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The drug may be especially useful to park rangers, emergency workers, hikers, and others who find it difficult to avoid poison ivy. As long as the possibility of exposure to the poisonous plants exists, Ivy Block should be reapplied every four hours for continued protection. It can be washed off with soap and water.
Ivy Block should not be used by anyone who already has a rash from these plants. It is not recommended for children under 6.
Enviroderm of Louisville, Ky., manufactures Ivy Block.
(See also "Outsmarting Poison Ivy and Its Cousins" in the September 1996 FDA Consumer.)
The Reliance Urinary Control Insert Device was approved by FDA Aug. 16, after an expedited review based on its potential usefulness.
Trained in the use of the device by her doctor, a woman places the insert in her urethra (tube that carries urine from the bladder) with the aid of a reusable syringe. Because the length of the urethra varies, doctors prescribing the device fit their patients for the insert using the Reliance Sizing Device, also approved in August.
After insertion, a balloon at the tip inflates in the bladder to block urine leakage. To urinate, the woman pulls an attached string to deflate the balloon and removes and discards the insert, replacing it with a new one after urination.
Women shouldn't wear the insert for more than six hours and shouldn't use it during sexual intercourse. The device's safety and effectiveness in pregnant women has not been studied, and FDA does not recommend its use during pregnancy.
In approving the insert, FDA followed a July 25 recommendation of the Gastroenterology and Urology Devices Advisory Panel.
In a study of 215 women with incontinence, an evaluation of data from 50 women who used the device for one year showed it reduced urine leakage in those women.
Based on study results, about 44 percent of users will likely develop urinary tract infections within the first year of use. About 78 percent will likely have urethral discomfort and irritation--a problem that caused many women to drop out of the study. Other side effects were bleeding (20 percent) and undesirable movement of the device into or out of the bladder (6 percent).
FDA is requiring the product's manufacturer, UroMed Corp. of Needham, Mass., to conduct a postmarketing study to determine the long-term rate of urinary tract infections and the effect of long-term use on urethral tissue.
Serostim (somatotropin), a human growth hormone, was approved last Aug. 23 for HIV wasting syndrome, a condition characterized by severe weight loss, leading to muscle weakness and organ failure and contributing to death. In one clinical study, patients receiving the drug increased lean body mass by an average of 1.6 kilograms (3.5 pounds), compared with no increase for patients receiving a placebo.
As part of the approval, the drug's manufacturer agreed to conduct additional studies both to confirm the finding of increased lean body mass and to evaluate whether Serostim helps improve the patients' physical performance.
Under the accelerated drug approval process, FDA grants early approval of drugs found to provide meaningful benefit over existing therapies for serious or life-threatening diseases.
FDA granted Serostim treatment investigational new drug status in December 1994, allowing AIDS patients access to the drug before approval. Since then, more than 300 patients have been treated with it. The most common side effects are tissue swelling and muscle and joint pain.
Serostim is distributed by Serono Laboratories Inc. of Randolph, Mass.
(See also "Warding Off HIV Wasting Syndrome" in the April 1995 FDA Consumer.)
MAC causes chronic, weakening symptoms such as fever, weight loss, fatigue, and gastrointestinal problems. To prevent or delay MAC symptoms, the new use approved last June, Zithromax is given in one weekly dose of 1,200 milligrams. Alternatively, the single weekly dose may be given in combination with daily doses of Mycobutin (rifabutin), the first drug approved to prevent MAC in patients with advanced HIV infection. (See "Mycobutin Approved to Prevent MAC," in the Updates section of the April 1993 FDA Consumer.) Biaxin (clarithromycin) also is approved to treat MAC.
Zithromax is not for use in patients highly sensitive to other macrolide antibiotics, such as erythromycin and clarithromycin.
In clinical trials, Zithromax caused mild to moderately severe side effects, mainly nausea, vomiting, diarrhea, and abdominal pain. Rare but potentially serious side effects were localized swelling and jaundice. Studied both alone and in combination with other AIDS treatments, the drug showed very little interaction with the other therapies. It was not studied with the newest class of AIDS drugs, protease inhibitors. (See "Free Backgrounder on Protease Inhibitors" in the Updates section of the October 1996 FDA Consumer.)
Giglio, Parmalet, or Sol di Valle mascarpone cream cheese should not be used for any reason, even if it does not look or smell spoiled. The products come in 500-gram (about 17.5-ounce) containers.
FDA warned the public about the cheese Sept. 9, after being notified by the Italian Ministry of Health that these brands of mascarpone have been linked to one death and at least three other cases of botulism in that country. These products, all made by the Giglio factory in Reggio Emilia, Italy, were recalled in Italy.
According to Italian authorities, some of the cheese may have been exported to the United States. At press time in October, FDA was working with the Giglio company and importers to track the volume and location of any suspect product that may have entered this country.
