A U.S. Food and Drug Administration (FDA) safety review has found that Adult Type 2 diabetes medicines containing saxagliptin and alogliptin, including Onglyza and Nesina, may increase the risk of heart failure.
In 2014, a study published in the New England Journal of Medicine observed a “higher incidence of hospitalization for heart failure” for patients treated with saxagliptin. As a result, members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended that the FDA supplement such DPP-4 inhibitors Warnings and Precautions labeling to add new safety information. One committee member even voted to remove Onglyza (Saxagliptin) from the market.
Saxagliptin and alogliptin belong to a group of Adult Type 2 diabetes medications called DPP-4 inhibitors, along with Metformin. These medicines assist the pancreas in secreting more insulin and stop the liver from making excess sugar.
Onglyza (saxagliptin) was approved by the U.S. Food and Drug Administration (FDA) in 2009. The drug became popular, partly because it effectively controls blood sugar without encouraging weight gain like other diabetes medications.
For years, some doctors have been concerned by reports of a possible increased risk of pancreatitis (inflammation of the pancreas) and cancer associated with incretin-based therapies like Onglyza or Nesina.
Some people who have taken these medications have already filed lawsuits against the drugs’ manufacturers after developing pancreatitis or pancreatic cancer, claiming drug companies like AstraZeneca and Takeda failed to properly warn of the risks. Serious cases may lead to hospitalization, pancreatic cancer, or death.
In 2011, after the FDA received reports of patients suffering from acute pancreatitis after taking Onglyza, a potential risk of pancreatitis was added to Onglyza’s official warnings and precautions.
In a 2013 study, researchers found pre-cancerous cells in the autopsied pancreases of people taking incretin drugs. The researchers found small, benign tumors that can become malignant.
ABOUT THE LYON FIRM
Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.
The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.
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A 2013 study found a possible link between Onglyza and an increased risk for heart failure. Clinical trials considered in an FDA safety review showed that more patients who received saxagliptin or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment. Risk factors included a history of heart failure or kidney impairment.
Heat failure occurs when the heart pumps blood at a slower-than-usual rate. This prevents the body from receiving the oxygen and nutrients it needs.
Possible side effects of heart failure include the following:
• Congested lungs
• Bloating
• Increased need to urinate
• Dizziness
• Fatigue
• Rapid or irregular heartbeats
• Unusual shortness of breath
• Trouble breathing when lying down
• Weight gain with
• Swelling in the ankles, feet, legs, or stomach
The editor in chief of the Journal of the American College of Cardiology, Dr. Anthony DeMaria, stated that the drug should be avoided by people at risk for heart failure.
The FDA now recommends that health care professionals consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure. If a patient’s blood sugar level is not well-controlled with their current treatment, they note, other diabetes medicines may be required.
• Onglyza (saxagliptin)
• Kombiglyze XR (saxagliptin and metformin)
• Nesina (alogliptin)
• Kazano (alogliptin and metformin)
• Oseni (alogliptin and pioglitazone)
The Lyon Firm reviews drug injury cases and has experience engaging large pharmaceutical companies in drug defect lawsuits. We can work with industry experts to determine the root cause of an injury and build the strongest case possible.
By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.
When drug makers and large corporations are negligent and produce dangerous products that lead to serious illness and injury, legal action can be necessary. In the current corporate environment, filing lawsuits is one of the only ways to keep drug companies from selling untested and dubious pharmaceuticals in the name of profit. Pharmaceutical litigation – through a lawsuit against a drug manufacturer- helps bring awareness to these companies as to the necessary changes that need to occur in order to keep people safe a healthy while taking a certain drug.
By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.
In past litigation, it has been discovered that drug companies often delay adding serious side effects to a drug’s label due to concerns about the impact on the sales and marketing. If a drug carries more serious side effects, physicians and patients look for alternative treatments with less risk and the same or similar benefit. As a result, there is a financial incentive not to strengthen the warning label.
However, the label is the source of information that physicians and patients rely upon when making these important health decisions. There is no excuse for a company not to update its label when the science is sufficient to show an association with the medication.
Most experts would agree that the FDA is not designed nor does it have the resources to monitor every product through the post approval process once it has been granted clearance. Very simply, the volume of drugs that are presented for review is too demanding, so, while the FDA is a good initial step in the process, the responsibility of providing safe and effective pharmaceutical companies remains on the companies that profit from the sales.
While the pharmaceutical companies have yielded more influence over the review process, ultimately, the law is very clear that it is the company’s responsibility to run the appropriate tests, track the data, and to identify the side effects and then warn consumers and physicians adequately and in a timely manner. Government approval is not a shield for liability. The Failure to timely and sufficiently warn of side effects operates as the primary cause of action for pharmaceutical claims.
Most importantly, the FDA and the government do not provide for compensation when someone is injured by a pharmaceutical product. The civil justice system provides the means for an individual harmed by a pharmaceutical product to obtain justice and recover for the losses suffered.
Without the civil justice system, companies would not be required to pay for the harm they cause, and the public tax system, in terms of Medicare and Medicaid, would have to absorb that loss. In other words, without pharmaceutical lawsuits, the tax payers would pay for corporate malfeasance and neglect.
