The Food & Drug Administration received six additional reports of patients developing a dangerous form of pancreatitis while taking Byetta. Two of the patients died and four were recovering. The FDA is now telling patients and doctors to discontinue use of Byetta immediately if they develop signs of acute pancreatitis, a swelling of the pancreas that can cause nausea, vomiting, and abdominal pain.
The FDA further warned Byetta users that it is very difficult to distinguish acute pancreatitis from less dangerous forms of the condition. The FDA also said doctors should consider prescribing diabetes drugs other than Byetta for patients with a history of pancreas problems.
Byetta is most often prescribed for patients who have not been able to achieve adequate control on metformin and a sulfonylurea, two often prescribed diabetes medications that are taken orally. Byetta has been prescribed alone or in conjunction with other diabetes medicines. There have been over 6.6 million prescriptions of Byetta in the three-and-a-half years since it was approved by the FDA. It is manufactured by Amylin Pharmaceuticals, Inc. and Eli Lilly and Company.
Byetta (pronounced bye-A-tuh), the trade name for exenatide, is the first in a new class of medicines known as incretin mimetics. The idea behind Byetta is that it improves a diabetes patient's blood sugar by lowering both post-meal and fasting glucose levels. If effective, Byetta leads to better long-term control of the condition (as measured by hemoglobin A1C).
Pancreatic cancer is a serious problem. It is the fourth leading cause of cancer deaths in the U.S. While winning big in their battle with pancreatic cancer, many of these fights end in death. This insidious cancer has the lowest relative survival rate of all cancer: The statistics are chilling: 94% of pancreatic cancer patients will die within five years and 74% die within the first year of diagnosis.
We have known for some time of pancreatic injuries with Byetta. In 2009, many lawsuits were triggered by the FDA's decision to revise the warning label for Byetta to include information on the possible risk of acute pancreatitis. But in 2011, researchers in California made a frightening finding: the risk of pancreatic cancer was almost 3 times as high as Byetta. In 2011, a group of researchers from UCLA conducted an investigation into the side effects of Byetta and Januvia (another antidiabetic medication).New Byetta Study
In April 2013, the Institute for Safe Medication Practices (ISMP) released a Quarterly Watch report on GLP-1 Agents which are medications used to treat Type-2 diabetes. The report looked at five widely used drugs including Byetta, Victoza, Januvia, Onglyza, and Tradjenta. Concerns about the dangers of these drugs were raised shortly after these drugs went on the market, and those rumblings have continued over the years. In response, the ISMP performed a comprehensive study of these drugs by looking at the adverse drug event data reported to the FDA over a twelve-month period.
To say the least, the ISMP report is shocking. In one year, 1,723 instances of "serious adverse drug events" were reported to the FDA as a result of taking these drugs. Those "serious events" include pancreatitis, pancreatic cancer, thyroid cancer, and renal failure. And while 1,723 is a fairly large number alone, keep in mind that number only includes the cases that were actually reported.
We've known about the dangers of these drugs for a while, specifically with Byetta. In 2009, the FDA recommended the makers of Byetta change their warning labels to account for the risk of pancreatitis, an action which triggered a number of lawsuits. And, a 2011 study conducted by UCLA researchers showed that a patient taking Byetta was three times more likely to develop pancreatic cancer than a patient who wasn't taking the drug.
This new report shows the dangers may be even greater than previously thought, especially with Byetta and pancreatic cancer. The ISMP report shows that 612 of the 1,723 "serious adverse drug events" dealt with patients who took Byetta. That's roughly 35% of the total cases. Of those 612 cases, 263 of them were reports of pancreatitis and 71 were reports of pancreatic cancer.
Here's the problem: the makers of Byetta, in spite of all this data, have failed to acknowledge or recognize the correlation between the drug and the increased risk for cancer.... and to tell doctors and patients. They can make every argument under the sun that Byetta is not linked to cancer, but when 11% of the "serious adverse drug events" for a ONE YEAR period are due to pancreatic cancer, turning a blind eye and criticizing the data is not helping anyone. In fact, it's killing people.
Here's why: pancreatic cancer is practically lethal. It is the fourth leading cause of cancer deaths in the U.S. and it has the lowest survival rate of all cancers. And again, it bears repeating, 94% of pancreatic cancer patients die within five years and a chilling 74% die within the first year of diagnosis. So, of those 71 reports of pancreatic cancer caused by Byetta, roughly 5 of those individuals will survive. The other 66 will not. It is just awful.
