Pharmaceutical Legal Glossary
Glossary of Pharmaceutical Terms
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z #
Click on the first letter of the word from the list above to go to the appropriate section of the glossary.
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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.
