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New Report Warns of 21st Century Cures Act Shortfalls

In December 2015, non-profit group Public Citizen published a report highlighting a provision in the proposed 21st Century Cures Act that could cost taxpayers $12 billion — and that’s just one of the expenses. The report — written by Sammy Almashat and Sarah Sorscher of Public Citizen’s Health Research Group... Read more »

FDA Issues Warning about SGLT2 inhibitor Side Effects

The FDA has issued a safety communication involving potentially dangerous side effects associated with a category of type 2 diabetes drugs known as SGLT2 inhibitors. The agency has warned that use of the drug could lead to ketoacidosis, a serious condition often requiring emergency medical care. Urinary tract infections or... Read more »

Status Conference Scheduled for GranuFlo, NaturaLyte MDL

The parties involved in the GranuFlo and NaturaLyte multidistrict litigation were scheduled to meet on Friday, Nov. 22. In a status conference before U.S. District Judge Douglas P. Woodlock, both parties were expected to evaluate the proposed start dates for the first two bellwether trials, to see if they’re on-track. The... Read more »

Plaintiff Blames Invokana for Severe Kidney Damage

Plaintiff Gene Schurman, a resident of Illinois, claims he suffered severe kidney damage after taking the diabetes drug Invokana under the direction of his doctor. He is now suing Janssen Pharmaceuticals, Johnson & Johnson and Mitsubishi Tanabe Pharma Corporation on claims of failure to warn, product liability, design defect, fraud,... Read more »

Hundreds of Yaz Lawsuits Resolved with Settlements

Bayer Healthcare Pharmaceuticals has reported substantial progress during the latest status conference for the multidistrict litigation (MDL) No. 2100 regarding Yaz and Yasmin lawsuits. The status conference took place early in November 2015. It was presided over by U.S. District Judge David R. Herndon of the Southern District of Illinois.... Read more »

FDA Declines Approval of New Combination Diabetes Drug

London-based AstraZeneca failed to obtain FDA approval for a proposed diabetes drug that combines two different medications, saxagliptin and dapagliflozin. In October 2015, the FDA issued a complete response letter to the pharmaceutical giant’s application. The agency requested additional clinical research on the proposed combination drug. AstraZeneca recently released statements... Read more »

Invokana Targeted in Canadian Class Action Lawsuit

Already the subject of increasing controversy in the United States, next generation diabetes drug Invokana is now the target of a newly-filed class action lawsuit in Canada. Filed at the Ontario Superior Court of Justice, the lawsuit alleges that Jannsen’s treatment for Type 2 diabetes poses a serious risk of kidney... Read more »

FDA Requests That Pfizer Update Zoloft Label

The U.S. Food and Drug Administration has asked Pfizer to update its Zoloft safety warnings to acknowledge that some studies have linked the antidepressant to infant heart defects. There is still no concrete evidence definitively connecting the drug to birth defects, but some researchers have noted an “increased risk of... Read more »

FDA Updates Invokana Label Regarding Bone Fracture Risk

The U.S. Food and Drug Administration (FDA) has released a new drug safety communication regarding Invokana and Invokamet (canagliflozin). The safety announcement, which was released on September 10, 2015, adds a new warning to the drug’s label and updates the adverse reactions section with regard to the risk of bone... Read more »