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Posts Tagged ‘Food And Drug Administration Fda’

Feb
20

Protein has been garnering extra attention as the health conscious realize the benefits of including protein in their diets. protein is needed to help rebuild the body’s tissue, which is particularly important to athletes and bodybuilders. In fact, the body is in need of a continual supply of protein in order to repair and to build its tissue. Protein is also essential for producing antibodies, hormones, new muscle tissue, and blood hemoglobin. All protein that is lost within the body must be replaced and protein must be present in order for new tissue to be constructed.

While athletes swear by the ability of animal protein to build muscles, researchers are concerned about the potential effects of animal protein on the liver and the kidneys, as well as the link between animal protein and osteoporosis. As a result, many are turning toward soy protein and whey protein instead. But, what are the benefits, drawbacks, and differences between these different forms of protein? And, how much should you include in your diet in order to garner the benefits you are looking for?

Soy Protein

Soybeans contain high quantities of protein (considered to be of equal quality as animal protein) and also contain substantial amounts of amino acids. In addition, soy has been observed to lower cholesterol. Even the Food and Drug Administration (FDA) has stated 25 grams of soy protein per day can reduce the chances of developing heart disease.

Soy protein has also been found to reduce the symptoms of menopause, to reduce the risk of developing osteoporosis, and to help prevent a number of diseases related to hormonal issues. These include endometrial cancer, breast cancer, and prostate cancer. Soy protein has also been shown to speed up the metabolism of the thyroid, which can help with obtaining a leaner body. If you are intolerant to soy, however, its specific protein can actually have the opposite effect.

A number of soy protein products can be found at health food stores, including food bars, soy burgers, and even soy-based beverages. Those products containing soy protein isolate generally have the highest saturation. Other products containing soy protein include soy flour, whole soybeans, and tofu. Be sure to check the product label in order to determine the amount of soy protein the product contains.

Remember, however, soy isoflavones, which are sold as supplements in health food stores, are not the same substance as pure soy protein. Nonetheless, soy isoflavones possess a number of beneficial effects, such as improving kidney function and preventing bone loss.

If you are not allergic to soy, there are very few side effects to including soy in your diet. In some people, however, consuming soy on a routine basis can lead to an upset stomach and may even cause diarrhea or constipation.

Whey Protein

Like soy protein, whey protein has been shown to provide a number of benefits. For example, clinical studies have shown whey protein can:

Act as a natural antibacterial or anti-viralAssist in maintaining the proper weightReduce the symptoms of Chronic Fatigue SyndromeReduce liver damageImprove the function of the immune systemImprove blood pressureImprove athletic performanceImprove the function of the digestive systemReduce gastric mucosal injury

Whey protein is very high in biological value (BV), which is highly sought by athletes. In short, BV is the amount of protein your body can replace with 100 grams of consumed diet. The only other foods containing high levels of BV are whole eggs and egg whites. Unlike eggs, however, whey protein does not contain high levels of fat.

While soy protein is derived from soybeans, whey protein is derived from milk as a diluted byproduct of the cheese-making process. Fresh liquid whey protein contains only about 1% protein because it is mostly comprised of lactose and water. For this reason, it takes about 229 liters of milk to produce just one kilogram of high quality whey protein isolate.

While in its original form, whey protein affects the digestive tract in much the same way as yogurt. Therefore, it is considered to be a natural remedy for many intestinal issues. In fact, it is often used in Sweden to help prevent bowel problems, gas, and constipation. Nonetheless, it can have the opposite effect and actually lead to constipation for some individuals.

The amount of whey protein recommended in a person’s diet depends on his or her weight, gender, age, level of activity, and overall health. Including both soy and whey protein in your diet can be very beneficial to your health; but, since both can lead to constipation, be sure to follow a high fiber diet to help keep your bowel movements regular. Try one or both of these all-natural health supplements and discover the results for yourself!

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Feb
05

An antibiotic used to treat an array of bacterial infections among adults was approved recently by the Food and Drug Administration (FDA) for children.

Levaquin levofloxacin is part of the fluoroquinolone group of oral medications prescribed to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, noscocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections, mild to moderate uncomplicated skin and skin structure infections, chronic bacterial prostates, urinary tract infections and acute pyelonephritis caused by Escherichia coli, also known as E. coli, which is an infection affecting the lower intestines of humans and highly associated with food poisonings in the United States. The drugLevaquin, which is manufactured by from pharmaceutical firm Ortho-McNeil, was approved in 1996, but the oral solution was introduced in 2004 and this was followed by a 750-milligrams (mg) five-day oral treatment becoming widely available in 2005, although the Levaquin is also available intravenously as well.

