The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.

“Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research. “But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”

Caldolor will be available for hospital use only. It is approved to be administered in 400 mg to 800 mg doses, over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100-200 mg every 4 hours, as necessary. Read the rest of this entry »

If you're new here, you may want to subscribe to my RSS feed. Be sure to find out how you can change your life with the Free Fitness program.

Looking to make a change and lose some weight? I have reviewed the top diet on the internet and you can go and read over 200 comments people have made about why this diet has worked well for them, as well as some of the problems.

Tags: allergic reactions, Bob Rappaport, Congestive heart failure, director, Division, Division of Anesthesia, fda, FDA’s Center for Drug Evaluation and Research, fever, headache, high blood pressure, hysterectomy, ibuprofen, nausea, pain, pain management, U.S. Food and Drug Administration, vomiting

Hydroxycut is a product that many of us in the weight loss and muscle gain community have watched and used before and after health scares. Hydroxycut in the early part of the is decade, even in the 90s was a great product for stripping fat in the Spring and was already pulled once off the market and now Hydroxycut is gone again.

Hydroxycut has a history as a fat loss supplement and was one of the first popular products to have and ECA stack. Back in the 90s the ECA stack was Ephedra and caffeine to raise the metabolism and aspirin as a buffer to help your stomach and get rid of any shakes from the ephedra and caffeine. Well once ephedra was pulled from the market for giving seemingly healthy people heart attacks Hydroycut was gone to, at least I thought so.

Hydroxycut was eventually successfully relaunched as a completely natural product and I wrote a review of it just a little while back (now I will pull that review) and now the FDA had pulled Hydroxycut off the market again. Read the rest of this entry »

Tags: abdominal pain, cardiovascular disorders, fatigue, Hydroxycut, Iovate Health Sciences Inc., Iovate Health Sciences USA Inc., itching, kidney failure, liver failure, liver injuries, liver transplant, nausea, Oakville, Ontario, rhabdomyolysis, seizures, U.S. Food and Drug Administration, vomiting

The very capable guys and gals at the Mayo Clinic have an article today about Bisphenol A health risks. This is something very new to most of us but it involves plastic containers that we store food in.

An important article in the Sept. 17 issue of the Journal of the American Medical Association discusses the health effects of the chemical Bisphenol A. What is this compound and what are its effects? What might happen as a result of this study?

Bisphenol A is a chemical in plastics. It is widely found in the lining of food containers, plastic bottles, compact discs, carbonless paper, and many medical devices. It also is used to coat metal products (food cans and bottle tops), and even water supply lines. Some dental sealants also contain this ingredient.

Now for the Bisphenol A health risks. Animal studies done in the 1980s and ’90s identified that low doses of Bisphenol A have adverse effects on the brain, reproductive system, and metabolic processes related to insulin balance and liver function. It may also be related to cancer or even obesity and heart disease. Although it is not immediately lethal, studies show that greatest sensitivity to Bisphenol A occurs during periods of early development and that the substance accumulates over time in the body and environment. Read the rest of this entry »

Tags: American Medical Association, cancer, dishwasher, Environmental Protection Agency, food cans, food containers, food in., heart disease, Mayo Clinic, medical devices, metal products, National Institute, National Institute of Environmental Health Sciences, obesity, plastic food containers, plastic sports bottles, plastics, the Journal of the American Medical Association, U.S. Food and Drug Administration

You have probably seen the news stories over the last couple of days about the FDA and Lasik eye surgery. As a lifelong contact lens and glasses wearer I thought that it would be important to look at why this is important and what you should think about when considering any corrective eye surgery.

Criticism of FDA policy

First of all the FDA does have a site dedicated to Lasik surgery and the benefits as well as the risks of the quick and easy surgery. One of the criticisms by consumer groups was that the FDA was not stressing hard enough the bad side effects that are possible with Lasik surgery.

Another issue that is often overlooked is regular aging of people and of eyesite. Any reputable ophthalmologist will agree that most men begin losing near sitedness in their 40s so the idea that Lasic or any other corrective surgery will get rid of glasses for life is not very realistic. Read the rest of this entry »

Tags: American Academy of Ophthalmology, American Society of Cataract and Refractive Surgery, Cataract, Detroit, eye surgery, fda, Jayne Weiss, Kresge Eye Institute, laser, laser eye surgery, LASIK, Lasik Surgery, National Eye Institute, panel chairwoman, surgery, U.S. Food and Drug Administration

The U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.

