|February 1998||Bruce H. Woolley, Pharm.D., Editor||Vol. 5, No.2|
1998 DRUG APPROVALS
Purified chick embryo cell culture vaccine for rabies (RabAvert«/ChironBehring), has been approved by the FDA for both pre-exposure and post-exposureprophylactic use in humans. The product is expected to allow for greater flexibility intreatment choices for people who develop sensitivity to one of the other availablevaccines.
Intravenous fat 30% emulsion (Liposyn III«/Abbott) has beenapproved as a pharmacy bulk package for parenteral nutrition.
PRODUCTS RECOMMENDED FOR APPROVAL
Although formal approval has not yet been received, FDA advisory panels haverecommended approval for the following:
Hydroxyurea (Droxia«/Bristol-Myers Squibb) for the treatment ofmoderate to severe sickle-cell anemia in adult patients. Currently there is no approvedtreatment for the disease. Due to some concerns of the panel, the committee recommendedthe drug only be available for adults with recurrent moderate-to-severe crises and thosewho had a minimum of three crises the previous year.
Emedastine difumarate (Emadine«/Alcon)is an antihistamine that hasbeen approved as an ophthalmic solution 0.05% for the temporary relief of the signs andsymptoms of allergic conjunctivitis.
NEW INDICATIONS, DOSAGES AND FORMULATIONS
Ticarcillin disodium/clavulanate potassium (Timentin«/SmithKlineBeecham) has been available as an injectable for adult patients. It has now been clearedby the FDA for use in treating a wide range of infections in children ages 3 months to 16years.
Ceftriaxone (Rocephin«/Roche) has been approved for the treatmentof acute pediatric otitis media. The company states that it is the first single-doseantibiotic approved for this indication.
Dirithromycin (Dynabac«/Lilly) has been approved for a 5-daycourse of therapy to treat acute bacterial exacerbation of chronic bronchitis causes by Haemophilusinfluenzae, Moraxella catarrhalis or Streptococcus pneumoniae. The five daytherapy is also approved for uncomplicated skin infections caused by Staphylococcusaureus or Streptococcus pyogenes.
Fifty or 75 mg diclofenac/200 mcg misoprostol (Arthrotec«/Searle)has been approved for the treatment of osteoarthritis and rheumatoid arthritis patients athigh risk of NSAID-induced ulcers.
The FDA recently approved acetaminophen/aspirin/caffeine (Extra Strength Excedrin«/Bristol-MyersSquibb) as the first otc treatment for mild-to-moderate migraine headaches. Although thefull mechanism of action is unknown, it may be due to a decrease in vessel constriction.The recommended dose is two tablets at the first indication of impending symptoms. Thedose is repeated every 6 hours as necessary. As a result of the new indication, theproduct will be repackaged under the trad name Excedrin Migraine.
FINDINGS OF THERAPEUTIC STUDIES
A British study, which involved 530 people with insulin-dependent diabetes, reportedthat lisinopril appears to slow the progression of diabetic retinopathy (an eye diseasethat develops in 70% to 100% of people with insulin-dependent diabetes). The studyparticipants had normal blood pressure and little or no nephropathy and were randomlyassigned to take lisinopril or a placebo. The study lasted for two years.
James Leitch of the Department of Cardiology at John Hunter Hospital in New SouthWales, Australia, reported in the Journal of the American College of Cardiologythat the incidence of a second heart attack or sudden death does not increase with the useof calcium channel blockers. However, findings found that beta-blockers had significantlylower rates of recurrent heart attacks, sudden death, and death for all other causes thanthose taking calcium channel blockers.
Daniel Cramer of the Obstetrics and Gynecology Epidemiology Center at Brigham andWomen's Hospital in Boston, reported in Lancet that long-term use of otcacetaminophen may cut a woman's risk of ovarian cancer in half. The 5-year study comparedthe use of otc analgesics (aspirin, ibuprofen, acetaminophen) in two groups ofMassachusetts women. Use was defined as at least one dose of the medication per week overa period of at least six months. The authors reported a 48% reduction in risk for ovariancancer with acetaminophen compared with non-users.
Psychiatrists in Finland described two cases of postnatal depression in which 2 weektreatment with sublingual estrogen proved successful in relieving symptoms. The report in TheLancet stated that neither woman, ages 30 and 27, had a personal or family history ofdepression, however, both developed symptoms of severe postnatal depression two weeksafter delivery. Symptoms included depression, trouble sleeping, anxiety, irritability andtension. Blood tests of both woman showed below normal estrogen levels before treatment.
A nation-wide telephone survey of more than 1,000 adults found that just four of 10people ages 18 to 24 stated they were aware of lupus (a chronic inflammatory disease inwhich the immune system attack's a person's health tissues). Lupus is more prevalent amongwomen of this age group. The Lupus Foundation of America in Rockville, MD stated that oneout of every 100 women will be diagnosed with lupus at some point in their life.
