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Updates

New Device Stops Bleeding Faster

A first-of-its-kind plug-like medical device is making it possible for doctors to stem bleeding more quickly in patients who undergo angioplasty and related procedures.

Nearly a million Americans each year have two procedures: angioplasty, to unblock clogged arteries, and angiography, in which pictures of the arteries are taken. In both procedures, a catheter is inserted into a leg artery at the groin, threaded through to the heart, and then, when the procedure is finished, removed, leaving a wound.

Doctors have traditionally applied pressure manually to the groin to stop bleeding from the wound. The Vasoseal Vascular Hemostasis Device, approved by FDA last Sept. 29, reduces the time of manual pressure in most procedures.

A study of 626 patients found that the inch-long plug stopped bleeding about 75 percent faster than manual pressure and was equally as safe. After angioplasty, the plug stopped bleeding in eight minutes, compared to 30 minutes for manual pressure. After angiography, it stopped bleeding in five minutes, compared to 18 minutes for manual pressure.

The device is inserted through a sheath that extends from the outside of the leg to the artery surface. Only three to five minutes of manual pressure are needed to stop the bleeding once the device has been placed.

The plug, manufactured by Datascope Corp. of Montvale, N.J., is made of bovine collagen and absorbed into the body in about six weeks.

Laser Procedure for Nearsightedness

A new type of surgical procedure uses an ophthalmic laser system recently approved by FDA to correct distance vision in people with mild to moderate nearsightedness.

The procedure, photorefractive keratectomy (PRK), corrects nearsightedness (myopia) using the SVS Apex Excimer Laser System, made by Summit Technology, Waltham, Mass. FDA approved the system for PRK last Oct. 20.

The laser delivers bursts of ultraviolet light that vaporize precisely targeted corneal tissue (the clear part of the front of the eye). This alters the corneal curvature, permitting light to focus properly on the retina in the back of the eye. In a myopic eye, light focuses in front of the retina, causing blurred distance vision.

PRK surgery takes about 30 minutes. The actual lasing itself, done under local anesthesia, takes less than three minutes. In studies of about 1,600 healthy myopic eyes, the corneal surface healed in three days in most eyes, and vision took at least three months to stabilize.

Most patients studied could be corrected to 20/20 vision or better with glasses or contact lenses before surgery. Best corrected vision was slightly worse after surgery in about 5 percent of patients and significantly worse in less than 1 percent.

In 95 percent of eyes, vision without glasses was corrected to 20/40 or better. In 65 percent, it was corrected to 20/20 or better. About 5 percent of patients continued to need glasses all the time for distance, and up to 15 percent needed glasses occasionally, such as for driving. Results were best in younger patients with lower degrees of myopia.

Some 63 percent of patients had mild corneal haze after surgery, and 10 percent experienced glare and halos around lights. These conditions diminished or disappeared in most patients in six months.

PRK has not been shown effective for severe myopia, farsightedness, or astigmatism. It should not be done on pregnant women, or on people with uncontrolled vascular disease, autoimmune disease, or certain eye diseases such as glaucoma. In the studies, people who previously had radial keratotomy to correct myopia lost more vision from PRK than those who had not had the other procedure.

Patients contemplating PRK to correct nearsightedness should carefully consider the potential risks and alternative means of correction. PRK cannot be reversed. Alternative choices to correct nearsightedness include glasses, contact lenses, and radial keratotomy.

Skin Patch Replaces Testosterone

A skin patch that can be placed on a variety of body sites to boost testosterone levels has received FDA clearance as a treatment for hypogonadism, a condition in which the body produces inadequate levels of the hormone.

Called Androderm (Testosterone Transdermal System), the new patch can be worn on the abdomen, back, thighs, or upper arm to help relieve symptoms of both primary hypogonadism (disorders of the testes) and secondary hypogonadism (disorders of the pituitary gland or hypothalamus area of the brain). A previously approved patch can be applied only to a shaved scrotum. Transdermal patches offer alternatives to testosterone injections, a therapy administered every two to four weeks that can create abnormal highs and lows in hormone levels. Androderm was cleared for marketing last Sept. 29.

Only about 5 percent of the estimated 4 million to 5 million American men with hypogonadism currently receive testosterone replacement therapy. Symptoms of the disorder include sexual dysfunction (loss of libido or impotence), fatigue, depressed mood, muscle wasting, osteoporosis, or absence or regression of secondary male sexual characteristics (muscle development, deep voice, or hair distribution).

In clinical trials, Androderm restored normal testosterone levels in 86 of 94 patients who completed the trials. The most common side effects reported were temporary mild-to-moderate redness or itching at patch sites.

Androderm is made by TheraTech Inc., of Salt Lake City, and is marketed by SmithKline Beecham Pharmaceuticals of Philadelphia. (See also "Testosterone: Key to Masculinity and More" in the May 1995 FDA Consumer).