In an early communication based on the FDA’s ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.

The adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults. Read the rest of this entry »

Tags: botox, Botox Cosmetic, botulism, cerebral palsy, fda, food and drug administration, respiratory failure, safety reviews, symptoms of botulism, U.S. Food and Drug Administration

Treatment of severe acne is something that some of us need to deal with at one time or another. Severe acne is when you have lumpy acne that does not go away and is very red. When I was younger I took Accutane to get rid of my severe acne as well as injections and drainage to get rid of my severe acne.

Drainage and Surgical Excision
Some large cysts do not respond to medication and may require drainage and extraction. Drainage and extraction, or acne surgery as it is also called, should not be performed by patients. Dermatologists are trained in the proper technique and perform acne surgery under sterile conditions. Patient attempts to drain and extract comedones by squeezing or picking, can lead to infection, worsening of the acne and scarring.

Severe acne requires an aggressive treatment
regimen and should be treated by a dermatologist.

Acne Injections
When an acne cyst becomes severely inflamed, there is a good chance it will rupture and scarring may result. To treat these severely inflamed cysts and prevent scarring, dermatologists may inject such cysts with a much-diluted corticosteroid. This lessens the inflammation
and promotes healing. An interlesional corticosteroid injection works by “melting” the cyst over a period of 3 to 5 days. As painful as this may sound I never found it to be bad at all, the needle is this and it is really good to get rid of the lumpy red zits.

Accutane
Accutane is a potent drug reserved for treating severe cystic acne and acne that has proven itself resistant to other medications. Accutane is a synthetic (man-made) retinoid (form of vitamin A) that comes in pill form. It is usually taken once or twice a day for 16 to 20 weeks.

Today, it is the most effective acne treatment available because it is the only acne treatment that works on all four factors that predispose a person to acne – excess oil production, clogged skin pores, P. acnes and inflammation. The remissions achieved with Accutane usually last for many months to many years. For many patients, only one course of Accutane therapy is needed.

While Accutane is the most effective acne treatment available, it cannot be prescribed to everyone due to a number of potential side effects, some serious. One of the most serious side effects is the potential to cause severe birth defects in a developing fetus. For this reason, the U.S. Food and Drug Administration (FDA) requires that women not be (or become) pregnant while taking Accutane. FDA regulations require women of childbearing age to take 2 pregnancy tests prior to beginning Accutane therapy and use 2 forms of birth control for 1 month before therapy begins, while taking the drug and for 1 full month after therapy. It is also important that women not breast feed during this time. Women who wish to become pregnant after taking Accutane should talk to their dermatologist and gynecologist about when it is safe to get pregnant after receiving Accutane therapy.

Other possible severe side effects that may occur while taking Accutane include:

* Severe pain in the chest or abdomen
* Trouble swallowing or painful swallowing
* Severe headache, blurred vision or dizziness
* Bone and joint pain
* Nausea or vomiting
* Diarrhea or rectal bleeding
* Depresion
* Dryness of the skin, eyes and nose
* Thinning hair

If any side effect occurs, the patient’s dermatologist or other healthcare practitioner should be contacted immediately because some of these side effects can lead to serious health problems.

While taking Accutane, patients are regularly monitored for side effects through follow-up visits. For most people, these side effects are tolerable and not a reason to discontinue therapy before remission is achieved. However, it is important to keep appointments for follow-up visits because monitoring can reveal conditions that a patient might not notice. For example, a patient may not realize a rapid increase in bad cholesterol that is detected through a blood test.

The decision to use Accutane should be made jointly by patient and dermatologist. When used with all due caution under close medical supervision, Accutane can resolve severe acne that has not responded to other therapy. It has proven especially effective in resolving cystic acne, a severe form of acne that usually does not respond to other therapies.

For a substantial number of patients, one course of Accutane therapy is all they will ever need. A small number of patients require more than one course of Accutane therapy to control severe acne.

It is important to take Accutane as prescribed even if the skin clears before all of the pills have been taken to prevent relapse. At the end of an effective course of Accutane therapy, all or most of the acne lesion will have cleared. Patients may notice residual erythematous (reddish) macules (flat spots) where acne lesions were present. These macules are not scars, and they will fade in 6 to 8 weeks.

