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In September 2003, the US Food and Drug Administration ordered Lilly to add a warning. Lilly is not disclosing details, but has said that the total amount to be paid will be substantially less than the $700m paid for over 8 000 claims in a June 2005 settlement. CEO Sidney Taurel said the claims are without merit, and Lilly has vowed to vigorously defend Zyprexa in some 1 200 remaining product liability cases. Pharma analyst Jonathan Goodall of Globallnsight said the sheer number of claims that this agreement resolves represents a significant positive for the company, but notes that Lilly still faces claims from third-party payer groups, who are seeking damages amid claims that they would not have paid a premium for Zyprexa had they been adequately informed of the drug’s potential adverse effects. Sales of Zyprexa, which was approved in 1996 and has been used by more than 20 million people, reached $4.2bn in 2005.
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argued that the patent for the drug should never have been issued because Zyprexa was already covered by another patent. Lilly, however, contended that its drug was different from previously patented medications. The judge dismissed all claims against Lilly, noting among other findings that “defendants have failed to prove by clear and convincing evidence that anyone associated with the prosecution of the [Zyprexa] patent misrepresented or concealed … information with an intent to deceive the Patent and Trademark Office.” Ivax officials expressed disappointment with the ruling. “Ivax continues to strongly believe that the Zyprexa patent is invalid and we immediately intend to aggressively pursue all remedies available to us, including appealing this decision to the U.S. Court of Appeals,” the company said in a statement. But Lilly officials hailed the ruling, saying it “sends a clear message on the strength of” the patent.
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Concern about Zyprexa’s side effects has been increasing since at least 2004, and Zyprexa’s prescriptions and market share have fallen sharply over the period. As a result, the new warnings may have only a moderate impact among doctors and patients, said S. Nassir Ghaemi, M.D., director of the Bipolar Disorder Research Program at Emory University.
“The knowledge has been out there, and it’s already impacted prescribing patterns a great deal,” Ghaemi told the Times.
The new label will also indicate that patients who take Zyprexa may keep gaining weight for as long as two years after starting therapy. That contradicts earlier public statements by Lilly that weight gain on Zyprexa tends to plateau after a few months of use. One in six patients who take Zyprexa will gain more than 33 pounds after two years of use, the label says.
Weight gain and high blood sugar are risk factors for diabetes, although Lilly says there has been no proof that Zyprexa causes diabetes more than its competitors do.
“Obviously, we know that weight gain is a known risk factor for diabetes,” said Marni Lemons, a Lilly spokeswoman. “However, not all patients who gain weight develop diabetes.”
Lemons also noted that older anti-psychotic medicines also have severe side effects, including a tendency to cause facial tics.
Lilly said it had made the label changes as a part of continuing discussions with FDA.
Lilly has asked FDA to allow it to begin marketing Zyprexa for adolescents, despite clinical trial data showing that Zyprexa causes weight gain and metabolic problems in teenagers that can be even more severe than in adults.
The label changes come 11 years after Lilly began selling Zyprexa and more than 12 years after a large Lilly clinical trial first showed that Zyprexa might have negative effects on weight and blood sugar.
Internal Lilly documents disclosed by the Times last December indicated that Lilly was aware of Zyprexa’s tendency to cause weight gain and blood sugar changes by the late 1990s but played down the risks.
Lilly said at the time of those disclosures that the drug’s risks were already reflected in the label. Lemons said the company had not delayed releasing information about Zyprexa’s side effects, and had made yesterday’s label change after a new review of clinical trials showed the drug’s potential risks.
“It’s not like this is information that we have had since 1995,” Ms. Lemons said.
The documents disclosed by The Times in December also indicated that Lilly had told its sales representatives to encourage doctors to prescribe Zyprexa to people who do not have schizophrenia or bipolar disorder, Zyprexa’s only approved uses.
Federal laws prohibit drug companies from so-called off-label marketing, although doctors may prescribe drugs for whatever use they see fit.
Lilly has spent $1.2 billion since 2004 to settle lawsuits from 28,500 people who claimed they developed diabetes or heart problems after taking the drug. At least 1,200 more lawsuits are still pending.
In 2004, the American Diabetes Assn. said that Zyprexa was more likely to cause diabetes than other commonly prescribed antipsychotic medicines, although FDA has never made a distinction between Zyprexa and other drugs.
Even now, Zyprexa’s label does not say it causes diabetes more than the other medicines, only high blood sugar.
COPYRIGHT 2007 Washington Information Source, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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FDA confirmed its inquiry in response to questions from the Times. The agency said it had not yet decided whether to take any action against Lilly.
A Lilly spokesman, Phil Belt, told the Times that the company had rechecked its database and found errors in the original statistics. The data submitted later was accurate, Belt said.
