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Updates

New Safety Standard for Device Electric Wires

Under a new FDA safety standard, manufacturers must protect the electric wires connecting patients to their medical devices so the wires cannot be mistakenly plugged into a live electric outlet.

The wires, called electrode lead wires and patient cables, have an electrode at one end attached to the patient, with the other end attached to the device. Without protection, this other end could be mistakenly plugged into an electrical outlet while the electrode is attached to the patient, possibly burning or even electrocuting the person.

Although many manufacturers voluntarily protect the wires and cables, accidents have occurred in both hospitals and homes. Between 1985 and 1994, 24 infants and children received severe electric shocks from unprotected wires, and five died.

Most of the cables and wires must meet the standard within three years. However, protection must be in place within one year for the 10 highest-risk devices: breathing frequency monitors, apnea monitors, electrocardiographs, physiological signal radio transmitters and receivers, heart monitors, electrocardiograph electrodes, transducer and electrode cables, medical magnetic tape recorders, arrhythmia detectors and alarms, and electrocardiograph telephone transmitters and receivers.

FDA published the mandatory standard in the May 9, 1997, Federal Register.

Prison, Fines for Perpetrators
Of Food and Drug Fraud

Three men face up to three years in prison for selling rotten shrimp and an unapproved drug touted as a cure-all for serious diseases. Those who sold the rotten shrimp were fined, and the company was ordered to pay $1 million.

Charles R. Pixley, a New York book publicist found guilty of selling the unapproved drug 714X, lost his appeal and will serve one year and one day in federal prison, as ordered in 1996.

The U.S. Court of Appeals for the 2nd Circuit, based in New York, affirmed Pixley's conviction May 7, stating that because 714X was promoted as a treatment for cancer, AIDS and other diseases, it is subject to FDA's new drug approval requirements. FDA's case against Pixley was reported in the Investigators' Reports section of the November 1996 FDA Consumer.

In another case, reported in the April 1997 FDA Consumer, a company and three employees were sentenced for selling rotten imported Chinese shrimp that had been chemically treated and passed off to consumers as "fresh frozen."

Sigma Corp. Inc. of St. Petersburg, Fla., and Sigma managers William A. Walton and Charles Sternisha were sentenced May 9 in the U.S. District Court for the Middle District of Florida. Robert Fields, a salesman, had been sentenced March 24.

The corporation was fined $1 million, placed on five years' probation, and ordered to pay $160,916 in prosecution fees, special assessments, and restitution. Walton was sentenced to three years, five months in prison and two years' probation and fined $10,600. Sternisha was sentenced to two years, three months in prison and two years' probation and fined $6,250. Both men remain free without bond, pending their appeals. Fields was sentenced to two years' probation and fined $2,500.

Urgent Factor VIII Recall

Possible contamination with penicillium mold recently prompted the Hyland Division of Baxter Healthcare to recall three lots of Recombinate (recombinant human Factor VIII). Recombinate is injected intravenously to treat the blood disorder hemophilia A.

The possible contamination, announced by FDA last July, may cause infection and, in patients allergic to penicillin, allergic reaction. Both could be severe and even life-threatening.

The recalled lots are:

Anyone who has these lots should return them to the place where they obtained them. Patients and customers with questions may call the company at (1-800) 423-2090.

Catfish Cleared of Dioxin;
Eggs Still Being Sampled

Catfish that had consumed feed inadvertently contaminated with the toxic chemical dioxin are now cleared by FDA for processing and shipping. FDA had originally halted sale of these fish, but new data show that dioxin levels are below the level of concern. At press time, the agency still had not cleared for sale eggs from poultry that ate the contaminated feed.

The detected dioxin levels pose no immediate health hazard, and consumers should not hesitate to consume catfish or eggs bought on the retail market.

After finding elevated levels of dioxin in two of 80 poultry samples, FDA on July 7 told makers of the tainted animal feed to stop further distribution and use of the feed. The agency told catfish and egg producers not to ship their products if the fish or chickens had eaten the feed. The agency said the companies could resume shipping only if they showed through testing that the human food contained less dioxin than 1 part per trillion.

Investigation by FDA and other federal and state agencies showed that the dioxin source was "ball clay," a common anti-caking agent added to soybean meal. The ball clay was traced to a Mississippi clay mine, which stopped shipping the clay for feed use.

"Dioxin" refers to a class of chemical pollutants created as byproducts of chemical manufacturing, incineration, chlorine bleaching of paper pulp, and other industrial processes. Dioxins exist in the environment at low levels and are known to accumulate in the food chain. Continued high exposure to dioxins can increase the risk of cancer and other health problems.

States Join FDA in Enforcing Tobacco Rule

Florida and Washington are FDA's first state partners for enforcing the agency's 1996 rule to protect children from tobacco.

