Aggrastat (tirofiban) and Integrilin (eptifibatide) were approved in May. They join ReoPro (abciximab), which was approved in 1994, as "anti-platelet" treatments that inhibit clot formation.
When patients undergo cardiac procedures such as angioplasty and stent placement, blood vessels sometimes react as if they have been injured, forming blood clots. In an injury, such clots are protective, but in cardiac procedures, a blood clot interferes with blood flow and leads to symptoms similar to those of a heart attack. Some patients may actually have a full heart attack or other complication, requiring emergency procedures.
The three anti-platelet medications reduce the signals that trigger clot formation. Aggrastat and Integrilin are approved for use in acute coronary disease. Reopro and Integrilin are approved for use around the time of balloon angioplasty and related procedures.
In clinical trials involving several thousand patients, those who took these three drugs suffered fewer heart attacks and required fewer urgent procedures. However, the trials did not evaluate the effect on long-term survival. The only known important side effect of the drugs is excessive bleeding.
SD plasma, approved May 6, is made from the pooled plasma of thousands of donors. The advantage of the pooled product is that it undergoes a solvent detergent procedure that inactivates some viruses, including hepatitis B and C and the human immunodeficiency virus, which causes AIDS. Current screening methods used on all blood donors do not always detect early infections.
The disadvantage of SD plasma is that pooling may increase the risk from other viruses that are not inactivated by SD treatment. Fresh frozen plasma comes from single donors.
However, both SD plasma and fresh frozen plasma are manufactured with overlapping safeguards that result in an effective, safe blood product.
SD plasma is manufactured by V.I. Technologies Inc., Melville, N.Y., under the trade name VIPLAS/SD. The company has a contract with the American Red Cross to distribute the product.
Rebetron, approved June 3, combines Intron A (interferon alfa-2B recombinant for injection) with Rebetol (ribavirin) capsules.
Chronic hepatitis C, a blood-borne liver disease, affects about 4 million Americans. It can lead to cirrhosis, liver cancer, or liver failure.
While Rebetron does not cure hepatitis C, and it is unknown if the treatment will delay liver disease progression, the product appears to suppress blood levels of the virus better than re-treatment with interferon alone. In clinical trials, 50 percent of patients treated with the combination showed improvement in liver inflammation, versus 34 percent treated with interferon alone.
Serious side effects can occur with Rebetron, and physicians should monitor patients closely. For example, because animal studies have linked both Rebetol and Intron A to adverse reproductive effects such as fetal death and malformations, women must not become pregnant during therapy and for six months after. Rebetol also causes anemia, which can be especially serious in patients with underlying cardiovascular disease. Intron A is associated with psychiatric disorders such as depression and suicidal behavior, as is the Rebetol/Intron A combination. Intron A also prompts flu-like symptoms, which often can be relieved with over-the-counter medications.
Rebetron is marketed by Schering Corp., Kenilworth, N.J.
Apligraf protects wounds and fosters the growth of healthy new skin in those ulcers caused by a lack of proper blood flow to the skin, a condition that is estimated to affect thousands of Americans each year and often requires multiple surgeries.
Apligraf, manufactured by Organogenesis Inc., Canton, Mass., was approved May 26 for use along with standard therapy.
Rifapentine is intended to be used in combination with other anti-tuberculosis drugs to treat pulmonary tuberculosis, a lung infection that can be highly contagious and life-threatening. Rifapentine has been designated an orphan drug because pulmonary tuberculosis affects a relatively small population of patients in the United States.
Despite a higher relapse rate of pulmonary tuberculosis for patients treated with a drug combination that includes rifapentine during clinical trials than those treated with the similar drug rifampin, an agency advisory committee recommended approval because neither relapse rate was alarmingly high and:
Marion Merrell Dow, Kansas City, Mo., will manufacture rifapentine under the trade name Priftin.
Air delivery ... A ventilator that provides precise breath delivery for critically ill infant, pediatric and adult patients has received FDA clearance. The Nellcor Puritan Bennett 840 Ventilator System comes with touch screens that display monitored data separately from the ventilator settings. An area on the screen allows the clinician to set up and preview all proposed ventilator and alarm limit settings before they are applied to a patient. The ventilator settings are organized according to procedures followed by clinicians and physicians.
Fail-safe pacing ... A new kind of pacemaker cleared by FDA can monitor whether each electrical impulse delivered results in a heartbeat. If no response is detected, the pacemaker automatically delivers a back-up pulse within milliseconds. Autocapture, manufactured by St. Jude Medical, Inc., was tested for three years on 21,000 patients for automation, simplicity and safety.