First Liver Stent Approved

The first implantable liver stent was recently approved by FDA for preventing recurrent bleeding from esophageal veins in people with cirrhosis, a severe scarring of the liver caused by several different diseases.

The Wallstent TIPS Endoprosthesis is a flexible metal stent that is threaded into the liver by a catheter through a neck vein. The stent then expands and remains in place so that the blood bypasses circulation through the scarred liver, relieving blood pressure in the liver. If untreated, this pressure can cause bleeding from veins in the esophagus and could result in death. FDA approved the stent Sept. 29.

In a clinical study of 97 patients at eight sites in the United States, the new stent successfully diverted blood from the liver in all but one patient. Patients in the study had a significant improvement in survival over that reported with abdominal surgery, and less bleeding after treatment than that reported with alternative medical treatment.

In 1994, liver disease caused more than 119,500 U.S. hospitalizations for conditions including chronic hepatitis and cirrhosis of the liver. An estimated 8,000 to 10,000 patients in the United States may benefit from the new stent.

The stent is manufactured by Schneider USA Inc. of Plymouth, Minn.

Joint Task Force Targets Illegal Herb Imports

Eight government agencies, including FDA, have formed a joint task force to end illegal importation by certain herbal medicine importers and their foreign suppliers. Some of the substances imported are unapproved drugs that pose a risk to the public health.

The Herbal Medicine Import Task Force consists of representatives from FDA (San Francisco district office and Office of Criminal Investigations), the U.S. Department of Justice, U.S. Customs Service, U.S. Department of Agriculture, U.S. Environmental Protection Agency, U.S. Fish and Wildlife Service, Internal Revenue Service, and the California Department of Health Services. Other state counterpart agencies contributed expertise and resources.

Investigations have revealed importation of:

Agents also found evidence of conspiracy to evade customs laws.

The U.S. attorney for the Northern District of California is coordinating the effort, beginning with activities such as educational mailings to community leaders, trade associations, and individual importers and customs brokers. This will be followed by investigation of persistent suspected criminal conduct and, where appropriate, prosecutions.

The task force will work with local communities to identify underlying problems and explore culturally sensitive solutions, within the framework of applicable regulations and laws.

In addition, FDA's Los Angeles district office took part in a Fish and Wildlife Service press conference last October to launch a consumer education campaign on illegal importations and related health risks. Community agencies, private groups, and the Los Angeles Unified School District participated. FDA and the Fish and Wildlife Service are exploring a possible partnership to monitor illegal importations.

Recommendations for Vitamin A Intake

As a precautionary measure to prevent birth defects, FDA has issued several recommendations for women of childbearing age regarding excessive consumption of foods, including dietary supplements, containing one form of vitamin A.

The vitamin form of concern is called preformed vitamin A. It is found in animal products, primarily liver, and is also sometimes added to fortified foods such as breakfast cereals and dietary supplements. The products' ingredient listings should note the addition as, for example, retinyl palmitate and retinyl acetate. Women need to limit their intakes from these sources to about 100 percent of the Daily Value (5,000 IU).

On the other hand, beta carotene, a substance found naturally in plants and which the body converts to vitamin A, is considerably less toxic. Women of childbearing age are advised to choose fortified foods that contain vitamin A in the form of beta carotene rather than preformed vitamin A, whenever possible. The vitamin A in fruits and vegetables is naturally in the form of beta carotene, and high intakes of vitamin A from these sources is generally not of concern.

Vitamin A is an essential nutrient and, as with all nutrients, the good health of women throughout childbearing years, including pregnancy, depends on consuming appropriate amounts.

FDA offered these recommendations in response to an October New England Journal of Medicine article on the possible relationship between some types of birth defects and the consumption of vitamin A at levels at or above 10,000 IU (or 3,000 Retinol equivalents). A relationship between vitamin A intakes and birth defects has been known for some time, but the level of vitamin A-associated birth defects in earlier studies was much higher.

Actual Consumption Pyramid

[food pyramid] Actual U.S. diets make a top-heavy pyramid, compared with the USDA-HHS Food Guide Pyramid. The latter recommends these daily intakes: 6-11 servings of bread, cereal, rice, pasta; 3-5 servings of vegetables; 2-4 servings of fruits; 2-3 servings of milk, yogurt, cheese; 2-3 servings of meat, poultry, fish, dry beans, eggs, nuts; and only sparing use of fats, oils and sweets. American diets come up particularly short in the vegetable and fruit groups.

(Source: Eating in America Today, Edition II, A Dietary Pattern and Intake Report commissioned by the National Live Stock and Meat Board)

FDA Freebies

A new brochure and two new backgrounders are available free from FDA. They are:

To order single copies, write to FDA, HFI-40, Rockville, MD 20857. To order two to 100 copies (brochure only), write to FDA, HFI-40,at the same address, or fax your order to (301) 827-5308. Include the publication number.

[Note (June 5, 2003): Print copies of these documents are no longer available.]

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FDA Consumer magazine (January-February 1996)