Are Generic Drugs the Same Medicine?
by Linda J. Creapeau CNH, Circkles Staff Writer.

We've all thought it at one time or another: "If it's so inexpensive, it must not be as effective or safe."

You're not alone. Food and Drug Administration (FDA) pharmacist Brenda Stodart, Pharm.D., who for 14 years has answered questions on FDA's Drug Information line (1-855-543-DRUG ) says, "Every day without fail we educate consumers and health care professionals about the safety and efficacy of generic drugs."

So, what are generic drugs and how does FDA ensure they are a safe and effective alternative to name brands?

When a new, FDA-approved drug goes on the market, it may have patent rights or exclusive rights that enables the manufacturer to sell the drug exclusively for a period of time. When those expire or no longer serve as a barrier to approval, other companies can make it in generic form. The FDA must still approve the generic drug before it can be marketed.

FDA Standards for Generics:

Lawrence Yu, Ph.D., FDA acting deputy director for science in FDA's Office of Generic Drugs, explains that for a generic drug to be approved by FDA, its manufacturer must show that it is "equivalent" to the innovator drug (brand name). This means that to gain FDA approval, a generic drug must:

• contain the same active ingredients as the innovator drug. Active ingredients make the drug effective against the disease or condition it is treating.
• come in the same dosage form. If the brand name is a capsule, the generic should be a capsule, too.
• be administered the same way. If the brand name is taken orally, the generic should be taken orally, too.
• be identical in strength
• have the same conditions of use
•be the bioequivalent (an equal rate and extent of drug absorbed the bloodstream)
• meet the same standards for identity, strength, purity and quality
• be manufactured under the same standards that FDA requires for the manufacture of innovator products

"Then, and only then, we can assure consumers that the generic will work as well as the name brand," Yu says.
According to Mansoor Khan, R.Ph., Ph.D., the agency's director of the Division of Product Quality Research, the review process includes a review of scientific data on the drug's manufacturing, ingredients and performance. Often new complaints or evidence arise indicating that a generic drug may not have the same safety or effectiveness as was previously believed. "If we have reasons to believe a generic drug does not perform the same as a brand name product," Khan says, "we have the ability to perform experiments in the FDA laboratories and take a comprehensive, scientific look at the differences between the products."

This happened with the generic drug Budeprion XL 300 mg, a generic form of Wellbutrin, a drug used to treat depression. FDA's original bioequivalence evaluation had been of a lower dosage (150 mg). After receiving reports of adverse effects from consumers who used Budeprion at the 300 mg dosage level, the FDA conducted another study and determined that Budeprion XL 300 mg was not bioequivalent to the Wellbutrin XL 300 mg. FDA requested that the manufacturers of Budeprion XL voluntarily withdraw the 300-mg version from the market, which they promptly agreed to do.
While FDA goes to great lengths to ensure that the brand and generic drugs perform equally, in rare instances, such as Budeprion XL, these efforts do not succeed. "BudeprionXL is definitely an outlier." Khan says, " However, there are literally thousands of approved generic products that perform equally without problems or complaints."

Why is generic so much cheaper?

"Generic manufacturers are able to sell their products for lower prices because they are not required to develop a new drug from scratch with pre-clinical studies or to repeat the many costly clinical trials of new drugs", Khan says. "Generally, they also do not pay for costly advertising, marketing and promotion."
According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics. But not every drug has a comparable generic. To find out if there is a generic equivalent for your brand-name drug, use Drugs@FDA. You can also search for generic equivalents by using FDA's "Electronic Orange Book."You can also consult the most recent monthly approvals for "First Generics."
FDA encourages consumers and health professionals to notify FDA of any adverse side effects found when using drugs and devices the agency regulates, by reporting them online to Medwatch, FDA's safety information and adverse event reporting program, or by telephone at 1-800-FDA-1088. This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

Energy Drinks: Is This What We've Taught Our Kids to do? Shame on us.
by Linda J. Creapeau CNH, Circkles Staff Writer.

I was recently dealing with a computer repair company, and I noticed that every time I walked into the place, almost every employee had a can of Jolt, Red Bull, or some other "energy drink" at their work station. I probably don't have to add that they were all young adults in their early twenties. If they keep "living on" that kind of resource for energy, they will certainly die of heart attacks and have a myriad of health problems before they reach forty.

