FDA Panel Backs Diabetes Drug, Despite Heart Risks
Experts advising the U.S. Food and Drug Administration voted Friday to recommend FDA approval of the Bristol-Myers Squibb diabetes drug Pargluva (muraglitazar), despite an increased risk of heart failure among users, the Bloomberg news service reported.
Pargluva is among a new class of non-insulin drugs that allows diabetics to control blood sugar levels. It's also designed to help patients maintain healthy blood cholesterol levels. But there were 17 cases of heart failure among Pargluva users in clinical trials, compared with two cases of heart failure among those who took a different drug, Bloomberg said.
The consumer group Public Citizen warned against FDA approval, citing the drug's heart failure risks and two other common side effects, fluid retention and weight gain. Bristol-Myers argued that the drug's benefits outweigh its risks.
A company spokesman told Bloomberg that the company would address the heart failure risks in the drug's label and in its marketing materials to doctors.
The full FDA normally follows the recommendations of its expert panels but isn't bound to do so.
On Thursday, an FDA advisory panel voted to back an inhaled form of insulin that's designed to end or supplement the need for injections that control diabetics' blood sugar levels.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 7-2 to recommend that Exubera, developed by Pfizer, Sanofi-Aventis, and Nektar Therapeutics, be approved by the full FDA.
Senate Passes Bill Restricting Cold Medicine Access
Sales of cold medicines that can be used to make the addictive street drug methamphetamine would be restricted under legislation passed Friday by the U.S. Senate.
The measure, approved unanimously, would require cold medicines containing the decongestant pseudoephedrine to be sold only from behind pharmacy counters, the Associated Press reported.
Buyers would have to show a photo ID and sign a log, and would be limited to about 7.5 grams worth of the medicine per month. Purchases would be tracked to prevent the same consumer from buying larger quantities at different stores.
The House of Representatives has yet to consider the bill, the AP said.
Study Shows 900,000 Teens Planned Suicides While Depressed
Approximately 900,000 American teens had made a plan to commit suicide during their worst or most recent episode of major depression, and 712,000 attempted suicide during such an episode, a new federal study reports.
The findings are contained in a study on children ages 12 to 17 that was released Friday by the Substance Abuse and Mental Health Services Administration.
The data came from the 2004 National Survey on Drug Use and Health, which asked teens about symptoms of depression, including thoughts about death or suicide. The report defines a major depressive episode as a period of at least two weeks in which a person experienced a depressed mood or loss of interest or pleasure in daily activities and had at least five of the nine symptoms of clinical-diagnosed depression.
The report, "Suicidal Thoughts Among Youths Aged 12-17 With Major Depressive Episode," found that more than 7 percent of teens, or 1.8 million children, had thought about killing themselves during their worst or most recent episode of major depression.
The data also showed that about 3.5 million teens had experienced at least one episode of major depression in their lifetime. Almost 20 percent of females in this age group and 8.5 percent of males had at least one of these depressive episodes. Rates of major depressive episodes were similar among racial and ethnic groups and increased with age, the study found.
Brigham Young Named Fittest College Campus
Men's Fitness magazine has named Utah's Brigham Young University as the fittest college campus in the United States.
Working with the Princeton Review, the magazine surveyed more than 10,000 students from 660 campuses. The rankings appear in the October issue.
Questions posed to students included whether they had gained weight during college, if they worked out regularly, and whether campus facilities encouraged healthy habits, according to the Associated Press.
Other schools near the top of the list included the University of California, Santa Barbara; Boston University; the University of Vermont; and Northwestern University.
The magazine's list of least-fit schools, presumably compiled before Hurricane Katrina decimated the Gulf Coast last week, included the University of Louisiana at Lafayette, the University of New Orleans, and Mississippi State University.
British Researchers Look to Create Embryos From 2 Women
British authorities have approved experimental research by University of Newcastle scientists that could lead within a few years to the first genetically altered babies being born in Britain.
The goal of the research, according to the scientists: To eliminate 50 or so metabolic disorders, including muscular dystrophy, that are linked to faults in a small set of genes outside the nucleus of cells, The Daily Telegraph reported.
The Newcastle researchers hope that in as few as three years, they will be able to combine in-vitro fertilization with cell and genetic surgery to "wipe out diseases caused by the equivalent of faulty batteries in cells," the newspaper said.
The result would be a baby who would be a combination of genes from one man and two women. If a girl were born in this way, her genetic alterations would be passed to future generations to free them of potentially deadly disorders, the paper said.
Pro-life advocates are denouncing the research as efforts to create "designer babies."
But Prof. John Burn, of the department of clinical medical sciences at Newcastle University, said, "I would use the analogy of simply replacing the battery in a pocket radio to explain what we are doing. You are not altering the radio at all, just giving it a new power source."
Health Tip: Treating Leg Cramps
If leg cramps wake you during the night, there's no cause for alarm.
In most cases, the spasms are innocuous and are caused by simple muscle fatigue or an imbalance of chemicals such as sodium, potassium, phosphorous, calcium and magnesium in the blood, according to Calgary Health Region in Canada.
Night-time cramps usually subside by themselves, but sometimes applying heat, massaging the leg or stretching the muscle by pulling your toes up toward you will help.
If you get cramps while you are pregnant or after you've been sweating heavily, you should talk to your doctor.
Health Tip: Are You at Risk for AIDS?
Acquired immunodeficiency syndrome (AIDS) is a disease caused by the human immunodeficiency virus (HIV), which is passed from person to person through exchange of body fluids like blood, semen and vaginal fluid.
According to Seton Hall University in New Jersey, risk factors for infection include:
Sex of any type with an infected person. A history of a sexually transmitted disease, such as herpes, gonorrhea or syphilis. Multiple sex partners. Sex with a prostitute, either male or female. Sex with a man if you are male. Shared use of needles and syringes to inject drugs. Blood product transfusions between 1978 and 1985. If you have one or more of the above risk factors, you should be tested for HIV infection.