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Corticosteroids: Side Effects, Legal Considerations and Legal Adventures

Corticosteroids: Side Effects, Legal Considerations and Legal Adventures

Dermatologists use topical, intralesional and intramuscular corticosteroids every day. Dermatologists also use oral steroids, although their use has decreased with the advent of intravenous immunoglobulin (IVIG), methotrexate, azathioprine, mycophenolate mofetil, narrow band ultraviolet B photherapy boxes and 308-nm excimer laser. Most dermatologists do not prescribe a long course of oral steroids. I can remember a time when oral steroids was the only treatment to save a patient who had pemphigus. I also recall a patient I had inherited from another dermatologist. This patient was an obese, white female who had been on oral steroids for years and eventually got every side effect, including cataracts (which were removed) and avascular necrosis (she had hip replacement and knee replacement surgeries). I tried to shift her to mycophenolate mofetil while tapering the steroids, and she developed aplastic anemia, which I wrote about in the Journal of Dermatological Treatment in 2007.1 I tried dapsone and she got dapsone hypersensitivity syndrome. Then, I put her on IVIG and her pemphigus became quiescent. Treatment of complex dermatological conditions is neither easy or without its therapeutic adventures.

Long-term courses of oral steroids can lead to side effects. The exact rate is unknown. When I searched steroids and avascular necrosis in Lexis, 140 hits surfaced and most involved not malpractice but disability claims. The side effects of oral steroids and even long-term courses of topical steroids are manifold in diseases and infections that they cause. Side effects from topical and intralesional steroids have been implicated less in these diseases and infections, but do occur when used. Most cases involving the use of corticosteroids involved oral steroids. A 6-week taper of topical steroids started at 40 mg to 60 mg followed by decreasing the dose to 20 mg for 2 weeks then 10 mg for a week and then 5 mg for a week (the total cumulative dose being 400 mg or less) does not appear to have resulted in reported litigation. Although, I have heard of successful disability claims arising from short term use of corticosteriods which resulted in osteonecrosis with no claim of medical malpractice. Recent studies have reported the risk of avascular necrosis to be dose related.2,3 See Table 1 for diseases and infections caused by corticosteroids.

table 1 

Legal Cases

Because corticosteroids are the standard treatment and treatment can be chronic, failure to monitor their use over the long-term can lead to a lawsuit when untoward side effects result. Thus, in one instance, a patient who had used oral steroids for 9 years and developed glaucoma sued the internist for failing to monitor him. Although the jury found the internist negligent in filling prescriptions without seeing the patient and writing prescriptions for amounts exceeding what the patient needed, it also found that the patient’s use of doses far beyond what had been prescribed and his failure to come to office visits were intervening causes that made the physician not liable.4 

The take-home lesson is simple: do not give out refills of a Class 1 topical corticosteroid. If the condition is chronic, do patch testing, phototherapy or give the patient triamcinolone, even if the patient argues and says that nothing but a Class 1 steroid works.

Using the Westlaw database from March 1996 to November 2008, Nash3 et al compiled data on conditions treated, litigation claims and complications. Data were complied on the demographics of the defendant, plaintiff, expert witness specialty, allegation, complication, indication for steroid use, verdict and judgment. There were a variety of conditions for which steroids were prescribed (Table 2).3

table 2

The study found 83 cases that resulted in judgments. Of the 83 cases, 10 cases (12%) were brought against dermatologists as at least one of the defendants and represented the most common specialty named in a lawsuit; 49 cases (59%) were found for the defendant; 24 cases (29%) were found for the plaintiff and 10 cases (12%) settled out of court. The monetary awards ranged from $25,000 to $8.1 million, with an average of $1.15 million. One case involved psoriasis and resulted in skin changes and lost wages. Other cases included a skin condition (unspecified) that resulted in visual changes; a skin infection that resulted from oral steroid use; intralesional and oral steroid use for alopecia that resulted in cataracts; a rash and anaphylaxis treated with oral steroids that resulted in avascular necrosis and one case of urticaria treated with oral steroids resulted in avascular necrosis.3

Studies have shown that avascular necrosis can result from topical steroid use. Remember that the package insert for most products indicated for psoriasis states they should not be used if the psoriasis involves more than 10% of the body or for longer than 2 weeks for Class 1 corticosteroids and 4 weeks for less potent steroids. 

