Legal Glossaries

Pharmaceutical Legal Glossary
 

Glossary of Pharmaceutical Law Terms

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Zyban: According to the Telegraph, Doctors in Great Britain monitoring the safety of Zyban, an anti-smoking drug, have reported the deaths of 18 patients who had been prescribed the medicine. Since it became available on a prescription basis last June, 270,000 smokers in Britain have been given courses of the drug, which works by inhibiting the craving for cigarettes. The Telegraph reports that the British version of the FDA, the Medicines Control Agency, which is conducting an intensive monitoring program on Zyban, has received reports of 3,457 patients complaining of adverse reactions. There have been 73 reports of people suffering seizures. One of those was a Manchester ambulance driver who crashed when responding to an emergency call. A Department of Health spokesman said: "We have asked GPs to report all suspected adverse reactions. The drug has been widely prescribed so we were expecting a large number of reports. Australian Health authorities are investigating the deaths of nine Australians to establish whether their use of the controversial anti-smoking drug Zyban was a contributing factor. Canadian officials are also investigating the safety of Zyban, according to Health Canada data dating back to September 1999. There have been 407 adverse events related to Zyban, of which include three reported deaths. In the United States, Zyban has been prescribed to more than 5 million smokers since it was approved by the FDA, as a prescription anti-smoking drug in 1997. Previously, it was available as an antidepressant under the brand name Wellbutrin. In a New York Post story in May 2001, Dr. Jerome Giron, pulmonary specialist at the NYU Downtown hospital believes the deaths overseas should not be ignored. Giron has prescribed Zyban to about 100 patients, and only around a third has stuck with the drug for the full eight-week course. "I've found it's not very well tolerated. People have said that they feel "spaced out" and "jittery" like they were going out of their minds. There've been a lot of problems with nervousness."

Zyprexa: Zyprexa is an anti-psychotic medication made by Eli Lilly & Co., and approved in 1996 by the U.S. Food and Drug Administration for the treatment of schizophrenia and bipolar mania. Zyprexa is a member of a class of drugs known as “second generation anti-psychotics” (SGAs) or “atypical anti-psychotics”. Of the six SGAs currently available on the market, Zyprexa, generic name olanzapine, is the most commonly prescribed drug. On June 9, 2005, Eli Lilly & Co. announced that it will pay nearly $700 million to settle about three-quarters of the current liability cases. These cases claim that labels on Zyprexa failed to provide adequate warning that the drug could put patients more at risk for developing diabetes. Most of the nearly 8,000 lawsuits claim that before September 2003, the information on Zyprexa labels did not adequately warn patients that taking the drug might put them at risk of developing hyperglycemia and diabetes. In September 2003, the FDA ordered Eli Lilly & Co. to revise the labeling and product information. Among the more serious outcomes resulting from hyperglycemic abnormalities are diabetic ketoacidosis, diabetic coma and, in some cases, death. In February 2004, Eli Lilly & Co. notified doctors and psychiatrists that elderly patients with dementia face an increased risk of stroke with Zyprexa treatment. While not approved for use in elderly dementia patients, or for anxiety or depression, physicians still prescribed the drug on an “off-label” basis. Off-label use refers to the practice of marketing or prescribing a drug in a different dose, for a longer period of time, or for a different medical condition than approved by the FDA. Other health risks associated with Zyprexa and other antipsychotic medications include:

• A life-threatening nervous system problem called neuroleptic malignant syndrome (NMS). NMS can cause a high fever, stiff muscles, sweating, a fast or irregular heart beat, change in blood pressure, and confusion. NMS is considered a medical emergency.
• A movement problem called tardive dyskinesia.
• High blood sugar and diabetes.
• Strokes have happened in older patients treated for mental illness from dementia. Zyprexa is not approved for this use.