One in four American adults suffer from toenail fungus. Are you one of the 50 million that have been seeking treatment, but can’t seem to find a permanent solution? Pharmaceutical commercials are full of promises, warnings, and most importantly to patients, hope. Commercials for prescription drugs finally offering a solution allows for a hopeful window of opportunity for most.
Lamisil did just that for many Americans suffering from toenail fungus, and because of an advertisement offering falsified hope, the FDA released a warning letter noting the overstatement of efficacy. In 2003, the FDA released the warning letter stating that Lamisil’s television advertisement, “Digger”, “overstates the efficacy of Lamisil through their visual portrayal of the clinical effects of Lamisil and the failure of the ads to accurately portray the efficacy rates for the drug.” The ad also suggests that Lamisil works immediately, when in fact it takes about ten to twelve months for the new healthy toenail to grow back. Also, it is not clearly communicated that “only 38% of patients in clinical trials achieved complete effectiveness or cure of their condition (i.e., a mycological cure plus a clinical cure) and some of those patients relapsed.” Statements in the ad about Lamisil being the number one brand for treating infected nails was also noted in the warning letter, as there is no substantial evidence or clinical experience supporting this statement.
Although most prescription drugs have a list of noted serious side effects, it is important to pay close attention to those side effects others have actually experienced, along with “common effects.” It has been noted that some taking Lamisil have developed severe liver damage with need for a liver transplant and some leading to death. It is not exactly clear whether the patients had previous liver issues or Lamisil caused the liver damage. Although clearly noted that Lamisil should not be taken by anyone with liver or kidney problems, the drug can still potentially cause severe issues in other patients. In 2004, the FDA issued a public health advisory on the safety of Lamisil tablets due to a study finding 16 potential cases of liver failure, including 11 related deaths. It is always important to discuss any existing or potential medical issues with your doctor before beginning any prescription drug regimen.
In most cases, any prescription medication comes with risk of an allergic reaction, side effects, and even risk of death. It is important to understand warnings, effectiveness, and any changes surrounding the drug in question. Knowing your options when it comes to eliminating toenail fungus is the key to a permanent, healthy solution.
In October 2010, the PinPointe FootLaser was approved for medical use by the FDA. The laser treatment lasts about 30 minutes and is relatively painless with no serious side effects, removing the fungi from the nail and allowing a new healthy nail to grow in over the next several months. Dr. Mark Spier is the exclusive area provider of the PinPointe Footlaser—the first podiatrist licensed and trained and able to offer the PinPointe Footlaser to patients in the Baltimore area. Don’t wait another day to get rid of your toenail fungus when Dr. Spier is only a phone call away.