Chinese Government Admits Toys Contained 'Date-Rape' Chemical
| The Chinese government acknowledged over the weekend that millions of Aqua Dot toys recalled in the United States do indeed contain a chemical that can turn into what is known as the "date-rape" drug if it is ingested. The Associated Press reports the Chinese General Administration of Quality Supervision Inspection and Quarantine issued a statement Nov. 10 saying that the toys were coated with the industrial chemical 1,4-butanediol (GHB) and were from a factory in a city near Hong Kong. U.S. stores began removing Aqua Dots toys from their shelves last week after an investigation by the Consumer Product Safety Commission found the presence of the dangerous chemical, the wire service reported. Aqua Dots are beads that can be arranged into designs that hold together when the beads are sprayed with water. At least nine children in the United States and three Australian children have been hospitalized after swallowing the beads, the A.P. reported. "The Shenzhen factory started to produce the bead toys after its trial products provided to the agent received no objection," the state-run Xinhua News Agency said in a stetment to the A.P. The investigation revealed that the toys were coated with harmful 1,4-butanediol -- widely used in plastics and cleaners -- instead of the specified 1,5-pentanediol, a nontoxic compound found in glue. The date-rape drug gamma hydroxy butyrate can cause death. Its symptoms include respiratory difficulty, loss of consciousness, seizures, drowsiness and coma. |  |
In 1999, the U.S. Food and Drug Administration declared 1,4-butanediol a class I health hazard because it can cause life-threatening harm, the AP reported.
Aqua Dots were sold in 40 countries, the wire service said.
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U.S. Infant Mortality Rate Still Needs Improvement, Statistics Show
It isn't surprising that the U.S. infant mortality rate continues to drop. But what may be surprising is that even with a lower infant death rate, the United States ranks near the bottom among modernized nations, the Associated Press reports.
First, the good news. According to the U.S. Centers for Disease Control and Prevention, the U.S. infant mortality rate for 2004 (the latest year with complete statistics) was about seven babies for every 1,000 live births before reaching the first birthday, compared to 26 deaths per 1,000 births in 1960.
But what may at first seem like a remarkable achievement is actually not impressive when statistics show the United States ranking near the bottom among industrialized nations in infant mortality, the A.P. reports. A 2006 Save the Children report listed the U.S. ahead of only Latvia, and tied with Hungary, Malta, Poland and Slovakia near the bottom of the list.
Why aren't infant death rates even lower? Racial and economic disparities, the wire service reports. For example, CDC statistics show that babies born to black mothers in the United States die at two-and-a-half times the rate of babies whose mothers are white, the A.P. reports.
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FDA Approves Products That Reduce Spread of Dangerous Bacteria
The spread of the deadly strain of staphylococcus bacterium known as MRSA away from hospitals and into schools and the general population has prompted the U.S. government to speed up the approval process of products designed to combat the antibiotic-resistant germ.
The Chicago Tribune reports that Deerfield Ill.-based Baxter International has announced U.S. Food and Drug Administration approval of an IV connection tube coated with an antimicrobial substance to prevent bacteria from entering the blood stream.
The FDA has established more streamlined procedures in the approval process, the newspaper reports. "This is becoming more of an issue, so we are developing guidance on it so when manufacturers submit information on their device it is appropriate information for the types of things we want to look at," the Tribune quotes William Maloney, an FDA reviewing physicist, as saying.
Maloney was involved in assessing an infection-resistant tube that would allow easier breathing for pneumonia patients. The tube, developed by C.R. Bard Inc. of Murray Hill, N.J., also received FDA approval las week.
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Drug Maker Reaches Settlement Over Off-Label Marketing Practices
While the decision by pharmaceutical Giant Merck & Co. to pay almost $5 billion to settle thousands of claims over whether the company's pain relief drug Vioxx caused heart damage, a smaller but nonetheless significant settlement was reached last week in a dispute between the U.S. government and Cephalon Inc., which makes sleep and pain drugs.
According to the Bloomberg News service, Cephalon, headquartered in Frazer, Pa., has announced it would plead guilty to one misdemeanor charge and pay $425 million to settle a federal investigation into its sales and marketing practices.
The criminal charge stems from a federal investigation into how Cephalon was promoting "off-label" sales and marketing practices for three of its drugs, Gabitril -- used to treat epilepsy-- narcolepsy drug Provigil and Actiq, which is marketed to relieve cancer pain. The government was also investigating whether Cephalon was attempting to delay generic drug competition, Bloomberg News said.
While physicians can prescribe drugs for uses beyond those approved by the U.S. Food and Drug Administration, pharmaceutical companies can't promote the drugs for those purposes, the Associated Press reported.
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Non-prescription Zyrtec-D Approved by FDA
The U.S. Food and Drug Administration approved on Friday the allergy drug Zyrtec-D for non-prescription use in people 12 and older. It combines the antihistamine Zyrtec with a nasal decongestant.
Zyrtec-D (cetirizine hydrochloride/pseudoephedrine) has been sold as a prescription drug since 2001. Sold by McNeil Consumer Healthcare, it's prescribed for relief of allergy symptoms, including runny nose, sneezing, itchy eyes and nose, and nasal congestion.
Zyrtec-D also is used for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring freer breathing through the nose.
Hay fever and other allergies are the sixth-leading cause of chronic disease, with about 50 million sufferers each year in the United States, according to the U.S. National Institute of Allergy and Infectious Diseases.
"The approval of this widely used drug for nonprescription use will enable many people to have access to another effective treatment for their allergy symptoms," Dr. Andrea Leonard-Segal, director of the FDA's Division of Nonprescription Clinical Evaluation, said in a prepared statement.
Common side effects of Zyrtec-D include drowsiness and dry mouth, the FDA said.
Because the drug contains pseudoephedrine, it is subject to sales restrictions imposed by the federal Combat Methamphetamine Epidemic Act, passed in 2005. These restrictions include limiting the amount that a person can buy, and tracking requirements imposed on stores distributing the product, the FDA said.
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Lead Concerns Prompt Recalls of More Chinese Toys
| Two more recalls of Chinese-made toys and products with dangerous levels of lead have been announced by the U.S. Consumer Product Safety Commission. One recall involves 51,000 yellow children's sunglasses distributed by Dolgencorp Inc., of Goodlettsville, Tenn. The other recall involves 175,000 Curious George plush dolls distributed by Marvel Toys of New York City. The recalled 12-inch Curious George dolls are dressed to represent five themes: birthday, fireman, sweet dreams, tool time, and tool time with a soft face. The dolls were sold with a Curious George storybook or activity book at U.S. toy and discount department stores from December 2005 through August 2007. |  |
The yellow sunglasses (no other colors are included in the recall) have the word "China" printed on the left side of the frame. The UPC #400007860896 and words "Fashion Sunglasses" and "Time to Play Every Day" are printed on the product's red hangtag. The glasses were sold at Dollar General stores across the United States from March 2005 through October 2007 for $1.
Consumers should immediately take the sunglasses and dolls away from children, the CPSC said.
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