FDA Approves 1st Pill to Help Prevent HIV Infection

HealthDay – 16 hrs ago MONDAY, July 16 (HealthDay News) -- For the first time, the U.S. Food and Drug Administration has approved the use of a pill to help prevent HIV infection in uninfected, high-risk people.

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US approves first-ever pill for HIV prevention

US approves first-ever pill for …

The first-ever daily pill to help prevent HIV infection was approved Monday by US regulators for use by healthy adults who are at risk for getting the virus that causes AIDS.

Truvada, made by Gilead Sciences in California, has been on the market since 2004 and was approved by the Food and Drug Administration for a new use as a tool to help ward off HIV, in combination with safe sex and regular testing.

The pill as pre-exposure prophylaxis (PrEP) has been hailed by some AIDS experts as a potent new tool against human immunodeficiency virus, while other health care providers are concerned it could encourage risky sex behavior.

In addition, the regimen is estimated to cost around $14,000 per year, making it out of reach of many.

"Truvada alone should not be used to prevent HIV infection," said Debra Birnkrant, director of the division of antiviral products at the FDA.

"Truvada as PrEP represents another effective, evidence-based approach that can be added to other prevention methods to help reduce the spread of HIV."

The FDA said Truvada should be used as "part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing."

Truvada was previously approved as a treatment for people infected with HIV to be used in combination with other antiretroviral drugs.

The decision by the FDA followed the advice of an independent panel in May that supported Truvada for prevention in uninfected people, after clinical trials showed it could lower the risk of HIV in gay men and heterosexual couples.

One study of men who were sexually active with other men but were not infected with the virus that causes AIDS found 44 percent fewer infections in those taking Truvada versus a placebo.

Those in the study who took the drug regularly had almost 73 percent fewer infections.

A second study on heterosexual couples in which one partner was infected with HIV and the other was not showed that Truvada reduced the risk of becoming infected by 75 percent compared with a placebo.

Common side effects were the same as experienced by people with HIV who were taking Truvada, and included diarrhea, nausea, abdominal pain, headache, and weight loss.

However, the adherence rate -- meaning how often people in the study actually took the drug daily -- was low in the study of men who have sex with men, at just 30 percent, Birnkrant said.

In the study of heterosexual partners, adherence was much higher, at between 80 and 90 percent.

Therefore, the drug label must include special instructions for health care providers on how to counsel potential users of the drug.

The drugmaker must also include a warning that Truvada for PrEP "must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use."

As to concerns about whether the pill might boost risky sex practices and lead people to abandon condoms as a first line of protection, Birnkrant said the studies have not shown that so far.

"We don't really have any strong evidence to show that condoms were not used or that there was a decrease in condom use when Truvada was used," she told reporters.

The goal of the approval is to eventually cut back on the rate of new infections in the United States, which have stayed steady in recent years at about 50,000 annually, she said.

A key goal of the US strategy against HIV/AIDS, set forth in 2010, is to decrease the number of new infections by 25 percent by 2015.

"The hope is that over time it will decrease the rate of new infections or incidence in the United States," Birnkrant said.

The FDA approval drew the support of amfaR, The Foundation for AIDS Research.

"We know that Truvada, when taken as directed, works. Now we need to figure out how to properly use it to change the course of the epidemic," said a statement by amfaR chief executive Kevin Robert Frost.

However, the AIDS Healthcare Foundation described the move as "reckless," largely because the FDA recommends but does not explicitly require a negative HIV test prior to use.

"The FDA's move today is negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people," said AHF president Michael Weinstein.

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Delta Needle-Stick Victim Faces Sleepless Nights

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Green Tea and Gold to Treat Prostate Cancer? User Comments

Oh for crying out loud, stop with the drama queen hysterics of having sleepless nights and having to take HIV medications. What a bunch of overkill intended only to pad a lawsuit. These were sewing needles, not injectibles – you can’t get HIV (or hepatitis either as they claim he is worried about) from sewing needles. While he should be entitled to some compensation for the incident, the amount of overacting this guy is doing is worthy of an Oscar.

