A drug designed to prevent blood loss during certain types of heart surgeries appears to increase users' risks of kidney failure, heart failure and stroke, the U.S. Food and Drug Administration announced Friday. The agency advised doctors to carefully monitor patients given the Bayer Pharmaceuticals drug, Trasylol (aprotinin injection).
The drug, made from the lung tissue of cattle, is used to slow or prevent bleeding, avoiding the need for a blood transfusion. On Sept. 27, Bayer informed the FDA of new study data about Trasylol showing the drug could increase a user's chances of death, serious kidney damage, congestive heart failure and stroke, the agency said in a statement. The study involved 67,000 patients who had undergone coronary artery bypass graft surgery.
The FDA said it was unaware of this new information when its advisors met last week to discuss the drug's safety. The agency said further study was needed since many of the people who were given Trasylol were already at greater-than-average risk of serious complications.
Until the agency is able to review the latest data, it advises doctors to carefully monitor Trasylol patients for damage to the kidneys, heart, or brain, and to promptly report any adverse reactions to Bayer or to the FDA. The agency also says doctors should limit the drug's use to cases where Trasylol's use is "essential to medical management of the patient and outweighs the potential risks."
Hotel Guests Leave Behind Cold Germs
Hotel guests with colds leave behind germs on surfaces like door handles, pens, light switches, and TV remotes after they check out of a room, researchers said Friday at a meeting of the American Society for Microbiology.
The scientists studied 15 people with colds who spent a night in individual rooms at a hotel. After the guests checked out the next morning, researchers tested 10 items in each room that were touched by the sick volunteers. About one third of the items were contaminated with cold viruses, the Associated Press reported.
Cold germs were found on 7 of 14 door handles, 6 of 14 pens, 6 of 15 light switches, TV remotes and faucets, and 5 of 15 phones. Viruses were also detected on alarm clocks, coffee makers, and shower curtains.
However, the germ testing was done before the room was cleaned by hotel staff, the AP reported.
California Drug Program Can Be National Model: Group
A new California bill requiring drugmakers to significantly discount prescription medicines for low-income and uninsured people should send a message to the U.S. Congress that it can do the same for Medicare beneficiaries, says the nonprofit group Consumers Union.
The California bill was to be signed Friday by Gov. Arnold Schwarzenegger. The discount program is expected to offer savings of up to 40 percent on brand name drugs and up to 60 percent on generic drugs to millions of people.
"If California can use its purchasing power to negotiate lower drug prices for the needy and uninsured, why shouldn't Medicare do the same for seniors and the disabled," Earl Lui, senior attorney for Consumers Union, said in a statement.
"California's leaders on both sides of the political aisle agree that drug price negotiation makes sense, not only for patients, but for taxpayers, as well. Congress should do the same and remove the roadblock it specifically put in the Medicare program against price negotiation," Lui said.
In passing the new Medicare Part D drug benefit, Congress prohibited Medicare from negotiating with drug companies for lower drug prices for seniors and the disabled, Consumers Union said.
European Union Approves Anti-Smoking Pill
The European Union has approved the sale of the anti-smoking pill Champix, drugmaker Pfizer said Friday.
Champix (varenicline) will be available with a patient support plan that can be customized by smokers to help them tackle individual smoking behaviors, the Associated Press reported.
It's believed the drug reduces the severity of the urge to smoke and eases many withdrawal symptoms suffered by smokers when they try to quit. The drug may also reduce the satisfaction associated with smoking.
In May, the U.S. Food and Drug Administration approved the drug (sold in the U.S. under the name Chantix) to help smokers quit, the AP reported.
Workers at Small Firms Pay Higher Health Insurance Deductibles
American workers at the largest private-sector companies pay about half as much in health insurance deductibles as workers at the smallest firms, says a report released Thursday by the U.S. Agency for Healthcare Research and Quality.
It said that workers at companies with 1,000 or more employees paid, on average, $859 to meet their deductible for family plan coverage in 2004, while workers at companies with fewer than 10 employees paid an average of $1,779.
The report also said that:
The average annual deductible for workers in firms with 10 to 99 employees was $1,700, and $1,114 for workers in companies with 100 to 999 employees. About 59 percent of private-sector workers were enrolled in company-sponsored health insurance plans that required deductibles to be met before benefits were paid. Workers at the smallest firms had an average co-payment of $19.40 per doctor office visit, compared to $17.42 for employees of the largest companies.
Judge Halts Medicare Repayment
A U.S. federal judge on Thursday halted the Bush administration's attempt to recoup about $50 million erroneously paid out to 230,000 Medicare beneficiaries, The New York Times reported.
The mistake involved refunds of premiums paid for prescription drug coverage. The government had ordered the beneficiaries to repay the money by Saturday, Sept. 30.
Judge Henry H. Kennedy Jr. of the Federal District Court in Washington, D.C., said that many of the beneficiaries might qualify for waivers because repayment of the premium refunds might cause them hardship.
He ordered the government to immediately send all 230,000 beneficiaries a notice informing them they have the right under federal law to request such waivers, the Times reported.
Kennedy said the Bush administration can't enforce its demand for repayment of the money unless it first gives beneficiaries the opportunity to seek an exemption. If a beneficiary does request a waiver, the government can't seek repayment until the Secretary of Health and Human Services rules on the request, the judge said.