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Updates

New Bottled Water Standards

New FDA standards for bottled water take effect May 13.

The final regulation, published last November in the Federal Register, sets standard definitions for different types of bottled waters, including artesian, ground, mineral, purified, sparkling, spring, sterile, and well water.

The regulation also requires mineral water to meet the bottled water quality standards. It must come from a protected underground source and contain at least 250 parts per million in total dissolved solids. Mineral water had previously been exempt from standards that apply to other bottled waters.

The regulation also requires that water bottled from municipal water supplies must be clearly labeled as such, unless it is processed sufficiently to be labeled as "distilled" or "purified" water. The regulation also requires accurate labeling of bottled waters marketed for infants.

Bottled water, like all other foods regulated by FDA, must be processed, packaged, shipped, and stored in a safe and sanitary manner and be truthfully and accurately labeled. Bottled water products must also meet specific FDA quality standards for contaminants.

(See "Bottled Water: New Trends, New Rules," in the June 1993 FDA Consumer.)

Lung Protection for Babies

For the first time, infants at high risk for certain lung problems have a product to help reduce the severity of respiratory syncytial virus (RSV) disease, the most common cause of lower respiratory infections in children.

The product, RespiGam (Respiratory Syncytial Virus Immune Globulin Intravenous (Human)), was licensed by FDA last Jan. 19 for use in high-risk infants under 2 years old with lung problems due to prematurity or chronic bronchopulmonary dysplasia. (Chronic bronchopulmonary dysplasia causes abnormal cell and tissue growth.)

RespiGam is made from plasma taken from large numbers of normal, healthy individuals, and contains a high concentration of protective antibodies against RSV. These antibodies do not prevent RSV infections, but do help protect children against the most serious consequences of the virus.

In the United States, more than 90,000 children are hospitalized and 4,500 die each year from RSV.

Treatment with RespiGam begins in November before the first outbreaks of RSV normally occur. The treatment regimen involves an intravenous dose once a month through March.

Clinical trials whose data supported the licensing of RespiGam included the pivotal PREVENT trial, a randomized, placebo-controlled, double-blind study. PREVENT involved 510 patients who either had chronic bronchopulmonary dysplasia and were younger than 2, or were born prematurely and younger than 6 months.

In the PREVENT trial, RespiGam reduced hospitalizations by 41 percent and reduced hospital time by 53 percent. In addition, children required fewer days of supplemental oxygen during their hospital stays.

Because infants with pulmonary disease may retain fluids, a small percentage of infants in the trials needed new or extra diuretics after receiving RespiGam.

As with any human immune globulin product, rare allergic reactions to RespiGam are possible. In addition, a small risk exists for the transmission of blood-borne viruses. However, the risk is low because plasma donors are screened carefully, and the product is treated with a procedure that inactivates most significant blood-borne viruses, including the one that causes AIDS.

RespiGam is manufactured by Massachusetts Public Health Biologic Laboratories of Boston, and will be distributed by MedImmune Inc., of Gaithersburg, Md.

New Tracks Speed Device Reviews

[picture of train showing approvals of medical device applications] This 95K JPEG graphic shows that medical device applications were processed more quickly in 1995 than 1994. (Infographic by Sam Ward.)

Study of Ritalin's Cancer-Causing Potential

An animal study of Ritalin (methylphenidate hydrochloride), a stimulant widely prescribed for children with attention deficit hyperactivity disorder (ADHD), has produced a "weak signal" that the drug may have the potential to cause cancer, according to FDA, which has taken steps to alert health professionals to the possible problem.

The agency has asked the drug's sponsor, Ciba Pharmaceuticals, to include the study findings in the labeling for Ritalin, and to alert prescribers by sending them a Dear Doctor letter. The company complied in late January. FDA also plans to initiate additional follow-up studies, including both animal tests and epidemiological studies in humans using Ritalin.

The agency continues to regard Ritalin as a safe and effective drug, but says the potential risk needs to be considered and further studied because of the increasing and often long-term use of Ritalin in children. In the last five years, there has been about a two- to threefold increase in the use of the product.

The agency's actions are based on findings of a draft report by the National Toxicology Program on cancer-causing potential of Ritalin in a study in mice and a study in rats.