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UNAIDS welcomes US approval of drug to stop HIV

"The UN agency tasked with fighting AIDS welcomed the decision by the United States to allow the use of Truvada, an HIV prevention pill for the first time. (AFP Photo/Justin Sullivan)" title

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First Drug Approved to Lower Risk of Acquiring HIV

HealthDay – 2 hrs 2 mins ago TUESDAY, July 17 (HealthDay News) -- Truvada (emtricitabine/tenofovir disoproxil fumarate) is the first drug to be approved by the U.S. Food and Drug Administration to reduce the risk of contracting HIV among adults at higher risk of acquiring the AIDS-causing virus.

In a statement, the agency said Truvada was meant to be taken daily to reduce the chances of becoming HIV-infected among adults exposed to the virus. The agency previously approved Truvada in combination with other anti-viral drugs to treat HIV-infected people 12 years and older.

The FDA said it would strengthen the drug's label to warn that people who take the drug as a preventive should confirm they are not already HIV infected.

Truvada's safety and effectiveness were clinically evaluated among 2,499 HIV-negative gay men and transgender women "with evidence of high risk behavior for HIV infection," the agency said. Results showed the drug reduced HIV infection by 42 percent, compared with those who took a placebo.

A second study involved 4,758 heterosexual couples where one partner was infected, while the other was not. Truvada reduced the risk of transmitting infection by 75 percent, compared to those who took a placebo, the FDA said.

The most common side effects reported were diarrhea, nausea, abdominal pain, headache and weight loss. Most serious but less common adverse reactions included kidney or bone toxicity.

Drugmaker Gilead Sciences, based in Foster City, Calif., is required to conduct follow-up studies to evaluate long-term HIV resistance, and the drug's effects among pregnant women, the FDA said.

More information

To learn more about this disease, visit AIDS.gov.

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Colo. Dental Patients Advised to Get HIV Testing

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U.S. busts $108 million black market in Medicaid drugs

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Leaky bladder affects young women too

Reuters – 2 hrs 20 mins ago NEW YORK (Reuters Health) - Bladder control problems may be seen as a problem of older people, but a good percentage of college-age women have symptoms too, a study published Monday suggests.

In a survey of 1,000 young Australian women, researchers found that 13 percent said they'd had urinary incontinence in the past month. That meant problems like leaking urine when they exercised, or often having to rush to the bathroom to avert an accident.

"The traditional belief has been that incontinence really occurs as a consequence of pregnancy and aging," senior researcher Susan R. Davis, of Monash University in Melbourne, said in an email.

"What prompted us to undertake this study was the fact that nobody had actually looked at incontinence in younger women who had never been pregnant," said Davis, whose work was supported by Australian state and federal funds.

The study "contributes significantly to current knowledge about urinary incontinence in young women," said Mary K. Townsend, an epidemiologist at Brigham and Women's Hospital and Harvard Medical School in Boston.

Townsend, who was not involved in the research, has studied the prevalence of urinary incontinence and possible risk factors for it.

"Overall, a key message from this study is that urinary incontinence is a significant problem for women of all ages," Townsend said in an email.

But, she noted, the 13 percent figure could be either an underestimate or overestimate.

That's because the study participants, who were about 22 years old on average, were recruited from college campuses and health clinics. So they may not be representative of all young women.

"It will be important for future studies to confirm these results in a larger, population-based sample of young women," Townsend said.

LINK TO BIRTH CONTROL USE

The study, which appears in the Annals of Internal Medicine, also tried to weed out the possible risk factors for urinary incontinence in young, never-pregnant women.

It turned out that women were sexually active and not using birth control pills had the highest risk: about 22 percent had urinary problems in the past month.

That compared with rates of around 10 percent among women who had either never had sex or were sexually active and on the Pill.

The link to sexual activity might be related to urinary tract infections, Townsend speculated. Sexually active women have a higher rate of UTI, and those infections can trigger incontinence.

But the reasons for the birth control finding are not clear.

Townsend said past studies have come to conflicting conclusions on whether birth control pills are related to higher or lower risks of urinary incontinence -- or whether there's a relationship at all.

She and Davis both said more research is needed to see whether birth control pills, themselves, have any effect on bladder control problems.

There was no strong evidence that overweight young women had an increased risk of incontinence. And that's in contrast to what's been seen among older women.

But Davis said that may be because of numbers: only 15 percent of the study participants were overweight. And as a group, they were fairly healthy and physically active.