Kane5 et al noted a 27-year-old man attending a dermatology clinic for the management of psoriasis complained of severe bilateral hip pain of recent onset. Psoriasis vulgaris affected 15% of his body surface for which he was applying a combination of topical corticosteroids obtained from 2 separate physicians (0.05% betamethasone dipropionate 100 mL lotion, mometasone furoate 1% cream 30 g and betamethasone valerate 0.1% cream 65 g) every month. Plain radiography of the hips demonstrated minor flattening of the superior aspect of the left femoral head and a normal right hip. Magnetic resonance imaging (MRI) and T1 weighted images demonstrated areas of isointense necrotic bone surrounded by hypointense revascularization in the collapsed superior aspects of both femoral heads (consistent with a diagnosis of Stage III osteonecrosis of both femoral heads). This association is extremely rare, but systemic effects of potent topical corticosteroids can occur. Osteonecrosis should be considered as a cause of new-onset hip joint pain or limitation in patients using long-term potent topical corticosteroids, particularly in combination. Plain radiography is insensitive in the early stages of disease, and MRI is the imaging modality of choice.

Similarly, Hickman6 et al noted 10 patients from North Carolina who used topical steroids and developed bone death. Psoriasis was the only associated condition found in 3 of the patients. Only 2 patients had received systemic corticosteroids in significant amounts (>1 g of prednisone), while 4 patients received methotrexate therapy for psoriasis. This case also underlines the perils of long-term potent topical steroid use. Gilbertson7 el al also noted cases where super potent topical steroids lead to adrenal suppression.

In a 2007 article, Richards8 noted that he was sued for treatment of a patient with severe poison ivy. Richards placed the patient on prednisone 40 mg, tapered to zero over 3 weeks, with a total cumulative dose of 400 mg. One year later another physician repeated this treatment. Then 3 years later, the patient developed hip pain and had a hip replacement the following year. The patient sued Richards on the basis that he was not informed about the risks, but the case was dismissed because the judge stated that it was not incumbent upon physicians at that time to inform patients of this material risk.

Furthermore, 2 separate studies by Turner9,10 draw attention to the unsatisfactory state of the law regarding steroid-induced psychosis as a defense for criminal activity. For example, a man with ulcerative colitis who required prednisolone 30 mg to 60 mg a day was accused of  shoplifting.  While hypomanic at the time of the alleged crime, he was found guilty and fined.10

Conclusion

The risks of adverse effects — including avascular necrosis and adrenal suppression — from long-term ultra-potent topical corticosteroids and oral steroids are supported in the literature.11-23 Physicians cannot assume that patients are only getting prescriptions from them and cannot be sure that even short courses of oral steroids are without risk. Prudent use of topical and oral steroids and informing patients of the risks with proper documentation is the best way to protect patients and your practice. While many patients would like quick fixes and our schedules are full, this article demonstrates that creating an effective and safe therapeutic alliance takes time and care but is worthwhile and reduces the risk of litigation from inappropriate or excessive use of topical and oral corticosteroids.

 

NoahDr. Scheinfeld graduated from Harvard Law School in 1989 and Yale Medical School in 1997. He is an assistant clinical professor in the Department of Dermatology at Weill Cornell Medical College in New York, NY.

Disclosure: Dr. Scheinfeld has no conflicts of interest to report.

References

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4. Stilloe v. Contini, 623 N.Y.S.2d 213, (N.Y.App. 1995).

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19. McKee MD, Waddell JP, Kudo PA, Schemitsch EH, Richards RR. Osteonecrosis of the femoral head in men following short-course corticosteroid therapy: a report of 15 cases.CMAJ. 2001;164(2):205-206.

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21. Skinner JA, Mann BS, Carrington RW, Hashems-Nejad A, Bentley G. Male infertility and avascular necrosis of the femoral head. Ann R Coll Surg Engl. 2004;86(1):15-17.

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23. Young CA, Williams IR, MacFarlane IA. Unrecognised Cushing’s syndrome and adrenal suppression due to topical clobetasol propionate. Br J Clin Pract. 1991;45(1):61-62.

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