December 8, 2016
Several risks are involved with using indoor tanning products. For instance, if you use an indoor tanning booth or bed, you are exposing your body to UV (ultraviolet) radiation, which promotes skin damage, eye injuries, melanoma and other skin cancers.
Because of the gradual impact of UV radiation, it places children, adolescents and young adults at a higher risk for eye and skin conditions in their later years. The FDA is determined to minimize the damage of UV radiation caused by indoor tanning products by prohibiting the use of these products by people under the age of 18. Also, indoor tanning sites are required to provide literature about the possible risks associated with using an indoor tanning product and have the consumer acknowledge the awareness of such risks by signing an acknowledgment form.
The FDA is also considering another rule that will require makers of indoor tanning products and tanning sites to create more proactive strategies to prevent injuries from using these products.
Dr. Markham Luke, dermatologist and deputy office director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health tells us that using indoor tanning products at a young age (childhood and young adulthood) increases the potential to develop melanoma and other forms of skin cancer. Markham also states that several hundred youth each year in the US get injured from using an indoor tanning product.
The American Academy of Dermatology states that exposure to indoor tanning products make people 59% more likely to have melanoma than people who have never used an indoor tanning product.
Studies conducted by the Centers for Disease Control and Prevention (CDC) between 2003 to 2012 conclude that there are over 3,000 emergency room visits in the US alone due to indoor tanning product-related injuries. Interesting enough, over 400 of the patients were adolescents under the age of 18.
Things to Keep in Mind for those Still Planning on Using an Indoor Tanning Product
Now the FDA has taken steps to prevent injuries to minors who use tanning products. FDA-approved products will carry a disclaimer that prohibits the use of the tanning product by people under the age of 18. Indoor tanning products are required to have a visible, black-box disclaimer that people under age 18 should not use the product. Also keep these points in mind:
- Being exposed too long (like near the maximum time for the tanning device) can cause sunburn. Since it takes from 6 to 48 hours to realize your skin is sunburned, it’s going to be hard to tell if you’ve stayed exposed for too long.
- If you take medications or use certain cosmetics, it may make you sensitive to the sun (UV radiation actually), so consult your physician or pharmacist prior to using a tanning product.
- Neglecting to wear protective goggles while doing indoor tanning can cause temporary or long-term eye problems.
- Always follow the directions for the tanning product. If you have skin that easily burns or is hard to tan (or does not tan at all), then it is highly recommended you do not use an indoor tanning product.
November 23, 2016
Do you want to reach your fitness goals without spending a ton of money on supplements? Supplements can have wonderful benefits and help you reach your goals, but they won’t just do it for you. It is possible to get stronger without supplements. You have to train, eat, and rest correctly in order to do this.
The problem with supplements is that they do such a good job of convincing everyone that they won’t be able to reach any kind of fitness goal without them. In reality, they are just supplements. They are supposed to SUPPLEMENT your training, diet, and rest. You can take all the supplements in the world, but if you don’t do anything else, you will be pretty unhappy with the results.
When you are looking to boost strength and build lean muscle mass, you need supplements that have supporting science and a long history of gains. These supplements have all been used by body builders, fitness models, and fitness enthusiasts for over a decade, and are time tested.
You do not need the newest and most “hip” supplement to build lean muscle mass and boost your strength. Stick with the supplements that are proven muscle builders or which effectiveness were proved by science studies.
October 14, 2016
When your child next has ear pain the FDA wants to ensure they get only FDA approved prescription drugs that are effective and safe for your child.
The FDA is telling companies to cease marketing sixteen unapproved prescription drugs which have labels indicating they relieve swelling and ear pain. These drops contain active ingredients like hydrocortisone and benzocaine, but the FDA has not evaluated them for safety, quality, and effectiveness.
Pharmacies as well as health care providers have sold drugs that had labels which didn’t disclose that the product wasn’t approved by the FDA. Charles E. Lee, M.D of the FDA says that we don’t know if the drugs have any benefits and we can’t accept the chances that they may have risks.
