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Updates

Public Can Comment on PPA Proposal

Because of a possible link between phenylpropanolamine (PPA), an ingredient in certain over-the-counter (OTC) drug products, and a type of stroke, FDA recently proposed new warning labels for these products.

The public has until May 14 to send written comments on the proposal to: FDA Dockets Management Branch, HFA-305, Rockville, MD 20857. The proposal was in the Feb. 14, 1995, Federal Register.

FDA officials are concerned it may be harmful to take more than the recommended dose of PPA, an ingredient in OTC weight control, cough-cold, allergy, and nasal decongestant drug products. PPA affects the central nervous system and the cardiovascular system.

Some data indicate that PPA in OTC drugs may increase the risk of hemorrhagic stroke, which results from bleeding into the brain. Although FDA agrees that, to date, there is no definite link between using OTC drugs containing PPA and hemorrhagic strokes, the agency believes further safety data are needed. FDA awaits these data from an industry-sponsored PPA safety study.

The new labels would warn consumers not to take more than one PPA-containing drug at a time, or at the same time as a drug containing phenylephrine, pseudoephedrine or ephedrine--whose effects are similar to PPA's. Labels on weight-control products containing PPA would also warn that the products are for adult use only.

PPA interacts with certain antidepressants known as monoamine oxidase inhibitors, which when combined with PPA, can cause life-threatening adverse effects. Also, people with high blood pressure, heart or thyroid disease, or diabetes should not use PPA-containing products without consulting a doctor. Labels already include this information.

FDA Requires Folic Acid Fortification

Most enriched grain products marketed in the United States will be fortified with folic acid, under a new FDA rule intended to reduce the risk of certain birth defects.

Folic acid, or folate, reduces the risk of neural tube birth defects, such as spina bifida, when consumed in adequate amounts by women before and during early pregnancy. Spina bifida is a common disabling birth condition resulting from failure of the spinal cord to close.

In 1992, the Public Health Service recommended that all women of childbearing age eat 0.4 milligrams (mg) of folic acid daily because over half of all pregnancies are unplanned and because these defects occur in the developing fetus before most women know they are pregnant.

"By fortifying grain products, we are making it easier for women of childbearing age to achieve adequate folic acid levels in their diets," said FDA Commissioner David A. Kessler, M.D.

In addition to eating fortified foods, women of childbearing age should eat a diet rich in leafy green vegetables, citrus fruits and juices, and lentils or take a multivitamin a day to ensure adequate levels of folic acid, Kessler said.

Under FDA's rule, food manufacturers must fortify their enriched bread products, flour, corn grits, cornmeal, farina, rice, macaroni, and noodles with 0.43 mg to 1.4 mg of folic acid per pound of product. Breakfast cereals can have up to 0.4 mg of added folic acid per serving. These amounts are designed to keep daily intakes of folic acid below 1 mg because intakes above that amount may mask symptoms of pernicious anemia, a form of vitamin B12 deficiency that primarily affects older people. If untreated, pernicious anemia can lead to severe permanent nerve damage.

The rule allows food manufacturers to make claims on the labels of fortified products that adequate intake of the nutrient has been shown to reduce the risk of neural tube birth defects.

FDA published a final rule in the March 5, 1996, Federal Register. (See "To Reduce Birth Defects, FDA Proposes Folic Acid Fortification" in the May 1994 FDA Consumer.)

Smoking Cessation Aid Available OTC

Nicorette gum (nicotine polacrilex) became the first over-the-counter smoking cessation aid when FDA recently switched the drug from prescription to OTC status.

FDA approved Nicorette gum for adults last Feb. 9 in both 2-mg and 4-mg strengths, based on recommendations by the agency's Nonprescription Drugs and Drug Abuse Advisory committees. Previously available by prescription only, Nicorette will now be sold OTC as a 12-week smoking cessation treatment that includes a user's guide and audio tape.

When used according to directions, Nicorette delivers a low level of nicotine that helps reduce craving and other withdrawal symptoms.

Almost half of those who use Nicorette are able to stop smoking for at least a few days, but many start smoking again. The one-month quit rates among smokers who use Nicorette and who seek no additional treatment (such as support groups) is less than 10 percent. Approximately 45 million to 50 million U.S. adults are addicted to nicotine.

People with heart disease should consult their doctors before using Nicorette.

SmithKline Beecham Consumer Healthcare of Pittsburgh markets Nicorette gum.

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

Rogaine Now Available OTC

Rogaine Topical Solution (minoxidil 2%) was recently approved as the first over-the-counter drug to treat common hereditary hair loss. It was previously available by prescription only.

More than 40 million men and 20 million women experience hair loss or thinning at any given time, usually due to heredity. In patients with hereditary hair loss, Rogaine promotes gradual hair growth and may take at least four months before producing noticeable results. Hair regrowth varies by person, and not everyone responds to the drug. Rogaine has not been shown to help treat hair loss caused by nonhereditary factors.

About 25 percent of men and 20 percent of women attain at least moderate hair growth with the product, meaning new individual hairs cover some or all thinning areas. A larger fraction of users achieve growth of some new hairs, though not enough to cover thinning areas.

In some cases, Rogaine users have reported itching and other skin irritations of treated scalp areas. The product should not be used on children or babies. Pregnant or nursing women should see a health professional before using the drug. Users should discontinue the drug and see a health professional if they have chest pains, rapid heartbeat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet, or redness or irritation.