The current opioid crisis is a good example of how over-prescribing medications can lead to a huge public health crisis. Pain medications have been a great tool for physicians in treating a wide variety of conditions, however, the abuse of prescribing and using pain medication has turned into one of biggest areas of pharmaceutical litigation today.
It is not only opioids that have been prescribed in huge numbers. Other drugs that have only been tested in short trials are released to the market each year and injure patients. A few examples of drug injury:
Testosterone: Low T clinics are under investigation after many patients receiving testosterone therapy have reported strokes and heart attacks. Experts say doctors may be pushing the therapy when not every aging man requires testosterone therapy.
Antibiotics: Antibiotic injuries are being reported at record rates as the drugs are prescribed more than ever before. Drug resistance and drug injury rates are on the rise, concerning the medical community and consumer protection attorneys.
Diabetes Drug Injury: Severe side effects are being reported by diabetes patients taking Invokana and other diabetes medications. Amputations and gangrene cases have opened the eyes of many taking the drugs, and lawsuits have been filed on their behalf.
Drug Contamination: Valsartan and Losartan contamination cases have raised the risk of patient cancer. Drug companies have failed to control the production process and put consumers at unnecessary risk.
Opioid Painkiller Lawsuits: Purdue Pharma, Johnson & Johnson and other large drug companies are deep in pharmaceutical settlement talks many years after the beginning of the opioid addiction crisis. Thousands of Americans die each year in opioid-related overdose deaths, many of which begin with doctors over-prescribing pain medications.
Depo Provera: Confidential settlement from Pfizer to resolve all of the claims currently pending in the New Jersey State coordinated litigation. Joseph Lyon represented 13 females who suffered osteoporosis due to the failure of Pfizer to properly warn them and their physicians.
Seroquel: AstraZeneca resolved claims for $198 Million regarding claims that the company failed to warn about risks of diabetes and excessive weight gain. The Lyon Firm participated in this settlement and represented numerous claimants. In addition to the individual claims, Federal prosecutors and authorities from several U.S. states investigated whether AstraZeneca promoted Seroquel off-label, or for uses not approved by the U.S. Food and Drug Administration. The company announced a settlement of $520 million with the U.S. Justice Department over the matter.
Trasylol: Bayer resolved certain claims for $60 Million for patients who suffered heart failure and death as a result of the drug Trasylol. Trasylol was a drug used to prevent excessive bleeding during heart surgery. The science unequivocally showed Trasylol can cause kidney damage, heart failure and strokes, and greatly increase patients’ risk of post-surgery death when compared to rival treatments.
In 2006, a study by Dr. Dennis Mangano was published in the New England Journal of Medicine concluding that the drug more than doubled the risk of renal failure. After fourteen years on the market, Bayer suspended sales in November 2007. The Lyon Firm participated in this settlement.
Vioxx: Merck settled the outstanding Vioxx claims for $4.85 billion. The Lyon Firm participated in this settlement. In 2004, after a study showed Vioxx doubled the risk of heart attacks and strokes, Merck pulled Vioxx from the market. The case was then litigated with 16 trial ultimately going to the jury for a decision. Merck prevailed in 11 of the 16 trials.
Despite the settlement, Merck has not admitted that that Vioxx caused injuries. Each claim under the settlement was analyzed under an protocol that weighed such factors as a user’s age, their length of use, and their health risks such as obesity or hypertension. The individual extraordinary payout for a heart attack case was capped at $600,000.
Pharmaceutical litigation is a complex area of law that combines dense regulation, developing science, and multi-jurisdictional questions of law. Most cases involving claims of drug injury and pharmaceuticals become centralized in the federal multidistrict litigation process. Pharmaceutical litigation involving injury claims are not in most cases not class action lawsuits, but they are very similar.
Due to the volume of cases and number of similar issues, most pharmaceutical cases are handled through Multidistrict Litigation (MDL). The multidistrict litigation procedure is guided by the Judicial Panel for Multidistrict Litigation, where the case is centralized before one federal Judge for the purposes of pre-trial discovery.
The MDL process is appropriate where there are one or more common questions of fact in multiple cases pending in different federal district courts. While there often are parallel state consolidated proceedings, the federal MDL process is generally supported by both Plaintiff and Defendants in these cases.
The MDL process allows for efficiency where there are millions of pages of documents, many expert witnesses across multiple disciplines from epidemiology, pharmacology, toxicology and the specific discipline for the relevant mechanism of injury.
Although 28 USC 1407 does not specify a specific number of cases required before the formation of an MDL is appropriate, the Judicial Panel for Multidistrict Litigation reviews the Motions and conducts a hearing to determine whether consolidation is ripe given the number and location of the pending cases.
Most people understand what a class action lawsuit is, and fewer are aware of what an MDL refers to. It is important for a claimant to know, however, that an MDL is not a class action, as the term is often misapplied in this context, and the original court (home or transferee jurisdiction) retains the authority to present the case at trial.
In most MDL settings, the case is resolved by way of settlement or a summary judgment motion on the questions of science (i.e., Daubert Motion). If either settlement or dismissal on Motion occurs, the case is not remanded to the originating court. If the case is not resolved at the MDL, then the case may be remanded to original jurisdiction for additional discovery on the case specifics and ultimately trial.
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