The study in rats revealed no cancer-causing activity. The findings in mice included increased rates of noncancerous liver tumors and, in males only, the occurrence of cancerous liver tumors.

FDA considers the studies' results a signal of a weak cancer-causing potential because:

The agency also noted that animal studies do not necessarily reflect human findings. The kind of liver tumor found in mice is extremely rare in people, and its occurrence in recent years has not increased despite the increased use of Ritalin.

Clotting Factors and Hepatitis A

Hemophiliacs using Alphanate (Factor VIII) or AlphaNine S-D (Factor IX) clotting factors for their bleeding disorders should check their supply to make sure they don't use certain lots withdrawn from the market due to an association with hepatitis A virus (HAV) infection, FDA has advised.

Alpha Therapeutics Corp., Los Angeles, withdrew Lot AP5014A Alphanate last Dec. 8 due to suspected HAV transmission in three patients. Testing showed the illness in two of them to be linked to the withdrawn lot.

Later, a fourth case of hepatitis A was reported after a patient had received Alpha Therapeutics' AlphaNine S-D. Although HAV transmission by the product is unproven, as a precaution pending further investigation, the firm (with FDA's concurrence) placed on hold further distribution of AlphaNine S-D Lots CA5410A, CA5412A, CA5413A, and CA5421A.

FDA last January also advised hemophiliacs using any human-derived Factor VIII or Factor IX products to contact their doctors for hepatitis evaluation if they have flu-like illness with jaundice or liver tenderness. FDA advised doctors to report otherwise unexplained cases of hepatitis A to their state health department pending further instruction from the national Centers for Disease Control and Prevention.

HAV infection in children usually produces no symptoms. The infection is most serious in older patients, in whom deaths infrequently occur. In February 1995, FDA approved a vaccine that prevents HAV.

While reports of HAV transmission by clotting factor concentrates are uncommon, laboratory studies and surveillance are under way to determine whether transmission may occur from other products.

Mammography Quality Improves

The quality and reliability of mammograms in the United States have improved under FDA's new standards for taking and interpreting the breast x-rays, according to a recent report from the General Accounting Office (GAO).

FDA was given the responsibility of implementing the 1992 Mammography Quality Standards Act passed by Congress in response to concerns that women were dying as a result of poor mammography practices in many facilities.

The GAO report, released Nov. 1, said that when the new rules went into effect, about one-third of the clinics failed to meet the standards for accreditation. On second attempts, about two-thirds of the clinics that had earlier failed were able to pass, and still more passed on a third attempt.

According to the report, only about 4 percent, or 400, of the 10,000 to 11,000 mammography facilities in the country stopped operating, and in 97 percent of those cases, another clinic was within 25 miles.

Breast cancer strikes 182,000 women a year and kills 46,000. Mammography is currently the best method available to detect and treat breast cancer early, when it is most curable.

The National Cancer Institute recommends that all women over 50 have annual mammograms and that some women under 50 have them as well.

1995 Dietary Guidelines Include New Weight, Exercise Advice

New weight recommendations and increased emphasis on exercise are included in the advice offered in the recently issued 1995 edition of the Dietary Guidelines for Americans.

Developed by the U.S. departments of Health and Human Services and Agriculture, the 1995 Dietary Guidelines also reiterate the seven core recommendations of past editions, once again emphasizing balance, moderation and variety in food choices.

For the first time, the guidelines advise adults to maintain their weight in a single healthy range rather than increasing it over the years.

The new guidelines increase emphasis on physical activity, calling for 30 minutes or more of moderate physical activity on most (preferably all) days of the week. Physical activities can include brisk walking, calisthenics, home care, gardening, moderate sports exercise, and dancing.

The guidelines also acknowledge for the first time vegetarian diets as a healthful dietary alternative.

The Dietary Guidelines are published every five years. In addition to providing information for consumers, they form the basis for federal nutrition policy and programs.

A copy of the Dietary Guidelines bulletin may be obtained by:

New Reprint

A new FDA Consumer reprint is available free.

To order single copies of "A Status Report on Breast Implant Safety" (FDA 96-4262), write to FDA, Rockville, MD 20857. To order 2 to 100 copies, write to FDA, HFI-40, at the same address, or fax your order to (301) 827-5308. Include the publication number.

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FDA Consumer magazine (April1996)