandor and Warner Brothers, which sold the glasses, insisted that the principal cutomers were adult collectors and that they made the decision to pull the glasses in "an abundance of caution." But on Warner Brothers own website, the glasses were sold alongside a lunch box and children’s T-shirts with superhero images.

Source: Boston Globe

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