Fresh from the sea ... Scientists at FDA's National Center for Toxicological Research (NCTR) have developed an inexpensive freshness indicator that, when packed with seafood, will change color if the product spoils. The indicators will be marketed under the trade name "Fresh Tag" by Cox Technologies, Inc., a North Carolina company that has licensed the NCTR technology from FDA. The prototype is being tested on frozen shrimp at the University of Florida, Seafood Products Laboratory, Gainsville, Fla., and will be tested on thawed shrimp in major supermarkets in the next two months. Extension of the technology to other food products is under way at NCTR.
Salmonella clarification ... As reported in the July-August Updates section, Preempt, a product that introduces natural chicken bacteria into the intestines of newly hatched chicks, greatly reduces Salmonella bacteria colonization. It doesn't, however, eliminate Salmonella entirely. So, when preparing chicken products, consumers should continue to follow these safe food-handling practices:
Roche Laboratories of Nutley, N.J., and FDA announced in June the market withdrawal of Posicor (mibefradil), a calcium-channel blocker approved for high blood pressure and chronic stable angina, because of the drug's link to an increasing number of reports of adverse reactions in people taking other drugs, such as tamoxifen, lovastatin (Mevacor), imipramine (Tofranil), and simvastatin (Zocor).
FDA advised patients taking Posicor to consult with their doctors before stopping the medicine or beginning any new ones.
Posicor reduces the activity of certain liver enzymes needed to rid the body of other drugs. This allows some drugs to accumulate in the body to dangerous levels.
When Posicor was first marketed in August 1997, its labeling warned of possible interactions with three drugs. In December, two more drugs were added to the label warning. FDA also issued a public warning, and Roche notified doctors. Since then, through spontaneous reports and ongoing clinical trials, FDA and Roche have continued to learn of adverse reactions related to the co-administration of Posicor with other drugs.
While drug interactions can often be addressed through labeling changes and public education, FDA and Roche agreed that it would be difficult to prescribe Posicor safely because of the seriousness of the interactions and the complex prescribing information that would be needed. Posicor has not been shown to offer special benefits, such as effectiveness in patients who do not respond to other treatments.
Those with questions about Posicor can call Roche at 1-800-205-4611.
Duract, a nonsteroidal anti-inflammatory drug, was approved in July 1997 for short-term treatment of acute pain. The drug was not approved for longer use because clinical trials revealed a higher incidence of elevated liver enzymes with such use.
Reports that several patients who took the drug for longer than 10 days experienced severe hepatitis and liver failure prompted the manufacturer, Wyeth-Ayerst, St. Davids, Pa., in February 1998 to add a black-box warning to the labeling and send a "Dear Doctor" letter to health-care professionals about the reactions.
But FDA and Wyeth-Ayerst continued to receive reports of severe injuries and death from long-term use of the drug. Given that other therapies are available, the agency and Wyeth-Ayerst agreed last June to withdraw Duract from the market.
FDA says patients with questions should contact their doctors. Also, patients and health-care providers can call Wyeth-Ayerst at 1-800-281-9260.
In revisions to the drug's labeling and a letter to health-care providers from the drug's sponsor, health professionals are advised that Propulsid should generally be used in patients who have not responded adequately to lifestyle changes or other drugs for the condition and that the drug should not be used in patients who:
Health-care providers can report Propulsid-related adverse reactions to the drug's sponsor, Janssen Pharmaceutica, Titusville, N.J., by calling 1-800-526-7736 or to FDA's MedWatch program at 1-800-FDA-1088 (1-800-332-1088).
Synagis (palivizumab) was licensed in June to treat infants under 2 with lung problems related to chronic bronchopulmonary dysplasia or prematurity.
Synagis is a monoclonal antibody made using human and mouse antibody genes. Because it is genetically engineered, the product can be made consistently on a large scale.
The first product approved for the disease, RespiGam [RSV Immune Globulin Intravenous (human)], is made from plasma taken from large numbers of normal, healthy individuals. Although both products must be given in five monthly doses, Synagis, is given intramuscularly, rather than intravenously for hours as RespiGam is. Also, Synagis is more concentrated than RespiGam, an advantage because infants with certain pulmonary diseases may retain excess fluids.
Medimmune Inc. of Gaithersburg, Md., markets both Respigam and, through a marketing alliance with the Ross Products Division of Abbott Laboratories, Synagis.
