Generic Ambien Approved by FDA
The U.S. Food and Drug Administration approved Monday the first generic versions of the sleep aid Ambien -- generic name zolpidem tartrate. It's a sedative-hypnotic drug indicated for the short-term treatment of insomnia.
"This approval offers Americans more alternatives when choosing their prescription drugs," said Gary J. Buehler, director of the FDA's Office of Generic Drugs.
Zolpidem tartrate tablets in formulations of 5 milligrams and 10 milligrams are manufactured by a variety of generic drug companies in the United States. The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: Mylan Pharmaceuticals Inc.; TEVA Pharmaceuticals USA; Roxane Laboratories Inc.; Watson Laboratories Inc.; Ranbaxy Laboratories Ltd.; Dr. Reddys Laboratories Ltd.; Apotex Inc.; Synthon Pharmaceuticals Inc.; Genpharm Inc.; Mutual Pharmaceutical Company Inc.; Caraco Pharmaceutical Laboratories Ltd.; Carlsbad Technology Inc.; and Lek Pharmaceuticals, the FDA said in a statement.
In March, the FDA requested that all manufacturers of sedative-hypnotic drug products -- a class of drugs used to induce and/or maintain sleep -- strengthen their product labeling to include stronger warnings about potential risks. Those risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after taking a sedative-hypnotic drug, with no memory of the event.
According to the online magazine Drug Topics, in 2006, Ambien was the 13th best selling brand name drug. The sanofi-aventis (formerly Sanofi-Synthelabo, Inc.) patent for zolpidem tartrate expired on April 21, the FDA said.
Free Cervical Cancer Vaccine in Demand in New Hampshire
In New Hampshire, demand is outpacing supply of free vaccine to protect against human papillomavirus (HPV), which can cause cervical cancer, the Associated Press reported.
New Hampshire was the first state to approve free distribution of the Gardasil vaccine. The program began in January and state officials expected to vaccinate about 25 percent of eligible girls this year. However, advertising has spurred demand.
New Hampshire is offering the vaccine free to girls ages 9 to 18. The vaccine is approved for use in females ages 9 to 26. The normal cost is about $360 for three shots over six months, the AP reported.
In response to the high demand for the free vaccine, some medical practices have created lists that rank patients according to priority, while others are suggesting that patients find out if their health insurance will pay for the shots, which would help take pressure off the free program.
Medical Journal Criticizes Supreme Court Abortion Ruling
The New England Journal of Medicine on Monday published online two commentaries and an editorial that criticized last week's U.S. Supreme Court decision to uphold the federal ban on the controversial abortion procedure that opponents call "partial-birth abortion," the Boston Globe reported.
"With this decision the Supreme Court has sanctioned the intrusion of legislation into the day-to-day practice of medicine," wrote Dr. Jeffrey M. Drazen, editor of the journal. Physicians are amenable to oversight and discussion of controversial matters, he said, but those discussions should occur "among informed and knowledgeable people who are acting in the best interests of a specific patient," the newspaper reported.
The furor surrounding the right-to-die showdown involving Terri Schiavo in 2005 demonstrated "the disastrous consequences of congressional interference" in a medical case, Drazen wrote. "The judicial branch has regrettably joined the legislative branch in practicing medicine without a license."
The controversial abortion procedure, known medically as intact dilatation and evacuation (intact D&E), is usually performed after 12 weeks of pregnancy. It accounted for less than 1 percent of all U.S. abortions in 2000, according to a survey from the Alan Guttmacher Institute, a nonprofit group focused on sexual reproductive health.
According to the U.S. Centers for Disease Control and Prevention, 857,475 abortions were performed in the United States in 2003.
Asia Faces Dramatic Increase in Cancer Cases
Longer life spans and changing diet and lifestyles are among the factors that could lead to a dramatic increase in cancer cases in Asia by 2020, experts attending a conference in Singapore warn.
If current trends continue, the total number of new cancer cases in Asia could climb from 4.5 million in 2002 to 7.1 million in 2020, the Associated Press reported.
That increase could cause a major health crisis as poorer Asian countries struggle to pay the cost of cancer screening, vaccines and treatment, the experts said.
"This will put a tremendous burden on patients, their families and the health-care system in each country," said Singapore Health Minister Khaw Boon Wan, the AP reported.
