Drug Injury Attorney Blog

As a pharmaceutical injury attorney, I already knew that Type II diabetes drug Byetta (exenatide) had serious safety problems. In fact, when it was approved as a stand-alone treatment for diabetes this fall, I wrote about the labeling changes the FDA required as part of that approval, which included stronger warnings on the risk of kidney problems. Just last week, a financial analyst uncovered new information related to that approval that has major implications for Byetta’s safety. According to a Dec. 23 article from Bloomberg News, the FDA required the drug’s manufacturers to conduct more studies to determine the risk of acute pancreatitis, acute kidney failure and thyroid neoplasms.

Byetta is jointly manufactured by Eli Lily & Co. and Amylin Pharmaceuticals. In its Oct. 30 approval letter, the FDA told the manufacturers that it had post-marketing reports of the three serious diseases. They included reports of hemorrhaging or necrotic pancreatitis, both of which can be fatal; acute kidney failure leading to death or kidney transplants; and thyroid neoplasms, which can lead to thyroid cancer. Because this was new safety information not known when Byetta was approved, federal law required new studies to ensure that the drug’s benefits outweighed its risks. According to the letter, some of these studies are already in progress or even completed. But because this requirement was not mentioned in the manufacturers’ approval announcement, the new announcement before Christmas caused a drop in Amylin’s stock prices.

This is disturbing news not just for investors, but also for patients and defective drug lawyers like me. Byetta’s manufacturers almost certainly withheld the information because they didn’t want to hurt the drug’s sales or their stock prices. They may have achieved those goals -- at least until the financial analyst found the publicly available approval letter -- but they have also withheld safety information that can help patients make the best possible decisions about their own treatment. All three of the diseases that triggered the new studies are life-altering and potentially fatal. Acute pancreatitis, a sudden and serious digestive problem, can lead to the pancreatic tissue dying (necrotizing) and bleeding into the abdomen (hemorrhaging), both of which increase the chance of death significantly. Given the risk of death or disability from these diseases, patients and doctors should know about that risk so they can discuss alternatives.

Continue reading " FDA Requests Further Studies of Diabetes Drug Due to Reports of Pancreatitis " »

Posted by Carey, Danis & Lowe | Permalink | Email This Post

Posted In: Dangerous Drugs

Bookmark:

The hot medical news story of this week is one that interests me greatly as a defective medical device attorney. According to a Dec. 14 article from HealthDay News, two studies published this week in the Archives of Internal Medicine say CT scans, the commonly used diagnostic tool, may cause as many as tens of thousands of cancers each year. Doctors have always known that CT scans expose patients to radiation, but the studies found that patients who undergo them are exposed to more radiation than originally though. The authors of the study believe the risk is so serious that they asked doctors to carefully consider whether each CT scan is worthwhile and inform patients of the risk beforehand.

CT scans (formerly called CAT scans) use computer technology and X-rays to create detailed pictures of the inside of patients’ bodies. Dr. Rebecca Smith-Bindman, a lead author on one study, said doctors have lowered their thresholds for using CT scans so much that some patients get no real benefit from them. In fact, her team’s study said the use of the scans has grown dramatically in the past 30 years, from 3 million a year in 1980 to nearly 70 million in 2007. That’s a problem because the dose of radiation a patient receives during an abdominal scan can be as high as 90 millisieverts, which the article said was equivalent to thousands of X-rays. Radiation doses vary according to the type of scan, and tolerance varies across patients. One doctor quoted said that patients could expect to be exposed to that amount of background radiation over 30 years -- but with a CT scan, it comes all at once and focused on the body.

And this, the two studies said, can cause cancers. Smith-Bindman’s team found that one in 270 women and one in 600 men who undergo a coronary angiography CT scan at age 40 will develop cancer. That risk was doubled for 20-year-old patients and halved for 60-year-olds. The other study, headed by Amy Berrington de Gonzalez of the National Cancer Institute, broke down cancer risks according to gender, age and the type of scan. They predicted that CT scans performed in 2007 alone would result in 29,000 cancers, 14,500 of which would be fatal. The highest risks came from chest, head, abdominal and pelvis scans -- all of the most commonly performed. Women bore the greatest risk because they get the scans more often and are more likely to develop breast and abdominal cancers. In addition to warning patients and considering whether CT scans are truly necessary, study authors suggested tracking radiation exposure through a searchable database of medical records.

Radiologists stressed that fear of cancer should not stop patients from getting CT scans that help doctors address other major health issues, like heart disease. But as a dangerous medical device lawyer, I wonder how many patients have already developed life-threatening cancers because they submitted to a scan their doctors recommended. As a rule, patients trust that treatments and diagnostics their doctors recommend are safe and effective, or at least worth the risk. However, the oldest CT equipment, which tends to deliver the highest doses of radiation, is still in use, and patients are unlikely to be told how old the equipment is. That’s true even though the cancer risk from radiation is well understood and has been for decades. Going forward, patients can ask careful questions and give informed consent to CT scans. But for those already exposed, it may be too late to do anything more than assign responsibility after the disease develops.

