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Case ID: 4448 | Drugs / Medical | 09/30/2005
The FDA directed Eli Lilly and Company, the manufacturer of Strattera (atomoxetine), to revise the prescribing information to include a boxed warning and additional warning statements that alert health care providers of an increased risk of suicidal thinking in children and adolescents being treated with this medication. Strattera is approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adult patients.
FDA also informed Lilly that a Patient Medication Guide (MedGuide) should be provided to patients when Strattera is dispensed. The MedGuide advises patients of the risks associated with and precautions that can be taken when Strattera is dispensed. Further, pediatric patients being treated with Strattera should be closely observed for clinical worsening, as well as: •agitation The increased risk of suicidal thinking for this drug was identified in a combined analysis of 12 short-term (6-18 weeks) placebo-controlled trials (11 in ADHD and 1 in bedwetting). The 12 trials involved a total of over 2200 patients, including 1357 receiving Strattera and 851 receiving placebo. The analysis showed a greater risk of suicidal thinking during the first few months of treatment in those receiving Strattera. The average risk of suicidal thinking was about 4 per thousand patients treated with Strattera compared to no events in placebo-treated patients. There was 1 suicide attempt among these approximately 2200 patients, occurring in a patient treated with Strattera. Strattera increases the risk of suicidal thinking in children and adolescents with ADHD. Legal Action Kahn Gauthier is currently investigating claims of suicidal thoughts in children and adolescents. If you or a loved one has acted on or experienced suicidal thoughts while on Strattera, our attorneys may be able to assist you. Register your Eli Lilly ComplaintIf you or someone you know has been affected by this case, you may qualify for a money settlement as the result of your financial/economic or other damages that may be awarded either prior to a lawsuit or after the initiation of a lawsuit either currently in progress or filed just for you, possibly a class action lawsuit. Please simply register your complaint by clicking here for Eli Lilly, or click the red "submit" button on this page, and a lawyer will review your Eli Lilly complaint. By submitting your complaint, you are asking lawyers to contact you. You are under no obligation to accept their services and you are free to choose which lawyer you want to work with. Lawyers are usually paid out of the proceeds of the settlement or verdict rendered - the lawyers work on "contingency" by fronting the costs of your lawsuit based on their belief that they will recover a settlement for you. At Lawcash.com, it is our goal to keep you informed about important legal cases, class actions and settlements. Our lawyers offer free legal evaluations in tort cases, class actions, personal injury, and other lawsuits because we are dedicated to helping you resolve your legal complaints. Other Drugs / Medical Cases of Interest Thousands of Pennsylvania doctors may be eligible to join a lawsuit over a Blue Cross health plan's reimbursement rates after a federal judge granted the plaintiffs class-action status. Barbara Davison, a former resident of Shoreline Healthcare Center in Long Beach, California filed a class-action lawsuit against Nursing Home operator The Ensign Group for understaffing. The lawsuit alleges unlawful business practices, unfair and fraudulent business practices, and violations of health and safety codes. Several class actions have been filed against drug company aaiPharma, Inc. (Nasdaq: AAII) and certain of its officers and directors by stockholders who purchased the company's common stock between July 23, 2003, through Feb. 4, 2004. The actions claim that the defendants violated federal securities laws by issuing a series of material misrepresentations to the market over this time period, thereby artificially inflating the price of the company's securities. The issue of corporate health plan prescription contraceptive coverage is growing quickly. A class action has been filed against DaimlerChrysler Corporation on behalf of women employees who allege that the company discriminated against them by failing to include prescription contraceptives in its health plan coverage in violation of federal civil rights laws.
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