How do you measure excellence? We believe excellence is an ongoing process, achieved only through progression, momentum, and constantly thinking forward, moving
forward.
Goliath Labs is best known for its commitment to quality. We have spent a great deal of time and effort to ensure that our state of the art production facility is supported by an equally impressive chemical and microbiological laboratory.
» Read more about Goliath Labs…
More women die from heart disease than from any other cause. In fact, one in four women in the United States dies from heart disease, according to the National Heart, Lung and Blood Institute (NHLBI).
"The risk of heart disease increases for everyone as they age," says cardiologist Shari Targum, M.D., a medical officer at the Food and Drug Administration (FDA). "For women, the risk goes up after menopause, but younger women can also develop heart disease."
FDA offers many resources to help educate women of all ages about the safe use of FDA-approved drugs and devices for the treatment and prevention of heart disease. FDA has fact sheets, videos, and other web-based tools on heart disease and conditions like diabetes and high blood pressure that may increase a woman’s risk for heart disease.
FDA created the "Heart Health for Women" site to connect women to FDA resources to support heart-healthy living. Visit the website at: www.fda.gov/womenshearthealth
"I encourage women of all ages to look to FDA for resources to help them reduce their risk for heart disease and make informed decisions about their health," says Marsha Henderson, director of the Office of Women’s Health at FDA.
When you think about heart disease, you probably imagine heart attacks and chest pain. But women need to know that heart health is about more than just heart attacks. Women need to take steps to reduce their risk for heart disease:
"Menopause does not cause heart disease," says Targum. "But the decline in estrogen after menopause may be one of several factors in the increase in heart disease risk." Other risks, such as weight gain, may also increase around the time of menopause.
Hormone therapy is used to treat some of the problems women have during menopause. "However, the American Heart Association recommends against using post-menopausal estrogen hormone replacement therapy to prevent heart disease," says Targum.
Work with your health care team to make a plan for your heart health. Whatever your regimen, make sure to keep a list of your medicines and bring it with you to all of your appointments. Download a medication booklet and visit the FDA website for updates on medicine, nutrition and more.
This article appears on www.fda.gov/ForConsumers/ConsumerUpdates/default.htm FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
May 23, 2013
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm353680.htm
After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.
FDA encourages health care professionals and consumers to report problems with medical products, including
Report problems to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness or death.
Here are some of the most recent safety alerts and ongoing safety reviews prompted by reports FDA has received through MedWatch.
The anti-seizure medication Potiga (ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. FDA does not currently know if these changes are reversible. Pigment changes in the retina have the potential to cause serious eye disease with loss of vision.
Risk: It is not yet known whether the retinal pigment changes specifically caused by Potiga lead to visual impairment, although several patients have reported impaired vision. In cases reported, skin discoloration appeared as blue pigmentation, predominantly on or around the lips or in the nail beds of the fingers or toes. The discoloration generally occurred after four years of treatment with Potiga, but has appeared sooner in some patients.
Recommendations
For More Information
Saratoga Therapeutics, LLC of North Wales, PA, recalled 900 bottles of ebA Multivitamin Supplement because they may contain milk components—milk proteins and lactose—not listed on the label. Instead, the label lists the product as being free of milk components.
Risk: People with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction. People who are lactose intolerant run the risk of gastrointestinal symptoms.
ebA Multivitamin Supplement was distributed nationwide and in Australia, Canada, Costa Rica, England, Finland, Ireland, Malaysia, Switzerland and Tasmania. It reached consumers by mail order, fax order, Internet sales and doctors’ office sales.
The vitamins are in a white plastic bottle with white, green and blue labeling. The expiration date is listed beneath the warning section on the label. Affected lot numbers include #0912164/expiration date 12/12 and #1110354/expiration date 10/14.
Recommendations
For More Information
At very high blood glucose levels (1024 mg/dL and above), the One Touch Verio IQ Blood Glucose Meter from LifeScan Inc. will turn off instead of displaying the message “Extreme High Glucose above 600 mg/dL,” as intended.
Risk: Because diagnosis and treatment of extreme hyperglycemia (too much sugar in the blood) may be delayed or incorrect treatment may be given, serious adverse health consequences, including death, may occur.
The over-the-counter device is intended for use by patients when outside the health care facility to monitor glucose levels of blood drawn from the fingertips. When turned back on, it enters the “set-up” mode, requiring the user to confirm the date and time settings before retesting. If the glucose level is still dangerously high, it will shut down again. The meters were distributed from December 14, 2011 through March 7, 2013.
