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Updates

New Pertussis Vaccine Safer for Infants

An acellular vaccine recently licensed by FDA protects infants against pertussis, or "whooping cough," while causing fewer side effects than whole-cell pertussis vaccines.

Acellular pertussis vaccines contain only parts of the pertussis bacterium thought to be important for immunity, while whole-cell vaccines contain the whole, killed bacterium.

Currently, children in the United States receive a whole-cell pertussis vaccine in combination with diphtheria-tetanus toxoid, or DTP, at 2, 4 and 6 months of age, with additional doses of either a DTP or DT vaccine with an acellular pertussis component (DTaP) between 12 and 18 months and before entering elementary school.

The acellular vaccine licensed July 31 for the first three doses is one of two DTaP vaccines already approved for the fourth and fifth doses.

Pertussis is a highly communicable respiratory disease that can be especially serious for infants. The coughing and choking that occur make breathing difficult and can last for several weeks. Occasionally, infants can die from the disease.

According to the national Centers for Disease Control and Prevention, in 1994 and 1995 a total of approximately 9,500 cases of pertussis were reported in the United States. The World Health Organization reports that pertussis causes approximately 350,000 deaths worldwide.

Safety data from a number of studies indicate that the DTaP vaccines cause fewer adverse reactions than DTP vaccines in the first three doses. Reactions can include local redness or swelling, as well as fever, drowsiness, irritability, or prolonged, high-pitched crying. Studies are in progress to help determine the extent of these reactions when children receive the acellular pertussis vaccine for all five doses. Infrequent, serious events such as seizures have been reported after immunizations with both DTP and DTaP.

Two clinical studies were conducted to assess the efficacy of the pertussis component of this DTaP vaccine for infants. In these studies, the acellular pertussis vaccine was estimated to be between 69 and 80 percent effective in preventing pertussis, depending on the way the study was designed and completed. (The whole-cell vaccine is about 80 percent effective.)

Children who have begun their immunizations with DTP should continue to receive their fourth and fifth doses as DTaP. For those children who will now receive DTaP at 2, 4 and 6 months, a fourth dose of DTaP is recommended in the second year of life. Studies are being planned to help determine recommendations for the fifth dose.

The acellular pertussis component of the vaccine is produced by the Research Foundation for Microbial Diseases of Osaka University in Japan. It is combined with diphtheria and tetanus toxoids by Connaught Laboratories, Inc., Swiftwater, Pa., and is sold under the trade name Tripedia.

(See also "New Pertussis Vaccine Offers Prevention Alternative," in the September 1992 FDA Consumer.)

Nicotine Patches Available OTC

Two different nicotine patches to help smokers quit the habit have made the switch. Formerly available by prescription only, the smoking cessation aids have been approved by FDA for over-the-counter marketing.

The Nicotrol Transdermal System was approved as an OTC drug product for adults last July. The NicoDerm CQ was switched for adult use last August. When used according to directions, the patches deliver a continuous low level of nicotine that helps reduce nicotine craving and other withdrawal symptoms.

About 35 million to 45 million U.S. adults are addicted to nicotine due to cigarette smoking.

The six-week Nicotrol cessation aid includes an audiotape and other user information. The one-month quit rate among smokers who use the patch and accompanying materials is about 20 percent. Many smokers who use the Nicotrol patch stop smoking for at least a few days but may start smoking again. Most smokers quit several times before they completely stop.

The NicoDerm eight-to-ten-week treatment includes an audiotape, other user information, and a child-resistant disposal tray. It comes in 7-milligram, 14-mg, and 21-mg strengths as part of a "step-down" plan to gradually reduce the nicotine level as treatment progresses. Heavy smokers (more than 10 cigarettes a day) start with 21 mg for six weeks, while light smokers (10 or fewer cigarettes a day) start at 14 mg. After six weeks, consumers are to lower their dose for two weeks, with heavy smokers lowering their dose a second time.

