The Medico-Legal Advisor ®
DRUG BUSTS OF ANOTHER KIND
Ibuprofen was the first of the wave of Non-Steroidal Anti-inflammatory agents (NSAID's) to hit the market in the United States. Its uses are about the same as aspirin, i.e. as a pain-killer and an anti-inflammatory agent in arthritis and for relief of menstrual cramps. Ibuprofen has many of the side-effects of aspirin: dyspepsia, nausea and inhibition of coagulation of blood. Studies vary but as a pain-killer, 400 mg. of Ibuprofen is about as (or perhaps slightly more potent as two aspirin. Presumably because of its similarity to aspirin, it was cleared by the FDA for over-the-counter sales (OTC) after lot soul-searching and considerable disagreement among the FDA's consultants. And for reasons known only to the drug moguls and the Feds, it was released only in 200 mg. doses - one half the strength of the usual prescription dose. Because ibuprofen exhibits anti-inflammatory activity only in dosages of over 1200 mg. per day, and the over-the-counter version is usually more expensive than the generic offered by prescription, we fail to see how the public was served by the OTC release of ibuprofen. Besides being more expensive and requiring the user to swallow at least 6 pills a day to get therapeutic benefit as an anti-inflammatory, the OTC version carries a very inadequate package insert. 1. Kidney failure is a definite hazard with ibuprofen therapy. Those at greatest risk are people with impaired kidney function, many such as diabetics and persons suffering from high blood pressure (and hence prime candidates for impairment of kidney function) should have their kidney function tested before starting the drug. The presence of impaired function is often insidious in onset, not something the patient is aware of until it is advanced. Kidney failure from the drug, while usually temporary, may be permanent. 2. Those afflicted with lupus erythematosis are at tremendous risk but are partially protected because of their frequency of a troublesome allergic reaction to ibuprofen. 3. Edema (swelling) and hypertension may result from fluid retention caused by ibuprofen therapy. 4. Alopecia (baldness) was reported in one study but involvement was limited to 21 black patients using hair straighteners simultaneous with ibuprofen therapy. They all got their hair back and were able to resume the use of hair straighteners when ibuprofen therapy was discontinued! Conclusions: 1. While not dangerous to patients with normal kidney function, ibuprofen should be used with caution by patients with kidney failure or any of the chronic diseases which may lead to kidney failure (at least 25,000,000 Americans) 2. OTC release of the drug in half the therapeutic dose was an error. The drug probably should not have been released for OTC use. 3. Package inserts need to be revised and the packages clearly marked with warning labels to prevent inadvertent use by those with impaired kidney function. Average retail price equivalent for 100 tablets of ibuprofen at five pharmacies, three of which were discount chain stores. Motrin $15.47 Generic $ 13.21 OTC $15.49 (obtained by multiplying the average price of one hundred 200 mg tables by 2). Advil was consistently cheaper than Nupren and was about as inexpensive as the generic prescription version. Bibliography Adams, S.S.: Absorption, distribution, and toxicity of Ibuprofen. Toxicology and Applied Pharmacology, 15: 310-330, 1969. Brezin, J.H.: Reversible renal failure and nephrotic syndrome associated with nonsteroidal anti-inflammatory drugs. The New England Journal of Medicine, 301: 1271-1273, 1979. Ciabattoni, G. et al: Effects of Sulindac and Ibuprofen in patients with chronic glomerular disease. The New England Journal of Medicine, 310: 279-283, 1984. Guidry, J.B.: Fatal autoimmune hemolytic anemia associated with Ibuprofen. The Journal of the American Medical Association, 242: 804-807, 1978. Hayden, J.W.: Compartment syndromes. Postgraduate Medicine, 74: 191-202, 1983. Hyde, G.L. et al: Compartment syndromes: early diagnosis and bedside operation. The American Surgeon, 49: 563-568, 1983. Kantor, T.G.: Ibuprofen, Annals of Internal Medicine, 91: 877-882, 1979. Kimberly, R.P.: Reduction of renal functions by newer nonsteroidal anti-inflammatory drugs. The American Journal of Medicine. 64: 804-807, 1978. Kocushis, S.A.: Sensitization to Ibuprofen in systemic lupus erythematosus. The Journal of the American Medical Association, 244: 547, 1980. Meyer, H.C.: Alopecia associated with Ibuprofen. The Journal of the American Medical Association, 242: 142, 1979. Mubarak, S.J.: Acute compartment syndromes. Surgical Clinics of North America, 63: 539-565, 1983. Rorabeck, C.H.: The treatment of compartment syndromes of the leg. The Journal of Bone and Joint Surgery, 66: 93-97 Whitesides, T.E. et al: Tissue pressure measurements as a determinant for the need of fasciotomy. Clinical Orthopedics, 113: 43-51, 1975. Williams, T.M. et al: Compartment syndrome after anti-shock trouser use without lower extremity trauma. The Journal of Trauma, 22: 595-597, 1982. |