A study published in the May 1997 issue of American Society of Clinical Oncologyreported that shark cartilage was ineffective against advanced cancer in adults with alife expectancy of at least 12 weeks. The study reported data on 58 patients who wereprescribed a daily oral dose of shark cartilage as their only form of treatment. None ofthe patients achieved a complete or partial response to the shark cartilage treatment. Theresearchers concluded: "Shark cartilage was inactive in patients with advanced stagesof cancer, specifically in breast, colon, lung, and prostate cancer."
As reported in the November 1997 issue of Tufts University Health Nutrition Letter,researchers at the University of Maryland tested nine prescription prenatal vitamintablets to see whether the folate they contained would dissolve. Of the nine productstested, only three met study dissolution requirements. Two released less than 25% of thefolate specified on the label. This may be a significant potential problem to pregnantwomen who are taking folate to prevent birth defects. A question that may arise is:"If so many prescription products failed to dissolve properly, what assurance isthere that otc and health food products will dissolve properly?"
A study conducted in the Netherlands compared 131 patients with severe blockages in twocoronary arteries, 88 patients with moderate blockage of one coronary artery, and a groupof healthy people. (Arteriosclerosis, Thrombosis, and Vascular Biology 1997;17:989-95.) The authors reported a linear relationship between blood homocysteine levelsand severity of the coronary blockages. For every 10% of elevation of homocysteine, therewas nearly the same rise in the risk of developing severe coronary heart disease.
THERAPEUTIC NEWS ITEMS
An Associated Press article dated Jan 15, 1998, states that the world's twentylargest pharmaceutical companies have formed a task force to investigate the distributionof fake medicines to the people of poor or underdeveloped countries. People throughout theworld are suffering serious morbidity and even mortality because of these medications thatdo not work and may even be toxic themselves. The report also stated that thesecond-in-command at the World Health Organization had admitted to falsifying his owncredentials and lying about being a doctor.
Benjamin Schwartz, an epidemiologist for the National Center for Infectious Diseases atCDC was quoted in the Times-Picayune (New Orleans) on Jan 18, 1998 as saying:"For many severe diseases, the people at highest risk are the poor and the people wholive in inner cities. For antibiotic resistance, it's just the opposite. It's not povertythat's the problem. It's overuse of medical care that's the problem."
Reuters, Jan 26, 1998 reported that very frequently Medicaid patients areprescribed unneeded antibiotics for upper respiratory tract infections. This results inmillions of dollars of unnecessary government expenditure. In Kentucy alone, the price tagis an extra $1.62 million per year. Many URIs are caused by viruses which do not respondto antibiotics.
Researchers have recently reported in Pediatric Research that dextromethorphancauses severe defects in chicken embryos. There are no studies that link dextromethorphanand birth defects in humans, but the chicken data has been reported in the lay literatureand patients may ask questions of their health professional.
According to a recent statement by the World Health Organization, eating freshfruit and vegetables is more effective than pills for the prevention of cancer. The agencystated that the pills may actually increase the risk of lung cancer and cardiovasculardisease for smokers.
As a result of recent books indicting various foods as inducing nausea, miscarriages,or birth defects, researchers at the University of Minnesota conducted a prospective studyof 549 pregnant women. (American Journal of Obstetrics and Gynecology 1997;176:179-81.) Their data show no relationship between the intake of various vegetables, theoccurrence of vomiting early in pregnancy, an the incidence of adverse pregnancy outcomes.The authors refuted the claims that eating broccoli, cabbage, cauliflower, garlic, andspinach might cause miscarriages or birth defects.
A LOOK AT ECHINACEA: IS IT REALLY A PANACEA?
Echinacea is a popular herb that has been touted to be therapeutically beneficial innumerous conditions. A recent article in Tufts University Health Nutrition Letter(November 1997) reviewed the claims made by advocates of this herb. Some of the points inthe article are:
Recommended doses are not uniform among various brands or types of preparations.(However, Germany is much more regulated.) There is also disagreement on the label as towhich species of echinacea to take. Of the nine species that are known, only two (purpureaand angustifolia) have been used
extensively in scientific studies.
Due to the actions of echinacea on the immune system, patients with autoimmune diseases(e.g., arthritis) should not take the herb. Pregnant women, diabetics, or patients withmultiple sclerosis should also abstain from its use, as should anyone who has allergies tothe Asteraceae or Compositae family of plants.
GINKGO ADVERSE REACTION REPORTED
Temporary episodes of blurred vision were reported in a 70 year old man who had beentaking two tablets of Ginkoba daily for one week. (N Eng J Med 1997; 336:1108.)Physical examination revealed a small area of blooding into the iris of the eye. Althoughthe mechanism is not completely understood, it is known that one of the active ginkgolides(ginkgolide B) is known to interfere with blood clotting by inhibition of platelet action.No further bleeding occurred after the patient discontinues taking Ginkoba, even though hecontinued taking aspirin. Combinations of products that can exert a significantanticoagulant effect should be avoided. Some of these common otc/herbal products are:aspirin, vitamin E, Ginkgo biloba, garlic.
The information and opinions expressed in the Therapeutics Letter do not necessarilyreflect the official policy of the sponsoring organizations.