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Forest Pharmaceuticals

St. Louis-based Forest Pharmaceuticals Inc. in 2010 in Earth City. (Laurie Skrivan | lskrivan@post-dispatch.com)

Thousands of Missouri parents are entitled to refunds for antidepressants prescribed to children because the drugs were unapproved for use in that age group, a federal judge has ruled.

Forest Laboratories and its subsidiary Forest Pharmaceuticals, which is based in Earth City, agreed to pay up to $10.4 million in refunds for misleading parents into giving the drugs Celexa and Lexapro to children and teenagers, according to a recent settlement of a class action lawsuit.

A judge in the case ruled that under the Missouri Merchandising Practices Act, “parents have the right to be fully informed about the potential efficacy of a drug,” said Brent Wisner, a Los Angeles-based attorney for the plaintiffs.

Anyone who bought Celexa for someone under 18 from 1998 to 2013 or Lexapro from 2002 to 2013 is eligible for partial to full refunds, or $50 if the total amount spent on the drugs cannot be proven.

Several Missouri parents served as representatives in the lawsuit but cannot talk about it until the case is completed. A final settlement hearing is set for July 16 for a judge to hear any objections in the case.

If finalized, the settlement allows for plaintiffs’ attorneys to receive up to 34 percent of the award, plus $325,000 in expenses.

Several psychiatrists also said they were misled by the company. In his expert testimony in the case, Dr. Joseph Glenmullen of Harvard Medical School said, “Forest misrepresented both the efficacy and safety of Celexa and Lexapro use in children and adolescents, misled physicians and deprived patients of the benefit of their health care providers’ independent professional judgment.”

Forest Pharmaceuticals pleaded guilty in 2010 to federal charges that its Missouri-based sales force illegally marketed Celexa and Lexapro for use in children and teenagers when the drugs were only approved by the Food and Drug Administration to treat depression in adults. The company bribed doctors with cash, meals and travel to prescribe the drugs to children, according to the federal charges.

The charges also said that Forest Pharmaceuticals covered up negative clinical trial results that showed the drugs were no better than placebos in treating depression in children and teens. The cover-up denied parents and doctors enough information to make decisions about the drugs that children were given, attorneys said.

Representatives for Forest did not respond to interview requests. The company remains under a five-year corporate integrity agreement with the U.S. Department of Health and Human Services as part of the settlement requirements to comply with federal drug marketing regulations. Longtime CEO Howard Solomon retired at the end of last year, after facing threats from the government to exclude the company from Medicare and Medicaid payments.

UNTESTED IN CHILDREN

The Missouri case is the first of several class action lawsuits to call for refunds because of the company’s illegal marketing practices. Forest has already agreed to pay out $313 million to settle allegations with the government and millions more in dozens of personal injury lawsuits brought by people who claim Celexa or Lexapro led to violent or suicidal behaviors.

One of the cases involved 13-year-old Andrew Tradd of Massachusetts, who died of a brain injury days after he tried to hang himself in 2004, two years after being prescribed Celexa. The family of Danielle Henrikson, 15, sued the company after she hanged herself in her Idaho home the same year, weeks after starting the drug. A third teenager, Alex Kim of Georgia, hanged himself in 2004 after his dosage of Lexapro was doubled.

In 2004, the FDA gave Celexa and Lexapro and other antidepressants its most severe black box warning for their risk of suicidal thoughts and behaviors in children, teenagers and young adults. Lexapro, a newer version of Celexa, was approved for use in people 12 and older in 2009.

According to the National Institutes of Health, “children younger than 18 years of age should not normally take citalopram (Celexa), but in some cases, a doctor may decide that citalopram is the best medication to treat a child’s condition.”

Off-label drug use for children is common in psychiatric care, mainly because clinical trials needed for a drug’s approval have historically excluded children. While the amount of data has increased recently, doctors still face tough decisions about using unapproved drugs to treat children, said Dr. Dehra Glueck of the Child and Adolescent Psychiatry Center at Washington University.

“We know depression happens in children,” Glueck said. “Children even in the preschool ages can have depression and anxiety. The disorders don’t make an age distinction, only the studies do. When prescribing for any age, you closely look at all of the information on a medication and openly discuss risks and limitations with the family in order to help them make the best decision for their child.”

When included along with therapy, antidepressants can be appropriate for some children whose depression is so severe “they are unable to function in their daily lives,” Glueck said. “When part of a comprehensive treatment plan, this group of medicines can be one of the important tools that are beneficial to patients who have significant impairment.”

DOCTORS PAID TO SPEAK

This year, Celexa has been prescribed to 8,069 Medicaid participants under the age of 18 in Missouri. Lexapro has been prescribed to 1,226 children and teens on the government insurance plan, according to the state department of social services.

Dr. Greg Mattingly, a psychiatrist in St. Charles, is named in court documents as one of the country’s top prescribers of Celexa. The court files include notes from a phone call with a Forest sales representative where Mattingly agreed to incorporate information about Celexa for kids into his talks. Mattingly received more than $107,000 from Forest Pharmaceuticals in meals, travel and speaking fees in 2012 and close to $38,000 in 2013, according to the disclosure reports from the company.

Dr. Brian Barash, a Kansas City psychiatrist and chief medical officer of the Marillac children’s psychiatric treatment center, was paid “thousands of dollars to give dozens of speeches to Missouri doctors about Celexa,” and had specific expertise in off-label use of the drug for children and adolescents, according to court documents.

Mattingly and Barash could not be reached for comment.

The drugs continue to be prescribed to thousands of children “because pharmaceutical companies have done a marvelous marketing job. It’s easy to sell a lie but much harder to sell a correction, to paraphrase Mark Twain,” said Dr. David Healy, a British psychiatrist who runs the blog Data Based Medicine and was a consultant in the class action lawsuit.

Healy said the drugs have not been shown to be effective in children or teenagers and are potentially dangerous.

“The risk from treatment is greater than the risk from the illness,” he said.

Antidepressants and children

The state of Missouri has spent $1.4 million on antidepressants prescribed this year to children under 18 who are Medicaid recipients. Prozac is FDA approved to treat major depressive disorder in children and teens. Lexapro is approved to treat depression in teens. Zoloft is approved for treatment of obsessive compulsive disorder in children and teens. There are no other approved uses of the drugs in those age groups. All of the drugs carry a black box warning for risk of increased suicidal thoughts and behaviors in children and teens. Here are the specifics for the most common drugs called selective serotonin reuptake inhibitors.

Drug State spending Pediatric patients
Citalopram (Celexa) $430,599 6,103
Escitalopram (Lexapro) $113,952 1,384
Fluoxetine (Prozac) $416,540 5,557
Paroxetine (Paxil, Pexeva) $50,168 579
Sertraline (Zoloft) $391,814 5,881