Get Vaccinated

November 6, 2017

Forgot to get your vaccine back in the fall and think it’s too late to get one?

Well according to the Food and Drug Administration (FDA), you can still get your flu vaccine while the virus is still going around. So even though the flu season begins most of the time at the start of October, it peaks during the first two months of the year and can go on as far as May

The FDA ensures the vaccines produced every year are safe and actually work, and this work begins long before the next flu season begins because it often occurs while the current flu season is going on. Thus, the task of assuring vaccines are safe and effective is a year-round endeavor.

Why do we need new vaccines every year?

Dr. Marion Gruber, director of the Office of Vaccine Research and Review for the FDA states that there are sound reasons for why the flu vaccine has to be new each year.

Gruber tells us that because the virus mutates each year, a vaccine has to be created that closely resembles the new strain going around because the previous year’s vaccine loses effectiveness as time passes by.

Identifying likely virus strains

During the month of February—the peak of the current flu season—the World Health Organization, FDA and CDC (Centers for Disease Control and Prevention) gather worldwide data to determine the next flu season’s makeup. Their findings will determine which strains are used to produce the next US vaccine.

Studying the virus strains allows the makers of the vaccines to create a matching vaccine that provides better protection.

The FDA also examine the companies making the vaccines regularly to assist in making sure these companies vaccines are effective. Reagents are prepared by the FDA and distributed to these companies to standardize the vaccines and ensure they have the right dosage strength. Each year, the manufacturing facility has to undergo an approval process to verify each lot of vaccines is appropriate for use.

The people impacted the most by the flu

According to the studies conducted yearly by the CDC, children and the elderly are the two populations that are impacted the most by the flu even though other populations may be greatly affected as well (for instance young and middle-aged adults).

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Injectable products are becoming a popular alternative for those desiring to alter their skin color for the purpose of lightening or whitening their complexion. Despite the popularity of these products, they have yet to be FDA-approved (Food and Drug Administration) and are considered to be unsafe for use. These products are also believed to not have a significant effect on altering skin color.

One FDA representative noted that injectables contain mystery substances that may be extremely harmful to one’s body. Also, because no one knows how these injectables are made, it adds to the uncertainty of their safety.

A Costly Promises

Like most skin brightening and whitening products on the market, injectables promise to even skin tone, remove blemishes and lighten skin tone. You can find these products online and in some retail and health stores. Most products come with instructions on how to inject the product under the skin, in a vein or in a muscle. However, most people fail to realize that while these products are being marketed, they are not approved as safe by the FDA. Some injectable products claim to treat conditions like Parkinson’s or liver disease, which is also not able to be proved or verified by the FDA. Because it is not known how these products are made, no one can vouch for the safety of these products.

What Consumers Should Do

If you are having adverse reactions to using an injectable product in the past, contact your health care provider immediately.

Also, contact your health care provider if you want to try a safer way to deal with your skin problems (like melisma or hyperpigmentation). That way, you can use a topical product that is known to be approved by the FDA.

Unlike the injectable products for skin condition, FDA-approved drugs are verified to be safe and effective in doing their intended purpose. Also, if a product is FDA-approved, the manufacturer has also meet specific qualifications that verify the product was produced in a safe way.

Located at the top of each kidney, the adrenal glands produce hormones that help the body control blood sugar, burn protein and fat, react to stressors like a major illness or injury, and regulate blood pressure.

Adrenal gland health is important for overall human health. Adrenal gland diseases occur when the adrenal glands don’t make enough hormones. Symptoms include fatigue, muscle weakness, decreased appetite, and weight loss. Some people experience nausea, vomiting, and diarrhea. The good news is that the conditions caused by overproduction or underproduction of adrenal hormones are usually treatable.

What to eat to support adrenal gland health?

  • Eat fresh, whole foods – preferably organic, locally grown, seasonal food – for meals and snacks.
  • Avoid preservatives, added hormones, artificial colors, dyes, and chemicals.
  • Include lean protein with each meal and snack to help stabilize blood sugar and stave off cravings for refined sugars and caffeine.
  • If you buy prepared food, try to buy it at a health food store or grocery offering natural, whole foods.
  • Try to prepare extra nutritious snacks to have on hand so they are ready and available when you are having cravings.

Beverages also make a difference in supporting adrenal health. If you are used to choosing adrenal draining liquids like alcohol, sports drinks, or caffeinated drinks, this handy chart can show you some alternatives.

Adrenal gland diseases can be treated with natural treatment options. Read more about adrenal disorders and treatment in source page: www.yourwebdoc.com/adrenalglands.php

Biosimilars

August 18, 2017

Inflectra (Infliximab-dyyb), a biosimilar of Remicade (infliximab), and Zarxio (filgrastim-sndz), a biosimilar of Neupogen (filgrastim), are in a new line of medications destined to become more commonplace in the future as more Biosimilars are approved by the Food and Drug Administration (FDA).

Dr. Leah Christl (Associate Director for Therapeutic Biologics at the FDA) tells us that in order to understand what a biosimilar is, we need to first understand what biologics (also called biological products) are.

Biologics: Medications from Biological Substances

A biologic is any medicine derived from living creatures—be it a microorganism (like bacteria and yeast), animal or human.

Dr. Christl tells us that the major difference between biologics and traditional medicines is in the source of material they are derived from. Traditional medicines are derived from chemical substances and byproducts and are easy to replicate.

Because biologics come from living organisms, they are just as unique as the organisms they come from. So there is no one exact recipe one can follow to replicate a biologic. Thus, the procedure for replicating a biologic is more difficult than with traditional medicines.

