Invokana Risks May Result in Yeast Infections for 10% of Patients: Study
A new study raises further concerns about the potential side effects of Invokana and other diabetes drugs that are part of a new class of medications, suggesting that one out of every 10 users may suffer a yeast infection or lower urinary tract infection.
The findings were presented at the American Academy of Physician Assistants 2015 meeting in San Francisco last week, coming on the heels of recent FDA warnings about the risk of ketoacidosis from Invokana and reports of users suffering kidney problems.
Invokana is the first member of a new class of diabetes drugs, known as sodium glucose co-transporter type 2 (SGLT2) inhibitors, which combat high glucose levels by lowering some kidney functions, leading to increased glucose being passed through the urine. However, this latest study suggests that the increased sugar in the urine may also lead to increased mycotic infections or yeast infections.
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In addition to those infections, researchers from the Jones Center for Diabetes and Endocrine Wellness in Macon, Georgia, warned that nearly 20% of patients using Invokana or another member of the class may face a risk of dealing with some type of recurring infection.
Researchers warned that while women are likely to be more familiar with dealing with such infections, male patients may need to be particularly warned and educated about the risks and potential treatments. One doctor involved in the study had three male patients who developed mycotic infections after the use of SGLT2 inhibitors like Invokana. Two of those patients were uncircumsized, which some studies have suggested increases the risk of infections among men.
The findings suggest that doctors should be encouraged to talk with all patients about the increased risk of infections when prescribing Invokana or similar drugs. Their findings have not yet been published or peer-reviewed.
Invokana Safety Concerns
The FDA approved Invokana (canagliflozin) in March 2013. However, it has quickly grown to become a blockbuster medication, with nearly half a million prescriptions in the second quarter of 2014.
The drug was introduced and heavily marketed by Johnson & Johnson’s Janssen subsidiary in the wake of heart attack concerns over the drug Avandia, bladder cancer concerns involving the diabetes drug Actos, and the beginning of pancreatic cancer concerns involving the diabetes drugs Byetta, Januvia, Janumet and Victoza.
After the drug was rapidly adopted within the medical community, the FDA issued a drug safety communication about a potential link between Invokana and ketoacidosis in May 2015, indicating that the medication may cause a build up acid levels in the blood, which can result in severe injury and hospitalization.
The FDA identified at least 20 cases of diabetic ketoacidosis among users of Invokana or other members of this new class, with all cases involving hospitalization or emergency room treatment.
Symptoms of ketoacidosis include difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. The FDA warned users to be on the lookout for signs of acidosis while taking Invokana or another similar drug. However, users have been told not to stop or change their diabetic medications without first consulting their prescriber.
Reports have also raised concerns about whether there may be a link between Invokana and kidney failure, as the medication is known to impact the normal function of the kidney and a large number of adverse event reports have been submitted by users and physicians involving kidney toxicity.
Last month, a report released by the Institute of Safe Medication Practices (ISMP) questioned whether the Invokana risks may actually outweigh the benefits provided by the drug.
During the first year the drug 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.
The ISMP report found that at the cost of those risks came very few benefits. According to the report, the Invokana clinical trials showed that the drug typically lowered levels of glycated hemoglobin (HbA1c), a primary type 2 diabetes blood sugar measurement, by about only one percent. It also caused weight loss of a mean of five to six pounds in users.
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 as a result of the drug makers’ failure to adequately research the potential risks and warn about the side effects.
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