The new design also brings "Notebook" items up front to join "Updates." Now all the latest news from FDA and other important health news sources is in one place.
"Notebook's" old spot, however, is still worth a visit. There you'll find "fda.gov," a new section about FDA's Internet site and other Internet sites with important health and consumer information.
Because some foods containing psyllium seed husk can be hard to swallow, foods carrying the coronary heart disease claim also must state the need to drink adequate fluids with the food or, for those who have difficulty swallowing, to avoid the food altogether.
FDA's authorization of the claim in the Feb. 18, 1998, Federal Register follows a 1997 approval of a claim about the association between foods containing soluble fiber from whole oats and a reduced risk of heart disease. In allowing that claim, FDA noted that because soluble fibers are very heterogeneous substances, it would have to evaluate soluble fiber sources individually to determine the effect each has on lowering blood cholesterol levels and thus the risk of heart disease.
Studies FDA evaluated showed that 10.2 grams of psyllium seed husk (about 7 g of soluble fiber) a day, as part of a diet low in saturated fat and cholesterol, consistently and significantly lowered blood cholesterol levels.
To qualify for the psyllium-and-heart-disease claim, a food must provide at least 1.7 g of soluble fiber from psyllium seed husk per serving. A single serving four times a day totals the 7 g amount consumed in the studies.
The new health claim responds to a petition by the Kellogg Co., Battle Creek, Mich.
Droxia (hydroxyurea) was approved Feb. 25 for sickle cell patients over 18 who have had at least three "painful crises" in the previous year. Sickle cell anemia causes red blood cells to become brittle and crescent shaped. Painful crises occur when sickle cells get stuck in narrow blood vessels, causing pain and swelling of hands and feet, along with fever, fatigue, and a pneumonia-like condition.
Though Droxia doesn't cure the disease, it may ease symptoms. Because the drug depresses blood count, doctors must monitor patients closely to ensure they are not at risk for infection or bleeding.
Sickle cell anemia affects about 91,000 people, mostly of African American heritage, in the United States.
Because of the small number of people with the disease, FDA has designated Droxia as an orphan drug. This status guarantees the developer seven years of market exclusivity following FDA approval and provides other financial incentives for drug development.
Droxia is marketed by Bristol Laboratories, Princeton, N.J.
A MedWatch report can be made by:
FDA encourages consumers to report through their doctors, but if they prefer, they may submit the MedWatch form themselves.
Duract is specifically indicated for short-term management of acute pain (use for 10 days or less), and is not labeled for long-term use in chronic conditions such as osteoarthritis or rheumatoid arthritis.
Duract's manufacturer, Wyeth-Ayerst Laboratories, Philadelphia, will add a boxed warning to the label emphasizing the importance of taking the drug exactly as directed. The company has sent a letter to doctors alerting them that some patients who have used the drug for longer than 10 days have developed severe hepatitis and liver failure.
Wyeth-Ayerst advised doctors that if use of Duract beyond 10 days is warranted, close monitoring of the patient's liver enzymes is necessary.
Health-care providers should report any adverse events to Wyeth-Ayerst at 1-800-934-5556 or to FDA's MedWatch program.
Grapefruit juice and certain drugs, if taken with Hismanal, can affect the way the body handles the drug and potentially lead to dangerous allergic reactions or heart problems.
The drugs that should not be taken with Hismanal, according to an FDA warning, include:
The new label will also warn patients with liver disorders not to take Hismanal.
Health professionals should report any adverse events to Janssen Pharmaceutica's one-to-one customer action center at 1-800-JANSSEN (1-800-526-7736) or FDA's MedWatch program.
In announcing the labeling change Feb. 25, FDA said it had received reports of depression, psychosis and, rarely, suicidal thoughts and actions in people using Accutane, a drug approved in 1982. The drug's previous labeling included information about depression, but FDA said a stronger warning was needed to ensure that health-care providers and others receive sufficient information about the adverse reactions.
The warning will inform health-care providers that merely discontinuing the drug will not necessarily remedy the problems and that further patient evaluation may be needed.
The exact cause of the mental problems is not known, and the population likely to be using the drug may already be at risk for depression. But the reports FDA received indicated that depression in some patients subsided when they stopped using Accutane and returned when they resumed use.
Health-care providers can report Accutane-related adverse reactions to Roche Laboratories at 1-800-526-6367 or to FDA's MedWatch program.