The rule prohibits the sale of cigarettes and smokeless tobacco to children under 18 and requires retailers to check photo ID's of anyone under age 27. (See "Saving Our Children from Tobacco" in the October 1996 FDA Consumer, as well as Children and Tobacco on this web site.)

Under contracts with FDA, announced in June, each state will conduct about 300 unannounced retail checks monthly for eight months. Children ages 15 and 16, accompanied by an adult, will try to purchase cigarettes or smokeless tobacco in retail stores throughout the respective state.

FDA will issue a warning the first time a retailer is found selling to children and will plan repeat inspections. The agency will seek a $250 fine for the second violation and greater fines after that.

Unapproved Lasers Seized
From Florida Manufacturer

As part of a crackdown on the sale and use of lasers not approved for eye surgery, U.S. marshals, on behalf of FDA, seized nine excimer lasers and components valued at more than $3 million from Photon Data Inc., of Winter Park, Fla.

The lasers, which FDA had not reviewed for safety and effectiveness, were being sold to reshape the cornea to treat nearsightedness and other eye conditions. They were seized June 9.

FDA is concerned about the potential for serious eye injury from unapproved excimer lasers because manufacturers have not submitted success rates, number of adverse events, critical safety engineering data, and other information FDA requires to show the devices are safe and effective. Physicians using unapproved excimer lasers might not have enough information to counsel patients adequately on the benefits and risks of the treatment.

FDA's concern about unapproved excimer lasers has been heightened by recent reports of serious eye injuries from the devices such as permanently damaged eyesight or temporary blindness requiring a corneal transplant. The agency asks patients who have been injured, or doctors aware of such injuries, to inform FDA's MedWatch service by phone, (1-800) FDA-1088; by fax, (1-800) FDA-0178; or by modem (1-800) FDA-7737.

Currently, FDA has approved only two lasers for photorefractive keratectomy (PRK), a surgical procedure that treats nearsightedness. The laser manufacturers, Summit Technology Inc., of Waltham, Mass., and Visx Inc., of Santa Clara, Calif., conducted clinical studies to show that their lasers were safe and effective. (See "Laser Procedure for Nearsightedness" in the Updates section of the January-February 1996 FDA Consumer.) FDA also has approved a Visx laser to treat astigmatism.

Several other lasers for eye surgery are currently in FDA-sanctioned clinical trials.

Patients considering laser surgery for nearsightedness or astigmatism should ask their doctors if the laser is an approved Summit or Visx product. If not, they should make sure the laser is part of an FDA-sanctioned clinical study.

At press time, only the Photon Data devices had been seized, but FDA plans to take enforcement action against other unapproved excimer lasers on the market.

Risk of Tick-Borne Illness
Prompts Blood Recall

The possibility of transmitting tick-borne disease through blood transfusions recently prompted a voluntary recall of blood products from six states.

United Blood Services, also known as Blood Systems Inc., collected the potentially infected blood at Fort Chafee, Ark., during May and June. The states that may have received the recalled red blood cells, platelets, and recovered plasma are Alabama, Arizona, Louisiana, Mississippi, Oklahoma, and Texas.

In addition, other blood and plasma collections sites may have received potentially infected blood from individuals in training at Fort Chafee from April through June. FDA and the national Centers for Disease Control and Prevention advised that individuals who donated blood within four weeks of leaving the fort should immediately notify the center where they donated. If notified, a center should take immediate steps to retrieve the potentially affected blood and blood components intended for transfusion.

Patients who received these blood products should have been notified by their physicians in July and told to report any illness. All tick-borne infections can cause fever, as well as headache, muscle pain, and sometimes a rash. While the majority of infections are mild, often without symptoms, a small number can be serious and even fatal.

People with questions about the source of blood products they received should contact their doctors. Health professionals should report any adverse events associated with these products to FDA's MedWatch program.

Less Foreign Inspection Likely

Recent agreements may reduce dramatically the need for FDA inspection of regulated firms in European Union countries.

The United States and countries in the European Union have agreed that FDA and its EU counterparts may exchange inspection reports on pharmaceutical and medical device firms. In addition, the agencies may exchange medical device evaluation reports prepared by third parties, based on the existing FDA external review pilot program for selected devices. Appropriate confidentiality will be maintained, as well as public access to certain information.

Currently, FDA and the EU regulatory agencies conduct hundreds of such overseas inspections annually, at considerable expense to their taxpayers. Under the agreements when fully implemented, the agencies would each inspect the appropriate domestic firms and ensure compliance with the regulations of the country to which the firms export.

FDA's readiness to participate in such agreements is based on demonstrated equivalence of EU inspection procedures and good manufacturing practice standards. Equivalence would be assessed during a three-year transition period.

