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An examination of adverse event reports involving problems with different diabetes drugs suggests that users may face a broad range of potential side effects based on the class of the medication, including risks of ketoacidosis, pancreatic cancer, kidney problems and heart problems.
AdverseEvents.com released a special report last month, which examines three major classes of diabetes drugs, including GLP-1 (Bydureon, Byetta, Tanzeum, and Victoza), DPP-4 (Nesina, Tradjenta, Onglyza, Kombiglyze XR, Januvia, Janumet, and Janumet XR) and a new class known as SGLT2 (Farxiga, Invokana, and Jardiance).
The report appears to confirm many concerns about serious and potentially severe side effects of the diabetes drug, including some health risks that are still being hotly debated within the medical community.
Researchers collected data from the FDA Adverse Event Report System, indicating that many of the potential side effects seen could not have been detected until extensive post-marketing surveillance took place.
The report also identified potential new areas of concerns, including cases of heart failure and cerebral-related adverse events, mostly linked to incretin mimetics, particularly Onglyza and Nesina. There were 19 cases of heart failure linked to Onglyza and five cases linked to Nesina. However, the analysis also found six cases of heart failure associated with Farxiga use.
Farxiga is part of a new class of diabetes drugs, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Before the FDA approved the first member of this class in 2013, marketed as Invokana, concerns were raised about the risk of heart problems among users of the diabetes drugs.
The report identified a potential link between acute pancreatitis and pancreatic cancer and a class of drugs known as incretin mimetics, which includes both glucagon-like peptide -1 agonists like Byetta and Victoza, and dipeptidyl peptidase-4 inhibitors (DPP-4) like Januvia, Onglyza and Nesina.
Concerns over the link between incretin mimetics and pancreatic cancer have been debated for several years and have resulted in thousands of pancreatic cancer lawsuits.
The report found that more than 750 Byetta patients have developed pancreatic cancer, as well as 335 Victoza patients. Pancreatic cancer has also struck 696 Januvia patients, and 167 patients who used Janumet.
Invokana, Farxiga Risks
Last month, the FDA issued a warning about the risk of ketoacidosis from Invokana, Farxiga and other SGLT-2 inhibiting diabetes drugs, indicating that users may face health problems from a build up of acid levels in the blood.
The special report by AdverseEvents.com provides further details about these potential side effects of Invokana, Farxiga and other related drugs. Researchers found 23 cases of ketoacidosis linked to Invokana use, and another 16 cases linked to Farxiga.
Over the first two years Invokana was on the market in the U.S., the diabetes drug was aggressively marketed by Johnson & Johnson’s Janssen unit, resulting in rapid sales growth and a dominant position within this new class of medications. However, as more and more individuals are switched to this diabetes drug, it appears that Invokana risks are surfacing that may suggest the drug was not thoroughly researched before it was introduced and that inadequate warnings may have been provided for potential users and the medical community.
The same month as the FDA warnings, the Institute of Safe Medication Practices (ISMP) released a report that also evaluated adverse event reports submitted to the FDA, identifying potential safety signals involving kidney toxicity and raising questions about whether the potential Invokana risks may actually outweigh the benefits provided by the diabetes drug.
During the first year Invokana was on the market, ISMP highlighted 457 serious adverse event reports submitted to the FDA involving complications from Invokana. These adverse event reports typically only account for a small portion of the total problems associated with prescription medications on the market.
Many of the reported Invokana problems involved kidney failure, kidney impairment or problems with kidney stones, urinary tract infections, dehydration, hypersensitivity and abnormal weight loss. Looking at reports to the FDA’s adverse event reporting system, the ISMP found that Invokana received more serious adverse event reports than 92% of the other drugs regularly monitored by the group.
Given the emerging safety concerns and rush to market this new class of diabetes drug, some product liability lawyers are now reviewing whether individuals who suffered an injury may be entitled to financial compensation through an Invokana lawsuit or Farxiga lawsuit as a result of the drug makers’ failure to adequately research the potential risks and warn about the side effects.