The discrepancy between Lilly’s initial data and what it later submitted came at a time when Zyprexa’s sales were soaring, even as some doctors and foreign regulatory agencies were questioning the drug’s safety.
FDA has never concluded that Zyprexa causes diabetes more than other widely used psychiatric drugs, although the American Diabetes Assn has, according to the Times.
Zyprexa and other anti-psychotics are intended to quell the hallucinations and delusions associated with schizophrenia and to treat some cases of mania.
The document from 2000 and others were provided to The Times by James B. Gottstein, a lawyer who represents mentally ill people he says are forced to take psychiatric medications against their will.
Besides the FDA inquiry, Lilly is facing federal and state investigations into the way it marketed and promoted Zyprexa. The company has already agreed to pay $1.2 billion to settle 28,500 lawsuits from people who contend that they developed diabetes or other diseases after taking the drug. At least 1,200 more lawsuits are pending.
Lawyers who represent drug companies said FDA largely depended on the companies to be honest about the side effects of their drugs. With a staff of fewer than 3,000, including support personnel, the agency’s drug division oversees more than 12,000 prescription medicines and 400 non-prescription drugs, the Times reported.
In most cases, said William W. Vodra, senior counsel at the law firm of Arnold & Porter and a former FDA associate chief counsel, the agency does not perform detailed audits of clinical trials or independently check the integrity of the data that companies send to it.
“There’s no way they could police the system with the resources they have,” Vodra told the Times. “Companies provide the agency’s scientists with so much information that “there is a point at which you can’t even think about what they’ve given you,” he added, “let alone what’s behind that stuff that they may not have given you.”
The Zyprexa document that has aroused the most interest at FDA is a Feb. 21, 2000, paper in which Lilly scientists discussed whether Zyprexa’s label should be changed to alert doctors of the risk of hyperglycemia, or high blood sugar, associated with the drug. The paper showed that 154 of 4,234 patients, or 3.6%, who took Zyprexa in clinical trials developed high blood sugar. Only 1.1% of patients who took a placebo developed the condition.
The data that Lilly provided to FDA was notably different from the results discussed in the February 2000 paper, with the gap between the two patient groups much narrower. The company told the agency that patients taking Zyprexa developed high blood sugar at a 3.1% rate, while those taking the placebo had a 2.5% rate, according to the Times.
Belt said that after the February 2000 paper, Lilly performed a final quality check of the data and discovered that some patients had been incorrectly included in the analysis, while others had been excluded.
The Times reported in December on the existence of the February 2000 document, as well as other company documents and e-mail messages that contradicted public statements by Lilly about Zyprexa’s risks.
Lilly has said that the documents and e-mail messages were taken out of context and do not present a balanced view of Zyprexa’s risks and benefits. A federal judge has criticized the Times for violating a protective order that covered the documents.
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Lilly still faces product liability lawsuits from roughly 750 patients.
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In September 2003, the Food and Drug Administration required a label change for all atypical antipsychotics that added information about a relationship between diabetes and this type of medication. Zyprexa has been approved for the treatment of schizophrenia and bipolar disorder. “While we remain confident that these claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their physicians,” Sidney Taurel, CEO of Eli Lilly, said in a statement. The settlement also means that any claims in which physicians are named as codefendants will be dismissed, according to Eli Lilly. Approximately 1,200 Zyprexa claims were not included in the settlement.
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Egilman acknowledged that he had intentionally and illegally given attorney James Gottstein documents that had been made available by Lilly during discovery, and that “he knew that these materials painted an incomplete picture of the issues related to Zyprexa,” according to a statement by Lilly. Mr. Gottstein shared the documents with the New York Times, which wrote a series of articles in December 2006 contending that Lilly had withheld information about side effects. Lilly said it would donate Dr. Egilman’s settlement to the International Center for Clubhouse Development.
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Zyprexa is a big seller for Eli Lilly, accounting for $4.3 billion of its $12.6 billion in sales last year. Several other states, including Kentucky and West Virginia, have also excluded Zyprexa from their preferred drug lists. Opponents of these moves say that each patient responds differently to different medications and that Zyprexa may be the best drug in some cases. Patients currently stabilized on Zyprexa can continue receiving it without prior authorization.
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WARNINGS
Hyperglycemia and Diabetes Mellitus
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including Zyprexa. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia related adverse events in patients treated with atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
Should you have any questions or concerns regarding this important safety information, please contact your Eli Lilly and Company sales representative or contact the Lilly medical department at 1-800-Lilly-RX. Please refer to the full prescribing information for Zyprexa included with this letter. As always, we request that serious adverse events be reported to Lilly at 1-800-Lilly-Rx or to the FDA MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178) or by e-mail (www.fda.gov/medwatch).
Copyright Main State Nurses’ Association May-Jul 2004
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