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The Minnesota Attorney General’s Office settled certain claims against GlaxoSmithKline for marketing off-label uses for three medications. Under the settlement agreement, the State of Minnesota received approximately $1.9 million in settlement funds related to the drugs Advair, Paxil, and Wellbutrin.

 

  1. Advair
  2. Advair is approved by the Food and Drug Administration (FDA) for the prevention of asthma attacks and flare-ups or worsening of chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and/or emphysema. Patients who received Advair for treatment other than for FDA-approved purposes between January 1, 2000, and December 31, 2010, may be eligible for reimbursement of their out-of-pocket expenses. A common off-label use of Advair is as a first-line treatment for mild asthma patients who were not on inhaled corticosteroid (ICS) medication and only used short-acting beta-agonists (SABAs) intermittently.

  3. Paxil
  4. Paxil is approved by the FDA for treatment of the following conditions in individuals 18 years of age and older:


    • Depression;
    • Panic attacks;
    • Obsessive-compulsive disorder;
    • Anxiety disorders;
    • Post-traumatic stress disorder; and
    • Premenstrual dysphoric disorder.

    Patients who received Paxil for treatment other than for FDA-approved purposes between January 1, 1999, and December 31, 2003, may be eligible for a payment of their out-of-pocket expenses. A common off-label use of Paxil is for treatment of individuals under 18 years of age.

  5. Wellbutrin
  6. Wellbutrin is FDA-approved for the treatment of depression in individuals 18 years of age and older. Patients who received Wellbutrin for treatment other than for FDA-approved purposes between January 1, 1999, and December 31, 2003, may be eligible for a payment of their out-of-pocket expenses. Common off-label uses of Wellbutrin are for treatment of the following conditions:


    • Weight loss or treatment of obesity;
    • Sexual dysfunction;
    • Attention deficit hyperactivity disorder (ADHD);
    • Addiction;
    • Anxiety;
    • Bipolar disorder; and
    • Treatment of an individual under 18 years of age for any reason.

 

This Office recently sent letters to Minnesota hospitals and pharmacies about the settlement in order to receive their help in providing patients who were prescribed Advair, Paxil, and Wellbutrin in the relevant time period with information about their eligibility to receive settlement funds. This Office has contracted with CAC Services Group, LLC (CAC) to administer this settlement.

Please note that we are not asking that you identify (and you should not identify) patients to this Office or provide us with any of their information or records. Rather, to protect the privacy of the patients, we ask that you provide the names and contact information of potentially eligible patients to CAC.

If you wish to provide patient contact information to our settlement administrator, please call CAC at (800) 932-3017 or contact CAC to arrange for the execution of a business associate agreement and provision of patient contact information to CAC. A claims review process will ultimately determine whether a claim will be paid under the settlement.

 

If you have questions or concerns about executing the business associate agreement or submitting information to CAC, please call CAC at (800) 932-3017 or contact CAC.

If you have questions about the settlement or any other questions or concerns, please contact Assistant Attorney General Frances Kern at (651) 757-1373.