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September 2007 Archives

FDA Warns on Fentora Side Effects

The U.S. Food and Drug Administration (FDA) has issued a warning to consumers and healthcare professionals on dangerous side effects associated with use of the cancer drug Fentora. FDA states that most recent adverse events and deaths associated with use of Fentora were caused by improper patient selection, incorrect dosing, and inappropriate substitution of Fentora for other pain medications. Fentora is used only for treatment of "breakthrough pain" in cancer patients, meaning intense increases in pain that occur with rapid onset. Earlier this month, Fentora manufacturer Cephalon Inc. issued warning letters to healthcare professionals on the dangers of incorrect administration of Fentora.

Microsoft to Replace Scratched 'Halo 3' Discs

Microsoft Corporation has announced that it will replace all 'Halo 3' video game discs that were scratched after coming loose inside of special limited-edition packaging. Under Microsoft's Disc Replacement Program, customers who purchased a damaged 'Halo 3' disc can submit a Disc Replacement Program Form to receive a new disc. The deadline for submitting the form is December 31, 2007. 'Halo 3,' released on September 25, operates only on Microsoft's X-Box gaming system.

General Motors and Union Reach Tentative Deal

U.S. automaker General Motors and the United Automobile Workers (UAW) union have announced the end of a two-day auto workers' strike, and a tentative agreement on a new contract. The New York Times reports that "the key provision of the new contract is a health care trust that would get G.M.'s vast liability off its books, while workers and retirees would receive their current coverage until the trust is put in place."

Supreme Court to Consider Lethal Injection, Voter ID Laws

The U.S. Supreme Court opens its October Term 2007 on Monday October 1. The Court has announced that it will review the case of two Kentucky death row inmates, and decide whether states' use of lethal injection as a method of administering the death penalty is constitutional under the Eighth Amendment's "cruel and unusual punishment" standards. The Court will also consider a challenge to an Indiana law that requires most voters to present government-issued identification at the polls, and will decide whether such laws have a discriminatory impact on minority and low-income voters.

FBI Releases "Crime in the U.S. 2006"

The Federal Bureau of Investigation (FBI) today released the Crime in the United States 2006 report, a comprehensive collection of local, state, regional, and national crime statistics for 2006. Providing in-depth information on offenses, arrests, and police personnel, the report shows that violent crimes increased nationwide by 1.9 percent compared to 2005, and property crimes decreased by about the same percentage.

1 Million Cribs Recalled

About 1 million Simplicity cribs are being recalled due to a hardware problem that could lead to infant suffocation or entrapment, according to an announcement from the U.S. Consumer Product Safety Commission (CPSC). Some of the affected cribs carry a "Graco" logo. A CPSC Press Release contains detailed information about the recall, including affected model numbers and photos illustrating the hardware and installation issues. At least three infant deaths and seven infant entrapments are among the more than 50 incidents that have been reported to CPSC involving these cribs.

House Passes Drug Safety Bill

Under a bill passed Wednesday by the U.S. House of Representatives, the U.S. Food and Drug Administration (FDA) will have greater power to regulate the safety of prescription medications, including more oversight of drugs that are already on the market. The Washington Post reports that "in the wake of the Vioxx withdrawal and subsequent problems with other drugs, lawmakers seized on the legislation to overhaul how the FDA handles the safety of the drugs it regulates." The bill is expected to pass a Senate vote later this week.

Warning on Cancer Drug Fentora

The manufacturer of cancer pain medication Fentora has sent letters to doctors and health care professionals, stressing the need for correct patient selection, proper dosing, and appropriate administration of Fentora to reduce the risk of respiratory problems. In a Press Release, Cephalon, Inc. reported that it sent the warning letters "in response to recently reported serious adverse events, including some deaths in patients who were not appropriate candidates for Fentora." A U.S. Food and Drug Administration (FDA) Safety Alert stresses that "Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain."

Dole Bagged Salad Recalled, Linked to E. coli

All packages of "Dole Hearts Delight" bagged salad with a September 19, 2007 "best if used by" date and production codes A24924A or A24924B are being recalled by Dole Food Company Inc., in the U.S. and Canada. In a Press Release, Dole reports that "the recall is occurring because a sample in a grocery store in Canada was found through random screening to contain E. coli O157:H7." The E. coli bacterium, one of the leading causes of food poisoning, produces a powerful toxin that can cause severe stomach and intestinal illness. Dole states that it has received no reports of illness related to this product. Consumers who have questions about the recall can call Dole's Consumer Center at 800-356-3111 (toll-free).

September 17 is Constitution Day

Constitution Day celebrates the signing of the final draft of the U.S. Constitution in Philadelphia on September 17, 1787. To commemorate Constitution Day, FindLaw offers a special collection of resources including the official text of the U.S. Constitution, links to each state's constitution, Constitution Day resources, legal commentary on the Constitution, and much more.