Why FDA Is Taking Action at this Time
The FDA has its Unapproved Drugs Initiative, so it’s taking action. The FDA seeks to protect consumers from drugs that aren’t proven to be safe, of high quality, or effective.
It’s a risk to public health when a drug isn’t shown to be effective, especially if it has some safety concerns. The FDA has received reports that state the products can cause mouth, face, neck, eye, and ear local allergic reactions. Other symptoms can include burning, stinging, itching and irritation of the ear.
Unapproved ear drug products which require a prescription containing these ingredients are covered by the action of the FDA:
- benzocaine and antipyrine
- benzocaine, antipyrine and zinc acetate
- benzocaine, chloroxylenol and hydrocortisone
- chloroxylenol, pramoxine and hydrocortisone
- chloroxylenol and pramoxine
The quality of the drugs isn’t known for certain. When a drug is approved by the FDA, the drug manufacturing process is reviewed which ensure that the drug is of purity ad well as consistent quality. These unapproved ear drops have not been examines in this way. The products are prescribed for infants and small children so this is troubling. Drugs that are intended to be used on children should be tested in children. The drugs mentioned haven’t bene shown to be effective in anyone so there’s no proof that the products actually work.
Alternatives Approved by the FDA Available
There are other treatment options available for children with ear problems. The FDAs action only impacts a small percentage of drugs prescribed to treat otitis externa (outer ear infections), excess buildup of earwax, and otitis media (middle ear infections). There’s also F many OTC products available that can be used for earwax buildup or swimmers ear.
There are other solutions for ear problems and choices for consumer sot make. You need to use the products that are known to be safe and avoid the ones that haven’t been test fully for safety and effectiveness.
August 28, 2016
Americans spend quite a bit of money on lotions, creams and cosmetic products that offer a promise of improved eyelashes, hair and skin. In many cases, these promises go too far in what they have to offer the consumer.
The FDA or Food and Drug Administration warns those that make cosmetics to be careful when they make claims about product and to classify them as drugs and not cosmetics. The FDA has sent warning letters citing drug claims associated with hair care, topical skin care, eyebrows, and eyelashes. These claims were found on websites as well as product labels. Some examples of drug claims are for dandruff treatments, acne treatments, as well as restoration of hair.
The letters say that the products on the market have drug claims. Meaning that the product is intended to prevent or treat a disease or change body functions or structure. The FDA wants companies to remove drug claims from products or seek the FDA approval to market cosmetic products as drugs.
Consumers need to know that drug claims on these products are not approved by the FDA when they decide to buy one of the products says MPH, director of FDA’s Office of Cosmetics and Colors, Linda M. Katz, M.D. The FDA must evaluate the products as drugs before the company can claim that the product treats skin problems or changes the skin.
Drug claims have gone as far as to say the product changes elastin or college of the skin. Other claims include that the product prevents wrinkles or allows for firmer and more elastic skin.
Some products say that there’s regeneration of cells, reduce inflammation, less facial muscle contractions or give you the same results as surgery or injections. Conditions like psoriasis, eczema, rosacea, and acne are promise dot be treated.
Drugs or Cosmetics?
The federal law sates that a cosmetic is designed for beautifying, cleansing, altering appearance or promoting attractiveness. The FDA is not required for approval before these products go to the market.
Drugs are defines as products intended to cure, diagnose, mitigate, prevent, or treat a disease or condition. A drug is also said to affect the structure or function of the body. Drugs need FDA approval in most cases before they can be marketed to consumers.
Many companies have crossed the line and stated that their products will enhance a person’s appearance or that the structural appearance of the skin and will prevent or treat certain medical conditions.
For several years the FDA has been tracking claims that have been made about cosmetic products and there are many claims on the Internet or on product packages that simple aren’t true. If a product is making a drug claim then they have to be evaluated as a drug and not a cosmetic product.
