More 'Black Box' Warnings Added to Anemia Drugs' Labels
The manufacturer of three popular anemia drugs -- erythropoiesis-stimulating agents (ESAs) -- has expanded each medication's "black box" warning to include information about tumor growth and death in patients with early stage breast cancer and cervical cancer.
The Associated Press reports that California-based Amgen has added the warnings about accelerated tumor growth on each container of Aranesp, Epogen and Procrit (Procrit is made by Amgen but sold by New Jersey-based Johnson & Johnson). There are already similar alerts about other types of cancer on the drugs' labels, the wire service said.
The decision to expand the warning comes less than a week before the U.S. Food and Drug Administration was scheduled to review the risks of using the drugs, which increase the production of red blood cells at a rapid rate, restoring a patient's energy, at least temporarily.
On Nov. 8, 2007, the FDA approved new black box warnings on labels of the three ESAs. The warnings detailed the dangers to patients with cancer and patients with chronic kidney failure. Those dangers include heart attack, stroke, heart failure and cancer tumor growth and shortened survival, the FDA said.
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Drug Maker Withheld Diabetes Link to Schizophrenia Drug, Expert Witness Says
The pharmaceutical firm Eli Lilly knew about serious side effects from its best selling anti-psychotic drug Zyprexa as early as 1998 and should have warned physicians that using the drug could cause diabetes, an expert witness testified in an Alaska lawsuit March 7.
According to the New York Times, Dr. John Guriguian, a diabetes specialist and reviewer for the U.S. Food and Drug Administration for more than 20 years, said that Lilly had evidence of the link between Zyprexa, introduced in 1996, and diabetes, but put "profit over concern of the consumer."
The State of Alaska is suing Eli Lilly in an attempt to recover Medicaid costs it incurred by treating schizophrenia patients who developed diabetes after taking Zyprexa, the newspaper reports.
Alaska claims that although the drug company knew by 1998 that Zyprexa caused weight gain and blood sugar changes in many schizophrenia patients, the company deliberately withheld the information from the FDA, the Times reports.
In fact, a 2002 company internal memo specifically instructed its sales representatives not to discuss diabetes concerns with U.S. doctors, the newspaper reports. "We will NOT proactively address the diabetes concerns," the Times cites an internal Lilly memo as saying.
Lilly denies that it withheld any information from the FDA and that the issue of linking Zyprexa's use with diabetes is still subject to clinical review and debate, the newspaper reports.
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Many Later-Stage Premature Babies Require Long-Term Care
About a third of premature babies born between 29 and 33 weeks still need specialist care at age 5, says a French study that looked at 400 full-term babies (40 weeks) and 1,800 born before 33 weeks.
It was already known that very early birth greatly increases the risk of physical and learning problems later in childhood. But this new study suggests that many children born at a later stage of prematurity still require long-term care, BBC News reported.
All the children in the study underwent physical and mental assessments at age 5. As expected, those born before 28 weeks had the highest disability rate (195 children/49 percent), but the actual number of children with disabilities was highest among those born between 29 and 33 weeks -- 441 children/36 percent.
When the researchers examined the specialist health services (such as physiotherapy, psychology, occupational therapy) required by the children, they found that these resources were used by 42 percent of children born at 24-28 weeks, 31 percent of children born at 29-32 weeks, and 16 percent of children born at 39-40 weeks.
The study appears in The Lancet.
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New Anesthesia Recovery Drug Appears Effective: FDA
A new injectable drug designed to reverse the effects of anesthesia in patients after surgery appears effective, but there are still questions about its safety, according to a U.S. Food and Drug Administration analysis posted Friday on the agency's Web site.
The Schering-Plough Corp. drug, called Bridion, will be the subject of a review next Tuesday by an FDA panel of experts, the Associated Press reported. The panel's recommendation will be an important factor as the FDA considers whether to approve Bridion.
In its analysis, the FDA said the drug appears safe in healthy adults, but said more studies may be needed to investigate concerns about allergic reactions and Bridion's effects on children's teeth.
While there are already similar drugs on the market, Schering claims that Bridion is unique because it reverses the effects of mild and serious anesthesia, the AP reported.
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Hamilton Beach, Proctor-Silex Toasters Pose Fire Hazard
About 482,000 Hamilton Beach and Proctor-Silex toasters are being recalled due to a potential fire hazard, the U.S. Consumer Product Safety Commission said.
The 2-slice and 4-slice toasters can remain on after popping up and ignite flammable items covering or in contact with the toaster. To date, there have been 63 reports of malfunctions, but no reports of fires or injuries.
The recalled toasters, made in China, were sold across the United States from August 2007 through February 2008 for between $13 and $40. The toasters are black, red, white chrome or brushed chrome and have Hamilton Beach or Proctor-Silex printed on the side, the CPSC said.
Consumers with these toasters should immediately stop using them and contact Hamilton Beach Brands Inc. of Glen Allen, Va., for instructions on how to receive a free replacement toaster. Contact the company at 1-800-574-6800 for more information.
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U.S. Senate Passes Bill to Improve Safety of Children's Products
A public database of consumer complaints and new safety standards for toys are among the measures included in a U.S. Senate bill meant to improve the safety of children's products made outside the United States.
The bill, approved Thursday by a 79-13 vote, would also ban lead in children's goods, boost the ability of the Consumer Product Safety Commission to certify the safety of foreign-made goods, and increase the civil penalty cap for safety violations, the Associated Press reported.
The Senate bill also calls for a ban on phthalates -- chemicals in plastic believed to be a health threat to youngsters -- from children's products.
In December, the House of Representatives passed its own version of a children's product safety bill. Negotiators from each chamber will now try to reconcile their differences.
These moves by U.S. lawmakers are in response to recalls last year of millions of Chinese-made toys that posed a health and safety threat to children, the AP reported.
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