Updates

FDA on the Web

Electronic FDA information is available on the Internet's World Wide Web.

FDA's "home page," a graphic menu, offers information on foods, human drugs, toxicology, FDA news, and other topics. The menu includes FDA Consumer articles, press releases, backgrounders, talk papers, industry guidance, new product approvals, and budget and scientific information. Eventually, it will include links to all areas of FDA and will replace FDA's Electronic Bulletin Board.

The Internet address of FDA's home page is http://www.fda.gov/. For more information, phone FDA's Office of Information Resources Management at (301) 443-7549; E-mail: vcamp@bangate.fda.gov.

Children's Motrin Goes OTC

A doctor's prescription will no longer be needed for a children's form of Motrin (ibuprofen).

FDA approved Children's Motrin Oral Suspension in June. Available in pediatric strength by prescription since 1989, it is the first nonsteroidal anti-inflammatory drug approved for pediatric, over-the-counter (OTC) use.

It is approved to reduce fever and relieve minor aches and pain due to colds, flu, sore throat, headaches, and toothaches in children ages 2 to 11.

Doses are based on age and weight. The labeling advises parents:
not to give the drug to a child for more than three days without a doctor's approval
to call a doctor if the child doesn't improve within 24 hours after the first dose or appears to worsen
not to give the drug to a child allergic to aspirin or a child dehydrated due to continued vomiting, diarrhea, or lack of fluid intake.

Last March, an FDA advisory committee of outside experts recommended that the agency approve Children's Motrin as a nonprescription medication. The committee's decision came after presentations by the sponsor and FDA reviewers, including results from a safety study in more than 80,000 children.

Children's Motrin is one of the first OTC drugs to carry new, more consumer-friendly labeling. It will be distributed by Johnson & Johnson's McNeil Consumer Products unit of Fort Washington, Pa.

Tagamet Cleared for OTC Sales

An over-the-counter version of the prescription ulcer medicine Tagamet (cimetidine) has received FDA clearance for use as a heartburn remedy.

Tagamet HB, cleared for OTC sales June 19, is the second such drug this year to switch to OTC status. Pepcid AC Acid Controller (famotidine) was the first, on April 28. Both drugs treat heartburn by reducing the amount of stomach acid produced. Antacids, also available over the counter to treat heartburn, work by neutralizing stomach acid. (See "Taming Tummy Turmoil" in the June 1995 FDA Consumer.)

Tagamet HB will be sold in 100-milligram tablets to relieve symptoms of occasional heartburn, acid indigestion, and "sour stomach" in people age 12 or older.

The labeling advises consumers to:

consult their doctors before taking Tagamet HB if they are taking theophylline (for asthma), warfarin (for blood-thinning), or phenytoin (for seizures)
take no more than 400 mg over 24 hours
take the drug no longer than two weeks at maximum dose without consulting a doctor
see a doctor if they have swallowing difficulty or persistent abdominal pain, because these symptoms could indicate a more serious problem.

Consumers seeking information about drug interactions or having other questions about Tagamet HB can call SmithKline Beecham Consumer Affairs at (1-800) 482-4394. The product will be distributed by SmithKline Beecham PLC, of Philadelphia.

New OTC Labels

New FDA prototypes of easier-to-read labels for over-the-counter drugs reflect the agency's continuing interest in making labeling more consumer friendly.

The prototypes deliver information clearly and concisely by using bullets rather than paragraphs, and highlighting active ingredients, uses, directions, and warnings. Much like the "Nutrition Facts" food labels FDA introduced in 1994, the OTC drug label prototypes provide a standard format, so consumers can readily find information in the same location.

FDA already is applying its new format concept to drugs switching from prescription to OTC use, such as the new Children's Motrin Oral Suspension (ibuprofen) and Pepcid AC Acid Controller (famotidine). Manufacturers of some other OTC drugs are voluntarily moving to the new format. FDA encourages this trend and expects to publish a proposal for a more useful OTC drug label in the Federal Register.

The agency released its prototypes at a Nonprescription Drug Advisory Committee meeting last fall to stimulate discussion and provide a model for more useful OTC drug labeling.

