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PRESCRIPTION DRUG LEGALGLOSSARY |
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Glossary of
Prescription Drug Terms
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Lamictal: An epilepsy medicine. There are reports of dispensing errors involving Lamictal and Lamisil, a medication for the treatment of toenail fungus. Patients receiving Lamisil instead of Lamictal would be inadequately treated for epilepsy.
Lamisil: On May 9, 2001. The Food and Drug Administration (FDA) issued a Public Health Advisory to announce significant safety-related updates to the labeling of Lamisil tablets and Sporanox products. Lamisil and Sporanox are used to treat nail (onychomycosis), skin and other systemic fungal infections. This FDA warnings alerts healthcare professionals to rare cases of serious liver problems including liver failure, transplantation and death associated with the use of Lamisil tablets. While adverse liver effects were previously included in the labeling for Lamisil products, the FDA decided to include this information in the advisory because some cases involved patients with no preexisting liver disease or any serious underlying medical condition. As of March 2001, the FDA has reviewed 16 possible Lamisil associated cases of liver failure, including 11 deaths and two liver transplant patients. Given the possible serious risks associated with Lamisil tablets, the new labeling for both products now recommends that healthcare professionals should obtain nail specimens for laboratory testing prior to prescribing the medications for fungal nail infections, to confirm the diagnosis.
Litigation: A lawsuit.
Loss of Consortium: Damages awarded to a family member (usually a spouse) for loss of companionship.
Lotronex: A drug used to treat irritable bowel syndrome in women. The manufacturer voluntarily withdrew Lotronex from the market after it was associated with reports of serious side effects such as intestinal damage, severely obstructed or ruptured bowels, and death.
Lymerix: Federal health authorities are investigating whether some people who received the Lymerix vaccine against Lyme disease later developed severe cases of arthritis and even Lyme disease itself as a result. The Food and Drug Administration has received reports of such problems, mainly from doctors and researchers in the Northeast. The FDA approved the vaccine, made by SmithKline Beecham Biologicals, a subsidiary of the British pharmaceutical giant SmithKline Beecham, two years ago, and about 440,000 Americans havereceived it. It is too early to know how many people have been injured by the Lymerix vaccine. But in interviews, reported in the New York Times, more than a dozen doctors in areas where Lyme disease is common say they have treated 170 people with arthritis and Lyme disease that they attribute to the Lymerix vaccine. In May 1998, the FDA advisory committee endorsed the vaccine. But when the drug agency's vaccine advisory committee recommended that the vaccine be approved for marketing, several members expressed concern that the vaccine could set off an autoimmune condition that, in turn, would result in arthritis. Some also said they feared it could cause flare-ups of Lyme disease among people who had been previously infected with the Lyme bacteria, Borrelia bergdorferi. The New York Times also reports that some doctors say the drug agency should never have approved the Lyme vaccine or should have responded more quickly to adverse reports.
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