Botulism is caused by the bacterium Clostridium botulinum. Symptoms of this illness are general weakness, dizziness, double vision, speaking and swallowing difficulties, breathing problems, muscle weakness, abdominal distention, and constipation. Consumers with these symptoms should seek immediate medical attention.
FDA made the request last August after evaluating the final report on the International Primary Pulmonary Hypertension Study. Preliminary evaluation of the study, before approval of Redux, found the PPH risk in users of appetite-suppressant drugs for three months or longer to be about nine times higher than in nonusers. The final report estimates the risk to be about 23 times higher.
Previous labeling reported PPH occurrence to be about 18 cases per million for adults using Redux three months or longer, compared to about 1 or 2 per million adults in the general population. Occurrence is now estimated at 23 to 46 cases per million patients per year.
Although the risk of PPH in patients taking appetite-suppressant drugs remains small, this is a serious disorder with a four-year death rate of 45 percent.
Redux treatment should be stopped if the patient develops unexplained symptoms, including breathing difficulty, chest pain, faintness, or swelling in the lower legs or ankles. Those taking Redux should call a doctor if they have any PPH symptoms or problems exercising. Any appetite-suppressant drug should be taken only under careful medical supervision.
Questions have been raised about studies showing long-term changes in the brains of animals. The relevance of these findings to humans is unknown.
The manufacturer of Redux, Interneuron Pharmaceuticals Inc. of Lexington, Mass., and the distributor, Wyeth-Ayerst of Philadelphia, sent letters to more than 300,000 health-care providers advising that the new findings reinforce the conclusion that Redux should not be used for "cosmetic" weight loss--that is, when the person's height-to-weight ratio does not provide a medical reason for weight loss. (See "New Weight-Loss Drug" in the Updates section of the July-August 1996 FDA Consumer.)
Wyeth-Ayerst has agreed to report cases of PPH to FDA within 15 days.
Health-care professionals should report adverse events to Wyeth-Ayerst by calling (1-800) 934-5556, or to the FDA MedWatch Program by calling (1-800) FDA-1088, or by mailing the report to MedWatch, HF-2, FDA, Rockville, MD 20857.
(For more about weight loss, see "Losing Weight Safely" in the January-February 1996 FDA Consumer.)
Patients who have swelling, tenderness, other signs of infection at the site of injection, or other adverse reactions should contact their doctors immediately.
FDA announced a nationwide alert last Aug. 30 about the unapproved adrenal cortex extract, in 30-milliter vials, due to the product's potential for causing serious and life-threatening injuries. It is distributed by Phyne Pharmaceuticals of Scottsdale, Ariz.
FDA, the national Centers for Disease Control and Prevention, and numerous state agencies have received reports since April 1996 of abscesses--serious bacterial infections--forming at sites where patients had been injected with the product. By early September, there were at least 54 reports.
Adrenal cortex extract is not approved by FDA for any use. It is usually derived from the adrenal glands of cattle, sheep or swine. Although it has never been shown to be effective for treating any medical condition, it has been promoted over the years for a wide variety of uses, including weight loss, burn treatment, and combating substance abuse addictions.
Other possible problems with the Hallmark Labs adrenal cortex extract include preparation under conditions that could lead to its contamination and labeled indications for use that might expose patients with low immunity to particular risk.
FDA has worked with other government agencies to investigate how this potentially contaminated product was manufactured and distributed. The agency has taken regulatory steps to identify the responsible parties and to ensure prompt removal of the products from the market.
The agent, Nofetumomab, is a fragment of a monoclonal antibody that, when "tagged" with the radioisotope technetium, can detect a protein found on the surface of most SCLCs. By detecting tumors in different parts of the body at one time, the product can help doctors advise certain patients with extensive disease about treatment options without requiring further diagnostic tests.
FDA licensed the new agent last Aug. 20 for patients diagnosed with SCLC through a confirmed biopsy but not yet treated. Nofetumomab should be used only once. The product should not be used to rule out suspected lung cancer or its spread in patients without confirmed SCLC. It also should not be used to evaluate subsequent treatment.
In a clinical trial of 89 patients with confirmed SCLC, Nofetumomab accurately determined 82 percent of the time whether the disease was extensive or limited. If the agent indicated extensive disease, the result was true in 94 percent of patients. But if the agent indicated limited disease, it was less valuable as a diagnostic aid, failing to image some tumors in about 23 percent of patients. Because of this potential for false negatives, additional standard diagnostic tests should be performed when Nofetumomab indicates limited disease.
Each year in the United States, about 30,000 new cases of SCLC are diagnosed. For those with extensive disease, the median survival is 33 weeks, and only 1 to 3 percent of these patients survive more than three years. In contrast, up to 20 percent of patients with limited disease may survive more than three years.
The Nofetumomab kit will be distributed under the trade name Verluma by the Dupont Merck Pharmaceutical Co., Billerica, Mass.
Their titles and publication 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 numbers.