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February 2003
FORMULARY ADDITIONS
Fish Oil Concentrate 1000 mg Eicosapentaenoic Acid (EPA)
180 mg Docosahexaenoic Acid (DHA)
120 mg 1000 mg softgels Major Pharmaceuticals Fish
oil has been used orally for cardiovascular disease, hyperlipidemia,
and various other disease states. It is classified as a dietary supplement
under the Dietary Supplement Health Education Act of 1994 (DSHEA). It is not
FDA-approved for the treatment, prevention, or cure of disease. However, several clinical trials have
examined the role of the W-3 fatty acids in fish oil in the
secondary prevention of heart disease. Published epidemiologic data exist
suggesting the beneficial effects of W-3 fatty acids in heart
disease and hyperlipidemia. Published clinical
trials have demonstrated the cardioprotective
effects of fish oil supplements. In a randomized, controlled trial of 2033
men who had experienced a recent myocardial infarction (average of 41 days
post infarction). Total mortality and ischemic
heart disease events were reduced by intake of dietary and supplemental fish
oil (29% and 30% with dietary intake; 57% and 62% with supplemental intake).
In another randomized, placebo-controlled trial, 360 patients with recent
myocardial infarction were randomized to receive fish oil, mustard oil, or
placebo. Both patient groups receiving fish oil or mustard oil responded with
a significant reduction in cardiac events after one year (24.5% and 28%
respectively) compared to 34.7% in the control group. Significant reductions
were also seen in nonfatal infarctions, total cardiac arrhythmias, left
ventricular enlargement, and angina pectoris for both groups compared to
placebo and in total cardiac deaths for the fish oil group. Fish oils can moderately lower blood pressure and reduce blood pressure readings in patients with hypertension. Additive effects may be seen in patients taking anti-hypertensive medications. Theoretically, use of fish oils may lower mean arterial pressure to hypotensive levels. Fish oils might normalize ECG readings in some patients with ventricular ectopic beats. Greater than three grams of fish oil per day might decrease blood coagulation, increase INR and PT, and increase the risk of bleeding. The most commonly reported adverse reactions to fish oil include gastrointestinal distress, nausea, a “fishy taste” in the mouth, and bloating. Fish
oils should be used with caution in aspirin-sensitive individuals because W-3 fatty acids can
decrease pulmonary function in these patients. Symptoms of hypomania can develop in patients taking fish oils who
have bipolar or major depressive disorders. Fish oils in doses greater than
six grams per day can increase blood glucose levels. However, lower doses do
not seem to affect blood glucose. Patients with diabetes should avoid
exceeding a dose of three grams per day. Fish oils might further increase the
risk of cancer in people with familial adenomatous polyposis. Higher doses of fish oils might
cause suppression of immune and inflammatory response. Fish oils appear to suppress
T- and B-cell function and to reduce the production of cytokines, which might
be detrimental to elderly people and people with suppressed immune function
such as patients with HIV infection. Immunocompromised
patients should avoid exceeding a dose of three grams per day. Some
fish oil preparations (e.g. cod liver oil) contain large amounts of vitamin A
and vitamin D. If these preparations are used long-term or in large doses,
there is a risk of vitamin A and D toxicity. There is some concern that fish
oil products might be contaminated with toxins or pesticides if the fish were
caught in contaminated waters. Heavy
metals, especially mercury, are a particular concern. Mercury accumulates in
fish meat much more so than fish oil, and there is very little risk of
mercury poisoning from fish oil supplements.
Fish
oil provides nine kilocalories per gram and fish oil capsules containing 500
mg W-3
fatty acids in one gram of oil would supply about 13.5 kilocalories per
capsule. Fish oil supplements may cause weight gain if used long-term. Fish
oil supplements also contain cholesterol in amounts from one to six
milligrams per gram of fish oil. Fish oil can reduce vitamin E levels by an
unknown mechanism. Decreased vitamin E levels might result from reduced
vitamin E absorption or increased utilization by other tissues to block free
radicals and prevent peroxidative damage. Concurrent
use with anticoagulant or antiplatelet drugs can
increase the risk of bleeding. Some of the drugs include aspirin, clopidogrel, dalteparin, dipyridamole, enoxaparin,
heparin, ticlopidine, and warfarin.
DRUG AND FOOD
INTERACTIONS: No interactions are known
to occur between fish oil and food. DOSAGE AND
ADMINISTRATION: Wide
ranges of doses have been reported for fish oils. In coronary artery restenosis, the usual adult dosage is 4.5 grams EPA and
DHA daily or 3 to 7 grams of fish oil daily. In clinical trials, daily doses
of 900 mg EPA and DHA, 850-882 mg EPA and DHA, and 1.08 grams EPA alone were
shown to be effective in reducing sudden cardiac death and total mortality.
Gastrointestinal side effects can be decreased if fish oils are taken with
meals and if doses are started low and gradually increased. SECOND
GENERATION ANTIHISTAMINES Cetirizine (Zyrtec®) Fexofenadine (Allegra®) Loratadine (Claritin®) Desloratidine (Clarinex®) Three
nonsedating antihistamines (desloratadine,
loratadine and fexofenadine)
and one low-sedating antihistamine (cetirizine) are
marketed in the Antihistamines
are reversible, competitive, H1 receptor antagonists that reduce or prevent
most of the physiologic effects that histamine normally induces at the H1
receptor site. They do not prevent histamine release nor bind with histamine
that has already been released. Second generation antihistamines are
selective for peripheral H1 receptors and, as a group, are less
sedating. Second
generation antihistamines have been compared with first generation
antihistamines and with each other. Clinical trials with first generation
antihistamines indicate that these agents are equally efficacious in treating
seasonal and perennial allergic rhinitis and
chronic urticaria. Comparative studies among the
second generation antihistamines also demonstrate equal efficacy. CONTRAINDICATIONS
AND WARNINGS: Second generation
antihistamines are contraindicated in patients with hypersensitivity to
specific or structurally related antihistamines. ADVERSE
DRUG REACTIONS AND DRUG INTERACTIONS: Second
generation antihistamines have a lower potential for adverse effects on the
CNS than first generation antihistamines. Concurrent use with alcohol and
other CNS depressants should be avoided because additional reductions in
alertness and additional impairment of CNS performance may occur. PREGNANCY
CATEGORY: Loratadine is a pregnancy Category B: No
evidence of risk in humans. Either animal findings show risk, but human
findings do not; or if no adequate human studies have been done, animal
findings are negative. DRUG AND FOOD
INTERACTIONS: There are no reported interactions with food |