FDA announced in July the nationwide recall of the Moulding Body Electrical Body Belts, also called the Personal Electro-Sauna, by TV Store Corp., also known as Body Fitness Inc., of Miami. FDA, which had not approved the product, warned consumers to stop using it at once.
The electrical pad resembles a heating pad that is wrapped around the waist, thighs or arms. Sold across the United States, as well as in Puerto Rico and Canada, it had been promoted through ads on Hispanic television.
Anyone with questions about the product can call the company at 1-800-366-9940, Monday through Friday, 9 a.m. to 1 p.m., Eastern time.
The M1000 ImageChecker analyzes the content of mammograms and highlights suspicious areas on the images after the radiologist has done the initial evaluation.
The device first scans the image with a laser beam, then converts it into a digital signal that a computer can process. After the computer marks suspicious areas on a video display of the image, the radiologist can compare the image to the original mammogram to see if any of these areas escaped notice and requires further evaluation.
The device, made by R2 Technology Inc., Los Altos, Calif., has been shown in studies to improve a radiologist's detection rate from about 80 out of 100 to 88 out of 100 cancers.
As proposed, the rule would allow dissemination only of reliable and balanced information that has been, or will be, studied and submitted for FDA approval. Companies could distribute information about the safety, effectiveness or benefits of an unapproved use of a drug, biologic, or medical device if the information is not false or misleading and:
Also, companies would be required to give FDA a copy of the information for the agency's evaluation of its objectivity and balance.
Nerve rebirth ... Patients suffering from strokes or injuries to the brain and spinal cord may have hopes for recovery in the future. In research at the University of Zurich in Switzerland, brain-damaged rats injected with a specially engineered antibody sprouted new, healthy nerve fibers in undamaged areas of their brains and spinal cords, enabling them to regain use of their limbs. Damaged fibers also showed regeneration. Since strokes tend to damage only one side of the brain, and because damaged nerve fibers in human adults do not regenerate on their own, the study's findings could help lead to new approaches for treating neurological injuries. (Nature Neuroscience, June 1998)
Spray relief ... An experimental vaccine sprayed as a fine mist into children's nostrils appears to be highly effective in preventing the flu and flu-related ear infections, say researchers at the National Institute of Allergy and Infectious Diseases. The vaccine, FluMist, proved 93 percent effective against the flu and provided 98 percent protection in 1,314 children between 1 and 6 years old who participated in the study. (The New England Journal of Medicine, May 1998)
Shots on the menu ... Edible vaccines someday may fight diseases such as hepatitis, whooping cough, and tetanus, says a study conducted in part by the University of Maryland. Volunteers who ate bite-size pieces of a genetically engineered potato developed defenses against certain germs. Scientists hope the concept can be launched in the developing world, where storing and administering vaccines are often major problems. The National Institute of Allergy and Infectious Diseases sponsored the study. (Nature Medicine, May 1998)
Fake fat found fine ... The fat substitute Olestra is still considered safe for consumers, says FDA, despite recent health concerns. New safety data convinced the agency that the fake fat does not cause significant health problems. Products containing Olestra must carry a warning label indicating that the fat substitute may cause gastrointestinal upset. The agency approved Olestra in 1996 on the condition that its manufacturers and marketers report any adverse health effects.
Cause and effect ... The same gene mutation that causes cystic fibrosis also appears to protect against a bacterial infection from typhoid fever, says a study by Brigham and Women's Hospital and Harvard Medical School in Boston. The finding emphasizes how basic research in one disease can lead to discoveries in others. (Nature, May 1998)
Bottled up inside ... Manufacturers of bottled water must now monitor their water sources and finished products at least once a year for nine possible contaminants, under an amended quality standard published in an FDA final rule. The amendment lifts the stay on the effective date for allowable levels of the chemicals antimony, beryllium, cyanide, nickel, thallium, diquat, endothal, glyphosate, and dioxin in bottled water imposed in the 1996 final rule. (Federal Register, May 11, 1998)
Snore no more ... Radio wave energy can shrink the soft palate tissue of people with severe snoring problems, says a sleep disorders study. The technique offers a painless outpatient alternative to surgery or wearing a mouthpiece or mask, say study doctors. A probe is inserted into the back of the roof of the mouth and aims energy into the palate, which creates heat and shrinks the tissues obstructing the air passage. (Chest, May 1998)
FDA Consumer magazine (September-October 1998)
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