The makers of a class of diabetes drugs known as thiazolidinediones, including GlaxoSmithKline's Avandia, have agreed to add stronger warnings labels on an increased risk of heart failure in certain patients, the U.S. Food and Drug Administration said Tuesday.
The so-called "black box" warning also will apply to two Takeda Pharmaceuticals drugs, Actos and Duetact, and two other Glaxo medications, Avandaryl and Avandamet, the agency said. The drugs, when used in conjunction with diet and exercise, are designed to improve blood sugar control in people with type 2 diabetes.
A review of adverse event reports found cases of excessive weight gain and swelling (edema), two warning signs of heart failure, the FDA said.
The strengthened labels will advise health professionals to monitor patients carefully for these warning signs, and to reconsider use of the drugs if heart failure is diagnosed. The labels also will recommend that the drugs should not be used by people with "serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair," the agency said in a statement.
On July 30, an FDA expert advisory panel voted 22-1 to recommend keeping Avandia on the market despite recent research suggesting it could increase users' risk of heart attack and other heart problems. In doing so, the panel advised that the drug carry a stronger warning label.
Mattel Announces Another Major Toy Recall
California-based toy maker Mattel announced Tuesday that it is issuing another major recall of toys made in China, due to "impermissible" levels of lead in the toys' paint.
This time, the company says it is recalling one toy from the "CARS" line of die-cast vehicles, the "Sarge" character. More than 436,000 such toys, including 253,000 sold domestically and 183,000 sold outside the United States, are being recalled.
In a statement, Mattel said the toy vehicle was made for Mattel by Early Light Industrial Co., Ltd, which subcontracted the painting to another Chinese company, Hong Li Da. The latter company was supposed to use paint supplied to it by Early Light, but instead obtained lead-tainted paint from a third party, Mattel said.
Mattel's senior vice president of Worldwide Quality Assurance, Jim Walter, said the company is enforcing a new three-point check system, including unannounced random factory inspections, to stop these types of incidents. "We've met with vendors to ensure they understand our tightened procedures and our absolute requirement of strict adherence to them," Walters said in a statement.
In another move, Mattel announced Tuesday that it was expanding a recall announced in November of magnetic toys that include "certain dolls, figures, play sets and accessories that may release small, powerful magnets." The majority of the 18.2 million magnetic toys subject to the recall are no longer on store shelves, the company said, and newer toys have been designed to retain their magnets.
Details on the exact toys under recall can be found at www.service.mattel.com.
Earlier this month, Mattel recalled more than one million Chinese-made toys that had excessive levels of lead paint that, if ingested, could harm children. The toys were made by Lee Der Industrial in southern China.
Following the recall, Mattel stopped accepting products made by Lee Der and the Chinese government last week revoked the company's export license, The New York Times reported. One of the owners of Lee Der committed suicide last Saturday.
Millions of Nokia Cell Phone Batteries Could Be Defective
Up to 46 million batteries in some Nokia cell phone models could be defective and pose a risk of overheating, the company said Tuesday.
The BL-5C batteries were made by Matsushita Battery Industrial Co. Ltd. of Japan from December 2005 to November 2006, reportedly in one of their China plants. Nokia said about 100 incidents of the batteries overheating have been reported worldwide, but there have been no reports of serious injuries or property damage, the Associated Press reported.
"Consumers with a BL-5C battery subject to this advisory should note that all of the approximately 100 incidents have occurred while charging the battery," and "this issue does not affect any other use of the mobile device," Nokia said.
The company did not issue a recall of the batteries. However, concerned customers can ask for a replacement for any BL-5C battery covered by the advisory, the AP reported.
Doctors Reminded About Safe Use of HIV Drug in Children
Doctors need to be careful when using the anti-HIV drug Kaletra in children, says an Abbott Laboratories letter posted on the U.S. Food and Drug Administration's Web site.
The drug maker wrote the letter after the accidental overdose death of an infant born with HIV, who died nine days after receiving a 6.5 millimeter dose of Kaletra, the Associated Press reported.
In the letter, Abbott reminds doctors that children should receive less than a 5 millimeter dose of Kaletra oral solution.
"Special attention must be paid to accurate calculation of the dose, transcription of the medication order, dispensing information and dosing instructions to minimize the risk of medication," the letter states.
Kaletra prevents reproduction of HIV, the virus that causes AIDS.
FDA Approves 2 New Drugs for Global Fight Against AIDS
Tentative approval of two antiretroviral drugs under the President's Emergency Plan for AIDS Relief (PEPFAR) was granted Monday by the U.S. Food and Drug Administration.
PEPFAR supports treatment for people in 15 countries in sub-Saharan Africa, Asia and the Caribbean.
The two newly approved drugs are nevirapine tablets, indicated for use with other antiretroviral drugs for the treatment of HIV-1 infection; and the pediatric triple fixed dose combination tablet of lamivudine, stavudine and nevirapine, the first fixed dose anti-HIV product designed to treat children under age 12.
These are the 50th and 51st antiretroviral drugs tentatively approved under PEPFAR. These two new drugs and 46 other generic drugs (or drug combinations) have been evaluated by the FDA under PEPFAR, but are not available for sale in the Unites States because of patent or other kinds of marketing protections.
Three other drugs evaluated by the FDA under this program are for sale in the United States. All 51 drugs approved by the FDA under PEPFAR can be purchased outside of the United States by PEPFAR partners using U.S. taxpayer dollars.
Medicare Drug Benefit Premium Will Average $25 in 2008
The average premium for Medicare Part D drug coverage in 2008 will be about $25, the U.S. Centers for Medicare and Medicaid Services (CMMS) said Monday.
That premium for basic coverage is nearly 40 percent lower than the $41 originally projected when the program was signed into law in 2003, Newsday reported. The average premium this year is $22.
Low-income Medicare beneficiaries can receive assistance in paying their Part D premiums.
"Competition and smart choices have been two important factors in holding down the cost of the Medicare drug benefit," Herb Kuhn, acting deputy administrator of the CMMS, said in a prepared statement. He said increased generic drug use has also been a major factor in controlling costs, Newsday reported.
World's Oldest Person Dies at 114
The world's oldest person -- 114-year-old Yone Minagawa of Japan -- died Monday and it's believed the title now belongs to 114-year-old Edna Parker of Shelbyville, Ind., who's about four months younger than Minagawa, the Los Angeles Times reported.
Minagawa was born Jan. 4, 1893 in Fukuoka Prefecture. She was widowed at an early age and supported her five children by selling flowers and vegetables that she grew at home. She lived alone for many years but moved into a nursing home in 2005.
All but one of her five children are dead. She's survived by a daughter, seven grandchildren, 12 great-grandchildren and two great-great grandchildren.
When she was certified earlier this year as the world's oldest person, Minagawa credited sensible eating and plenty of sleep for her longevity, the Times reported.