At all times, each agency retains full responsibility for products marketed in its own country and can take action necessary to protect the public health.

1997 Food Code Available

The latest science-based food safety information is available in FDA's 1997 Food Code, a publication that gives food safety guidelines for restaurants, grocery stores, nursing homes, and other institutional and retail food operations.

The Food Code is used by the more than 3,000 state and local regulatory agencies that establish and enforce food safety rules. (See "New Food Code: A Menu of Modern Safety Standards" in the April 1994 FDA Consumer.)

The 1997 edition features for the first time separate guidelines on serving safe food to susceptible populations, such as young children in day care and older adults in long-term health-care facilities. It also gives appropriate wording for consumer advisories on consumption of raw and undercooked foods of animal origin and includes language on in-shell egg pasteurization, a new technology in which eggs are heated long enough to destroy a specific bacterium without actually cooking the eggs.

As in previous editions, the 1997 Food Code guidelines are based on the Hazard Analysis Critical Control Point food safety system, which involves identifying and monitoring the points in food preparation where the risk of food-borne hazards is greatest.

The Food Code is available on FDA's World Wide Web site at http://vm.cfsan.fda.gov/~dms/foodcode.html and is provided in several different formats. Spiral-bound copies (order number PB97133656) and a WordPerfect 6.1 version on diskette (order number PB97501274) are available for $35 each from the National Technical Information Service, Springfield, VA 22161; (703) 487-4650. The e-mail address is orders@ntis.fedworld.gov. To place an order by facsimile, dial (703) 321-8547. For rush orders, call (1-800) 553-NTIS.

Supplements with Plantain
May Pose Danger, FDA Warns

Consumers should stop buying and using certain dietary supplements labeled as containing plantain because they may contain Digitalis, a plant that contains powerful heart stimulants.

FDA issued this warning after finding Digitalis in samples of raw material labeled as plantain and used by various manufacturers in herbal laxatives, poultices and tea. Some of the suspect plantain also was distributed to retailers who sell it in bulk for making tea. The labels of suspect products may list plantain as an ingredient.

Consumers who have herbal laxatives or tea labeled as containing plantain should contact the store where the products were bought to learn whether or not the product is from one of the manufacturers or distributors believed to have received the mislabeled raw material. Consumers also can get an updated list of manufacturers and distributors of suspect products from FDA's Consumer Hotline, (1-800) FDA-4010, or on FDA's World Wide Web site at http://www.fda.gov/bbs/topics/NEWS/NEW00570.html.

Consumers who experience adverse reactions associated with the consumption of plantain-labeled products should see a doctor. Consumers and health professionals can report adverse reactions associated with these products to FDA's MedWatch adverse event reporting line at (1-800) FDA-1088.

FDA investigated the plantain-labeled products after receiving a report of an abnormal heart rate with heart block--a life-threatening condition--in a young woman who ate a dietary supplement labeled as containing plantain. FDA analysis indicated the presence of lanatosides, constituents of the herb Digitalis lanata, in raw material.

Digitalis is an active ingredient of some prescription heart medicines. It can cause nausea, vomiting, dizziness, headache, confusion, low blood pressure, vision problems, and abnormal heart rate and rhythm, including cardiac arrest.

Plantain is a perennial weed of the genus Plantago, which includes more than 200 widely distributed species. It is not the same as the tropical banana plant of the same name whose fruit is cooked and eaten as a vegetable.

Final Feed Rule
Reduces Risk of BSE

To protect ruminant animals such as cattle, sheep and goats from transmissible neurological diseases, including bovine spongiform encephalopathy (BSE), and to keep potential human risk very low, an FDA final rule prohibits most mammalian protein from feeds for these animals.

The rule, which also requires controls to ensure that feeds are free of prohibited protein, took effect Aug. 4.

BSE, a transmissible degenerative disease of the nervous system, has never been documented in cattle in the United States. If it were ever found here, the rule would prevent its spread through feeds.

The rule excludes animal products that pose minimal risk of transmitting BSE, including blood, blood products, gelatin, milk, and milk products. It excludes inspected meat products originally produced for human consumption, such as plate waste from restaurants and institutions that is then further heat processed before being made into animal feed. Also excluded are pure pork and pure equine protein. Because pigs and horses are not known to have transmissible spongiform encephalopathies, their protein is excluded when it is from facilities that handle only these species.

FDA published the rule in the June 5, 1997, Federal Register. To reach it on the Internet, go to http://www.fda.gov/cvm/fda/infores/updates/bse/6597bse.html.

Free Reprints

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 number.

