An overview of Eli- lily Medications

Eli Lilly continues to manufacture and market multiple drugs, including:

• Zyprexa, to treat schizophrenia and bipolar disorder
• Evista, to prevent and treat postmenopausal osteoporosis
• Axiron, to treat low testosterone due to medical conditions
• Strattera, to treat attention deficit hyperactivity disorder (ADHD)
• Symbyax, the first FDA-approved medication specifically for bipolar depression
• Byetta, to treat Type 2 diabetes
• Cialis, to treat erectile dysfunction
• SGLT2 inhibitors, Jardiance and Glyxambi, to treat Type 2 diabetes
• Erbitux, to treat certain cancers
• Tradjenta, to treat Type 2 diabetes

Problematic Medications

Although Eli Lilly has helped countless patients find a better quality of life, the company is also responsible for a number of controversial products. Drugs like Actos, Prozac and Axiron come with side effects that led many to take legal action against Lilly. The antipsychotic drug Zyprexa landed the company in court for illegal marketing.

Axiron

In 2010, the FDA approved Axiron, the first “underarm” testosterone replacement therapy (TRT) treatment. Men with low or no testosterone associated with a medical condition can apply the drug like deodorant to counter symptoms such as sexual difficulties, osteoporosis and loss of muscle mass.

With sales of $178.7 million in 2013, Axiron is one of the best-selling testosterone drugs on the market, second only to AbbVie’s AndroGel. Despite the growing success of Axiron and other TRTs, research studies on the long-term safety of testosterone replacement therapy are nonexistent.

After two recent studies linked testosterone products to a higher risk of heart attack, stroke and death, the FDA announced it will reevaluate the treatment’s safety. Eli Lilly faces legal action alongside other TRT drug manufacturers over the therapy’s risk for heart attack and other adverse events. Thousands of testosterone therapy lawsuits are pending in the U.S. District Court Northern District of Illinois.

Actos

Eli Lilly partnered with Japan-based drug manufacturer Takeda to market Actos (pioglitazone) in the U.S. from 1999 to 2009. The oral medication, used to treat Type 2 diabetes, is linked to congestive heart failure and bladder cancer. Complications with the drug led thousands of patients to file lawsuits against both companies.

In April 2015, Takeda Pharmaceuticals settled thousands of lawsuits for a $2.37 billion Actos settlement. The settlement was one of the largest in U.S. history.

Byetta

In 2005, Lilly cooperated with Amylin Pharmaceuticals to introduce Byetta (exenatide), an injectable Type 2 diabetes drug. Both companies are now targets of numerous lawsuits over the drug’s link to serious side effects such as pancreatitis and pancreatic cancer.

In late 2011, the two companies agreed to end their decade-long partnership and transfer all responsibility of Byetta commercialization and development to Amylin in an effort to resolve outstanding litigation between the two companies. In 2012, Bristol-Myers purchased Amylin for $5.3 billion.

The FDA began studying the connection between drugs like Byetta and cancer in 2013.

Tradjenta

Tradjenta (linagliptin) is an oral medicine doctors prescribe to treat Type 2 diabetes. The drug emerged from a 2011 partnership between Eli Lilly and German manufacturer Boehringer Ingelheim. Like patients taking Byetta, some Tradjenta users reported serious complications like pancreatitis and pancreatic cancer.

Prozac

Prozac, an antidepressant that revolutionized the medical landscape, has a low risk of causing birth defects if taken while pregnant and can increase suicidal thoughts and behavior in children and young adults. Patients have targeted Lilly with numerous Prozac lawsuits, claiming the company didn’t properly warn them about the drug’s dangerous side effects.

Eli Lilly paid more than $50 million by 2000 to settle dozens of lawsuits related to Prozac. The drug remains on the market, although the FDA now requires it to carry a black-box label warning stating that it may increase suicidal thoughts or behavior in young people. So far, the company has refused to admit liability in birth defect cases.

Zyprexa

Eli Lilly pleaded guilty in January 2009 to illegal marketing of its drug Zyprexa, which the FDA only approved to treat bipolar disorder and schizophrenia. The company also marketed the drug as a treatment for dementia and for pediatric uses. Lilly paid $1.42 billion to end the criminal investigation and settle civil lawsuits, and another $62 million to settle similar cases in 32 states and Washington, D.C.

Symbyax

Symbyax, a drug that combines Prozac and Zyprexa, can have the undesirable side effects of both. Like Prozac, the drug can cause birth defects when taken by pregnant women. Parents reported problems including cleft lip and palate, spina bifida, anencephaly and club foot. Lilly faces lawsuits over Symbyax side effects.

Diethylstilbestrol

In January 2013, Lilly settled a lawsuit filed by four sisters who claimed its version of diethylstilbestrol (DES) gave them breast cancer after their mother took it in the 1950s. Eli Lilly and hundreds of other manufacturers marketed the drug as a way to prevent miscarriages. However, a Harvard public health doctor and expert witness in the case explained that DES can cause cancer in the babies of some women who took the drug.

According to one of the lawyers representing the sisters, Lilly failed to test the drug on pregnant women before marketing it. The FDA issued a recall for DES in 1975. The settlement was for an undisclosed sum, and joins a number of similar cases Lilly has settled, including claims related to cervical and vaginal cancer.