After therapy, patients should continue to follow the Skin Care Guidelines for People with Acne.

Antibiotic pills
Oral antibiotics have been a mainstay of therapy for severe acne for many years. Like topical antibiotics, oral antibiotics work to reduce the P. acnes population (a contributing factor in acne), which, in turn, decreases inflammation. Treatment with oral antibiotics usually begins with a high dosage, which is reduced as the acne resolves. Over time, the P. acnes bacteria can become resistant to the antibiotic being used to treat it. When this happens, another antibiotic can be prescribed. Numerous studies support the effectiveness of the following broad-spectrum oral antibiotics that are used to treat acne in the United States: doxycline, erythromycin, minocycline and tetracycline. For information about each of these oral antibiotics, see Prescription Acne Medications.

Birth Control pills
Birth Control pills have been shown to effectively clear acne in women by suppressing the overactive sebaceous glands. Oral contraceptives can be used as long-term acne therapy; however, this medication should not be prescribed to women who smoke, have a blood-clotting disorder, are older than 35 or have a history of migraine headaches without the advice of a gynecologist.

Spironolactone, a synthetic steroid, may be used in combination with birth control pills to treat acne in adult females. Spironolactone inhibits androgen production. Side effects include irregular menstruation, breast tenderness, headache and fatigue

Are these tips all you need to prevent acne? If not you should be interested in a proven method to rid you of your acne. Then read my review of a best acne cure. Another great product I have reviewed is Acnezine.

Tags: accutane, acne, Acne Treatment, acne_cures, antibiotics, birth control, birth defects, blood-clotting disorder, cyst, cysts, diarrhea, dizziness, drainage, excess oil production, gynecologist, headache, healthcare practitioner, inflammation, joint pain, migraine headaches, nausea, Oral, Oral contraceptives, pain, scars, surgery, U.S. Food and Drug Administration, United States, vitamin a, vomiting

Well this was a long time in coming and we will have to wait to see the effect but the FDA has set new rules for standards and purity for all of those supplements that we see out there.

The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.”

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

“The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements.

As a companion document, FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing of specific dietary ingredients used in the processing of dietary supplements.

The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

Tags: Andrew C. von Eschenbach, Commissioner, consistent product, Dietary Supplement, dietary supplements, director, fda, FDA's Center for Food Safety and Applied Nutrition, Robert E. Brackett, U.S. Food and Drug Administration

Alli is now out. The news we have been looking at for months is here. Alli, which is the over the counter version of Xenical for weight loss is now on the market so that people can use this as a aid to their weight loss program. I have said for years that you can not trust any pills to have you lose weight and I am still a little apprehensive to recommend that people use Alli to try to lose weight as the most important things in your weight control program are proper eating and exercise. Here is the press release for the product

Before you go out and buy Alli I just wanted to let you know that in researching this product I looked for a natural alternative. I have found one product that does what Alli does but is natural, cheaper and best of all has no side effects. That product is called Avatrim. Check out Avatrim before you go out to purchase Alli.

GlaxoSmithKline Consumer Healthcare announces today that the U.S. Food and Drug Administration (FDA) approved the weight-loss product orlistat 60 mg capsules for over-the-counter (OTC) use in the United States. GSK Consumer Healthcare will market OTC orlistat under the brand name alli(TM) (pronounced AL-eye). Approved for use by overweight adults in conjunction with a reduced-calorie, low-fat diet, alli helps people lose 50 percent more weight than with diet alone. alli is the only FDA-approved weight-loss product available to consumers without a prescription, and it is the first clinically-proven over- the-counter product to be combined with a comprehensive support program. alli is expected to be available in stores nationwide by summer 2007. This approval marks the start of an educational program that includes a series of resources online at myalli.com.

GSK Consumer Healthcare selected alli as the brand name because it conveys the concept of partnership with consumers in their weight-loss efforts. Consumers spend billions of dollars each year on fad diets, unproven miracle pills, and potentially unsafe weight-loss supplements that may not work. alli is the clinically proven option to these hyped, quick-fix products that mislead overweight adults away from weight-loss strategies that are backed by medical science. With alli, consumers have access to an individually tailored online action plan that provides support and the necessary tools to help them lose 50 percent more weight than with diet alone.
Read the rest of this entry »