Recommendations
For More Information
FDA received 458 reports of medical bed mattress covers that failed to prevent blood and body fluids from leaking into the mattress. This can occur if the mattress covers become worn or damaged from small holes or rips in the fabric from incorrect cleaning, disinfecting and laundering. Some reports say that if fluids penetrate the mattress, they can later leak out if another patient is placed upon it.
Risk: Patients are at risk for infection if they come into contact with blood and body fluids from other patients. In addition, wet and soiled mattresses can be a source of contamination during outbreaks of infection. FDA is concerned this problem may be under-recognized by health care providers, staff and caregivers. These reports came in from January 2011 to January 2013.
Recommendations
For More Information
Several manufacturers have recalled their products due to concerns associated with quality control processes that have been compromised and cannot ensure the products’ sterility.
Risk: Patients are at an increased risk of infection if a sterile medical product is compromised.
Recommendations
For More Information
In March 2013, FDA required safety labeling changes to be made to 53 drugs, including the antidepressant Wellbutrin (bupropion hydrochloride) and the nonsteroidal anti-inflammatory drug (NSAID) Anaprox (naproxen).
In general, changes were made to the prescribing information and, in some cases, to the patient package inserts and medication guides (paper handouts for patients that come with many prescription medicines) to warn about potential harmful reactions, tell who shouldn’t take the drug, or give other safety information.
For More Information
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
May 21, 2013
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm353341.htm
Share this article (PDF 305 K)
Although everyone is aware of skin cancer and the role of sunscreen in helping to prevent it, the details that will save lives are often surprising even to savvy consumers.
Did you know that some sunscreens protect against only the sun’s ultraviolet B (UVB) rays and not its ultraviolet A (UVA) rays, which also contribute to skin cancer? That no sunscreen completely blocks UV radiation, and that other protections are needed too? That no sunscreens are waterproof?
As summer approaches, the Food and Drug Administration (FDA) has taken steps on multiple fronts to protect consumers from the skin damage that can be caused by too much exposure to the sun.
This is the first summer in which FDA’s new rules governing sunscreen labeling are in effect. Using the latest available science, in 2011 the agency established testing and labeling requirements, which became final in December 2012.
One of the most important requirements: Testing and labeling that identifies sunscreens that are "broad spectrum," meaning they offer protection against both UVB and UVA rays. All sunscreen products offer protection against UVB rays, which are the primary cause of sunburn. But both UVB and UVA rays contribute to sun-induced skin cancer and premature skin aging.
"Based on scientific studies, we have determined that broad spectrum sunscreens with a Sun Protection Factor (SPF) of at least 15 can help reduce the risk of sun-induced skin cancer and premature skin aging when used with sun protective measures, as directed," said Reynold Tan, Ph.D., a scientist in FDA’s Division of Nonprescription Regulation Development. "We hope consumers use the information to make good choices."
Under final FDA regulations, products that pass a broad spectrum test can be labeled "broad spectrum" on the front of the product.
Sunscreens that are not broad spectrum or that lack an SPF of at least 15 must now carry a warning: "Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging."
And FDA’s regulations now require that if a product’s front label makes claims of being water resistant, it must designate whether it’s protective for 40 or for 80 minutes while swimming or sweating. Additionally, manufacturers may no longer make claims that their sunscreens are "waterproof" or "sweatproof."
Products may no longer be identified as "sunblocks" or claim instant protection or protection for more than two hours without reapplying.
 |
FDA is supporting "Don’t Fry Day." The awareness campaign is sponsored every year on the Friday before Memorial Day by the National Council on Skin Cancer Prevention. The Environmental Protection Agency (EPA) also supports the effort.
The message:
For more information on "Don’t Fry Day" and skin safety, visit: www.skincancerprevention.org.
FDA is considering whether additional changes are needed to sunscreen regulations, including requiring that sunscreens with an SPF value of more than 50 to be labeled simply "SPF 50+." FDA has no data demonstrating that sunscreens with an SPF of more than 50 provide additional benefits compared to those with SPF 50.
FDA has also requested additional data from manufacturers of sunscreen spray products to ensure their effectiveness and to determine whether they present a safety concern if inhaled unintentionally. In both cases, FDA is currently evaluating information received in response to public opportunities for comment.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
May 15, 2013
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm352255.htm
Thanks to nick of perfect body,i was offered a bottle of each of this product to sample a few guys.
so far i and 2 other guys have tried it and these are our reviews on it,
now im going to keep the detail in very basic terms so no one gets offended as its not a product intended for muscle and strentgh,but i was actually proven wrong on this too so read on,
first will start off with my mate,he is 21 years old.
his first trial with the product was on wednesday,
» Read full review…
