The Vicious Cycle of Dangerous Diabetes Drugs
Diabetes medications can be lifesaving drugs that come with life-threatening risks. As new diabetes drugs are approved by the FDA despite alarming side effects, a vicious pharmaceutical cycle seems to be repeating itself: Patients take drugs that raise their risk of developing type 2 diabetes, only to suffer even more dangerous side effects—including heart failure and cancer—when they take additional medications to control their blood sugar.
For instance, millions of people take statins like Zocor, Crestor and Lipitor to lower their cholesterol. However, a study published in the British Medical Journal in May 2013 found that these drugs actually increased a person’s risk of developing new-onset diabetes by 10 to 22 percent. Statin patients are then prescribed diabetes drugs like Actos or Avandia to help them lower their insulin levels – only to find that these diabetes drugs come with a increased cancer risk.
Diabetes drugs can work miracles, not without serious risk
Although diabetes drugs can be lifesaving, they also represent one of four types of drugs responsible for two-thirds of emergency room visits among older Americans, according to a 2011 report published by Dr. Dan Budnitz, director of the Medication Safety Program at the Centers for Disease Control and Prevention. Insulin injections cause 14 percent of ER visits and oral diabetes drugs were implicated in 11 percent of hospital visits, according to the study. Blood thinners and anti-platelet drugs were also listed as top causes for the 100,000 emergency hospitalizations of patients 65 and older.
Sometimes it’s problems with dosage or drug interactivity causing these visits, but other cases can be traced back to manufacturer negligence and the suppression of health risks just to make a profit.
Common diabetes medications – serious side effects
Each class of diabetes drug carries its own set of risks, so patients should weigh their options with their doctors very carefully.
Diabetes medications and their side effects include:
- Biguanide Drugs – Biguanides like Metformin works by increasing insulin sensitivity. Two drugs in this class, Phenformin and Buformin, have been withdrawn from the market due to their tendency to cause lactic acidosis – a build-up of lactic acid in the body, causing symptoms of rapid breathing, irregular heartbeat, vomiting, and abdominal pain. A third of the patients taking biguanides experience diarrhea and dyspepsia.
- Thiazolidinediones – TZD medications increase insulin sensitivity and decrease insulin resistance. Edema, fluid retention and weight gain are common side effects associated with this class of drugs. Worse yet, Avandia has been linked to heart disease and Actos to bladder cancer. A study published in the Journal of the National Cancer Institute found that 20 percent of the drugs prescribed to diabetics in America are two to three times more likely to cause bladder cancer than sulfonylurea class drugs for five or more years. The NY Times reports that the makers of Avandia knew of clinical test results linking their drug to heart disease, but spent 11 years “trying to cover them up.”
- Incretin Therapy Drugs – What was once called “the new darlings of diabetes treatment” is now the focus of mass litigation. A new British Medical Journal report and UK documentary revealed that there is an increased pancreatic cancer risk for patients taking drugs like Byetta, Januvia, Victoza, Ongylza, and Tradjenta. The report called for the release of all safety information held by manufacturers and lambasted the FDA and European Medicines Agency for not responding to safety research as well as they should have.
- Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors – In March 2013, the FDA approved Invokana, a first-of-its-kind diabetes drug that works by causing blood sugar to be excreted in urine, rather than affecting the supply or use of insulin. Clinical trials involving more than 10,000 patients found that Invokana succeeded in improving blood sugar levels, lowering blood pressure and encouraging weight loss. However, the trial also uncovered elevated risks for strokes and heart attacks related to heightened cholesterol levels.
Despite these findings about dangerous Invokana side effects, the labeling does not include any warnings about the increased risk for heart attacks or strokes. The FDA is requiring manufacturer Johnson & Johnson to conduct five post-marketing studies to determine whether they need to include better safety information on the packaging. The drug’s most common side effects are urinary tract and vaginal yeast infections, reports the NY Times.
The FDA approved of the second SGLT2 drug, Farxiga, in January 2014. Before gaining approval, the drug went through 16 clinical trials involving more than 9,400 patients with type 2 diabetes. Even so, Medical News Today says that Farxiga is not suitable for individuals with type 1 diabetes, diabetic ketoacidosis, or patients with kidney problems. Worse yet, the studies revealed an increased risk of bladder cancer among users of the new diabetes drug. The most common side effects of Farxiga were dehydration, fungal infections and urinary tract infections. Six post-marketing studies are being conducted to assess cardiovascular outcomes and bladder cancer risks.
Miracle drugs result in thousands of lawsuits
Not surprisingly, diabetes drug lawsuits are flooding the court system. Avandia (MDL 1871) had 3,292 lawsuits pending and Actos had 2,692 lawsuits pending as of January 15th, 2013. Charges filed against Merck & Co, Novo Nordisk, Eli Lilly and Bristol-Meyes Squibb were consolidated in Southern California (MDL 2452) to address more than 262 pancreatic cancer claims related to diabetes medications. Since last month, 100 new claims have been added to the multidistrict litigation, which underscores just how widespread the problem is.
- JPML – Pending Dockets (January 15, 2014), http://www.jpml.uscourts.gov/pending-mdls-0
- NY Times - FDA Approves A New Diabetes Drug From J&J, http://www.nytimes.com/2013/03/30/business/invokana-wins-fda-approval-for-diabetes-treatment.html?_r=0
- BMJ – Statin Use Linked To Increased Risk of Developing Diabetes, Warn Researchers, http://www.bmj.com/press-releases/2013/05/23/statin-use-linked-increased-risk-developing-diabetes-warn-researchers
- Penn Medicine - Diabetes Drugs Prescribed to More than 15 Million Americans Raises Risk of Bladder Cancer, Penn Medicine Study Shows, http://www.uphs.upenn.edu/news/News_Releases/2012/08/diabetes
- NY Times - Four Drugs Cause Most Hospitalizations in Older Adults, http://well.blogs.nytimes.com/2011/11/23/four-drugs-cause-most-hospitalizations-in-older-adults
- NY Times – Diabetes Drug Maker Hid Test Data, Files Indicate, http://www.nytimes.com/2010/07/13/health/policy/13avandia.html