U.S. Food and Drug Administration
FDA Consumer magazine
November-December 2001
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Nearly 5 million people in the United States have congestive heart failure. Each year, there are an estimated 400,000 new cases, and half of those diagnosed with the condition will be dead within five years, according to the National Heart, Lung, and Blood Institute.
Researchers continue to develop treatments for this condition, in which the heart cannot adequately pump blood around the body, causing fluid to seep into the lungs and hinder breathing. Two of these treatments--a drug injection and a new type of pacemaker--recently were approved by the FDA.
Natrecor (nesiritide) Injection, a synthetic version of a human hormone, works by dilating the veins and arteries so more blood can flow through them.
In a study of 489 people who needed to be hospitalized because of shortness of breath due to congestive heart failure, participants were treated with either Natrecor, intravenous nitroglycerin, or an inactive substance (placebo) for three hours. Those receiving Natrecor reported greater improvement in shortness of breath than those receiving a placebo.
Natrecor's major side
effect is low blood pressure. The
drug is made by Scios Inc., of Sunnyvale,
Calif.
People with congestive heart failure
who have not been completely helped
by drug treatment and whose hearts'
pumping chambers (ventricles) don't
beat in synchronization may be candidates
for a biventricular pacemaker. The
InSync Biventricular Cardiac Pacing
System is the first biventricular
pacemaker approved for treating the
symptoms of congestive heart failure.
The InSync system consists of a pulse generator implanted in the chest and connected to the heart chambers by three wires (leads) that deliver electronic impulses. The impulses stimulate the left and right ventricles to pump together, helping the blood to flow more efficiently. The InSync pacemaker differs from a standard pacemaker in that it has three leads instead of one or two.
In a study of the InSync system, physicians implanted the device in nearly 600 people with moderate to severe congestive heart failure. They switched the system "on" in half of the study participants, and "off" in the other half. After six months, the majority of people with the activated device showed improvement in either quality of life scores, distance they were able to walk, or heart failure classification. About one-third of the people with the pacemaker turned off showed improvement. The study showed no major safety issues with the device itself. However, implanting the device requires special training for the physician.
The InSync system is made by Medtronic Inc., of Minneapolis. The FDA is requiring Medtronic to conduct a post-market study of the device in 1,500 people followed over three years.
The FDA has approved several generic versions of the popular antidepressant drug Prozac (fluoxetine). Approved in 1988, Prozac was the first of a new class of antidepressant drugs called selective serotonin reuptake inhibitors (SSRIs). The drugs are thought to work by increasing the activity of the hormone serotonin in the brain--a process believed to stave off depression's symptoms.
The FDA approved several manufacturers' applications to market various dosages in capsules and tablets, as well as an oral solution.
The FDA has approved Entocort EC (budesonide) capsules for the treatment of mild to moderate Crohn's disease involving certain sections of the small and large intestines.
Crohn's disease is a chronic inflammatory bowel disease characterized by diarrhea, abdominal pain or cramping, fever, fatigue, loss of appetite, and weight loss. Entocort EC, an orally administered steroid, is released in the intestine, where it works to decrease inflammation.
Because most of Entocort EC is not absorbed into the body, people taking the treatment may experience fewer of the typical side effects associated with other steroids used to treat Crohn's disease such as prednisone and prednisolone tablets.
Entocort EC was studied in 651 patients with active Crohn's disease. Those treated with Entocort EC experienced significant improvement in their symptoms. The most common adverse events were headache, respiratory infection, and nausea. In addition, fewer people receiving Entocort EC experienced facial swelling and acne than those receiving prednisolone.
AstraZeneca LP of Wilmington, Del., manufactures Entocort EC.
The FDA has announced approval of a flexible, transparent contraceptive ring that is inserted into the vagina. The product, called NuvaRing, releases a continuous low dose of the hormones etonogestrel and ethinyl estradiol, which are similar to the active ingredients in some oral contraceptives. The new birth control product is available by prescription only.
