Updates

Plan Will Give Consumers Better Prescription Drug Info

A new public-private plan for giving patients useful, easy-to-read information about their prescription drugs aims to help consumers better understand their medicines and reduce the medicine misuses that yearly lead to thousands of hospitalizations.

The voluntary plan calls for the information to reach 75 percent of patients by the year 2000 and virtually all patients (95 percent) by 2006.

It parallels requirements of a 1995 FDA proposal for medication guides that would be easily understood, non-promotional in tone and content, and scientifically accurate. (See "FDA's Rx for Better Medication Information" in the November 1995 FDA Consumer.) Following publication of the proposal, Congress directed HHS Secretary Donna E. Shalala to convene a committee of diverse interest groups to develop a long-range, voluntary plan to improve oral and written communication to patients about their prescription medicines.

The plan fulfills the congressional mandate by:

encouraging health-care professionals to communicate better with patients about prescription medicines
ensuring that voluntary efforts meet the distribution targets for the years 2000 and 2006
establishing criteria for developing useful written drug information for patients
encouraging activities to increase patients' understanding of the benefits of the information
providing periodic evaluation of the voluntary program
promoting consistency with relevant state board regulations.

A 34-member steering committee developed the Action Plan for the Provision of Useful Prescription Medicine Information with assistance from The Keystone Center, a nationally recognized, nonprofit organization for mediating public policy. The steering committee represents the pharmaceutical industry, pharmacists, doctors, consumer and patient advocacy groups, patient drug information database companies, and other interested groups.

In accepting the plan in a Jan. 13 letter to Keystone, Secretary Shalala said the information provided to patients will cover all uses that FDA has approved for a medicine. In addition, she said, doctors and pharmacists may provide any further needed information about "off-label" use, provided they customize the information for each patient. Information can therefore be made available about uses that generally lack the strong scientific base required for FDA approval but are deemed appropriate by the prescriber or dispenser. She said she would continue to evaluate progress by the private sector in meeting the plan's goals and welcomed similar monitoring by industry and consumer groups.

Drug, Biologic Approvals Up, Review Times Down

A record-setting 139 drugs and biological products were approved by FDA in 1996--an increase of 63 percent over the number approved in 1995.

FDA attributed the increase to the Prescription Drug User Fee Act five-year program, in which the agency uses fees paid by manufacturers to shorten drug review and approval times. Median approval times in 1996 were 15.4 months for drugs and 14.9 months for biologics, down from 16.5 months and 17.6 months, respectively, in 1995.

Fifty-three of the drugs approved were new molecular entities. They included three drugs for HIV (the virus that causes AIDS), two for cancer, and one each for asthma, Alzheimer's disease, and multiple sclerosis.

Eight of the licensed biological products were first-time entities. Major biological products licensed in 1996 included Respigam, the first medication to protect infants against serious respiratory syncytial virus disease; Avonex, the second interferon product for multiple sclerosis; and Verluma, a diagnostic imaging agent for determining at one time the extent of small cell lung cancer in different parts of the body. Also of note were five new HIV test kits.

New Health Claims Approved for Whole-Oat Products

The claims that foods with soluble fiber from whole oats may reduce heart disease risk when eaten as part of a diet low in saturated fat and cholesterol is now allowed under an FDA final rule. Foods covered by the action include rolled oats, oat bran, and whole-oat flour.

FDA concluded that the beta-glucan soluble fiber of whole oats is the primary component responsible for lowering total and LDL (low-density lipoprotein), or "bad," blood cholesterol in diets including these foods at appropriate levels. This conclusion is based on a scientific review showing a link between the soluble fiber in whole-oat foods and a reduction in coronary heart disease risk.

To qualify for the claim, whole-oat foods must provide at least 0.75 grams of soluble fiber per serving. About 3 grams of soluble fiber is needed daily for an effect on cholesterol levels.

The whole-oat claims must include the words "diets low in saturated fat and cholesterol" because consumers might otherwise think that eating a diet high in oats is all that is needed to reduce heart disease risk.

FDA acknowledges that other sources of beta-glucan soluble fiber and other types of soluble fiber may have similar effects on cholesterol levels. But the agency is awaiting evidence before judging these effects.

FDA regulates health claims on food labels to ensure that claims are accurate and don't mislead consumers. The agency requires a "significant scientific agreement" on claims before allowing them. (See "Look for 'Legit' Health Claims on Foods" in the FDA Consumer special report Focus on Food Labeling.)