Tags: Alli, Boston Medical Center, Caroline Apovian, Center for Nutrition and Weight Management, Center for Nutrition and Weight Management at Boston Medical Center, diabetes, director, educational tools, food, GlaxoSmithKline, heart disease, hypertension, individualized online action plan, low fat diet, obesity, online action plan, online support program, physician, Steven L. Burton, the-counter product, U.S. Food and Drug Administration, United States, Vice President, Weight Control, Xenical

I remember watching an old episode of Chips where Ponch cracked an egg into a glass and drank it. I have done this in the past as well in the misguided belief that it would make me stronger. Raw eggs can be dangerous to eat and you should always cook your eggs before eating. Here are some tips that have come out from the FDA:

The U. S. Food and Drug Administration (FDA) reminds consumers to pay special attention to the handling of eggs and preparation of foods that contain eggs during this holiday season. Some holiday favorites, such as cookie dough, homemade eggnog, and some types of stuffing, may contain eggs that are raw or undercooked. Eggs sometimes contain a bacteria called Salmonella, which can cause illness if eggs are not handled and cooked properly. An FDA national survey of consumer food safety practices, the 2006 FDA/FSIS Food Safety Survey, found that cookie dough is one of the major sources of raw egg in the American diet, and that only three percent of respondents always use a food thermometer when they cook baked egg dishes such as stuffing.

To avoid egg-related illness from holiday foods:

* Do not eat unbaked cookie dough.
* Cook baked egg-containing dishes to160 degrees F.
* Make recipes that call for raw or undercooked eggs, like eggnog, with eggs that have been treated to destroy Salmonella or with pasteurized egg products.

An estimated 118,000 illnesses per year are caused by consumption of eggs contaminated with SE. To help consumers avoid these illnesses, FDA requires the following statement on packages of fresh eggs that have not been treated to destroy Salmonella:

Safe Handling Instructions: To prevent illness from bacteria, keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly.

Following these instructions is important for everyone, but especially for those most vulnerable to food borne illness�young children; the elderly; persons with weakened immune systems due to conditions such as AIDS, cancer or diabetes, or treatments such as chemotherapy for cancer; persons with weakened immune systems due to steroid use; and persons with immune suppression after organ transplantation.

So what about Eggnog? This is poured straight out of the carton at Christmas isn’t it? Well Eggnog that is sold in stores in North America is pasteurized. Using a pasteurized product means that no further cooking is necessary.

Tags: AIDS, cancer, chemotherapy, Chips, christmas, consumer food safety practices, diabetes, egg-related illness, fda, food, food thermometer, north America, pasteurized egg products, transplantation, U.S. Food and Drug Administration, weakened immune systems

My brother in law told me at one point that he had sleep apnea. The next week my boss, who never slept well and had a problem staying up in meetings, told me that he had sleep apnea and after having it treated he was really happy to be sleeping better and to be more rested all of the time.

Sleep Apnea is a very exhausting condition that causes you to wake up a bit all night long all the time so that you never get a restful night sleep. A horrible thought for everyone and real hell if you are the one that is suffering from this.

What is Obstructive Sleep Apnea?

The most common kind of sleep apnea is called Obstructive Sleep Apnea Syndrome. Sleep apnea means “cessation of breath.” It is characterized by repetitive episodes of upper airway obstruction that occur during sleep, usually associated with a reduction in blood oxygen saturation. In other words, the airway becomes obstructed at several possible sites. The upper airway can be obstructed by excess tissue in the airway, large tonsils, a large tongue and usually includes the airway muscles relaxing and collapsing when asleep. Another site of obstruction can be the nasal passages. Sometimes the structure of the jaw and airway can be a factor in sleep apnea.

What are the symptoms of Sleep Apnea?

* excessive daytime sleepiness
* frequent episodes of obstructed breathing during sleep. (The patient may be unaware of this symptom — usually the bed partner is extremely aware of this).
Read the rest of this entry »

Tags: airway obstruction, apnea, deformities, depression, ENT surgery, heart attacks, heart disease, high blood pressure, home healthcare, impotence, insomnia, insurance, jaw forward, laser, maxillofacial surgery, Nelson Powell, Obstructive Sleep Apnea, Obstructive Sleep Apnea Syndrome, oral mouth devices, plastic surgery, respiratory distress, respiratory equipment, Robert W. Riley, scar, sleep apnea, Sleep Technologist, Stanford University Sleep Disorders Center, strokes, surgery, U.S. Food and Drug Administration