AMO introduces blink Tears eye drops
SANTA ANA, Calif. Advanced Medical Optics on Monday announced the U.S. introduction of blink Tears, a new line of over-the-counter lubricating eye drops for the estimated 40 percent of Americans who suffer from occasional or chronic dry eye symptoms.
“The introduction of blink Tears lubricating eye drops is our first entree into the dry eye category and marks an important expansion of AMO’s complete refractive solution of eye care products,” stated AMO chairman and chief executive officer Jim Mazzo.
“I believe that blink Tears will be a significant improvement to our treatment regimen for managing the symptoms of dry eye,” stated Eric Donnenfeld, who is in private practice with Ophthalmic Consultants of Long Island and is a trustee of Dartmouth Medical School. “The unique formulation of blink Tears distinguishes it from other currently available artificial tears because it can provide both a long duration of effect as well as superior visual clarity.”
AMO developed a formula for blink Tears lubricating eye drops that includes a blend of ingredients naturally found in the eye. Product benefits include: long-lasting relief with less blurring of vision; up to 60-minute moisture retention time; restored tear film with each blink; improved tear film stability; and adapts to an individual’s dry eye needs by thickening when the eye is open, and thinning when the eye blinks.
Dry eye syndrome is a common disorder of the tear film, afflicting especially those aged 40 years and older. Symptoms of dry eye may include redness, burning, itching, light sensitivity, excessive tearing, a gritty “foreign-body” feeling and dryness.
It is estimated that women are twice as likely as men to suffer from dry eye, especially as they grow older. Dry eye syndrome also can be associated with other illnesses or conditions. For example, people with diabetes or auto-immune diseases, such as rheumatoid arthritis or lupus, may be more susceptible to dry eye. Certain environmental factors can also aggravate dry eye, such as living in an arid climate. The dry air on planes can also make flying uncomfortable for those with dry eye.
One of the most common causes of dry eye syndrome is a dysfunction of the meibomian gland, which produces an oil that coats the eye. It is this oil, mixed with tears, which creates a healthy tear film that keeps one’s eyes properly lubricated. Without this oil, the eye compensates by producing more tears. But even with excessive tearing, a person’s eye is still left feeling dry, itchy, uncomfortable and even painful because the tear film’s moisture is out of balance.
CRN adds new members
WASHINGTON The Council for Responsible Nutrition on Thursday announced the addition of six members to its roster—voting members Avon Products and Country Life Vitamins and associate members Burdock Group, EAS, Grifcon Enterprises and Miami Research Associates.
“We are pleased to have added two voting companies in segments of the industry that offer important growth,” stated Steve Mister, CRN president and chief executive officer. “Avon is a household name worldwide and they add to the prestigious portion of our direct selling representation. Country Life represents a segment of the industry—the natural health business—that we view as integral to the sale of supplements. “
EAS and Miami Research Associates are returning to CRN.
CRN also announced the promotions of two CRN staffers at its March quarterly meeting. Judy Blatman, who joined CRN in 2001, has been promoted to senior vice president, communications, and John Hathcock, a 12-year CRN veteran, has been promoted to senior vice president, scientific and international affairs.
“[Judy] Blatman has spearheaded numerous successful communications initiatives at CRN and Dr. Hathcock has brought world-wide recognition to the association’s commitment to science,” stated Marjorie Fine, CRN chairman and executive vice president and general counsel of Shaklee Corporation.
FDA issues consumer advisory for Total Body dietary supplement products
ROCKVILLE, Md. The Food and Drug Administration on Friday advised consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue, the agency stated.
The Total Body Formula products are sold in eight-ounce and 32-ounce plastic bottles. The Total Body Mega Formula is sold in 32-ounce plastic bottles. Both products are distributed by Total Body Essential Nutrition of Atlanta. The company is the sole distributor of the products and has voluntarily recalled Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.
The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. The FDA subsequently learned and is investigating a report that some individuals in Tennessee using the same products have experienced similar reactions.
FDA laboratories are analyzing samples of the products to identify the cause of the reactions, including the possibility that the products contain excessive amounts of selenium, which is known to cause symptoms such as those described in the adverse events reported to the agency. Selenium, a trace mineral, is needed only in small amounts for good health.
The products have been distributed in Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.
The FDA is advising consumers in all states to avoid using the products immediately and to discard the products by placing them in a trash receptacle outside of the home.
Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional.
The FDA is working with the Florida Department of Health in its investigation.