FDA looks at excessive sleepiness with Eli Lilly’s Zyprexa
INDIANAPOLIS The Food and Drug Administration has stated that Eli Lilly’s schizophrenia drug, Zyprexa, when taken through an injection, has risks that include excessive sleepiness, according to published reports.
People with schizophrenia taking a monthly injection instead of daily tablets already on the market may experience “profound sedation,” staff of the FDA said in documents posted today on the agency’s Web site. The sleepiness is a “serious safety concern” because of its severity and “relatively high” incidence, the FDA said.
An FDA advisory panel plans to meet Feb. 6 to consider whether Lilly should be allowed to sell the monthly Zyprexa. The company is investing in new and reformulated products because the original Zyprexa may face generic competition as early as 2011.
Sales of Zyprexa tablets, also used to treat bipolar disorder, rose 9 percent to $4.76 billion last year.
Study shows no link between ADHD medication and drug abuse
WASHINGTON A new report published in the March issue of the American Journal for Psychiatry states that children who are given psycho-stimulants for attention deficit-hyperactivity disorder are not more susceptible to begin abusing drugs and alcohol than their peers.
ADHD is a disorder that includes systems of inability to focus, hyperactivity and impulsiveness. According to the Wall Street Journal, 9 percent of children have ADHD in America, but only 32 percent get the medication needed to treat it.
The report was funded by the National Institutes of health and was designed by the Massachusetts General Hospital investigators whose main goal was to make sure to cover all necessary angles in order to receive the correct data for the relationship between drug abuse and ADHD medication.
The researchers interviewed 112 men between the ages of 16 and 27, a decade after they were diagnosed with ADHD and asked about their consumption of tobacco, alcohol, drugs and the type of medication they used. The study concluded that there was no relationship between substance abuse and the prescription ADHD medicines.
“This study is a continuing effort to explicate the factors that mediate risk. It is methodologically sound and suggests that, as always, things are more complicated than we want them to be. The study demonstrates that the use of psycho-stimulants for ADHD children does not increase the risk for substance abuse in adulthood, but it also suggests there is no protective effect,” said Jon Shaw, director of the Division of Child and Adolescent Psychiatry and Behavioral Science at the University of Miami.
FDA rejects Labopharm’s Tramadol after response to second approvable letter
WASHINGTON Labopharm’s appeal of a second approvable letter from the Food and Drug Administration for a once daily formulation of its pain drug Tramadol has been rejected by the agency.
The director of the Center for Drug Evaluation and Research’s Office of New Drugs, John Jenkins, “has suggested additional statistical analysis of existing data as a means to potentially satisfy the agency’s requirements,” according to Labopharm.
The method Jenkins is proposing is different from the method the FDA requested following its first approvable letter in May 2007, the company said. Jenkins also recommended the company meet with the agency prior to any resubmission.
Labopharm is trying to introduce the once-daily formulation of tramadol, which is its lead product, in various international markets, including Canada, France, Germany, Spain, Italy and the UK.