California Bans Cell Phone Use by Teen Drivers

California drivers under the age of 18 will be prohibited from driving while using cell phones and other electronic devices, under a law signed Thursday by California Governor Arnold Schwarzenegger. Teens who violate the law would face a $20 fine for a first-time offense, and a $50 fine for any repeat violation of the law. A Press Release from the Office of the California Governor declares that California is joining fifteen states and the District of Columbia, which have also enacted laws "restricting the use of wireless communication devices by new and inexperienced drivers." The new law, which goes into effect on July 1, 2008, applies to all electronic devices, whether "hands-free" or hand-held. Also on July 1, a law prohibiting hand-held cell phone use by all drivers will go into effect. Both laws carry exceptions for emergencies.

Minority Home Loan Applicants Face Higher Costs

A federal government report on the home mortgage market in 2006 shows that minority loan applicants faced higher charges and interest rates than did white applicants. In its annual Home Mortgage Disclosure Act Report, the Federal Reserve found that in 2006, "American Indians, blacks, and Hispanic whites had higher denial rates than non-Hispanic whites; blacks had the highest rates; and Hispanic whites had rates between those for blacks and those for non-Hispanic whites. The pattern was less consistent for Asians, who had higher denial rates than non-Hispanic whites for home purchase, but lower rates for refinancings." Overall, the home loan denial rate for all home loan applicants increased to 29 percent in 2006 (up from 27 percent in 2005).

More Studies Link Avandia to Heart Risk

Two studies published in the Journal of the American Medical Association (JAMA) find that use of Avandia (rosiglitazone) greatly increases the risk of heart attack and heart failure, and suggest that safer diabetes medications are available. The New York Times reports that the studies "confirm what doctors and patients using Avandia have already done in great numbers, that is, switch to another drug." In August 2007, the U.S. Food and Drug Administration (FDA) announced that Avandia would carry "black box" warnings on the risk of heart failure associated with use of the drugs. The "black box" warning is FDA's strongest form of warning.

Sharp Rise in Prescription Drug Side Effects, Deaths

A new study finds a sharp rise in the number of harmful side effects and deaths associated with prescription drug use in recent years. In the September 10, 2007 issue of the Archives of Internal Medicine, researchers reported that incidents of serious side effects and negative reactions to medication increased from 34,966 to 89,842 between the years 1998 to 2005, and fatal adverse recations to prescription drugs rose from 5,519 to 15,107 during the same span. The study concludes that the statistics "illustrate the need for improved systems to manage the risks of prescription drugs." The study examined "serious adverse drug events"  -- including deaths, hospitalizations, and birth defects --reported to the U.S. Food and Drug Administration (FDA) from 1998 to 2005.

New Toy Safety Policies for Disney, Toys 'R' Us

After a string of recent toy recalls, The Walt Disney Company stated that it will begin independent testing of toys featuring Disney characters, and Toys 'R' Us announced the implementation of a more stringent toy safety checking policy. The New York Times reports Disney's independent testing, "set to begin within the next two weeks, will involve some of the more than 65,000 children's products from around 2,000 vendors of toys, jewelry, furniture and other Disney items. " And in a story on the new Toys 'R' Us safety check policy, Reuters quotes company spokeswoman Kathleen Waugh as stating that "a systematic recheck of all products on [Toys 'R' Us'] shelves" has already begun. Toys 'R' Us has also announced the launch of a new toy safety website. In August and early September 2007, Mattel announced three recalls involving about 10 million toys, due to injury risks from lead paint and small magnets.

Chemical in Microwave Popcorn Poses Risk

A number of microwave popcorn manufacturers are making efforts to remove the chemical food additive diacetyl from their products. Diacetyl, which is found in butter flavoring mixtures used in microwave popcorn, may cause bronchiolitis obliterans, a lung disease. The New York Times reports that "the three companies that sell Orville Redenbacher, Act II, Pop Secret and Jolly Time microwave popcorn said they planned to change the recipes for their butter-flavored microwave popcorn to remove diacetyl." For a number of years, workers at microwave popcorn manufacturing plants have been at known risk of developing lung disease (called "popcorn lung") due to on-the-job exposure to diacetyl. Now, ABC News is reporting the first known case of "popcorn lung" in a consumer who ate large quantities of microwave popcorn. The U.S. Food and Drug Administration (FDA) is investigating the link between the food additive diacetyl and development of lung disease.

Mattel Recalls More Toys Due to Lead Hazard

Mattel Inc. and the U.S. Consumer Product Safety Commission (CPSC) have announced a recall of about 800,000 toys due to the potential hazard of excessive amounts of lead in surface paint on the toys. Tuesday's recall announcement involves about 675,000 "Barbie" accessory toys, 8,900 "Bongo Band" toys, and 90,000 "Geo Trax Locomotive" toys. Mattel Inc. states that it has received no reports of illness or injury associated with the recalled toys, but the company is urging consumers to immediately take any recalled toys away from children, and to contact Mattel for information on returning the product and receiving a free replacement toy. Tuesday's toy recall is the third announced by Mattel in just over a month (More information on August 2 and August 14 recalls).