The popular antifungal medication Lamisil (generic: terbinafine) has recently been linked to liver failure in users with pre-existing liver problems. The U.S. Food & Drug Administration (FDA) reported that there have been at least 16 separate cases of liver failure attributed to Lamisil since it was first approved in 2001, including two patients who required liver transplants and 11 fatalities. Since early detection and treatment of liver issues can keep serious side effects from developing down the road, the FDA suggests that patients who are at risk for liver problems undergo blood testing in order to ensure that their liver is functioning properly.
What’s the Problem with Lamisil?
Manufactured and marketed by Novartis Pharmaceuticals, Lamisil is an FDA-approved antifungal medication used to combat yellowing and cracking common with many toenail fungi. Unfortunately, not only is the drug too expensive for most patients to afford, but it has also been reported to cause a number of serious side effects.
In 2001, the FDA reviewed a number of adverse event reports (AERS) involving Lamisil-induced liver failure, including two cases that required liver transplant, and another 11 that ended in the death of the patient. Given the serious nature of these side effects, the FDA required new warning labels for Lamisil which recommended healthcare providers perform testing to confirm the diagnosis prior to prescribing the drug.
A February 2008 article published in Australia’s Herald Sun titled ‘Anti-Fungal Tablet Linked to Liver Deaths’ reported that Australian drug regulators had issued a warning about individuals who had suffered serious liver-related complications after using Lamisil. The article reports:
“The Therapeutic Goods Administration (TGA) has issued a warning about serious adverse side effects reported with oral Lamisil, a pill formulation for ringworm and nail fungal problems. The medication is commonly prescribed to people who do not respond to topical fungal creams, but the regulator’s Adverse Drug Reactions Advisory Committee (ADRAC) warns it can cause liver failure. The committee has received 722 adverse event reports related to Lamisil, known generically as terbinafine, including 70 liver reactions, 61 implicating the tablet form as the sole suspected drug. Those affected ranged from 20 to 85 years old, with half suffering their liver reaction within the first month of taking the pills.”
Of the 722 adverse event reports linked to Lamisil, 70 involved hepatic reactions (the majority of which implicated the oral form of the drug). About half the patients reported onset of the hepatic reaction within the first month of initiating a regimen of Lamisil, and over 80% within the first seven weeks. Most of the reports involved minor liver injuries, but three described fatal liver failure, 10 described hepatitis, and 12 described jaundice. Twenty-seven patients fully recovered, 34 did not recover fully, and the outcome remained unknown in nine cases.
Signs and Symptoms of Liver Failure
Individuals suffering from Lamisil-induced liver failure may experience some or all of the following symptoms:
- jaundice (yellowing of the skin, eyes, and fingernails)
- light-colored stools
- abdominal pain
- personality changes
Lamisil Side Effects
In addition to having the potential to cause liver failure and other liver-related injuries, Lamisil has also been linked to the following serious side effects:
- congestive heart failure
- kidney failure
- serious skin reactions
Other, less severe side effects associated with Lamisil have been reported to include:
- upset stomach
- stomach pain
- changes in taste or loss of taste
- upset stomach that does not go away
- loss of appetite
- extreme tiredness
- pain in the right upper part of the stomach
- dark urine
- pale stools
- severe skin rash that keeps getting worse
- fever, sore throat, and other signs of infection
As a consumer and patient, you have the right to trust that your medications are safe. Unfortunately, this is not always the case. When a pharmaceutical company acts negligently and puts profits before public safety, its actions can result in serious consequences. However, victims may recover damages by filing a product liability lawsuit against the drug’s manufacturer.