Source: U.S. Food and Drug Administration
Published: October 04, 2005
Published: October 04, 2005
Strattera, an attention deficit hyperactivity disorder drug, may
increase suicidal thinking in children and adolescents, the Food and
Drug Administration warned on Thursday.
"Children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed (either increased or decreased)," the FDA said in a Public Health Advisory.
The warning follows a review and analysis of clinical trials conducted in children with ADHD that identified an increased risk of suicidal thinking for Strattera. There was one suicide attempt by a patient who received Strattera among nearly 2,200 patients in the trial. The analysis showed that 0.4% of children treated with Strattera reported suicidal thinking compared to no cases in children treated with the placebo.
Manufacturer Eli Lilly and Co. said last week it will add a "black box" warning to the Strattera label and is working with the FDA to finalize the product label content as well as information for healthcare professionals.
Strattera is the only non-stimulant drug approved for the treatment of ADHD. It has been on the market since 2002 and has been used in more than two million patients. Sales for Strattera topped $667million last year.
"Children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed (either increased or decreased)," the FDA said in a Public Health Advisory.
The warning follows a review and analysis of clinical trials conducted in children with ADHD that identified an increased risk of suicidal thinking for Strattera. There was one suicide attempt by a patient who received Strattera among nearly 2,200 patients in the trial. The analysis showed that 0.4% of children treated with Strattera reported suicidal thinking compared to no cases in children treated with the placebo.
Manufacturer Eli Lilly and Co. said last week it will add a "black box" warning to the Strattera label and is working with the FDA to finalize the product label content as well as information for healthcare professionals.
Strattera is the only non-stimulant drug approved for the treatment of ADHD. It has been on the market since 2002 and has been used in more than two million patients. Sales for Strattera topped $667million last year.
Read Full Story at U.S. Food and Drug Administration
Class Action Filed Against Pfizer Over Marketing of Lipitor
Published: September 15, 2005
Source: PR Newswire
Published: September 28, 2005
A
nationwide class action lawsuit was filed today against Pfizer Inc.,
alleging the world's largest drug company devised a promotional scheme
to boost sales of its anti-cholesterol drug Lipitor by misleading women
and seniors about the link between the drug and heart disease.
The lawsuit, filed in the U.S. District Court in Boston, alleges that Pfizer engaged in a massive campaign to convince both doctors and patients that Lipitor is a beneficial treatment for nearly everyone with elevated cholesterol, even though no studies have shown it to be effective for women and those over 65 years of age who do not already have heart disease or diabetes.
"We intend to prove that Pfizer pocketed billions in sales to those who do not benefit from Lipitor," Steve Berman, the lead attorney for the proposed class, said.
Lipitor, part of the class of drugs called statins, is the best-selling drug in the world, with sales in 2004 of more than $10 billion.
According to the complaint, women without heart disease taking Lipitor actually developed 10 percent more heart attacks than women treated with a placebo.
The proposed class action seeks to represent women who have taken Lipitor and who have no history of heart disease or diabetes; people aged 65 and over who have taken Lipitor and who have no history of heart disease or diabetes; and third-party payers such as insurance companies, union health and welfare funds, self-insured employers and others, who paid for Lipitor for patients in either of these two groups.
The lawsuit alleges that Pfizer violated state consumer protection laws against deceptive advertising and seeks reimbursement for women and seniors and third-party payers who bought Lipitor unnecessarily as a result of Pfizer's deceptive marketing and promotional campaign.
"We intend to prove in this case that Pfizer's false advertising created an enormous artificial demand for Lipitor, much of which would not exist if Pfizer had fully and fairly disclosed the truth about the drug," Berman said.
The lawsuit, filed in the U.S. District Court in Boston, alleges that Pfizer engaged in a massive campaign to convince both doctors and patients that Lipitor is a beneficial treatment for nearly everyone with elevated cholesterol, even though no studies have shown it to be effective for women and those over 65 years of age who do not already have heart disease or diabetes.
"We intend to prove that Pfizer pocketed billions in sales to those who do not benefit from Lipitor," Steve Berman, the lead attorney for the proposed class, said.
Lipitor, part of the class of drugs called statins, is the best-selling drug in the world, with sales in 2004 of more than $10 billion.
According to the complaint, women without heart disease taking Lipitor actually developed 10 percent more heart attacks than women treated with a placebo.
The proposed class action seeks to represent women who have taken Lipitor and who have no history of heart disease or diabetes; people aged 65 and over who have taken Lipitor and who have no history of heart disease or diabetes; and third-party payers such as insurance companies, union health and welfare funds, self-insured employers and others, who paid for Lipitor for patients in either of these two groups.
The lawsuit alleges that Pfizer violated state consumer protection laws against deceptive advertising and seeks reimbursement for women and seniors and third-party payers who bought Lipitor unnecessarily as a result of Pfizer's deceptive marketing and promotional campaign.
"We intend to prove in this case that Pfizer's false advertising created an enormous artificial demand for Lipitor, much of which would not exist if Pfizer had fully and fairly disclosed the truth about the drug," Berman said.
Read Full Story at PR Newswire
2nd Vioxx Lawsuit Goes to Trial
Published: September 15, 2005
The
second personal injury Vioxx lawsuit to go to trial started on
Wednesday in New Jersey-just one month after a Texas jury found Merck
and Co. liable for the death of a man taking Vioxx and awarded his
widow $253.5 million.
The plaintiff, 60-year-old postal worker, Vietnam veteran, Frederick "Mike" Humeston, claims that Vioxx caused his heart attack in September 2001, just two months after his doctor prescribed him Vioxx to relieve pain from a war injury.
Humeston maintains that long before Vioxx was first marketed in the United States, Merck knew that the drug carried cardiovascular risks.
The case is one of about 2,400 Vioxx lawsuits pending in New Jersey state court against Merck, which is based in Whitehouse Station, N.J.
Merck pulled Vioxx from the market in September 2004 after a study found that it increases a patients' risk of heart attack and stroke after 18 months of use.
More than 4,000 Vioxx lawsuits have been filed against Merck.
The plaintiff, 60-year-old postal worker, Vietnam veteran, Frederick "Mike" Humeston, claims that Vioxx caused his heart attack in September 2001, just two months after his doctor prescribed him Vioxx to relieve pain from a war injury.
Humeston maintains that long before Vioxx was first marketed in the United States, Merck knew that the drug carried cardiovascular risks.
The case is one of about 2,400 Vioxx lawsuits pending in New Jersey state court against Merck, which is based in Whitehouse Station, N.J.
Merck pulled Vioxx from the market in September 2004 after a study found that it increases a patients' risk of heart attack and stroke after 18 months of use.
More than 4,000 Vioxx lawsuits have been filed against Merck.