More details on the final rule are in the Jan. 23, 1997, Federal Register.

Test for Home Use Detects Drugs of Abuse

A home test system for drugs of abuse--such as marijuana, heroin and cocaine--will be available in drugstores, pharmacies, and other places selling over-the-counter medical products.

Earlier this year, FDA cleared Dr. Brown's Home Drug Testing System, the first nonprescription test system for detecting marijuana, PCP, amphetamines, cocaine, heroin, codeine, and morphine in urine. Results are available anonymously by identification number.

"The approval of this test gives parents another option to consider to help ensure that their children remain drug-free," said Health and Human Services Secretary Donna E. Shalala.

The system includes a kit to collect and mail a urine sample. Directions for use and for obtaining and interpreting results are also provided. The user labels the urine sample with an identification number provided in the kit and sends it to a specified government-certified laboratory for analysis. The laboratory evaluates the sample for possible tampering, tests it for drugs of abuse, does a confirmation test to minimize false positive readings, and then forwards the results by computer to the manufacturer's results center.

To obtain the results, which are available one to three days after the lab receives the urine sample, the user calls a toll-free phone number and provides the sample identification number. In addition to learning whether the test showed the presence of drugs, the user receives information explaining the results and the potential for erroneous results. If needed or requested, referrals are offered for drug abuse counseling and medical assistance.

A positive result indicates the presence of one or more of the drugs in amounts sufficient for detection. Some medicines and, rarely, certain foods can cause a false positive reading. A negative result indicates the absence of drugs, or an insufficient quantity to be detected. A result may be falsely negative if too much time has elapsed between exposure to the substance and urine collection. In rare cases, it is also possible that technical or procedural errors in the lab could interfere with test results. Therefore, both FDA and the test manufacturer recommend that test users who receive a positive result, as well as others who have questions about their results, consult a physician for follow-up evaluation.

Dr. Brown's Home Drug Testing System is manufactured by Personal Health and Hygiene Inc., Silver Spring, Md. FDA cleared the test system Jan. 21, and the company expected to start marketing it in March.

Rule to Protect Children From Iron Poisoning

Efforts to protect children from accidental iron poisoning are getting a boost from a new FDA rule.

Beginning July 15, when the rule will take effect, labels on all drugs and dietary supplements that contain iron or iron salts will have to display prominently and conspicuously this boxed warning:

"WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."

In addition, products containing 30 milligrams (mg) or more of iron per dosage unit, such as most iron pills for pregnant women, will have to be packaged as individual doses--for example, in blister packages. This is to limit the number of pills or capsules a small child could accidentally consume once the package is opened.

FDA published the final rule in the Jan. 15, 1997, Federal Register.

Accidental overdose of iron pills is a leading cause of poisoning deaths among young children. Since 1986, more than 110,000 incidents of iron ingestion by children have been reported, and 35 children have died.

Under U.S. Consumer Product Safety Commission regulations, most drugs and food supplements with more than 250 mg of iron per container must have child-resistant packaging. However, in some poisoning cases, young children had been left unattended in the presence of uncapped containers. FDA and a consensus of public health officials and industry groups hope that the additional safeguards, together with greater public awareness of the problem, will reduce the incidence and severity of iron poisonings in children.

New Type II Diabetes Drug May Reduce Insulin Needs

The first in a new class of drugs to treat the most common form of diabetes could reduce or eliminate the need for insulin in as many as 1 million patients.

Rezulin (troglitazone) reduces the body's resistance to insulin, an important underlying cause of adult-onset diabetes. In two clinical studies of more than 500 patients, the drug significantly improved the body's ability to use insulin in managing diabetes.

FDA approved Rezulin only for patients already taking insulin shots for adult-onset diabetes, also called Type II diabetes or non-insulin-dependent diabetes mellitus. The drug should be prescribed with caution in patients with advanced heart failure or liver disease. And, as with other drugs for diabetes, patients should maintain an appropriate weight and follow a careful diet.

FDA's Jan. 29 approval of Rezulin followed a unanimous recommendation by FDA's Endocrinologic and Metabolic Drugs Advisory Committee and came within six months of submission of the new drug application.

Parke-Davis, a division of Warner Lambert, Morris Plains, N.J., will market Rezulin. Under a business agreement between Warner-Lambert and Sankyo USA, New York City, the drug may also be marketed under the trade name Prelay.