Smoking is a major cancer threat. In a number of Asian nations, more than 60 percent of males smoke, said Dr. Donald Max Parkin, a research fellow at the University of Oxford's Clinical Trial Service Unit and Epidemiological Studies Unit.
In many Asian nations, large numbers of people have moved from rural areas to the cities. That switch has led to more sedentary lifestyles, increased consumption of meat and fried foods, and fewer vegetables in the diet.
Cyclist's 'B' Samples Positive: French Paper
The French newspaper L'Equipe reported Monday that follow-up tests on backup urine samples from American cyclist Floyd Landis tested positive for synthetic testosterone, the Associated Press said.
The tests were conducted at France's national anti-doping laboratory of Chatenay-Malabry outside Paris. The results on the seven "B" samples were sent directly to the U.S. Anti-Doping Agency, which requested the tests.
After Landis won the 2006 Tour de France, it was revealed that he'd tested positive for elevated testosterone to epitestosterone levels after the 17th stage of the world's premier cycling race, the AP reported.
Landis, 31, will have an arbitration hearing May 14 in California. If the doping allegations are upheld, he faces a two-year ban from competition and he would become the first rider in the 104-year history of the Tour de France to be stripped of the title.
U.S. Nursing Homes Standards Not Properly Enforced: Report
U.S. government oversight of nursing homes is criticized in a new report to be released next week by the Government Accountability Office (GAO), an investigative arm of Congress.
The report said that nursing homes repeatedly cited for mistreatment of patients receive only minimal penalties, The New York Times reported. As a result of the weak penalties, some nursing homes don't consistently meet federal standards and pose an ongoing threat to patient health and safety, the GAO said.
The U.S. Health and Human Services Department "fails to hold homes with a long history of harming residents accountable for the poor care provided," the report said.
"Some of these homes repeatedly harmed residents over a six-year period and yet remain in the Medicare and Medicaid program," the report noted.
In 1987, Congress established strict standards for nursing homes, the Times reported. In 1998, a GAO report said that "homes can repeatedly harm residents without facing sanctions."
Since then, a number of new initiatives to improve care were announced by the federal government and nursing home industry.
FDA Knew About Food Problems Before Outbreaks: Report
For years, the U.S. Food and Drug Administration knew about contamination problems on California spinach farms and at a ConAgra Foods peanut butter plant in Georgia that resulted in serious salmonella and E. coli outbreaks within the last year, according to documents and interviews.
Even though it knew about the problems, the FDA took only marginal steps to correct the issues and relied heavily on food makers to police themselves, the Washington Post reported. The FDA did this because it didn't have adequate resources.
The salmonella outbreak in Peter Pan and Great Value peanut butter sickened more than 400 people in 44 states. The plant that made the peanut butter has been closed. The E. coli outbreak in California spinach caused 205 illnesses and at least three deaths in 26 states and Canada.
The farm that grew the spinach and the companies that processed and marketed it just settled lawsuits with the families of three women who died.
FDA officials told the Post that changes need to be made in order for the agency to meet the huge growth in the number of food processors and imports. But they said the FDA could not have done anything to prevent the outbreaks caused by the contaminated peanut butter and spinach.
The FDA, which is responsible for safeguarding 80 percent of the United States' food supply, oversees 60,000 to 80,000 facilities a year.
On Tuesday, a House of Representatives' Energy and Commerce subcommittee is scheduled to hold a hearing on the recent wave of food recalls in the United States, the Post reported.
School Food Rules Reduce Number of Overweight Students
Within four years after banning soft drinks and sweets and introducing healthier lunches, 10 Stockholm, Sweden schools saw a six percent decline in the number of overweight students, says a study presented Monday at an international obesity conference in Budapest, Hungary.
The number of overweight or obese children ages 6 to 10 decreased from 22 percent to 16 percent, said the study by researchers at the Karolinska Institute, Agence France Presse reported.
In a control group of students in schools that did not introduce food restrictions, the number of overweight/obese children increased from 18 percent to 21 percent.
"Our results show that programs to reduce the increasing rate of obesity can be carried out within the schools' existing budgets," researcher Professor Claude Marcus said in a prepared statement. "We also interpret the results to mean that clear regulations in schools can help parents to set standards for their children and improve dietary habits at home."