"This leaves open the possibility that the rate of incontinence we observed may in fact be an underestimate of the rate in a less healthy group of young women," Davis said.

Both she and Townsend said that young women who find their urinary symptoms troublesome should seek help. In this study, women with symptoms scored lower on a measure of mood and psychological well-being.

"I think the most important take-home message is that if young women experience urinary incontinence they should not feel embarrassed to seek help," Davis said.

There are different options for combating the symptoms, she noted.

Sometimes all you need are lifestyle changes -- like cutting back on caffeine and alcohol, and limiting how much fluid you drink at night.

Another option is "bladder training," which involves tactics like going to the bathroom at fixed times, even if you don't feel like you need to go. That often includes Kegel exercises to strengthen the pelvic muscles that control urination.

Depending on the type of incontinence, medications -- like oxybutynin (Ditropan), solifenacin (Vesicare), tolterodine (Detrol) -- may also help. But research shows that they work for only a minority of women, and they can have side effects like dry mouth, constipation and blurred vision.

SOURCE: http://bit.ly/PdxBlf Annals of Internal Medicine, July 17, 2012.

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Health Tip: Heed the Warning Signs of Heat Exhaustion

HealthDay – 2 hrs 2 mins ago (HealthDay News) -- Some people, including seniors, have a harder-than-average time adjusting to rapid changes in weather.

Chronic medical conditions can make it more difficult for their bodies to adjust to extreme cold or extreme heat. So the elderly should be closely monitored for potential symptoms of heat exhaustion.

The U.S. Centers for Disease Control and Prevention offers this list of possible warning signs:

Sweating heavily or appearing pale.Muscle cramps, headache, vomiting or nausea.Dizziness, weakness, fatigue or fainting.Moist skin that's quite cool to the touch.A weak and fast pulse, or fast and shallow breathing.

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Health Tip: Don't Neglect Oral Hygiene During Pregnancy

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Incontinence Affects Young Childless Women, Too

HealthDay – 2 hrs 2 mins ago TUESDAY, July 17 (HealthDay News) -- Urinary incontinence is often thought of as a problem that occurs after childbirth or in old age, but a new study finds that many young women who have never given birth have the bothersome condition, too.

Researchers in Australia surveyed more than 1,000 women aged 16 to 30 who had never been pregnant and found that one in eight, or nearly 13 percent, reported having urinary incontinence.

Urinary incontinence means leaking urine during certain activities such as running or sneezing, or being unable to hold urine with a full bladder.

Previous research has found the rates are higher among women who've had children. But this study shows that urinary incontinence can affect women of all ages, regardless of pregnancy history, and that the condition may be underdiagnosed and undertreated in younger women, experts said.

"Although incontinence is more prevalent as women age and with an increasing number of pregnancies, incontinence can affect women of all ages," said Dr. Jill Rabin, professor of obstetrics and gynecology at Hofstra North Shore-LIJ School of Medicine, who was not involved with the study.

The study, by Tessa O'Halloran and colleagues at Monash University, in Melbourne, is published in the July 17 issue of Annals of Internal Medicine.

The women who answered the survey came from eight medical clinics and three university campuses in Australia. They were asked to complete a questionnaire about an important issue in women's health, but were not told it was about urinary incontinence prior to filling it out. About 63 percent of those who took surveys returned them.

Commenting on the study, Dr. Elizabeth Kavaler, a urology specialist at Lenox Hill Hospital in New York City, pointed out that because people who have a problem may be more likely to answer a survey about it, that may mean the study overestimates the number of young women with incontinence.

On the other hand, Rabin noted, the women in the study were mostly normal weight, healthy and active, which may make the incontinence rate a conservative estimate.

There are two types of incontinence -- stress and urge incontinence, which have different causes, experts explained. In the study, about 6 percent of women reported stress incontinence, 4.5 percent reported urge incontinence, and about 2 percent reported both.

Stress incontinence is often caused by a weakening of the pelvic floor muscles that hold the bladder in place. Pregnancy and vaginal deliveries can weaken or damage pelvic floor muscles. But other factors, such as obesity or being overweight, are also associated with stress incontinence, although this study did not find an association between weight and incontinence.

Urge incontinence, or feeling the urge to go but not making it to the bathroom, usually has a neurological cause, in that the brain doesn't have sufficient control over the bladder. Neurological conditions such as multiple sclerosis, dementia or simply advancing age can contribute to urge incontinence, Kavaler noted.

It's well known that some younger women can experience what is essentially premature aging of that bladder control, and can experience urge incontinence earlier in life.

To alleviate stress incontinence, Kegel exercises, which strengthen the pelvic floor muscles, may help. Women should squeeze their pelvic muscles as if they are stopping the flow of urine for five seconds, then release for five seconds. Repeat that about five times, Rabin advised. Take a break, and then increase your Kegel set up to 10 times in a day.

"Over time, it thickens the muscle that supports the bladder, vagina and rectum and stabilizes it," Rabin said.

If Kegel exercises aren't helping, see your doctor. "There are young women who have urinary control issues, there are treatments, and they should seek help and talk to their doctor about it," Kavaler said.

Rabin pointed out that some women will resort to restricting fluid intake to alleviate incontinence, but that's a bad idea, she said. Dehydration can contribute to urinary tract infections and constipation, which can also stress the pelvic floor muscles during bowel movements.

The study did not receive university or outside funding.

More information

The U.S. National Kidney and Urologic Diseases Information Clearinghouse has more on urinary incontinence.

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Health Highlights: July 17, 2012

HealthDay – 2 hrs 1 min ago Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Annual Report Ranks Mass. General as Top Hospital in U.S.

Massachusetts General Hospital in Boston knocked off long-time champion Johns Hopkins in Baltimore to take this year's title as top hospital in the United States.

Hopkins was first for 21 consecutive years in the annual rankings by U.S. News and World Report, the Associated Press said.

The first-place ranking is a "tribute to the more than 23,000" staff at MGH, hospital president Dr. Peter Slavin said. The competition was not with other hospitals, but rather with "disease, health care costs, accessibility of services, and social issues," Dr. David Torchiana, chairman of the Massachusetts General Physicians Organization, said.

MGH is a 950-bed facility that admits about 48,000 patients a year and delivers about 3,600 babies annually. The hospital was founded in 1811, the AP reported.

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U.S. Produce Testing Program Faces Uncertain Future

A produce-safety testing program operated by the U.S. Department of Agriculture will continue for the rest of the year but then may shut down due to lack of funding.

The Microbiology Data Program screens thousands of produce samples a year and is the nation's largest produce-safety testing program. It has detected more than two dozen bacteria-contaminated samples that led to recalls of produce such as lettuce and tomatoes, the Associated Press reported.

Funding for the program -- which cost $4.3 million to run last year -- was slashed in President Barack Obama's proposed budget earlier this year and the House and Senate have not included money for it in their agriculture spending bills.

In order to keep the program operating until the end of the year, the USDA will use existing agreements with states.

Ending the program would leave the nation without a vital way to investigate outbreaks of foodborne illness, food safety advocated and public health officials say. The program could not easily be replaced by more modest federal sampling programs or by companies' internal tests, according to Dr. Robert Tauxe, the top food-germ investigator at the Centers for Disease Control and Prevention, the AP reported.

Last year, contaminated fruits and vegetables caused nearly one-third of major multistate foodborne illness outbreaks in the U.S., the CDC says.

"It is unacceptable for this crucial, cost-effective program to be eliminated," said Rep. Rosa DeLauro, D-Conn., a longtime food safety advocate, the AP reported. She said she would continue to push for the program to keep operating beyond December.

In recent years, produce industry leaders have urged the federal government to eliminate the USDA program and have said they want the private sector to do more testing.

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California Sues Companies Over High Lead Levels in Costume Jewelry

California is expected to file a lawsuit Tuesday against 16 companies accused of selling and distributing costume jewelry containing dangerous levels of lead.

State investigators found that some of the items from the retailers, wholesalers, suppliers and distributors had lead levels more than 1,000 times the legal state limit, the Associated Press reported.

Along with being accused of violating lead safety standards, the state alleges that the companies engaged in deceptive practices by falsely advertising contaminated jewelry as lead-free.

The three-year investigation involved spot checks at stores and factories in which inspectors used hand-held X-ray devices to check for lead in items such as earrings, necklaces, tiaras and hair clips. Items with a high lead content were then sent to a laboratory for detailed analysis, the APreported.

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