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Brenda Fulmer
Brenda Fulmer
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J&J New Diabetes Drug on the market — Safer or not?

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The field of diabetes drugs is a potentially lucrative one, so it is no surprise that Johnson & Johnson (J&J), through its Janssen Pharmaceuticals, Inc. subsidiary, has entered the market with its new once-a-day medication, Invokana (also known as canagliflozin).

Adults with type-2 diabetes do not adequately metabolize sugars that are converted from food and must use medications to lower sugar that circulates throughout the body in the blood. The problem can be caused by either low insulin levels or resistance to insulin. Diabetics with uncontrolled blood sugar face serious, life-threatening complications, including, but not limited to, heart attacks, kidney problems, and blindness.

Invokana works on the elevated blood sugar problem by blocking the kidneys from reabsorbing sugar and increasing the amount of sugar excreted through the urine. With about 26 million Americans suffering from adult-onset diabetes mellitus, Johnson & Johnson predicts that Invokana will become a blockbuster drug generating more than a billion in sales annually.

Side effects of Invokana are said to include yeast and urinary tract infections from high sugar levels in the urine. Dizziness is also listed as a potential complication. More serious side effects associated with this new diabetes drug are low blood pressure (hypotension), impaired kidney function, low blood sugar (hypoglycemia), genital mycotic infections, hypersensitivity reactions, increases in LDL levels, and drug interactions with UGT enzyme inducers and digoxin.

Pre-market approval for safety and efficacy tested Invokana on 10,000 patients, and the FDA felt confident enough based upon the clinical study data submitted by the drug manufacturer to issue an approval for marketing. One would hope that the FDA has exercised extreme caution with approval of this diabetes drug, especially in light of the long history of quick FDA approvals of diabetes drugs leading to numerous avoidable injuries and patient deaths.

Rezulin, an insulin sensitizer manufactured by Warner Lambert, was linked to hundreds of patient deaths and injuries due to liver failure prior to its recall in 2000; the drug enjoyed more than $2 billion in sales prior to its recall. Avandia, the successor to Rezulin, was marketed by GlaxoSmithKline for several years amidst controversy after the drug was linked to an increased risk of heart attacks, strokes, and other cardiovascular injuries. Following thousands of lawsuits by patients who died or suffered severe injuries and enhancements to the drug’s warning label in 2007, most patients and physicians stopped using Avandia. Many patients alarmed about the heart risks associated with Avandia were switched Actos, a competing drug manufactured by Japanese pharmaceutical giant, Takeda. Actos has been linked to an increased risk of bladder cancer in patients who have taken the drug for as short as 12 months. As if the list of dangerous or defective diabetes drugs were not long enough, along came Byetta (also known as exenatide and sold by Eli Lilly & Co. and Amylin Pharmaceuticals) and Januvia and Janumet (also known as sutagliptin and marketed by Merck). Both Byetta and Januvia have been linked to an increased risk of pancreatic cancer and thyroid cancer and other serious health risks. A hearing will be held on May 30, 2013, in Louisville, Kentucky before the Judicial Panel on Multi-District Litigation to determine whether lawsuits filed by patients injured by Januvia, Byetta, and Janumet should be consolidated before a single federal judge.

As is the case with any new drug on the market, many wise doctors take a wait-and-see attitude before they prescribe it to their patients. They want to observe what the real-life effects will be on the public – sort of a final, ongoing clinical trial. Patients, likewise, need to be cautious in accepting prescriptions for new drugs and should ask their prescribing physicians some tough questions:

  • What are the proven benefits of this medication?
  • What is being reported in the medical literature as far as safety risks associated with this new drug? Are those independent studies or studies funded by the drug manufacturer?
  • Was the drug studied in a sufficient number of patients to provide an adequate evaluation of the drug’s safety or effectiveness?
  • What alternative therapies are available? Is there better evidence of safety and efficacy for these alternative treatments?
  • Other than marketing materials provided by the drug manufacturer, what evidence do you have regarding the drug’s safety profile and benefits?
  • Are you involved in testing this drug or have ties to the drug manufacturer?

While these are tough questions, they need to be asked. If your doctor can’t answer them, then turn to a pharmacist or another physician to answer the questions for you and give strong consideration to whether you need a new physician.

I often lecture consumer groups on drug safety and share several tips for patients based upon my personal experience in litigating defective drug cases for nearly two decades. Perhaps, one of the most important tips, which is supported by other drug safety advocates, is to be very cautious of drugs during the first 18 months they are on the market, as that is when many early safety signals first arise. Clinical trial subjects are so closely monitored for potential safety issues, such that the outcomes of those studies do not mirror the safety issues you would expect to see in large numbers of patients taking the drugs in real-life settings along with several other medications and numerous pre-existing medical conditions. I tell people, “if this new drug is not going to save your life, then perhaps you want to wait and let others be the guinea pigs during the first few years that the drug is on the market.” The sordid history of safety with the diabetes drugs Rezulin, Avandia, Actos, Byetta, Janumet, and Januvia have provided a perfect example of the lethal combination of quick FDA approvals and limited clinical trials leading to numerous patient injuries and deaths shortly after the drugs were first approved for marketing in the United States.