Contaminated Heparin Seized From Cincinnati Company
Eleven contaminated lots of the blood-thinning drug heparin were seized from Celsus Laboratories Inc. in Cincinnati, the U.S. Food and Drug Administration said Thursday.
The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium, which were manufactured from material imported from China, were contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.
Heparin Sodium USP may be incorporated into finished drug products while Heparin Lithium is used in certain medical devices, including vacutainer blood collection tubes, some in-vitro diagnostic assays, and as a coating for capillary tubes. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in the United States and other countries, the FDA said.
The agency has notified Australian, Canadian, European Union, Japanese and other international authorities about shipments of contaminated heparin from Celsus.
Earlier this year, the FDA received reports of multiple illnesses and deaths linked to OSCS contamination in injectable drug products containing heparin. In response, the agency said, it improved inspection and import controls programs and has initiated 13 recalls of contaminated medical products containing heparin from several companies.
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N. Dakota Warns About Lead in Wild Game Meat
Pregnant women and children younger than 6 years old shouldn't eat meat from wild game killed with lead bullets, North Dakota health officials warned after the release Wednesday of a study that looked at lead levels in the blood of more than 700 state residents.
The study, conducted by the U.S. Centers for Disease Control and Prevention and the state health department, found that people who ate wild game killed with lead bullets appeared to have higher lead levels than those who ate little or no such meat, the Associated Press reported.
The study is the first to link traces of lead in wild game meat with higher levels of lead in the blood of people who eat the meat. Dr. Stephen Pickard, a CDC epidemiologist, said the study found "the more recent the consumption of wild game harvested with lead bullets, the higher the level of lead in the blood."
While the elevated lead levels associated with wild game meat weren't considered dangerous, North Dakota officials decided to issue the caution because unborn babies and young children are considered most at risk from lead poisoning, which can cause learning problems, convulsions and, in severe cases, brain damage and death.
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Pfizer Halts Testing on Anti-Obesity Drug
Testing on a new anti-obesity drug has been halted by Pfizer Inc. because gaining U.S. Food and Drug Administration approval would be too slow, expensive and risky, Bloomberg news reported.
Pfizer said it's not willing to put money into new human tests likely to be required by the FDA. The experimental drug -- dubbed CP-945,598 -- was in the third of three stages required for approval.
A similar anti-obesity drug developed by Sanofi-Aventis SA was rejected by the FDA in June 2007, and Merck & Co. halted development of an anti-obesity drug last month. Sanofi and Merck found that their drugs may be linked to suicide and depression, Bloomberg said.
The Pfizer, Sanofi and Merck anti-obesity drugs all block the same brain receptor that makes marijuana smokers hungry. The last major drug company still developing a similar drug is Bristol-Myers Squibb, the news service said.
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Functioning Human Brain Cells Created From Stem Cells
In a world first, scientists in Japan created functioning human brain tissues from stem cells. The success raises hopes for new treatments for stroke and other brain disorders.
The scientists used human embryo stem cells to form tissues of the cerebral cortex, which plays a vital role in memory, attention, perceptual awareness, thought, language, and consciousness, Agence France Presse reported.
The tissues "self-organized" into four separate zones similar to the structure seen in human fetuses. The tissues also conducted neuro-activity, such as transmitting electrical signals, said the team at the Riken Center for Developmental Biology in Kobe.
The findings were published online Thursday in the journal Cell Stem Cell.
"Cultivated tissues are still insufficient and too small to be used to treat stroke patients. But study of in-vitro cultivation of more mature cortex tissues, such as those with six zones like in the adult human brain, will be stepped up," the Riken Center said in a news release, AFP reported.
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Drug Tricks Body Into Burning Fat
An experimental drug called SRT1720 tricks the body into burning off fat and protected mice against weight gain and insulin resistance even when they ate a high-fat diet, French researchers say.
The drug, a chemical cousin of the red wine extract resveratrol, shifts metabolism into the fat-burning mode that's normally triggered when energy levels are low, BBC News reported.
After 10 weeks of treatment, a low dose of SRT1720 partially protected against weight gain in mice on a high-fat diet. At higher doses, the drug completely prevented weight gain, said the study, published in the journal Cell Metabolism.
While these results are promising, scientists said more research into the safety and effectiveness of the drug is needed before it could be used in humans, BBC News reported.
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Big Increases Seen in Medicare Drug Plan Premiums, Co-Payments
American consumers can expect to see large increases in Medicare drug-plan premiums next year, along with higher co-payment costs, according to consulting firm Avalere Health.
The firm's analysis predicted premiums at the 10 largest drug plans will rise an average of 31 percent, with some rising more than 60 percent, the Wall Street Journal reported.
For example, the 2.7 million enrollees in the nation's biggest Medicare drug plan -- AARP Medicare Rx Preferred, sponsored by UnitedHealth Group -- are expected to face an average premium increase of 18 percent, to $34.92 a month. The plan will still have the same $7 co-payment for generic drugs, but enrollees who buy brand-name drugs on the insurer's preferred drug list will pay 21 percent more ($36.40) for each purchase.
The 1.4 million enrollees in the third-largest drug plan, Humana Inc.'s PDP Enhanced, will see an average premium hike of 51 percent, to $39.56 a month. Average co-payments for generic drugs will rise 75 percent, to $7, and increase 60 percent, to $40, for preferred brand-name drugs.
For this analysis, Avalere averaged expected prices for plans in California, Florida, Illinois, New York and Texas. The actual price consumers pay for premiums, deductibles and co-payments will vary depending on a number of factors, including what drugs they use and what part of the country they live in, the Wall Street Journal reported.
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