(See also "Probing the Pancreas" in the October 1996 FDA Consumer, "The New Food Label: Coping with Diabetes" in the November 1994 issue, and "Improving Blood Glucose Monitoring for Diabetes" in the May 1990 issue.)

Mammography Inspection Program Receives Good Report

According to a General Accounting Office report, FDA's program for inspecting the more than 9,000 U.S. mammography facilities "is having positive results."

GAO reports a growing compliance with mammography standards and a considerably reduced proportion of facilities cited for violations. The Mammography Quality Standards Act of 1992 requires GAO reports to Congress on the law's implementation and effect.

The report found:

During inspections the first year, 80 percent of the facilities had either no violations or minor ones, and only 2 percent had violations serious enough to warrant an FDA warning letter.
During inspections the second year, improvement continued, and facilities with serious violations in the first year did not have a recurrence of violations the second year.

Agreeing with GAO recommendations to strengthen several areas, FDA has already made changes for improvement, such as ensuring timely correction of violations.

(See also "Mammography Facilities Must Meet Quality Standards" in the March 1994 FDA Consumer.)

Prescription Nasal Spray OK'd for OTC Allergy Relief

For the first time, a nasal spray specifically for preventing and treating nasal allergy symptoms is available without a prescription.

The spray, Nasalcrom (cromolyn sodium), can be used regularly by adults and children age 6 and older.

When used before exposure to an allergy-causing substance--for example, before the start of hay fever season--Nasalcrom reduces runny, itchy nose, sneezing, and other nasal symptoms (rhinitis).

The product can also treat existing symptoms. But because it may require up to two weeks to take full effect, allergy sufferers may need to also use antihistamines or nasal decongestants during the first part of therapy.

Patients may have such side effects as brief sneezing and nasal stinging.

Available by prescription since 1983, Nasalcrom was switched to OTC Jan. 3, following the recommendation of FDA's Pulmonary Drugs Advisory Committee and Nonprescription Drugs Advisory Committee.

McNeil Consumer Products Co., Fort Washington, Pa., will market Nasalcrom.

(See also "Taking a Shot at Allergy Relief" in the May 1996 FDA Consumer and "It's Spring Again and Allergies Are in Bloom" in the May 1989 issue.)

Antihistamine Poses Possible Safety Risk

Patients taking drugs containing the antihistamine terfenadine--Seldane, Seldane D, and generic versions--should talk to their doctors about switching to alternative medicine, FDA advised earlier this year. The caution came as the agency took the first step toward withdrawing approval of the drug because of safety concerns.

Terfenadine's approval in 1985 made it the first prescription antihistamine to relieve allergic rhinitis without drowsiness. Since then, FDA has received reports of serious, sometimes fatal heart arrhythmias (irregular heartbeats) in users who have liver disease or take such other medicines as the antibiotic erythromycin or the antifungal drug ketoconazole. These drugs can make terfenadine build up in the blood, causing serious effects on the heart.

Efforts by FDA and the drug's sponsor, Hoechst Marion Roussel, to inform health-care providers and patients about these dangers, including FDA warning statements, labeling changes, and "Dear Doctor" letters, have reduced inappropriate prescribing and dispensing of terfenadine with certain other drugs. But FDA believes that such drug interactions almost certainly cannot be eliminated.

Initially, FDA considered terfenadine's benefits from appropriate use outweighed the risks from inappropriate use. But in a Jan. 13 announcement, FDA said it no longer considered this true because of the availability of a new drug, Allegra (fexofenadine). Approved by FDA in July 1996, Allegra also is made by Hoechst Marion Roussel. It provides nearly all of terfenadine's benefits without the associated serious heart risk.

In view of these developments, FDA began proceedings to remove the drug from the market and advised patients taking the medicine to talk to their doctors.

Free Publications Give Advice
About Young Children's Health and Safety

A free newly available FDA Consumer reprint, "Breastmilk or Formula: Making the Right Choice for Your Baby" (FDA 97-2309), updates information from two previous FDA Consumer articles.

Also available free is a new FDA backgrounder, "Preventing Iron Poisoning in Children" (BG 97-1).

To order single copies of the reprint, write to FDA, HFI-40 , Rockville, MD 20857. To order single copies of the backgrounder or 2 to 100 copies of the reprint, write to FDA, HFI-40, at the same address, or fax your order to (301) 827-5308. Include the publication number.

FDA Consumer magazine (April 1997)