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Viagra toxic liver

The American Journal of Gastroenterology (2005) 100, 1895–1896; doi:10.1111/j.1572-0241.2005.41983_6.x

Riadh Daghfous1, Sihem El Aidli1, Ahmed Zaiem1, Mohamed Hedi Loueslati1 and Chelbi Belkahia1

TO THE EDITOR: Sildenafil citrate (Viagra®) is a potent orally active cGMP-specific phosphodiesterase type 5 (PDE 5) inhibitor that is effective in the treatment of male erectile dysfunction (1). The use of therapeutic dosages (25–100 mg/day) is usually well tolerated. Adverse events such as flushing and headache are generally associated with the vascular change from PDE inhibition and decline with medication use (2). Serious side effects have also occurred (myocardial ischemia, sudden death) (3). We report a case of acute viagra toxic liver liver toxicity induced by sildenafil.

A 49-year-old man, with no liver disease risk factors and treated with glibenclamide for diabetes, received Viagra® (50 mg/day) because of erectile dysfunction. Routine blood tests were normal when sildenafil was started. Four weeks later, the patient developed a right hypochondriac pain without fever, jaundice, palpable hepatomegaly with no signs of encephalopathy. An increase in serum aminotransferases was evident on the same day (7.4 times the normal rate for AST and 1.2 for ALT). GGT, ALP, and total biluribin were normal.

Prothrombin time, hematocrit, leukocyte, and eosinophil counts were normal. Tests for hepatitis B surface antigen, antibodies to hepatitis B core, IgM anti-hepatitis A virus, anti-hepatitis A virus, anti-hepatitis C virus antibodies, and IgM anticytomegalovirus were all negative. Anti-mitochondrial, anti-nuclear, and anti-smooth muscle antibodies were absent in the serum (Table 1).


An abdominal ultrasound did not show signs of bile duct obstruction. Percutaneous liver biopsy was refused by the patient. A rapid relief from abdominal pain and a progressive normalization of serum liver enzymes occurred in 20 days after drug withdrawal. The rechallenge with 50 mg/day of Viagra® after normalization of serum liver enzymes did not induce the recurrence of hepatitis.

This case was classified as a probable sildenafil-induced liver disease, according to the Danan algorithm (4) because of the compatible onset of symptoms with a drug-induced liver disease (4 wk after sildenafil initiation), the normalization of serum liver enzymes after drug withdrawal, and the negative diagnostic work-up.

The other drug (glibenclamide) was excluded from the hepatitis genesis since it was not withdrawn before analytical alterations improved. We could not find any reports of sildenafil-induced liver disease in the literature.

The mechanism of this side effect is unclear. An immunological or pharmacological mechanism, by PDH inhibition, is discarded given the absence of hypereosinophilia, fever, cutaneous signs, and negative rechallenge at normal dose. In addition, despite the widespread use of this drug around the world, there are no similar cases reported in the literature.

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References

  1. Salonia, A, Rigatti, P, Montorsi, F. Sildenafil in erectile dysfunction: A critical review. Curr Med Res Opin 2003;19(4):241–462. | Article | PubMed | ISI | ChemPort |
  2. Lim, PH, Moorthy, P, Benton, KG. The clinical safety of viagra. Ann N Y Acad Sci 2002 May;962: 378–388.
  3. Carson, CC. Long-term use of sildenafil. Expert Opin Pharmacother 2003;4(3):397–405.
  4. Danan, G. Définitions et critères d'imputation des atteintes hépatiques aigues médicamenteuses. Conclusions d'une réunion internationale de consensus. Gastroenterol Clin Biol 1993;17: H18–H21.

Source: http://www.nature.com/ajg/journal/v100/n8/full/ajg2005338a.html


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