By now, almost everybody has heard or read of the cautions surrounding using energy drinks. To sum it all up, energy drinks supply high amounts of caffeine, sugar and other chemical stimulants to give you a boost. Problem is, they tend to spike your energy levels and blood pressure to abnormally high levels very quickly and could cause some individuals to experience dizziness, irritability, high blood pressure, body aches and pains, headache,s and on the extreme end, heart attacks. Not to mention, running at high blood pressure and metabolism levels generated by energy drinks over prolonged periods of times causes long term stress to the body overall.

We thought we would give our readers some alternatives to using those nasty chemical stimulants to get through the day. Besides just getting adequate amounts of sleep nightly, eating right, moderate exercise to release tension and stimulating your mental health, we are providing some "natural quick fixes" below.

Electrolyte Tea:
Medical reports are increasing regarding the number of people who are suffering health problems and heart damage due to not getting enough potassium in their diets. Potassium is found mostly in raw, uncooked foods and the majority of the public simply just does not eat enough unprocessed fruits and vegetables to get the RDA of 5000 mg of potassium daily. Reports show that the average person does not even get 2,000 mg of potassium daily. Electrolytes play a huge roll in providing energy to the body. The four major electrolytes are calcium, magnesium, potassium and sodium. This tea will give you an even electrolyte boost that is much healthier for the body than a sudden jolt caused by energy drinks.

This tea is not big on taste, but it is big on vitamins, minerals, and supplies more electrolytes than Gatorade.
1C alfalfa leaves and flowers
1C dried nettle leaf
1C dried oat straw
1/2 C crushed rose hips

Mix above dry ingredients together in a glass jar with a lid and store in a dark kitchen cupboard. When ready to have tea, use 1 Tbsp of this mixture for 1 cup of hot or cold tea. The above recipe makes enough for several cups, so it can easily get you through a week or more. If you want to sweeten it, using unrefined, unfiltered raw honey is best.
Optional: You can ad hibiscus, dried fruits or berries, mint or other herbs to boost up the flavor a bit. Flavored with fruits, it makes a good iced tea or cold beverage to take to work and replace sugar-laden sodas with.

Dark, organic, minimally-refined, low sugar chocolate: Hey, if you have to go, go out eating chocolate I always say. Also by now, most of us have heard or read the recent studies promoting all the health benefits of dark chocolate. Minimally processed, organic, dark chocolate that is at least 70% cocoa, and minimally sweetened with cane juice or raw cane sugar instead of corn syrup is what has the health benefits; not that Snickers bar - which has very little in the way of health benefits and is mostly sugar, which will give you a quick sugar fix and energy boost, but will cause you to crash a couple hours later. Not to mention all the ramifications associated with refined white sugar and corn syrup used in most highly commercial candy bars. The right kind of chocolate is actually a benefit to your body by providing a slower energy release than chocolate bars that are mostly sugar, having the added benefit of being loaded with antioxidants, and elevates your mood. Feeling cranky at work? Get some organic, minimally processed, dark chocolate. We can't think of a better way to fight the blues.

Healthy carbs such as nuts, seeds and whole grains are also necessary for the body and give you a slow-release energy boost that will last over several hours, which is much better that that quick sugar blast you will get from candy or energy drinks. The body uses carbs for energy, so they are very necessary as well, and the recent bad rap they have gotten is blown out of proportion mostly by the misunderstanding that there are "good carbs" and "bad carbs" and the idea is to eat the good ones. Trail mixes (not the ones with candy added) are good high energy snacks and energy bars instead of the drinks, this is why athletes and hikers use them - because they provide long-term healthy energy.

Of course, if you are eating right, you really shouldn't need energy boosters to get through a day, and there really is no substitute for just having a balanced, healthy diet. Also see our Cyber Lounge and Motivity Pages for meditation and exercises you can perform at your desk to also help get you through the day. Blocked circulation and energy flow from sitting all day is also not going to help your energy levels and stamina. Good circulation is paramount to good energy. In reality, if you are looking for something to get you through the day long-term instead of a quick fix; energy drinks are actually the worst thing to use unless they are derived from the ingredients we have mentioned above: and very few are.

© 2013 Redstone Promotional Communications / Circkles.com.

 

 

- Ask a Nutritionist

- Ask an Herbalist

- The brain needs some healthy time too?
Stop by The Cyber Lounge on your way out.

- Also see the Motivity Page for Mental Health.

- Find more health articles in our archives by using the Google Search above ealth product reviews are in The Hangout.