Right now, biologics are becoming a popular commodity in the pharmaceutical world   As with traditional medicines, biologics also undergo a strict process to get approved by the FDA.

What Are Biosimilars?

A biosimilar is a biologic that closely resembles the design of another biologic that is already approved by the FDA (commonly referred to as the reference product).

Unlike generics, which are replicas of brand name drugs, biologics are not as easy to replicate because it’s impossible to create an exact replica of an existing biologic. Therefore, the new brand will be similar but not identical to the original.

In order for a biosimilar to be approved, the FDA has to ensure the biosimilar has no significant differences in structure from the reference product. Thus, the biosimilar must produce the same effect, same method of being administered and have the same potency per dosage as its reference product to be considered an authentic biosimilar.

As stated earlier, Inflectra is the biosimilar of Remicade (infliximab). Like Remicade, Inflectra is used to treat:

  • plaque psoriasis
  • psoriatic arthritis
  • rheumatoid arthritis
  • Crohn’s disease
  • ulcerative colitis
  • ankylosing spondylitis

Respiratory infections are a common side effect of Inflectra. These symptoms include:

  • headache
  • sinus infections and sore throat
  • stomach discomfort
  • coughing

Sometimes, people experience chills, chest pain, low or high blood pressure, shortness of breath, itching, rash, or fever for up to two hours after taking the Inflectra infusion. It is recommended Health care professionals become well-knowledgeable about all prescription information concerning Inflectra—the good and the bad before prescribing it to patients.

While it is normal to feel an urge to urinate 4-6 times a day but if it exceeds this number, you may be suffering from the problem of frequent urination, especially if you need to urinate more than 8 times a day.

From diabetes, pregnancy, anxiety to bladder stones, kidney infections, urinary tract infection and prostate problem, there can be multiple causes of frequent urination. If you have not been drinking excess water or too close to your bedtime and still having to urinate for more than 8 times a day or wake up repeatedly at night, you must visit your doctor for underlying cause of frequent urination. This becomes crucial if your frequent urination is accompanied by fever and chills.

If there is nothing very serious about your frequent urination problem, you can use one or more of the home remedies for frequent urination.

Taking all dietary modifications along with some lifestyle changes like regular exercising and Kegel exercises for strengthening pelvic muscles will help you get rid of frequent urination. However, because frequent urination have various different causes, some of which are really serious, you should visit your doctor to get a proper diagnosis and treatment for the underlying cause of your frequent urination.

Regardless of your skin type, you need to use products that do more benefit to your skin than harm. While shopping for your ideal beauty product, take heed to the Food and Drug Administration’s (FDA) warning about lotions, skin creams and soaps that have mercury.

What is the best way to determine if a cosmetic product has mercury—in particular those labeled as skin lightening or anti-aging? Just look at the label and see if you can find the terms mercury, mercuric, mercurio, calomel or mercurous chloride. If you see any of these terms in the product, then it means it has mercury, and you need to stop using it.

These products are usually sold as anti-aging products and skin lighteners that eliminate freckles, blemishes, spots and wrinkles. Some teenagers use products like these for acne.

The FDA’s Office Regulatory Affairs representative Jason Humbert claims these products are made overseas and are marketed illegally in the US.  Ethnic shops targeting Asian, Latino, Middle Eastern and African communities often sell these products. Social media sites and other online outlets also market these products. Some people buy these products overseas and bring them back to the United States.

You can’t just assume a product is okay if the ingredients are not listed. It’s against federal law to fail to disclose the ingredients of a nonprescription or cosmetic product. So if the product has no ingredients listed, it is highly recommended you do not use the product Also, don’t use products that have ingredients listed in another language because that’s also a sign of an illegally marketed product.

These products may be marketed as cosmetic products, but they are not FDA-approved.  The only time the FDA allows mercury to be used in a drug or cosmetics is when that’s the only alternative for an efficient preservative. However, this is not the case in these illegal products.

Injunctions, enforcement action, legal seizure of all merchandise, and criminal prosecution are possible consequences for distributors and sellers who market these products.

Mercury is dangerous

The negative consequences of using mercury go far beyond that of the person using the product. It also affects the entire environment where the product is used.

Mercury vapors can be inhaled that are released from the products. Also, people in the house can touch objects like towels or washcloths that have absorbed the vapors.  Pregnant women and women who are nursing are vulnerable to mercury poisoning because the mercury can affect the unborn baby’s brain and nervous system, and it can be passed on to breast milk if a mother is breastfeeding. Other populations, including young children may be highly vulnerable to mercury poisoning.

High intensity exercise has quickly become a growing trend within the fitness community because it allows for more work to be performed in a shorter period of time and it helps the athlete achieve higher levels of anaerobic fitness. As our lives become busier, extended workouts or high volume training methods with multiple sets and extended rest periods are not practical for the average person due to lack of motivation, attention span or their busy lifestyle.

The more important aspect of high intensity exercise that has made it popular is the results. Research has shown that high intensity interval training (running, rowing or high repetition resistance training) improves anaerobic as well as aerobic endurance while moderate intensity endurance training can only improve aerobic endurance.

High-intensity exercises are one of the best ways to torch fat and get into shape. However, preparing your body with supplements for high-intensity exercises is just as important as actually doing the exercises.

Why do you take supplements? To fill the gaps in your diet, or to maximize the results you get from your training. But don’t forget this one: To perform better in the gym! Consistent daily use of supplements for high-intensity exercises can have several beneficial effects on power, strength, and performance!

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