The kits require the collection of a specimen, such as urine, which is mailed to a designated laboratory to be tested for marijuana, PCP, cocaine, and other drugs of abuse. The kits' manufacturer provides test results by phone to the person who sent in the test specimen.
FDA's proposal, issued in March, would allow manufacturers to sell drug abuse specimen collection kits without prior approval if:
The public has until July 6 to send written comments on the proposed rule to: FDA Dockets Management Branch, HFA-305, Food and Drug Administration, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857. FDA published the proposal in the March 5, 1998, Federal Register, available in some libraries and at www.fda.gov/cdrh/fr/fr0305af.html on the agency's Website.
The median approval time for original drugs was a record-low 14.4 months, 6 percent faster than in 1996. These original drugs included 39 "new molecular entities," which contain an active substance never before approved in the United States. FDA also set a record for generic drug approvals in 1997--431 approvals, the highest number in any year this decade.
The agency approved some biologics as much as 20 percent faster than 1996 approvals, including 10 that contained substances never before approved in the United States.
The Prescription Drug User Fee Act (PDUFA) of 1992, under which fees companies pay FDA are used to hire additional reviewers, helped speed up approvals. The FDA Modernization Act of 1997 (available on this Website both as a text file and a 392K PDF file) extended PDUFA for five more years.
Beginning in February 1999, marketing applications will have to include a disclosure statement on the following types of financial interests or arrangements:
The agency intends to propose a similar requirement for submissions dealing with foods, animal foods, and animal drugs.
Laser relief ... Men with symptoms of benign prostatic hyperplasia (BPH), or enlarged prostate, may find relief with a laser treatment FDA approved in January. Commonly found in men over 50, BPH chokes off the urethra, causing men to urinate more frequently. The Indigo LaserOptic Treatment System uses fiber optics to destroy sections of the prostate and restore urine flow. Patients treated with the laser have half the hospital stay as those treated surgically.
Reducing birth defect risks ... FDA now requires makers of enriched breads, flours, cornmeal, pastas, rice, and other grain products to add folic acid to their products. When consumed in adequate amounts by women before and during early pregnancy, folic acid reduces the risk of neural tube birth defects such as spina bifida, a common condition resulting from the failure of the spinal column to close.
For the dogs ... FDA approved the first artificial blood product in January--but it can only be used for dogs. Veterinarians are hailing the product, Oxyglobin, because few animal blood banks exist and blood is often needed quickly if a dog is critically injured, needs surgery, or has anemia. The product has a shelf life of two years at room temperature. Oxyglobin's maker, BioPure Corp., has developed a similar product for humans, which is in clinical trials.
Vaccinating for E. coli ... An experimental vaccine against E. coli O157:H7, the pathogenic bacterium that causes severe poisoning and sometimes death, shows promise in a trial conducted at the National Institute of Child Health and Human Development. Vaccine volunteers produced enough antibodies to kill the bacteria in laboratory cultures, and that deadly effect lasted throughout the six months of the trial. Volunteers did not experience any serious side effects. (Journal of Infectious Diseases, February 1998)
Signing Up to Keep Tobacco from Kids ... The Department of Health and Human Services has launched a national advertising campaign to help reduce illegal tobacco sales to children. The campaign, featuring radio, print and billboard ads, uses humorous illustrations and messages to remind retailers and consumers that it's against federal law to sell cigarettes or smokeless tobacco to anyone younger than 18. In addition, FDA has recently contracted with North Carolina to enforce the new regulations. Minors, accompanied by adults, will attempt to buy the prohibited products from retailers during unannounced compliance checks. North Carolina is the 11th state to contract with FDA.
"Ouchless" shots ... Scientists at Iomai Corp. in Washington, D.C., report they are testing a needle-free vaccine that is spread on the skin. Early trials showed that mice created antibodies to diphtheria or tetanus the same way they would with an injected vaccine.(Nature, Feb. 26)
Pressure drop ... Potassium can reduce blood pressure in people who have low intakes of the mineral, according to research at the Harvard School of Public Health. The study examined 300 middle-aged women who had low daily intakes of potassium and found that blood pressure "decreased significantly" in those who boosted potassium intake. Bananas, oranges, and leafy vegetables are good potassium sources. (Hypertension, January 1998)
Fishy benefits ... Eating a fish meal at least once a week may cut in half the risk of sudden cardiac death in men, says a study at Brigham and Women's Hospital in Boston. About 250,000 sudden cardiac deaths occur in the United States yearly. (Journal of the American Medical Association, Jan. 7)
FDA Consumer magazine (May-June 1998)