FDA granted Rogaine's OTC status last Feb. 12 following recommendations from two of the agency's advisory committees.

Upjohn Pharmaceuticals of Kalamazoo, Mich., markets Rogaine.

(For more on hair loss and its treatment, see "Hair! From Personal Statement to Personal Problem" in the December 1991 FDA Consumer.)

AIDS Drug Approved in 72 Days

The second in a new class of AIDS drugs was approved by FDA in only 72 days, the fastest approval of any AIDS drug so far.

FDA approved the protease inhibitor Norvir (ritonavir) last March 1 for use alone or in combination with nucleoside analog medicines, such as AZT (zidovudine, marketed as Retrovir), in people with advanced HIV infection. Both types of drugs inhibit HIV development, but at different points in the replication process.

Ritonavir may also be used for less advanced HIV infection under FDA's accelerated approved mechanism. Under this mechanism, the agency bases early marketing approval on improved laboratory markers--such as CD4 cell counts, an indicator of immune system strength, and viral load, a measure of virus level detectable in the bloodstream. Longer term data must be collected on clinical endpoints, such as disease progression and deaths.

Clinical researchers studied the new drug alone and in combination with nucleoside analogs in people at various stages of HIV infection.

None of the studies included clinical endpoints for patients with less advanced HIV infection. However, in people with advanced disease, the studies showed ritonavir not only increased CD4 cell counts and decreased viral load, but also reduced disease progression and deaths.

In the largest study, the cumulative death rate among patients on ritonavir was about 40 percent of that among patients on placebo. Treated patients also had a 50 percent greater reduction in disease progression during the six-month study.

Adverse events associated with ritonavir treatment included diarrhea, nausea, vomiting, weakness, tingling, liver inflammation, elevated lipid levels, and taste disturbance.

FDA worked with the manufacturer, Abbott Laboratories, to ensure that potentially severe drug interactions with Norvir are clearly highlighted in the package label and that education materials are available to patients.

Thalidomide Studied for Treating AIDS

Several trials are ongoing to determine the safety and effectiveness of thalidomide in treating conditions related to AIDS and HIV infection.

Thalidomide was marketed in Europe and other parts of the world in the 1950s and 1960s as a tranquilizer and for nausea in pregnancy before it was discovered that it causes severe birth defects. The drug was never approved in the United States.

AIDS-related conditions for which clinical studies of thalidomide are under way include:

For more information about these and other AIDS drug clinical trials, call (1-800) TRIALS-A.

Cholesterol Filter Approved

A medical device that filters harmful cholesterol from blood has been approved by FDA for use in people who have extremely high blood cholesterol levels that cannot be lowered with a low-fat diet and cholesterol-lowering medicines.

The Liposorber LA-15 System was approved Feb. 21 for treating the estimated 4,000 Americans with a genetic disorder causing extremely high cholesterol. These people are at very high risk for early heart disease, heart attacks, and death.

The Liposorber removes low density lipoprotein (LDL) ("bad" cholesterol) from the blood through a plastic tube inserted into the arm and connected to the filtering machine. The process, similar to kidney dialysis, takes about three hours and is done at a medical facility. Patients who receive the treatment should remain on a low-fat diet and continue to take cholesterol-lowering medication, even though these therapies may have little effect.

In a study of 74 patients at 11 U.S. sites, the treatment with the Liposorber immediately reduced blood levels of LDL in all patients. The patients were on cholesterol-lowering drugs and diet, which had not had much effect on their cholesterol levels.

Because patients' LDL levels returned to their pretreatment values 14 to 30 days after treatment, the treatment must be repeated every one to two weeks.

The study was not designed to, nor did it, show whether the treatment has long-term benefits, such as reducing angina, heart attacks, and death. To help determine long-term risks and benefits, FDA is requiring the manufacturer, Kaneka America Corp., of New York City, to establish a patient registry to continue to monitor the conditions of patients who receive this treatment.

Low-Risk Devices Exempt from FDA Review

To speed patient access to new medical devices, FDA has exempted 122 categories of low-risk devices from premarket review, adding to the 450 categories already exempted.

New exemptions include gas pressure gauges, oxygen masks, pacemaker chargers, dental floss, pneumatic tourniquets, patient scales, examination lights, and therapeutic massagers.

The revised policy, which went into effect Feb. 15, reclassifies 111 categories of devices from class II (medium risk) to class I (low risk) and exempts 11 device categories already in class I. Nearly three-fourths of all class I devices, or one-third of all classified medical devices, are now exempt from premarket review.

FDA will continue to regulate these products, which are still subject to good manufacturing practice regulations, factory inspections, and other general controls. But manufacturers no longer need agency clearance before marketing the products. FDA notified device makers with premarket clearances pending for the 122 categories that their devices are now exempt.

The exemptions are part of drug and medical device reforms included in the Clinton administration's National Performance Review.

Free Spanish, English Pubs

Teenage smoking, childhood poisoning, and stomach upsets are the topics of free new FDA Consumer reprints. The smoking reprint is available in both Spanish and English.

Also available are a brochure, in Spanish, about using medicine safely and a backgrounder about commenting on FDA rules.

The new publications and their pub numbers are:

To order single copies of the brochure and reprint, write to FDA, Rockville, MD 20857. To order single copies of the backgrounder or 2 to 100 copies of the brochure and reprints, 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 (May1996)