A woman inserts the ring herself, and it remains in the vagina for three weeks. She then removes the ring for one week, during which she will have her menstrual period. A new ring is used each month for continuous contraception.
Like oral contraceptives, NuvaRing is highly effective when used as directed. It's estimated that out of 100 women using NuvaRing for an entire year, one or two will become pregnant. Two large multi-center trials with more than 2,300 women were conducted in the United States, Canada, Europe, and Israel to evaluate NuvaRing's safety and effectiveness.
Women who use NuvaRing will receive a brochure describing how to use the product, as well as information on effectiveness, benefits, and risks. Side effects may include vaginal discharge, vaginitis, and irritation, and NuvaRing may increase the risk of blood clots, heart attack, and stroke. NuvaRing should not be used by women who smoke, or who have cardiovascular disease, blood clots, or certain types of cancer.
Organon Inc., headquartered in West Orange, N.J., and NV Organon, the Netherlands, developed the new vaginal ring.
The maker of a popular cholesterol-lowering drug has voluntarily withdrawn the product from the market after reports that people taking the drug died of a condition that causes muscle-cell breakdown known as rhabdomyolysis.
Baycol (cerivastatin), made by Bayer Pharmaceutical Division, is a member of a class of drugs known as "statins," used to lower cholesterol. Statins block a specific enzyme in the body that is involved in the formation of cholesterol. While all statins have been associated with rare reports of rhabdomyolysis, deaths as the result of using Baycol have been reported much more frequently than for other approved statins, especially when used at higher doses, by the elderly, and particularly in combination with the cholesterol-lowering drug gemfibrozil (Lopid and generics).
According to the FDA, people who are currently taking Baycol should ask their doctors about switching to one of the following alternative medications to control their cholesterol levels: Mevacor (lovastatin), Pravachol (pravastatin), Zocor (simvastatin), Lescol (fluvastatin), and Lipitor (atorvastatin).
Eight U.S. firms have voluntarily recalled some types of hip implants because they have a component that may crack. The affected component--the zirconia ceramic femoral head--is the ball portion of the prosthesis that connects the end of the large bone in the thigh to the pelvis.
The hip implant recall was initiated by French manufacturer St. Gobain Desmarquest in August because the femoral head was fracturing at a higher rate than expected in some patients 13 to 27 months after being implanted. St. Gobain Desmarquest distributes zirconia and alumina ceramic femoral heads worldwide to most of the orthopedic industry.
The French firm's recall applies to nine batches of zirconia ceramic femoral heads manufactured since early 1998, when St. Gobain Desmarquest changed its manufacturing process. No metal or alumina ceramic femoral heads are involved in the recall.
U.S. companies estimate that hip implants with zirconia ceramic femoral heads are used in less than 6 percent of hip implants in the United States. An estimated 150,000 to 200,000 hip implants are performed annually in this country.
People who have these hip implants should contact their surgeons with any concerns. Not all of the recalled hips are expected to fail, and the FDA is not recommending surgery to replace hip implants that are not causing problems. Physicians likely will choose to monitor the performance of the implant more closely as a result of the potential problem, according to the FDA.
Signs of fracture of the ceramic component may include a sudden pain in the implanted hip joint, sometimes preceded by an audible "pop" from the hip just before the onset of pain. No tests exist that can predict who will experience failure of their hip implants because of the defective component.
U.S. companies that use the St. Gobain Desmarquest zirconia ceramic femoral heads include: Apex Surgical LLC, Lakeville, Mass.; Biomet Inc., Warsaw, Ind.; DePuy Orthopaedics Inc., Warsaw, Ind.; Encore Orthopedics Inc., Austin, Texas; Osteoimplant Technology Inc. (OTI), Hunt Valley, Md.; Smith & Nephew Inc., Memphis, Tenn.; Stryker Howmedica Osteonics, Allendale, NJ; and Zimmer Inc., Warsaw, Ind.