While Levaquin is prescribed for an array of bacterial infections, it has also been approved to treat the effects of airborne anthrax. It was also recently approved for the use by in treating children as an anti-bacterial component and as a treatment of anthrax contamination among children as well. The drug is absorbed quickly, particularly after oral consumption and is usually allotted in 500 mg to 750 mg doses.

According to manufacturers, individuals who have kidney disease, diabetes, spinal or brain cord conditions are highly recommended to avoid the drug as it could cause serious side eaffects including:

* slow absorption of in kidney disease patients

* blood level spikes and irregularities of in diabetes patients

* uncontrollable seizures among spinal and brain injury patients

Levaquin Side Effects

According to manufacturers, the most common adverse drug reactions Levaquin side effects that occurred in U.S. individuals who underwent a Levaqin clinical trial experienced insomnia and dizziness as well as diarrhea, nausea and constipation. Additionally, the list of side effects continues to grow and patients thatwith exude any of the following symptoms should stop taking the medication and seek medical assistance immediately:

* abdominal tenderness, cramping or severe pain

* confusion, hallucinations or psychosis

* diarrhea (which may be bloody)

* fever

* blisters, redness and swelling of the skin

* sensation of burning skin

* trembling or seizures

* vomiting

* easy bruising or bleeding

* jaundice

* numbness in limbs, tingling in fingers

* swelling, pain in legs/muscles

Recent studies have also suggested that individuals with preexisting conditions (previously mentioned) as well as individuals taking specific types of medicine may increase their risk of these Levaquin side effects causing severe medical trauma.

Complications may occur when use of Levaquin is combined with:

* blood thinners (warfarin/coumadin)

* cyclosporine

* insulin

* theophylline

* aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)

* heart rhythm medications (Cordarone, Pacerone, etc.)

* antacids (Tums, Rolaids)

* ulcer medication (Carafate)

* didanosine (Videx)

* vitamins or supplements containing iron or zinc

Levaquin Tendon Rupture Risks

The most serious Levaquin side effect is the risk of Achilles tendonitis among current and former patients of Levaquin levofloxacin. Several studies published in accredited medical journals including the Journal of Antimicrobial Chemotherapy, The Journal of the American Board of Family Medicine, The Annals of Pharmacotherapy and Tthe Journal of Orthopaedics and Traumatology have all cited case studies in which individuals who have taken Levaquin have been adversely affected by levofloxacin-induced tendonopathy and tendon rupture.

According to the report from The Journal of American Board of Family Medicine, the onset of tendon ruptures among patients characteristically is abrupt in onset causing extreme sharp pains and swelling of legs when walking. The study also reports that while most of the tendonitis among Leva

quin patients occurs within the first two weeks of taking the drug., Hhowever, it can occur in patients long after the drug’s cycle has been completed.

In some patients, the Levaquin tendon ruptures occurred longer than six months after treatment administration of the drug. The study noted that the U.S. Food and Drug Administration (FDA) found that in 1991, tendon rupture could be a risk of quinolone drugs.

Although it wasn’t until 1996 when the FDA issued its first “Report of adverse Events” on the fluoroquinolones. In a 10-year period, at least 200 reports of Achilles tendonitis have occurred in association with Levaquin. Additionally, a report from the United Kingdom found that levofloxacin-induced tendonitis potentially affects approximately 3.2 out of approximatly every 1,000 Levaquin patients who have taken the drug at some point.

Victims of Levaquin Risks

Individuals who have previously been exposed totaken Levaquin, whether through intravenous or oral methods, should speak with their physician to asses any potential risk. Additionally, patients may which to consult with an experienced Levaquin lawyer a pharmaceutical lawyer especially if any of the previous symptoms have occurred. Additionally, because of the severity of tendonitis and potential long-term damage done, it is important for an individual to consider seeking out compensation in the form of a Levaquin Lawsuit that may provide monetary relief from the extensive surgical and medical procedures likely associated with solving or easing the pain of tendonitis caused through a prescription of Levaquinby having taken Levaquin.

