Novartis Allegedly Promoted Asthma Drug for Preterm Labor Despite Brain Damage Risk

Novartis, a pharmaceutical giant, has been accused of illegally promoting its asthma drug terbutaline (brand name Brethine) for the treatment of preterm labor, despite knowing it was ineffective and could cause abnormal fetal brain development. The lawsuit, filed in California, alleges that Novartis hired a professor at the University of California to author a study supporting the off-label use of the drug, even though animal studies had shown that terbutaline could affect fetal brain development.

According to the report, Novartis did not seek formal FDA approval for using terbutaline to treat preterm labor, even after being invited to do so. The lawsuit claims that the company made this decision because the drug was already widely used, and a formal approval would expose them to lawsuits for adverse effects. As a result, terbutaline became commonly used for 'maintenance tocolysis' to prevent preterm labor.

Why this matters: The allegations against Novartis raise serious concerns about the pharmaceutical industry's practices and the potential risks to public health. If proven true, this case could have far-reaching implications for the regulation and oversight of off-label drug promotion and the responsibility of drug companies to prioritize patient safety.

In 2011, the FDA required a black box warning against using terbutaline for maintenance tocolysis, and studies have shown an association between the drug and autism. The plaintiffs, individuals with autism and their mothers, are seeking unspecified monetary damages from Novartis and the University of California for negligence and intentional misrepresentation.

The lawsuit, filed by individuals with autism and their mothers, alleges that Novartis and the University of California were negligent and engaged in intentional misrepresentation by promoting terbutaline for preterm labor without adequate safety data. The plaintiffs are seeking unspecified monetary damages from both parties involved.

Key Takeaways

• Novartis accused of illegally promoting asthma drug terbutaline for preterm labor
• Terbutaline linked to abnormal fetal brain development, but Novartis did not seek FDA approval
• Lawsuit alleges Novartis hired a professor to author a study supporting off-label use
• FDA required black box warning against using terbutaline for maintenance tocolysis in 2011
• Plaintiffs seek damages from Novartis and University of California for negligence and misrepresentation