In January, FDA cosponsored a public workshop with the Drug Information Association on how to communicate OTC drug information to consumers more effectively through labeling. Experts in many disciplines explored consumer, industry, government, and academic research perspectives on the topic.

FDA will continue to meet with those interested in providing high-quality, consistent information about OTC medicines.

Bone Loss Test Approved

The first commercial test to detect bone loss was recently cleared by FDA. The test indicates when people may be losing bone, which may put them at a higher risk for osteoporosis, a condition in which bones become easily breakable. The test may not be used to diagnose osteoporosis.

Osteomark, made by Ostex International Inc., of Seattle, became available in clinical labs across the country last May. It measures the levels of a broken-down bone fragment called NTx that has been shown in laboratory and patient tests to be a reliable marker of bone loss.

When bone loss occurs more quickly than bone formation, bone mass decreases, leading to osteoporosis.

"By helping to identify patients suffering from rapid bone loss ... physicians can administer preventive therapy and ultimately lessen the need for costly hospital care following a fracture," said Charles Chesnut, M.D., director of the Osteoporosis Research Center at the University of Washington and chairman of Ostex's Scientific Advisory Board.

According to the National Osteoporosis Foundation, osteoporosis affects more than 25 million Americans, 80 percent of whom are women. Forty percent of all women will have at least one spinal fracture by the time they reach 80, and one-third of all men will be affected by the disease by 75.

(For more on osteoporosis, see "Osteoporosis Treatment Advances" in the April 1991 FDA Consumer.)

Investigational Drugs Available

Two investigational drugs--one for HIV infection and the other for Lou Gehrig's disease--have joined the growing list of treatments FDA is making available while they're under study to patients with serious illness.

In a lottery system, saquinavir is available in an open-label study to 2,280 persons infected with HIV, the virus that causes AIDS. The drug is being distributed under the trade name Invirase by its manufacturer, Hoffmann-La Roche Inc. of Nutley, N.J.

It is a protease inhibitor, a new class of anti-AIDS drugs that block an enzyme necessary for HIV replication in the body. Saquinavir is the first protease inhibitor available outside controlled clinical trials. None have been approved for marketing.

Patients who have not benefited from existing anti-HIV therapy and who are not currently enrolled in saquinavir trials are eligible to be registered for the open label study by their physicians by calling (1-800) 332-2144.

FDA has granted riluzole, an investigational drug, Treatment IND (investigational new drug) status, making it available to certain patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

Patients with ALS suffer progressive muscle weakness and paralysis. There is no cure, including riluzole.

A study has shown significant improvement in survival rates in patients on the drug during the first year of treatment. By two years, however, there has been no difference in survival between patients taking riluzole and those taking a placebo.

Riluzole is distributed by Rhône-Poulenc Rorer Inc. of Collegeville, Pa., under the trade name Rilutek.

Telectronics Takes Time Out
To Correct Problems

Telectronics Pacing Systems agreed to stop its U.S. distribution of all pacemakers and pacemaker leads made at two of its facilities while it corrects manufacturing problems.

In a consent decree signed by Telectronics (also called TPLC, Inc.) and its president, the firm agreed to bring its Englewood, Colo., and Miami Lakes, Fla., facilities into compliance with current good manufacturing practice regulations, FDA announced May 23.

Recent FDA inspections found that Telectronics' practices were inadequate in these areas:

testing and inspecting
investigating device failures, both before and after products were distributed
reviewing and investigating complaints.

FDA identified many of these same problems during 1993 and 1994 inspections, but Telectronics did not correct them. Since then, because of similar problems, FDA has prohibited importing products from the firm's Australian and French facilities.

Telectronics agreed to have its corrections certified by an outside consultant, and then to demonstrate to FDA that corrective action was taken. Outside audit inspections will be conducted at least twice a year for three years to ensure the facilities continue to meet the agency's regulations.

Last fall, certain implanted Telectronics pacemaker atrial "J" lead wires were reported to fracture in some patients. Telectronics alerted doctors and their patients with the implants to this problem. Unused leads were recalled. (See "Possible Defects in Pacemaker Leads" in the Updates section of the April 1995 FDA Consumer.)