Skin irritation or redness may occur where the patch is placed on the skin. Users should stop using the product if the skin irritation persists or if they have irregular heartbeat, palpitations, or other symptoms of nicotine overdose, such as nausea, vomiting, dizziness, and weakness.

People who have significant heart disease or take certain prescription drugs for depression or asthma should seek their doctor's advice before using either patch.

The Nicotrol Transdermal System is marketed by McNeil Consumer Products Co. of Fort Washington, Pa., for Pharmacia Upjohn Inc. of Kalamazoo, Mich. The NicoDerm CQ is marketed by SmithKline Beecham Consumer Healthcare of Pittsburgh for ALZA Corporation of Palo Alto, Calif.

(For more on nicotine patches, see "Prescriptions to Help Smokers Quit" in the December 1992 FDA Consumer.)

AIDS Drug Approved in 119 Days

The first in a new class of AIDS drugs--non-nucleoside reverse transcriptase inhibitors--was approved by FDA in only 119 days.

Viramune (nevirapine) was approved by the agency June 21 for use--in combination with other AIDS drugs--to treat adult HIV patients whose health has deteriorated. The drug interferes with HIV replication in a way similar to the older AIDS drugs AZT (zidovudine, marketed as Retrovir), ddC (zalcitabine, marketed as Hivid), ddI (didanosine, marketed as Videx), and d4T (stavudine, marketed as Zerit).

Viramune must be used in combination with at least one of these other AIDS drugs. Studies showed that AZT and ddI, combined with Viramune, were more effective than AZT and ddI alone in improving health indicators like CD4 cell counts (an indicator of immune system strength) and the amount of HIV detected in the bloodstream. When Viramune was used alone, the virus quickly became resistant to treatment.

Viramune's most significant side effect is a rash. According to the drug's labeling, treatment should be discontinued if patients develop a severe rash or a rash with fever, blistering, oral lesions, swelling, muscle or joint aches, general weakness, or conjunctivitis (inflammation in the eyes). To decrease the incidence of rash, patients take a 200-milligram dose of the drug once daily for two weeks, and then start on a 400-mg dose.

The drug manufacturer, Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., is conducting studies of Viramune's safety and effectiveness in children with HIV.

(See also "Living with Aids: New Treatments Give Hope," in the January-February 1992 FDA Consumer.)

First Urine Test for HIV

The first HIV test that uses urine samples has been licensed by FDA. Previous HIV tests use either blood or oral fluid samples.

The manufacturer, Calypte Biomedical Corporation of Berkeley, Calif., will market the new test as the Calypte HIV-1 Urine EIA. It will also be marketed by Seradyn Inc. of Indianapolis as the Seradyn Sentinel HIV-1 Urine EIA.

The new test uses an enzyme-linked immunosorbent assay (ELISA) method to detect the presence of antibodies to HIV-1, the virus that causes the vast majority of U.S. AIDS cases. While it is licensed to screen for HIV-1 infection, it may also be useful for medical purposes when the collection of blood samples is impractical. It is not licensed for blood donor screening, which requires more accurate ELISA blood tests.

Only doctors may order the test, and certified medical laboratories will analyze samples. Any initially reactive sample will be retested twice. If even one retest is reactive, the test will be considered positive, although this positive finding does not always indicate HIV infection. For confirmation of a positive urine test, the person must be tested with a more accurate blood test.

In clinical studies, 298 patients were diagnosed with AIDS and tested with both the urine test and a licensed ELISA blood test. The urine test was positive in initial screening 99.3 percent of the time. In patients infected with HIV-1 but without symptoms, the urine test would be expected to miss 1 or 2 people in every 100.

In other studies in people without HIV-1 antibodies in their blood, the urine test gave a false positive result in 1 or 2 in 100 people, compared to 1 in 1,000 with an ELISA blood test.

Before being screened with the new urine test, a person will receive a patient information sheet outlining the test's limitations. This is in addition to the usual information on HIV and AIDS already provided before any HIV testing. After reading the sheet, the person will initial a statement confirming they received the pretest counseling, peel off the sample label, and apply it to the urine collection cup.

New Drug for AIDS-Related Eye Infection

A new drug is available for treating cytomegalovirus (CMV) retinitis, a potentially severe eye infection that can lead to blindness.

While other therapies must be given daily, the new intravenous treatment, Vistide (cidofovir), is administered once a week for the first two weeks and then once every two weeks.

FDA based its June 26 approval on two studies in a total of 148 patients. One study showed that the retinitis progressed more slowly in patients treated immediately with Vistide than in patients with delayed treatment. The second study showed the drug was effective in patients with relapsing CMV retinitis who had received other therapy previously.

Vistide's most significant side effect is potential kidney damage, which can be reduced with the drug Benemid (probenecid) and by hydrating the body to increase its water content. Other side effects included decreased white blood cells, weakness, nausea, diarrhea, and decreased pressure in the eye.

Some studies have shown that the drug may cause cancer in rats, but such cancers have not been seen in human studies.

Vistide is manufactured by Gilead Sciences Inc., of Foster City, Calif.

(See also "Living with Aids: New Treatments Give Hope," in the January-February 1992 FDA Consumer.)

FDA Warns Against Using a Mexican Skin Cream

Consumers should not use a Mexican facial skin cream because it can cause mercury poisoning, FDA warned last July. The product was taken off the market in July, but consumers may still have some bought previously. Anyone using the product, Crema de Belleza--Manning, should stop at once, contact their local health authority, and see a doctor for a medical evaluation.

The cream, labeled in Spanish for reducing facial oil and removing pimples and blackheads, was sold mainly in Mexico, but also in Arizona, California, New Mexico, and Texas--mainly in Hispanic communities. The manufacturer is Laboratories Vide Natural SA de CV., Tampico, Tamaulipas, Mexico.

The label lists the ingredient calomel, which is mercurous chloride, a salt of mercury. Because of the toxicity of mercury compounds and because mercury is readily absorbed through the skin, FDA restricts its use in cosmetics. Mercury may be used only as a preservative in eye-area cosmetics at concentrations not exceeding 65 parts per million when there is no safe and effective nonmercurial preservative available for such use.

At the time of the warning, the national Centers for Disease Control and Prevention had identified about 200 users of the cream in the four U.S. border states. CDC testing showed elevated mercury levels in more than 80 people who had used the product. At least three people were diagnosed with mercury poisoning. Product samples were found to contain 6 percent to 10 percent mercury by weight. Chronic exposure to mercury salts can cause nervousness, irritability, tremors, weakness, fatigue, memory loss, changes in hearing or vision or taste, nausea, vomiting, diarrhea, kidney damage, and death.

The cream was sold in semi-opaque plastic bottles marked as containing 160 milliliters. The bottles, about 6 inches high, have beige plastic caps and red and blue labels. If undisturbed, the contents separate into an upper layer of clear liquid and a lower layer of white solids.

Both U.S. and Mexican authorities removed the product from the two markets.

Free Backgrounder on Protease Inhibitors

A free new backgrounder on proper use of protease inhibitors, a new class of drugs used to treat HIV, is available from FDA.

The new backgrounder provides information about appropriate dosing, the similarities and differences of each approved protease inhibitor, storage, potential drug interactions, and treatment options. A fairly technical document, the backgrounder will be of most use to doctors and other health professionals.

A free copy of "The Protease Inhibitors--Backgrounder" may be ordered from FDA's Office of AIDS and Special Health Issues by calling (301) 443-0104, by facsimile transmission at (301) 443-4555, or by E-mailing rklein@bangate.fda.gov.

Foods in Menu Claims Must Meet FDA Rule

Restaurants that include dishes with claims like "low fat" or "heart healthy" on the menu must be able to demonstrate that there is a reasonable basis for believing that the food is qualified to bear this claim, according to standards recently set by FDA.

The July 30 final rule for the standards allows restaurant owners considerable flexibility in establishing this reasonable basis and in presenting the information to consumers. However, owners must be prepared to show officials that their menu claims are consistent with the claim definitions established under the Nutrition Labeling and Education Act of 1990.

Unlike processed foods, restaurant menu selections don't have to supply complete nutrition information. Also, menu items bearing a claim can be shown to meet the rule by more economical means than the strict standards of laboratory analyses required for processed foods. For example, a restaurant could show that an item was designed to meet the requirements for the claim because it was prepared using a recipe from a recognized health professional association or dietary group, or that the nutritional values for the dish were calculated using a reliable nutrition database.

Furthermore, nutrition information can be provided to the consumer by any reasonable means. It does not have to be presented in the "Nutrition Facts" format seen on packaged food labels, nor does it have to appear on the menu. For example, information on the fat content of all menu items that bear fat claims could be compiled in a notebook available to consumers upon request.

FDA estimates that the rule's flexibility, limited scope, and compliance date of May 1997 should minimize its economic impact on the restaurant industry.

The new menu rules are identical to the standards that have been in effect since May 1994 for nutrient content claims on placards and signs in large and medium-sized restaurants, and since May 1995 for such claims in smaller restaurants.

FDA Eases Way for Limited-Market Devices

Medical devices used to treat diseases affecting fewer than 4,000 people annually now will be easier and less costly to bring to market, according to a recent FDA policy change.

This change is in addition to FDA's orphan drug program. (See "Orphan Products: New Hope for People with Rare Disorders" in the June 1994 FDA Consumer.)

The agency announced in a final rule that it will approve rare-disease devices for marketing as long as manufacturers show:

Makers of new medical devices usually must show that products are effective, a requirement that involves controlled clinical studies. The expense of such studies has been a disincentive to medical device firms--most of which are small--to develop products for rare conditions that have a limited market.

Manufacturers of rare-disease devices still may be required to do clinical studies to establish safety but will not have to establish effectiveness.

To ensure patient protection, such devices may be used only in medical facilities with local institutional review boards that have approved the device for a specific rare disorder. Also, FDA's approval of such a device is valid for 18 months but can be extended in 18-month increments as long as the criteria for a rare-disease device are met.

The new FDA rule--called the Humanitarian Device Exemption--was mandated by the 1990 Safe Medical Devices Act, which requires the agency to exempt manufacturers of products that benefit fewer than 4,000 people from effectiveness requirements of medical device law. FDA published the rule in the June 27, 1996, Federal Register.

Data Requested on Safety of Laxative Ingredients

After recent animal studies indicated a possible link between cancer and two ingredients in over-the-counter laxatives, FDA asked manufacturers for more data to establish the safety of the two ingredients and three similar ones.

In a letter dated May 21, 1996, FDA informed the firms it plans to reclassify the five ingredients--phenolphthalein, bisacodyl, senna, aloe, and cascara sagrada--from category I (safe and effective) to category III (more data needed).

Studies by the National Toxicology Program (NTP) provided new evidence that phenolphthalein (chemically related to bisacodyl) may cause cancer in rodents and that senna (chemically related to aloe and cascara sagrada) may cause gene or chromosome irregularities. FDA has no adverse reports or other information linking use of the ingredients with cancer in humans.

To determine whether the new evidence may translate into a risk for humans, FDA's Carcinogenicity Assessment Committee met twice with manufacturers and NTP representatives. Finding available safety information to be inadequate for a clear assessment, the agency requested the additional data.

Products containing the five ingredients may be marketed until FDA publishes a final regulation.

Psyllium, castor oil, docusate sodium, and 20 other ingredients are still considered safe and effective components of laxative products.

Reforms to Speed New Animal Drugs to Market

Recent FDA reforms promise to shorten the time needed for development of new animal drugs and significantly cut the agency's review time for such products.

The reforms, announced May 10, include:

In addition, FDA will propose rules providing clear, up-to-date guidance on all crucial phases of animal drug development and production processes.

Free New Reprints and Spanish-English Brochure

Two new FDA Consumer reprints and a new brochure--Spanish on one side, English on the other--are available free from FDA.

The publications and their numbers are:

To order single copies, 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 (October 1996)