If a company can’t comply then more action besides a warning letter is taken and the product may be removed from the marketplace altogether.
August 20, 2016
The marketplace for medications is about to get a lot larger. The FDA recent approved the first biosimilar product called Zarxio (filgrastim-sndz) and expects to approve more of them soon.
Associate Director for Therapeutic Biologic Leah Christly, Ph.D., says we need to understand biological products before we can understand biosimilars.
Biologics are medications we make from living organisms. This can include animal, humans or microorganisms like bacteria or yeast. These are different from conventional medications which are usually made from chemicals or are chemically synthesized and have an easy to define structure.
Biologics aren’t made by following a chemical recipe as they come from living organism which vary in nature. These are more complex and not easy to characterize or define. They need a more complex process to manufacturer.
The FDA thoroughly and rigorously evaluates a biologic just like they would do for a regular drug before it gets approval. These biologics are the fasted growing segment of the market for prescription drugs.
A biosimilar is a type of biologic that is very similar to an already FDA approved biologic which is called the reference product. The biosimilar is not just a generic drug. The structure is very complex and it’s not easy to produce as a generic drug. The biosimilar isn’t a copy of another biologic, it’s just very similar to it.
Before any biosimilar is approved by the FDA. It’s verified by experts to make sure there are no clinical meaningful differences between the reference product and the biosimilar.
The biosimilar must also have the same dosage form and strength as well as route of administration as the reference product. The Current Good Manufacturing Practices must be used in the manufacturing of the biosimilar.
FDA approved biosimilars are effective and safe and patients can rely on them. A physician must approve the biosimilar just like they need to approve a biologic. In the marketplace for medications the biosimilar products will create greater competition. This will increase the number of treatment options for patients and lead to less expensive alternative therapies when compared to regular treatments. There are many biosimilars on the market now and consumers get an effective and safe treatment when they use the product at lower costs to them.
August 15, 2016
Anyone can get cracked heel but some people are more prone to the condition than others. Some individuals suffer dry, cracked heel due to poor hygiene. The person may not exfoliate daily or moisturize well enough. Additionally, it could occur because the person is not drinking enough water. Each of these factors may contribute to dry, cracked heel.
The first sign of getting cracked heel is the development of dry, hard, thickened skin around the rim of the heel. This is called a callus and may be yellow or dark brown discoloured area of skin. Initially small cracks over the callus are visible.
If left untreated and as more pressure is placed on the heel, these cracks become deeper and eventually walking and standing will be painful. The cracks may be so deep that they begin to bleed. That is why it’s important to take care of your skin even on feet and find an appropriate remedy for cracked heel.
Severe heel infections may require that individuals take oral anti-fungal medication in order to alleviate or cure the symptoms. The most common ingredients in prescription anti-fungal drugs include ketaconazole, itraconazole, naftifine, and nystatin.
Those who desire a topical treatment should not simply select an anti-itch ointment. These ointments may promote moisture and exacerbate the condition. Experts recommend the use of gels instead of creams for application of topical treatments.
June 10, 2016
Tourette syndrome is a problem with the nervous system that causes people to make sudden movements or sounds, called tics, that they can’t control. For example, someone with Tourette’s might blink or clear their throat over and over again. Some people may blurt out words they don’t intend to say.
Treatments can control tics, but some people don’t need any unless their symptoms really bother them.
Tourette Syndrome has been linked to different parts of the brain, including an area called the basal ganglia, which helps control body movements. Differences there may affect nerve cells and the chemicals that carry messages between them. Researchers think the trouble in this brain network may play a role in Tourette’s. Doctors don’t know exactly what causes these problems in the brain, but genes probably play a role. It’s likely that there is more than one cause.
Dietary changes as well as certain supplements can be used to treat the condition. Eliminating trigger foods and ingredients as well as natural treatment for Tourette syndrome can nearly eliminate the presence of tics and other symptoms of the condition.