No one knows the settlement value of these Byetta or Januvia pancreatic cases. There is no certainty in litigation, and there is too much yet to learn about how these cases will play out. But many expect these cases to have seven-figure settlements. There is a reason for that: pancreatic cancer is just an awful injury.
To get some lens as to what the value of these cases might be, we need to find comparable facts. That's impossible because no two cases are alike. But illustrative of the value of pancreatic cancer cases might be looking at other verdicts involving pancreatic cancer:
- Medical Negligence Verdict for 1.8 Million. A 39-year-old female patient goes to her doctor and presents with jaundice and abdominal pain. Defendant doctor performs multiple pancreatic biopsies believing the patient has pancreatic cancer. The patient subsequently dies after the procedure, and Patient's estate brings a claim against the Defendant doctor. Patient's estate argues a biopsy is not a proper diagnostic test for pancreatic cancer, and that even if it was determined a biopsy is necessary, Patient should have been transferred to a different, more equipped medical center. A Minnesota jury agrees and awards the Patient's estate 1,800,000.
- Pancreatic Cancer Settlement for 2.75 Million. Plaintiff, a 40-year-old man, visits his gastroenterologist with symptoms of abdominal pain, nausea, regurgitation, and heartburn. A doctor diagnoses Plaintiff with acid-reflux disease and peptic ulcer disease. Plaintiff's symptoms worsen over time, and Plaintiff is seen by his family physician who orders a CT scan in 1999. The CT scan is interpreted as normal by the radiologist and radiological group. In September 2000, Plaintiff's gastroenterologist orders an additional CT scan with special emphasis to be placed on the pancreas. The second scan is interpreted as normal as well. In July 2002, Plaintiff is admitted to the hospital where a CT scan reveals a large pancreatic mass which cannot be removed. Plaintiff argues his doctors failed to properly interpret his radiological scans which led to cancer progressing to a non-curable stage and which will cause his untimely death. All Defendant doctors deny negligence but agree to a 2,750,000 settlement prior to trial.
- Pancreatic Cancer Verdict for 4.7 Million. A 44-year-old Patient sees his family doctor with complaints of abdominal pain, and the doctor diagnoses the patient as having a virus. Patient visits the ER the next day with increased severity of his symptoms and a CT scan is performed which reveals a mass on the Patient's pancreas. The patient is released from the hospital the following day but is not informed about the abnormality on his CT scan. The next year, a repeat CT scan is performed, and Patient is again not informed of the abnormal mass. Pancreatic cancer is diagnosed a year later, and Patient undergoes lengthy and invasive treatments but passes away soon after. Patient's family and estate bring claims of negligence against the treating doctors as well as the hospital that employed the doctors, and a Kentucky jury gives a $4,776,261 verdict for the Plaintiffs.
- Pancreatic Cancer Verdict for 3.9 Million. The patient goes in for a CT scan at the request of his doctor in the fall of 2000. A second doctor interprets scan and finds a small mass on the patient's pancreas, but does not bring it up with Patient. In the spring of 2001, Patient presents with elevated enzymes and abdominal symptoms and undergoes a second CT scan. The second scan reveals the pancreatic mass is larger than it was on the first scan and Patient is then made aware he has cancer. The patient undergoes surgery and chemotherapy but ultimately dies in early 2003. Patient's wife, as the administrator of her husband's estate, alleges the doctors were negligent for failing to inform her husband of his condition and that their failure to do so deprived him of a better chance of recovery. Defendant doctors deny any negligence, but a Kansas jury awards the estate $3,997,000.
You do not want to read too much into these verdicts. It bears repeating: no one can predict the value of any claim like this with certainty. But these verdicts may be about what you would reasonably expect a jury to find in a Byetta or Januvia pancreatic case if liability was demonstrated. In fact, you could argue a jury would be even harsher on a drug company than it would on a well-intentioned doctor who made a simple mistake.Byetta Kidney and Other Injuries
The FDA has received post-marketing reports (complaints from patients and doctors after a drug is released to the public) that some patients have developed serious, life-threatening injuries while taking Byetta. In the three-and-a-half years since Byetta's release, the FDA has been notified of 78 patients with "altered kidney function." Here is the breakdown, according to a November 2, 2009, FDA alert to healthcare professionals:
- 62 patients with acute renal failure (sudden and severe loss of kidney function)
- 16 patients with renal insufficiency (decreased ability of kidneys to remove waste from the body)
These problems occurred as soon as three days after taking Byetta, and as long as two years after starting a regimen of Byetta. 91% of the patients required hospitalization. Of the patients who reported problems after taking Byetta, four died, eighteen required dialyses, and two had subsequent kidney transplants. In some cases, the injured patients had pre-existing kidney disease, but some patients had no prior history of kidney problems.