Further details on the recall are available on FDA's web site at www.fda.gov/cdrh/recalls/zirconiahip.html.
Women whose silicone breast implants have ruptured and spread silicone gel beyond the fibrous scar that forms around the implant may be at increased risk for fibromyalgia, an FDA study indicates.
FDA researchers asked 344 women with silicone gel implants if they had experienced persistent joint pain, swelling or stiffness; rash on their breasts or chest; or fatigue. Those in the study also were asked whether a physician had diagnosed them with Raynaud's disease, Sjögren's syndrome, scleroderma, chronic fatigue, or fibromyalgia--a chronic condition marked by fatigue, musculoskeletal aches and sleep disturbances.
The women also had a magnetic resonance imaging (MRI) examination to detect whether their implants were intact or ruptured, and whether silicone gel had leaked outside of the scar tissue immediately surrounding the implant.
The study found that women with a ruptured implant in which the silicone hadn't leaked beyond the scar tissue were no more likely than women with intact implants to report that they had either the persistent symptoms or diagnosed illnesses listed on the questionnaire.
However, the women with silicone gel that had migrated outside the fibrous scar around the implant were nearly three times more likely to report that they had been diagnosed with fibromyalgia or other connective tissue disease than women without extracapsular silicone gel.
"If other studies are consistent with these findings, women should be informed of the potential risk of developing fibromyalgia if their breast implants rupture and silicone gel escapes outside the fibrous scar capsule," says lead study investigator S. Lori Brown, Ph.D., M.P.H., of the FDA's Center for Devices and Radiological Health.
The study, supported in part by the FDA's Office of Women's Health and the National Institutes of Health, was published in the May 2001 Journal of Rheumatology. An estimated 6 million to 8 million Americans have fibromyalgia. About 80 percent of those affected are women.
The FDA took silicone gel breast implants off the market for general use in 1992 because of safety concerns. They continue to be allowed in FDA-approved studies for women seeking breast reconstruction or revision of an existing breast implant. Additionally, those who need to have an existing implant replaced for medical reasons, such as implant rupture, are also eligible for these studies.
In 2000, the FDA approved the continued use of two manufacturers' saline breast implants. (See "Saline Breast Implants Stay on Market as Experts Warn About Risks" in the July-August 2000 FDA Consumer.)
Further information on breast implants may be found at www.fda.gov/cdrh/breastimplants/.
The FDA has issued its second warning in several months concerning gel candy imported from Asia that contains the ingredient "konjac" (also known as conjac, konnyaku, yam flour, or glucomannan.) The Consumer Product Safety Commission has confirmed that the mini-cup gel candy poses a serious choking risk, particularly to infants, children and elderly people.
The multi-fruit-flavored candy typically is packaged as an individual, mouth-sized serving, and often contains a chunk of fruit. Unlike gelatin products commonly found in the United States, this candy doesn't readily dissolve in the mouth.
The deaths of at least three children associated with choking on the gel candy have been reported in the United States.
The candy is sold under a variety of names in retail stores and on the Internet. The FDA issued its first warning on the candy last summer.
The infographic titled "How We See It" that appeared on page 26 of the September-October 2001 issue of FDA Consumer needs clarification. For myopia, the cornea is either too steep and/or the eye is too long. For hyperopia, the cornea is either too flat and/or the eye is too short. A "thick" or "thin" cornea can occur in both myopia and hyperopia.
An article titled "Antibiotic Resistance from Down on the Chicken Farm" in the January-February 2001 issue of FDA Consumer incorrectly stated that farmers treat whole flocks when a poultry veterinarian identifies a single chicken with a bacterial infection.
Current standards outlined in the "Guidelines for Judicious Therapeutic Use of Antimicrobials in Poultry" call for poultry veterinarians to assemble information on a representative sample of the affected flock before determining a course of action.
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2001-OCT-26.