This health section is updated monthly to give our members a chance to view it, so check back the first of every month for new posts. Disclaimer: This page is designed to offer information only on topics the average person can use themselves. It is not meant to be a substitute for professional medical advice.

HOME REMEDIES: Toothache Pain.

Clove oil or crushed cloves were used in dentistry before commercial anesthetics to treat oral pain. Cloves contain eugenol, which works as a natural pain killer and antibacterial agent. Clove oil has a powerful numbing action, which is why it works so well for toothache pain, but because it is also an anesthetic, it must be used with caution and in very small quantities.
Ideally, you want to put 1-2 drops of clove oil on a Q-tip (essential oil of clove can be purchased at most health stores) and rub it gently on the gum area of mouth pain. Let it sit for a couple hours before applying any more doses if the pain continues. Applying clove oil directly to the inside of the mouth is usually not a problem, but do not apply clove oil directly to the skin on your body, as it will burn. Do not drink it or swallow it in large quantities.

Warning: Do not rub more than a drop or two on the gum line over a 3-4 hour period or it can cause liver or kidney failure, respiratory distress and possibly stop your heart. Be very cautious using it with small children. Severe reactions may occur in people with allergy to cloves (about 1.5% of the population).

 


HERBS: Black Walnut Hull Juglans nigra:

How to use herbs for maximum benefit. Short and sweet descriptions and uses written by our on-staff Nutritional Herbalist. Always remember that herbs should be treated as a medicine. Almost all of our modern-day medicines are derived from compounds found in herbs and plants. If you have not used a particular herb before, try a half dose at first to make sure you do not have an unfavorable reaction to it.

Medicinal Properties: Used for digestive disorders and as a natural antibiotic for intestinal parasites and viruses. Makes a good alternative to Colloidal Silver because it is much safer and does not have the "blue skin" side effects. Safe enough to use on animals by putting a drop or two in their drinking water. Effective against giardia and dysentery.

How to Use: Make a decoction of the ground bark by simmering 1 Tbsp in 2 C. water for 20-30 minutes. Let cool. Use 1 Tbsp at a time every 4-6 hours for adults, or for animals, add just a couple drops to their drinking water. Herbal extract/tinctures are effective.

Parts Used: Inner bark, hulls.

Warnings: Can be laxative - try it out in small doses first.

Some Herb Basics: Most herbs work better on an empty stomach. A few exceptions are garlic, goldenseal and cayenne due to stomach upset. Herbs work in a cumulative fashion meaning they are not a "one dose wonder." They need to build up in the system a little, usually within 2-3 doses, before any real affect can be noticed. Fresh herbs always work better than old herbs and science is always proving the fact that a whole herb usually is more effective than one isolated compound of that herb.


FOODS THAT HEAL: Brazil Nuts:
Do you know what foods will give you more energy, calm your nerves, act as an anti-inflammatory, help prevent cancers, or help you lose weight? Hopefully this column will help you to have a better understanding of food and its healing properties. The best diet for optimal health is a wide variation of foods, plenty of fresh fruits and vegetables and minimally cooked whole foods. Sweets, fatty foods, meat, dairy and carbs in moderation.

Therapeutic Properties:
These rich, creamy nuts are high in protein, healthy fats, and selenium, a mineral that's essential for proper immune function and may help guard against infections and flu. In a 2001 study, University of North Carolina researchers found that mice infected with the flu virus showed higher levels of inflammation if they were deficient in selenium.

Your body only needs a small amount of selenium though, and getting too much may actually raise your risk for certain diseases. Just one nut contains more than the RDA of selenium. Adequate selenium in the diet helps to prevent coronary artery disease, liver cirrhosis, and cancers. However, too much selenium can cause vomiting, emotional problems, nerve pain and hair loss.

Acid or Alkaline: Slightly acidic.

Significant Nutrients: Selenium, magnesium, phosphorus copper, manganese, zinc. Additionally, these creamy nuts are an excellent source of B-complex group of vitamins such asthiamin (51% of RDA per 100 g), riboflavin, niacin, pantothenic acid, vitamin B-6 (pyridoxine) and folates. Also a fair amount of Vitamin E.

Total Omega-3 fatty acids - 23.9mg
 
Total Omega-6 fatty acid - 27350 mg

Warning: Do not eat more than 2-4 nuts per day as it could lead to selenium toxicity.

You can find more herbs and home remedies in The Circkles Hangout under the Main Menu.

 

March 2013
Health and Nutrition Circkles
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