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Ranitidine Cancer Risk Found Only By Litigation Plaintiffs’ ‘Unreliable’ Research, Judge Rules

 
• By Lauren Nardella

 Plaintiffs in Multi-District Litigation didn’t provide scientific evidence of OTC heartburn drug Zantac increasing risk of cancer. Federal judge says plaintiffs' research showed “a lack of substantiation for analytical leaps” in alleging dangerously high levels of NDMA in ranitidine drugs.

• Source: Shutterstock

The initial research sparking concern about a potential link between heartburn drug ranitidine and cancer and additional studies noted in thousands of complaints for damages from manufacturers were faulty and unreliable, a federal judge says.

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More from Legal

Xlear Sees Tip Of FTC Policy Iceberg In DoJ Dismissal Of False Advertising Complaint

 
• By Malcolm Spicer

It wasn’t a quick decision for Xlear to accept DoJ attorneys’ offer to dismiss the case. “I want the I want the FTC to change its policy and its behaviors,” says Xlear president Nathan Jones.

US FDA May Lose Some Autonomy Under HHS General Counsel Reorganization

 
• By Sarah Karlin-Smith

Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.

False Advertising Challenges To OTC Phenylephrine Efficacy Ineffective Against Federal Preemption

 
• By Malcolm Spicer

Although FDA concluded OTC oral phenylephrine is ineffective as a nasal decongestant in doses up to highest studied level, federal preemption precludes challenges to agency’s regulation of labeling for phenylephrine and other Rx and OTC drugs, according to recent decision in New York federal court.

Uncertainty Abounds With SEC Climate Reporting Rule Tied Up In Courts

 
• By Lauren Nardella

Despite questions surrounding the SEC rule, including disputes being litigated in the US Eighth Circuit, companies must prepare to meet the new climate disclosure requirements in addition to related mandates in California and abroad. Experts emphasize opportunities beyond compliance.

More from Policy & Regulation

Criticism Of US Progress On Sunscreen Ingredient Innovation Demands OMUFA Hearing Spotlight

 
• By Malcolm Spicer

Discussion of introducing additional OTC sunscreen ingredients escaped a total eclipse criticism of Trump’s health agency layoffs caused. Comments and questions by Republican members joined by several Democrats and focused testimony and answers by witnesses representing the industry and public health groups spotlighted sunscreen.

Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 
• By Jessica Merrill

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.

Eisai Switches Proton Pump Inhibitor Rabeprazole To OTC In Japan

 
• By David Ridley

Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.