Continue reading " New Studies Show CT Scans Cause Tens of Thousands of Cancers Each Year " »

Posted by Carey, Danis & Lowe | Permalink | Email This Post

Posted In: Dangerous Medical Devices

Bookmark:

As a pharmaceutical liability attorney, I was disturbed to read about a new warning of serious side effects for the antidepressant Norpramin (desipramine hydrochloride). According to a Dec. 2 article from Medscape, the FDA and drug manufacturer Sanofi-Aventis have made significant changes to the warning label on Norpramin to reflect a risk of serious heart problems in patients taking the drug. The label now advises health care professionals to use extreme caution when prescribing Norpramin to patients with a family history of sudden cardiac death, arrhythmia (a heartbeat that’s too slow, too fast or not regular) or cardiac conduction disturbances.

Norpramin (sold as Pertofrane outside the U.S.) is primarily used for treating depression, but also in patients with nerve pain, cocaine withdrawal or attention deficit disorder. It is part of the tricyclic class of antidepressants, which were widely used until the introduction of the newer selective serotonin reuptake inhibitors. Along with the warning on heart problems, the FDA letter announcing the labeling changes (PDF) added a general warning to health care professionals that some patients who suffered death and cardiac arrhythmia have suffered seizures beforehand. Because an overdose of Norpramin has shown a higher risk of death than overdoses of other tricyclic antidepressants, the label also included specific instructions for doctors to treat overdose patients. Finally, the label changes deleted previous treatment advice that narrowed doctors’ options for treating an overdose.

As a dangerous drug lawyer, I hope doctors and patients take quick action on this warning. Prior to this announcement, the primary known safety problem with Norpramin (and other tricyclic antidepressants) was a heightened risk of depression, particularly in children. With this announcement, it appears that adults with a family or personal history of heart problems, a very different group, may have been lulled into a false sense of security. The FDA letter did not say how it and Sanofi-Aventis discovered the elevated cardiac risks, but as a rule, major safety changes like this are announced only after multiple reports of patient safety problems or new scientific studies. That means the chances are good that thousands of patients were unknowingly exposed to the cardiac risks of Norpramin. And because overdose of tricyclic drugs is a significant drug poisoning problem -- British and Australian studies found that 8 to 12 percent of drug overdose deaths were from tricyclic antidepressants -- the risk of death may be greater still.

Continue reading " FDA Updates Antidepressant Warning Label to Include Risk of Sudden Cardiac Death " »

Posted by Carey, Danis & Lowe | Permalink | Email This Post

Posted In: Dangerous Drugs

Bookmark:

The Lowe Law Firm filed a lawsuit in November alleging that a client developed a life-threatening disease after being given certain drugs in support of an MRI test. So our pharmaceutical liability attorneys were extremely pleased to see a report just a few days later that the FDA has also been investigating this class of drugs -- and that it found a greater risk with one drug our client was given. According to a Nov. 25 article from Reuters, an FDA memo released the day before Thanksgiving showed that MRI contrast agents made by GE Healthcare, Bayer AG and Covidien raise patients’ risk, even compared to other manufacturers’ versions of similar MRI imaging contrast agents made with gadolinium. The agents are injected into patients undergoing MRIs to help doctors see the resulting images better.

The entire class of imaging contrast agents already carries a black box warning disclosing that they increase risk of nephrogenic systemic fibrosis in patients with kidney problems. NSF is a disease that builds up collagen in the skin, eyes, joints and internal organs. The hardening of the skin and contracture of the joints can leave patients disabled by limited movement, physically scarred and with chronic pain. In its memo, the FDA announced that the greatest number of NSF cases were linked to use of GE Healthcare’s Omniscan -- the first contrast agent given to our own client. The FDA also found a greater risk for Bayer AG’s Magnevist and Covidien’s Optimark. Its review recommended labels on those products warning of the greater risk. At an already-scheduled meeting Dec. 8, the agency plans to ask an expert panel for advice.

As a dangerous drug lawyer, I am extremely pleased that the FDA is taking aggressive steps to limit kidney patients’ exposure to this toxic substance. In this, our government is just a short step behind the European Medicines Agency, which on Nov. 20 classified gadolinium-containing agents into low-, medium- and high-risk agents for kidney patients based on their chemical content. All three of the agents the FDA found associated with higher numbers of NSF cases are on EMEA’s high-risk list. With so much evidence against these higher-risk agents, I hope the FDA takes steps to end their use entirely, or at least require very strong warnings about the risk to people who have -- or may have -- kidney problems. Otherwise, far too many people may suffer preventable but life-altering problems similar to our client’s, which include permanent disability, disfigurement and many thousands of dollars in medical bills.

Continue reading " FDA Finds Greater Risk of Fatal Disorder From Certain MRI Drugs With Gadolinium " »

Posted by Carey, Danis & Lowe | Permalink | Email This Post

Posted In: Dangerous Drugs

Bookmark: