October 29, 2012
People diagnosed with HIV—the human immunodeficiency virus that without treatment develops into AIDS—take antiviral medications to control the infection that attacks their immune system.
Now, for the first time, adults who do not have HIV but are at risk of becoming infected can take a medication to reduce the risk of sexual transmission of the virus.
The Food and Drug Administration (FDA) has approved the new use of Truvada—to be taken once daily and used in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 infection in adults who do not have HIV but are at high risk of becoming infected. (HIV-1 is the most common form of HIV.)
In two large clinical trials, daily use of Truvada was shown to significantly reduce the risk of HIV infection
- by 42 percent in a study sponsored by the National Institutes of Health (NIH) of about 2,500 HIV-negative gay and bisexual men and transgender women, and
- by 75 percent in a study sponsored by the University of Washington of about 4,800 heterosexual couples in which one partner was HIV positive and the other was not.
Debra Birnkrant, M.D., director of the Division of Antiviral Products at FDA, explains that Truvada works to prevent HIV from establishing itself and multiplying in the body. She notes that while this is a new approved use, Truvada is not a new product. It was approved by FDA in 2004 for use in combination with other medications to treat HIV-infected adults and children over 12 years old.
“In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world it still is. Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time,” Birnkrant says.
“But it is still better to prevent HIV than to treat a life-long infection of HIV,” she says.
Birnkrant stresses that Truvada is meant to be used as part of a comprehensive HIV prevention plan that includes consistent and correct condom use, risk reduction counseling, regular HIV testing, and treatment of any other sexually-transmitted infections. Truvada is not a substitute for safer sex practices, she says.
To help prescribers and other health care professionals advise uninfected people considering taking Truvada, the medicine is being approved with a Risk Evaluation and Mitigation Strategy (REMS). The goals of the REMS are to inform prescribers and potential users of Truvada of the importance of taking the medication every day, the importance of regular HIV testing and the importance of using Truvada in combination with other measures known to reduce the risk of HIV infection. As part of the REMS, a voluntary training and education plan will be made available to potential prescribers. This program includes a medication guide and safety brochure for the prospective Truvada users that would detail the risks, recommended screening tests and key information to share with a health care professional.
About 1.2 million Americans have HIV. The body’s immune system is devastated by AIDS, leaving those who have it vulnerable to deadly infections. Each year, about 50,000 adults and adolescents in the U.S. are newly diagnosed with HIV.
October 29, 2012
Testosterone replacement therapy can be prescribed as an intramuscular injection usually given on a biweekly basis, as a patch or gel placed on the skin, or as putty that is applied to the gums of the mouth. Each of the treatments has its risks and benefits.
The decision as to which form of testosterone to use depends upon the clinical situation. Discussions between the patient and health care practitioner often helps decide which medication to use.
October 21, 2012
More than one-third of U.S. adults are obese, and obesity contributes to a number of health conditions, including high blood pressure, type 2 diabetes, and high cholesterol.
To help obese and overweight Americans who have been unsuccessful in getting their weight under control with diet and exercise, the Food and Drug Administration (FDA) has approved two new medications—the first drugs for long-term weight management that FDA has approved in 13 years.
Marketed as Belviq and Qsymia, these prescription medications would be taken for the rest of a person’s life. “For many people, obesity is a life-long condition, but we don’t always think of it—or treat it—as such,” says Amy Egan, M.D., M.P.H., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products (DMEP).
“Qsymia and Belviq are considered life-long therapies in patients who respond to and tolerate them,” says Egan.
The drugs are meant to be used in conjunction with a balanced diet and exercise, says Mary Roberts, M.D., a medical officer in DMEP. “These drugs are another tool to be used by someone trying to reach and stay at a healthy weight,” she says.
How Do They Work?
Belviq—the trade name for the drug lorcaserin— is a 10 mg tablet taken twice a day that works by activating a part of the brain that controls hunger.
Belviq was tested in three clinical trials that lasted from 52 to 104 weeks and included nearly 8,000 obese and overweight patients.
- The average weight loss for patients taking Belviq ranged from 3 to 3.7 percent over those taking a placebo.
- In studies of patients without type 2 diabetes, about 47 percent of patients lost at least 5 percent of their weight compared with 23 percent of patients treated with placebo.
Belviq should be discontinued if a patient fails to lose 5 percent of their weight after 12 weeks of treatment, as it is unlikely that continued treatment will be successful.
Qsymia is a combination of two FDA-approved drugs: phentermine, an appetite suppressant, and topiramate, used to treat epilepsy and migraines. Roberts explains that Qsymia is taken once a day, with patients starting at the lowest dose (3.75 mg phentermine/23 mg topiramate extended-release), then increasing to the recommended dose (7.5 mg/46 mg). In some circumstances, patients may have their dose increased to the highest dose (15 mg/92 mg).
Qsymia, was tested in two clinical trials which included nearly 3,700 obese and overweight patients treated for up to one year.
- The average weight loss of patients taking Qsymia ranged from 6.7 percent (lowest dose) to 8.9 percent (recommended dose) over those taking a placebo.
- Sixty-two percent of patients on the lowest dose and 70 percent on the recommended dose lost at least 5 percent of their weight compared with 20 percent treated with placebo.
If after 12 weeks, a patient has not lost 3 percent of his or her weight on the recommended dose of Qsymia, FDA recommends that treatment be discontinued or increased to the highest dose. If after an additional 12 weeks on the highest dose, a patient does not lose at least 5 percent of weight, Qsymia should be discontinued gradually.
October 17, 2012
At the age of about 40 men suddenly notice they are not so exuberant and ravenous as they used to be. They begin to lose their hair and bones, experience insomnia or other problems with sleeping, difficulties in calculation, and memory disorders.
They become less motivated. Moreover they can feel sick, exhausted and depressed. From time to time these symptoms can be accompanied by other problems such as loss of muscle mass and strength, erectile dysfunction, increased fat, sweating, flushing, aches, pains and things like that. Almost every male in some degree experiences the listed symptoms. It impacts his self-image and confidence and as a result the man’s peace of mind is disturbed. Aging male syndrome is a menopause-like condition in aging men.
Aging Male Syndrome
Aging male syndrome means natural and continuous decrease of male hormone levels beginning when man usually gets thirty and carries on at a huge rate of ten percent per ten years. Testosterone is a principal male hormone responsible for sexuality, sperm production, the growth of body hair, increased muscle and bone mass. It is also essential for health and well-being and its decrease cannot be unnoticed.
This crisis of the middle age influences the whole life of a man. First of all it influences the body, and sometimes in a very negative way, leading to cardiovascular diseases and osteoporosis. This is up to you to decide if you wish to make the condition easier and eradicate the symptoms of aging male syndrome.
How to Prevent Aging Male Syndrome?
How to prevent aging male syndrome? The person should follow the strategy that unites different aspects such as diet, stress control, reduction of tobacco and alcohol intake. These lifestyle changes will help, but they do not cure the male mid-life crisis. However, certain enhancers can deal with aging male syndrome which is the most important part of the crisis. A number of people may think that these boosters are total money waste. But, there’re individuals who honestly think that erection enhancers can produce a huge difference in their day-to-day lives.
Why does it play such an important role? Some people think that sex can make or break their relationship. Sometimes wonders in relationship appear only because of sexual life. The reason for it is the fact that emotions come with sexual relationship. Women subconsciously desire partners with ravenous virility and strength. They are far less likely to adore a man with sexual or other physical problems.
Unfortunately, there are such men that have some problems while buying these products. They think that it is insulting for their pride and manhood. But today the number of men who don’t see anything insulting in buying erection enhancers constantly increases.
There are certain explanations why these enhancers help any relationship. First of all, they handle male’s testosterone decrease. Next, a man finds effects in his erection hardness. Third, the man taking the pills becomes healthier. His blood circulation improves. The fourth, the man experiences a better sexual stamina and the fact keeps him to go in bed. So, erection enhancers can be the first aid in saving your relationships and returning your partner’s love and confidence. So it is no surprise in fact that the number of men who use herbal erection enhancers constantly increases.
October 9, 2012
Benzocaine products—which are sold as gels, liquids, sprays and lozenges—are also widely used by adults. Doctors and dentists often use sprays containing benzocaine to numb the mucous membranes of the mouth and throat during such procedures as transesophageal echocardiograms, endoscopy, intubation, and feeding tube replacements.
Even though children are more at risk, it’s still a good idea to talk to your health care professional about using benzocaine, especially if you have heart disease; are a smoker; or have breathing problems such as asthma, bronchitis or emphysema. These conditions put you at greater risk for complications relating to methemoglobinemia, says Taylor.
FDA advises consumers to:
- store any products containing benzocaine out of the reach of children.
- use benzocaine gels and liquids sparingly and only when needed. Do not use them more than 4 times a day.
- read the label to see if benzocaine is an active ingredient when buying OTC products. Labels on OTC products containing benzocaine are not currently required to carry warnings about the risk of methemoglobinemia. If you have any concerns, talk to your health care professional before using them.
October 5, 2012
If you want to treat acne effectively, then you will have to find the right products at an appropriate price to cope with the problem. It may seem at times that it is hard to fulfill it at the current state of the market. This acne products FAQ is a simple guide to assist you make a wise decision while selecting between diverse skin care treatments that are meant to address acne breakouts.
Question: How to find a safe acne product?
If you want to buy the best acne product it is important to choose a natural or herbal based product. According to the FDA‘s current manufacturing practices ruling, these natural products have to meet certain demands: are manufactured in a high quality way and adhere to all suggested safe practices; are free of any harmful ingredients, contaminants or impurities; are labeled and have a proper package with the guidelines and recommendations In such a way, you are to choose an acne product following the FDA recommendations.
Question: How to find an effective acne product?
We live in an epoch of evidence-based medicine and should base our judgment on real testimonials and pure facts and evidences, and not just naked claims. You had better choose multi-component anti acne product which does not contain any ingredients without recommendations. Just on the contrary, you should try the product which contains only ingredients that have been clinically backed. Keep in mind that such products can be used without any prescription.
Question: How to avoid side effects?
When you choose products for your skin you should remember that such products should meet some requirements. The most important one is that they shouldn’t cause undesirable effects. It is important that a good skin care product for patients suffering from acne should suit the majority of patients of any age and gender. Visit acne forum and browse through reviews. Your product should be rated as giving equally fast and best results in young adults as well as in middle aged and elderly women and men.
Question: How to make sure the acne product work?
It is clear that a good product for you skin should lead to no undesirable side effects. In such a way, while planning to buy this or that anti acne product you should do your own research and find out whether side effects have been noticed. It can easily be done with the help of the authentic threads of specialized acne forums. Besides, any high quality product should be approved by some credible international authority on dermatology. In addition, you have to consider your own tolerance to the components of the skin care product you are giving preference to.
Question: How to avoid extra expenses?
It doesn’t mean that the product will be the best if it costs too much. Just the other way round, you may find the most effective product which will be affordable. So you are recommended to find the product, which offers the best correlation of price and quality.
Don’t think that you have a wide choice of high-quality products just because of the fact that the market offers thousands of them. The major part of all these products (special lotions, oils, supplements, and creams) do not come up to declared standards. Even more important is the fact that the majority of products, including the popular ones, still has side effects and influences your body in an undesirable way.
The useful approach here would be to find real user reviews in the acne products forum and choose a product that is commended as the safest and a most effective natural skin care product, comprising of several components to ensure that the user’s acne problem will be addressed on multiple levels.
October 1, 2012
When a baby is teething, many a mom or dad reaches for a pain remedy containing benzocaine to help soothe sore gums. Benzocaine is a local anesthetic and can be found in such over-the-counter (OTC) products as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase.
But the use of benzocaine gels and liquids for mouth and gum pain can lead to a rare but serious—and sometimes fatal—condition called methemoglobinemia, a disorder in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, says FDA pharmacist Mary Ghods, R.Ph., methemoglobinemia can result in death.
And children under 2 years old appear to be at particular risk.
Since the Food and Drug Administration (FDA) first warned about potential dangers in 2006, the agency has received 29 reports of benzocaine gel-related cases of methemoglobinemia. Nineteen of those cases occurred in children, and 15 of the 19 cases occurred in children under 2 years of age, says FDA pharmacist Kellie Taylor, Pharm.D., MPH.
The agency repeated the warning in April 2011 and remains particularly concerned about the use of OTC benzocaine products in children for relief of pain from teething, says Taylor. This concern is fueled by the serious potential outcomes and the difficulty parents may have recognizing the signs and symptoms of methemoglobinemia when using these products at home. These symptoms may not always be evident or attributed to the condition.
For these reasons, FDA recommends that parents and caregivers not use benzocaine products for children younger than 2 years, except under the advice and supervision of a health care professional.
The American Academy of Pediatrics offers some alternatives for treating teething pain:
- Give the child a teething ring chilled in the refrigerator.
- Gently rub or massage the child’s gums with your finger.