Legal Glossary Z

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 "a typical 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.