Onglyza Heart Failure Lawsuits
A rising number of lawsuits filed and a recent request for centralization of lawsuits have brought the focus on Onglyza, a drug designed to control blood sugar in patients with Type 2 diabetes. Onglyza was jointly developed by AstraZeneca and Bristol Myers Squibb as an alternative to insulin treatment. In 2009, FDA approved Onglyza based on the results of eight clinical trials provided by the manufacturers.
The active ingredient saxagliptin lowers the blood sugar levels in diabetic patients with the added advantage of no weight gain. Onglyza soon proved to be a money spinner for the company with sales crossing nine-figures as early as 2012.
FDA and Onglyza
A 2013 SAVOR clinical trial study found a possible link between Onglyza and an increased risk of heart failure. The study showed a 3.5% increased risk of heart failure-related hospitalization in patients who received the drug as compared to 2.8% of patients who received a placebo. This was amplified by the FDA receiving a number of Onglyza related adverse event reports linked to heart problems. In 2014, the FDA decided to follow it up with a heart-related side-effect review study. Finally, in 2016, after a thorough analysis, the regulatory body ordered the manufacturers to include a warning of increased risk of heart failure, particularly in patients already suffering from heart or kidney diseases.
Parallel studies conducted in 2013 also linked Onglyza to other side-effects like pancreatitis and pancreatic cancer due to which the FDA requested an adjustment to Onglyza labeling to have more detailed information. In 2016, the FDA required further postmarketing reports of acute pancreatitis and issued a stronger warning for Onglyza based on those findings.
In August 2015, a new warning and precaution for joint pain risk were added to the Onglyza label.
Effect on Sales
Initially, Onglyza sales soared making a fortune for the company. The ambitious figures led the company to quote a $3 billion projected sales number for 2023. However, the growing awareness of the side effects began to affect the sales, which dipped by 13% in the U.S. in 2015, by 10% in 2016, and a shocking 27% to $154 million as of April 7, 2017.
Thousands of users were kept in the dark of the potential risks associated with the drug, between 2009 and 2016, by the manufacturer. Filing of lawsuits increased in various courts across the country from the time the label was updated for heart failure risk.
Request for centralization for coordinated pretrial proceedings of heart failure Onglyza cases was put before the U.S. Judicial Panel on Multidistrict Litigation (JPML) by a group of plaintiffs this June. Plaintiffs are optimistic as federally-filed cases are growing, each showing a marked similarity. The defendants are opposing this request stating that informal coordination would be more effective as the number of lawsuits filed is not enough, there is no strong evidence indicating that the number of cases will grow significantly in the coming months and years and that the parties are already coordinating to maximize efficiency. Also, the range of injuries covered in these lawsuits is broad, unlike other mass tort MDLs which focus on a well-defined injury type. Oral argument on whether to consolidate these cases into an MDL is scheduled for January 2018.
Cases were also filed by patients who developed pancreatitis or pancreatic cancer. However, in May 2016, a federal judge in California granted a summary judgment and dismissed the claims. No similar claims are actively pending in any U.S. jurisdiction. Cases may be filed for pancreatic injuries or other severe complications.
Onglyza Medical Review
Medical record review of Onglyza cases will require the reviewer to sift through stacks of medical records and paperwork to locate specific and highly relevant pieces of information, focusing solely on injuries related to Onglyza which include pancreatic cancer, acute pancreatitis, severe joint pain, thyroid cancer, heart failure, and death. The reviewer will make it a worthwhile potential case by linking the injuries to evidence of usage from the medical and pharmacy records as well as the duration of Onglyza usage and proof of injury and treatment.
Related article: /blog/onglyza-missing-dose-disclosure
This article was submitted by Neural IT. Neural IT provides cost-effective and timely medical reviews for personal injury, medical malpractice, and mass tort cases. For more information, please visit www.neuralit.com. Email us at [email protected] or call +1-844-NIT-TEAM (648-8326).
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