Consumer-Friendly Birth Control Information

A new, easy-to-understand table from FDA that compares the effectiveness of birth control methods is available in both HTML format and as a 7K PDF file. FDA is working with manufacturers to include the table in the patient information for all contraceptive products. (See also "Protecting Against Unintended Pregnancy: A Guide to Contraceptive Choices" in the April 1997 FDA Consumer.)

Report Problems to MedWatch

To report serious health problems associated with products in the following updates,
health professionals should call FDA at (1-800) FDA-1088, or report by fax at (1-800) FDA-0178.

Health Advisory on Newest AIDS Drugs

Drugs called protease inhibitors may contribute to increases in blood sugar and diabetes in HIV-infected patients, and doctors should closely monitor patient glucose levels, FDA has advised doctors.

The agency informed doctors in June that it received reports of 83 cases of new or exacerbated diabetes mellitus and hyperglycemia in HIV patients taking the drugs. While many patients who discontinued protease inhibitor therapy saw a reduction in their symptoms, a clear causal relationship between the drugs and onset of the conditions has not been established. Many patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycemia.

Of the 83 patients, 27 were reported to require hospitalization, including six life-threatening cases. Five cases resulted in ketoacidosis, a serious diabetes-related condition. Protease inhibitors will carry revised labeling that delineates this potential side effect.

HIV patients on protease inhibitor therapy should be aware of the warning signs of hyperglycemia and diabetes: increased thirst and hunger, unexplained weight loss, increased urination, fatigue, and dry, itchy skin. These symptoms occurred in the reported cases, on average, in approximately 76 days from starting protease inhibitor therapy, but FDA is aware of cases where symptoms appeared as early as four days after starting this therapy. FDA will continue to monitor for additional events. Health-care professionals should report any cases of diabetes, hyperglycemia, or any other serious toxicity associated with the use of protease inhibitors to FDA's MedWatch program.

(See also "New Ways to Prevent and Treat AIDS" in the January-February 1997 FDA Consumer.)

Mixing Diet Drugs Calls for Caution

Reports of heart valve disease in women taking the obesity drugs fenfluramine and phentermine together have prompted FDA to advise doctors to closely monitor patients on this therapy.

In a letter to doctors, FDA noted that as of July 8 it had received reports of 33 cases of unusual abnormalities in heart valves in women ages 30 to 72 taking both drugs together for one to 28 months. The course of the disease when the drugs are stopped is unknown at this time.

There is no conclusive evidence of a cause-effect relationship between use of the drugs and development of this disease. However, because of the seriousness of the heart problems and their rarity in otherwise healthy obese women, FDA believes patients and health professionals need this information. The agency will continue monitoring adverse events reports.

FDA approved each drug for use alone and short term, not in combination or for long term. In accordance with approved labeling, only obese patients should take these drugs, and they should also follow a weight-loss regimen that includes a reduced-calorie diet and an exercise program. (See "Losing Weight Safely" in the January-February 1996 FDA Consumer, "New Weight-Loss Drug" in the Updates section of the July-August 1996 issue, and "Redux Relabeling Notes Higher Risk" in the Updates of the November 1996 issue.)

Health professionals should give patients on this therapy thorough heart evaluations and, if heart disease develops, pursue further such evaluation. They also should report any heart valve disease or other serious problems associated with the use of phentermine, fenfluramine, and also dexfenfluramine to FDA's MedWatch program.

Editor's Note: Herbal "fen-phen" is not similar to the prescription drug combination of fenfluramine and phentermine. Herbal fen-phen is marketed as a combination of herbals and, like all products sold as dietary supplements, can be marketed without FDA review of safety or effectiveness, in accordance with the Dietary Supplement Health and Education Act of 1994. For further information on a specific dietary supplement product, contact the manufacturer. Check with your health-care professional about use of the product.

Don't Buy Abortion Kits Over the Net, FDA Warns

Consumers should not purchase home abortion kits or female self-sterilization kits sold over the Internet, FDA warns. These unapproved products pose significant, possibly life-threatening health risks.

The abortion kit is inaccurately advertised as a "complete kit for early pregnancy termination without surgery ... scientifically proved safe and unrisky." The kit provides drugs not approved by FDA to terminate pregnancy.

The agency assessed the product and concluded that using the kit without a physician's supervision could cause heavy vaginal bleeding and even death. Birth defects also can result if a pregnancy is carried to term after using these drugs.

The self-sterilization kit claims to use a method similar to inserting an intrauterine device and to have a lower risk than surgical sterilization. The kit uses an unapproved drug, quinacrine hydrochloride, which can cause ectopic pregnancy, abnormal pregnancies, and permanent damage to reproductive organs.

FDA is continuing to investigate and monitor both products.

FDA Consumer magazine (September-October 1997)

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