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Aug
02
allergies and pregnancy


Rhinitis during pregnancy can be due to allergic rhinitis, sinusitis, or non-allergic rhinitis. If the woman has had allergic rhinitis prior to pregnancy, this could worsen, stay the same, or even improve. This change in symptoms may be dependent upon many factors, including the presence of seasonal allergens and increase in pregnancy hormones.

Non-allergic rhinitis in pregnancy may also be due to an increase in pregnancy hormones, leading to nasal congestion, runny nose and post nasal drip. This is called “rhinitis of pregnancy”. The symptoms may mimic allergies, but since they are non-allergic in nature, do not respond to anti-histamines.

The pregnant woman with rhinitis may be concerned about the safety of medications during pregnancy, and therefore avoid taking medications.

If avoidance of allergic triggers is not possible or successful, medications may be needed to control symptoms.

Diagnosis of Allergic Rhinitis During Pregnancy

Allergy testing includes skin testing or blood tests, called a RAST. In general, allergy skin testing is not done during pregnancy, given the small chance of anaphylaxis which may occur. Anaphylaxis during pregnancy, if severe, could result in a decrease in blood and oxygen to the uterus, possibly harming the fetus. Therefore, allergy testing is usually deferred during pregnancy, although a RAST would be a safe alternative if the results are needed during pregnancy.

Safety of Allergy Medications During Pregnancy

According to the Food and Drug Administration (FDA), no drugs are considered completely safe in pregnancy. This is because no pregnant woman would want to sign up for a medication safety study while she is pregnant. Therefore, the FDA has assigned risk categories to medications based on use in pregnancy.

Pregnancy category “A” medications are medications in which there are good studies in pregnant women showing the safety of the medication to the baby in the first trimester. There are very few medications in this category, and no asthma medications.

Category “B” medications show good safety studies in pregnant animals but there are no human studies available.

Pregnancy category “C” medications may result in adverse effects on the fetus when studied in pregnant animals, but the benefits of these drugs may out weight the potential risks in humans.

Category “D” medications show clear risk to the fetus, but there may be instances in which the benefits outweigh the risks in humans. And finally, category “X” medications show clear evidence of birth defects in animals and/or human studies and should not be used in pregnancy.

Before any medication is taken during pregnancy, the doctor and patient must have a risk/benefit discussion. This means that the benefits of the medication should be weighed against the risks – and the medication should only be taken if the benefits outweigh the risks.

Treatment of Rhinitis During Pregnancy

Nasal saline. Rhinitis of pregnancy tends not to respond to anti-histamines or nasal sprays. This condition seems to respond temporarily to nasal saline (salt water), which is safe to use during pregnancy (it is not actually a drug). Nasal saline is available over the counter, is inexpensive, and can be used as often as needed. Generally 3 to 6 sprays are placed in each nostril, leaving the saline in the nose for up to 30 seconds, and then blowing the nose.

Anti-histamines. Older anti-histamines, such as chlorpheniramine and tripelennamine, are the preferred agents to treat allergic rhinitis during pregnancy, and are both category B medications. Newer anti-histamines such as over-the-counter loratadine (Claritin/Alavert and generic forms) and prescription cetirizine (Zyrtec) are also pregnancy category B medications.

Decongestants. Pseudoephedrine (Sudafed, many generic forms) is the preferred oral decongestant to treat allergic and non-allergic rhinitis during pregnancy, although should be avoided during the entire first trimester, as it has been associated with infant gastroschisis. This medication is pregnancy category C.

Medicated nasal sprays. Cromolyn nasal spray (NasalCrom, generics) is helpful in treating allergic rhinitis if it is used before exposure to an allergen and prior to the onset of symptoms. This medication is pregnancy category B and is available over the counter. If this medication is not helpful, one nasal steroid, budesonide (Rhinocort Aqua), recently received a pregnancy category B rating (all others are category C), and therefore would be the nasal steroid of choice during pregnancy.

Immunotherapy. Allergy shots can be continued during pregnancy, but it is not recommended to start this treatment while pregnant. Typically the dose of the allergy shots is not increased, and many allergists will cut the dose of the allergy shot by 50 percent during pregnancy. Some allergists feel that allergy shots should be stopped during pregnancy, given the risk of anaphylaxis and possible danger to the fetus as a result. Other than anaphylaxis, there is no data showing that the allergy shots themselves are actually harmful to the fetus.



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