The FDA's Byetta warnings come on the heels of a March 2009 warning by the United Kingdom about kidney injuries following the use of Byetta. The U.K. warned that Byetta should not be used by patients with an end-stage renal disease or severe renal impairment.
Acute renal failure and renal insufficiency may cause the following symptoms and side effects:
- Changes in urination (color, frequency, amount)
- Unexplained swelling of the extremities
- Increased blood pressure
- Changes in appetite
- Aching in lower or mid-back.
Amylin and Lilly issued a "Dear Doctor" warning letter to healthcare physicians in October, 2009. In this letter, the manufacturer noted that acute renal failure was added to the Byetta prescribing information as postmarket adverse events. In the letter, they gave the following warning:
BYETTA should not be used in patients with severe renal impairment (creatinine clearance < 30 mL/min) or end-stage renal disease, and should be used with caution in patients with renal transplantation [see Use in Specific Populations (8.6)]. In patients with end-stage renal disease receiving dialysis, single doses of BYETTA 5 mcg were not well-tolerated due to gastrointestinal side effects. Because BYETTA may induce nausea and vomiting with transient hypovolemia, treatment may worsen renal function. Caution should be applied when initiating or escalating doses of BYETTA from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min).
The manufacturers of Byetta are clearly aware of the potential for harm created by their drug. Now, it is their obligation to adequately warn doctors and prescribers to prevent more injury.
Our attorneys have been monitoring potential Byetta cases since October 2008, when the first reports came out about the association between Byetta and various side effects, including pancreatic injuries. Our lawyers believe now is the appropriate time to begin a potential review of kidney-related Byetta injuries.
In 2005, Amylin Pharmaceuticals and Eli Lilly began to market Byetta in the United States. The idea behind Byetta was a good one: to improve a diabetes patient's blood sugar by lowering both post-meal and fasting glucose levels. If effective, Byetta leads to better long-term control of the condition (as measured by hemoglobin A1C).
The scientific community seems split on this question. There is no doubt that some patients on Byetta have reported good results. Byetta appears less likely to cause hypoglycemia or dangerously low blood sugar compared to the other available drugs. Moreover, for those who are at risk for weight gain, patients on Byetta are less likely to gain weight than on other diabetes medications, at least initially after taking Byetta. Obviously, this is a good thing given the cardio risks that travel with diabetes.
But still setting aside the risks associated with Byetta, some doctors remain unconvinced. Dr. Sonal Singh, a noted diabetes researcher and professor at Wake-Forest's medical school, says Byetta does not provide much clinical benefit. Dr. Singh does not prescribe Byetta and advises other doctors not to prescribe Byetta to diabetes patients.
A Georgetown study presented at the American Diabetes Association meeting confirms this concern. The study found that nearly 50% of people taking Byetta for Type II diabetes for more than a year stopped using Byetta because it was not working for them. The sales number bear this out. When Byetta was introduced to the market in 2005, Byetta prescriptions for it grew very quickly. But Byetta prescriptions have not increased in spite of the fact that it is still a new drug and has 250,000 prescriptions a month.
Byetta has side effects that can be harmful. Most drugs do. The question is whether the frequency of the side effects and whether the risks outweigh the benefit in light of all of the circumstances, including the availability of less risk drugs that are just as efficacious.
The FDA warned that Byetta may cause acute pancreatitis and reviewed 30 reports of pancreatitis. On Monday, August 18, 2008, the FDA announced that the Agency has received six new reports of patients developing severe hemorrhagic or necrotizing pancreatitis. All cases required hospitalization, with two patients dead and four still in recovery. As Dr. Singh also points out, there is a great risk of underreporting these side effects from Byetta.
Underreporting is always a problem with pharmaceutical drugs but particularly with Byetta because clinical diagnosis of pancreatitis is difficult to make. Accordingly, we do not know if these side effects from Byetta are relatively isolated or, as our lawyers suspect, the tip of an iceberg. Dr. Singh puts it very bluntly: "In my opinion, [Byetta's manufacturer] needs to go back to the lab and study this drug before launching it to millions of people. They have to try to find out the effects in real life practice."
But now a more important problem has taken front an center: pancreatic cancer from Byetta (and Januvia). You can read more about that here.