High-Quality Mammography

Women can locate high-quality mammography facilities in their area by calling the Cancer Information Service toll-free at (1-800) 4-CANCER (1-800-422-6237) Monday through Friday from 9 a.m. to 8 p.m. Eastern time. The service, also available in Spanish and for the hearing impaired, lists all facilities that FDA has certified as capable of providing quality mammograms.

The Mammography Quality Standards Act of 1992 requires all mammography facilities to be accredited by an accrediting body approved by FDA; be certified by FDA as meeting uniform, high-quality standards; and display the certificate prominently. The law applies to practically all facilities in the country, whether in a hospital, doctor's office, mobile van, or military base. (Exceptions are Veterans Administration facilities, which have similar standards of their own.)

As of June 1995, nearly 9,300 of approximately 10,300 facilities had been fully certified by FDA, and 940 more had been provisionally certified while undergoing accreditation review.

For certification, each facility must:

have adequately trained and experienced radiologic technologists who perform mammography, physicians who interpret mammograms, and medical physicists who survey equipment
have an effective quality control program and record-keeping system
have a system to track mammograms revealing potential problems and to obtain biopsy results
be inspected annually by FDA-trained inspectors to ensure safe and effective mammography.

FDA Revises Blood Donor Criteria
To Exclude Prisoners

Blood and plasma centers were recently advised by FDA not to accept as donors current and certain recent prison inmates as blood donors. Excluded for 12 months following their last date of incarceration are those jailed longer than 72 consecutive hours during the previous year.

FDA's Center for Biologics Evaluation and Research made the recommendation last June 8 after reviewing a series of reports by the U.S. Department of Justice, the national Centers for Disease Control and Prevention, and others. The reports found that a significant proportion of inmates are likely to have engaged in high-risk behavior--such as illegal intravenous drug use--before incarceration. This finding correlates with a high rate of infection among inmates and incoming prisoners with bloodborne transmissible agents, such as HIV and hepatitis viruses. Other risk factors for these disease agents, such as tattooing and high-risk sexual activity, have also been reported for inmates.

Obtaining blood and plasma donations from inmates, never a widespread practice in the United States, has declined in recent years and now occurs at only a handful of institutions.

People who wish copies of the recommendation may request document Number 4015 from the Center for Biologics Evaluation and Research at (301) 594-1800, the CBER Fax Information System at (301) 594-1939, or by return E-mail by sending a message to mem06895@a1.cber.fda.gov.

Precautions Advised for Blood Supply

An Ad Hoc Advisory Committee on Creutzfeldt-Jakob disease (CJD) has been established by FDA to advise the agency on the appropriate disposition of blood and plasma products made from donations by individuals subsequently diagnosed with the disease. CJD is a rare, invariably fatal, degenerative disease of the central nervous system.

The panel of 15 outside experts met for the first time June 22 and advised FDA, as a precaution, to remove from the market blood and plasma products donated by people subsequently diagnosed with CJD.

It is not known whether CJD can be transmitted by transfusion of blood products. No cases have been reported. However, CJD has been transmitted by transplantation of corneas and dura mater (a brain-associated membrane), injections of human pituitary-derived growth hormone, and reuse of electroencephalogram electrodes used on CJD patients. The risk of transmitting CJD by transfusion is considered extremely small, if it exists at all.

After hearing from people with hemophilia and others, the panel voted to recommend that the blood and plasma products from people with CJD not be used. The committee's recommendation is not binding on FDA, but the agency will consider it carefully when deciding what action to take. At press time in July, no decision had been made.

Over the past 12 years, seven cases of CJD have been confirmed in people who previously gave blood. In each case, blood centers voluntarily withdrew the unused blood products.

FDA has authorized the ad hoc committee to deliberate for one year.

5 Free Reprints

Five free FDA Consumer reprints are available:

Mercury in Fish: Cause for Concern? (FDA) 95-2285
Labeling Rules for Young Children's Food (FDA) 95-2292
An FDA Guide to Nonprescription Pain Relievers (FDA) 95-3213
Making It Easier to Read Prescriptions (FDA) 95-3217
Progress in Blood Supply Safety (FDA) 95-9013.

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

FDA Consumer magazine (September 1995)