Dangerous Drugs

Type 2 Diabetes affects approximately 18-20 million Americans, and is characterized by high blood glucose levels caused by the body’s inability to correctly respond to insulin. Left untreated, it can lead to blindness, kidney problems, and cardiovascular disease.

Actos, like Avandia, is an anti-diabetic drug classified as a thiazolidinedione (TZD). Pharmacologically, TZD’s produce a hypoglycemic effect by stimulating the transcription of insulin sensitive genes, ultimately lowering insulin resistance in patients with type 2 diabetes.

Actos was submitted to the FDA by Takeda Pharmaceuticals, and approved in 1999. It is marketed either alone as Actos, or combined with other active ingredients such as metformin (as Actoplus Met), or glimepiride (as Duatect). Sales of Actos skyrocketed in 2007 after a report in The New England Journal of Medicine suggested Avandia, its main rival, increased the risk of heart attacks and death. In 2008, Actos was the tenth best selling pharmaceutical, with sales over $2.4 billion. In 2009, sales reached $3.4 billion.

The Controversy

While research initially suggested Actos may be safer than Avandia, subsequent studies have cast doubt on this assertion. In 2007, a report in the Journal of the American Medical Association revealed that while Actos did show beneficial effects among diabetic patients, it also significantly increased the risk of serious heart failure. In another study, Actos and Avandia exhibited no significant differences with regards to their propensity to increase the risk of acute myocardial infarction, acute heart failure, or death.

Actos has also been associated with an increased risk for bone fractures, particularly in females. For example, one study found that both postmenopausal women taking Actos, and men taking Actos and a diuretic, were at an increased risk for fractures. Another study reached similar conclusions for both men and women, but also found that fracture risk was increased even in younger women. Finally, a collaboration between Medco Research and the University of Texas Health Sciences Center presented data to the American Diabetes Association which suggested that while both men and women were at risk of fractures, men took a longer period of time before experiencing a fracture. In all of the aforementioned studies, no differences between Actos or Avandia were observed.

In 2010, the FDA announced they had found a potential link between exposure to Actos and the development of bladder cancer. Specifically, when researchers took into account the duration of Actos administration, the risk of developing bladder cancer was significantly increased after 24 months exposure. In addition, they also reported an increased risk in patients with a high cumulative exposure to Actos.

Symptoms

Adverse side-effects associated with the use of Actos include:

• Bone fractures, especially around the hands, arms, feet, ankles, and lower legs
• Bladder cancer
• Heart attack
• Congestive heart failure
• Hepatitis
• Liver failure
• Inflammation of the liver
• Unusually rapid increases or decreases in weight
• Fluid retention (edema)
• Shortness of breath
• Unexplained confusion, fatigue, and weakness
• Chest pain

 If you or a loved one has been diagnosed with any cardiac problems, bladder cancer, or bone fractures and have used Actos in the past, please contact

Daniel P. Kondos today. 

Isotretinoin, most commonly known as Accutane, was developed by Hoffman-LaRoche Inc. and approved by the FDA in 1982 as a treatment for severe nodular acne. In addition to Accutane, isotretinoin has also been marketed as Roaccutane, Amnesteem, Clavarus, and Sotret.

While the precise mechanism of action for Accutane’s success in treating acne remains unknown, the chemical structure closely resembles that of retinoic acid, a natural vitamin A derivative which controls normal embryonic development and the proliferation of cells. This latter ability to kill rapidly proliferating cells led to an initial push to use isotretinoin as a treatment for certain forms of cancer. Soon thereafter, the manufacturer serendipitously discovered the drugs ability to combat severe acne. Since its approval, over 13 million prescriptions have been filled, making it one of the most lucrative treatments for acne ever invented.

The Controversy

In June 2009, Hoffman-LaRoche pulled Accutane from the market, citing decreased profits due to the rise of generic forms of Accutane, as well as the cost of defending personal injury claims. These claims resulted from studies linking the use of the drug to life threatening side effects such as, but not limited to: birth defects, premature closure of growth plates in developing adolescent bones, depression, suicide, and inflammatory bowel disease (IBD) manifested as either Crohn’s disease or ulcerative colitis.

Roche currently faces as many as 5,000 personal injury lawsuits regarding Accutane. Recently, a jury awarded a $10.5 million verdict after the plaintiff claimed that the drug-maker failed to properly warn them that the medicine would cause inflammatory bowel disease. A state-court jury in New Jersey found company officials did not properly warn doctors about Accutane’s health risks and awarded three men a total of $12.9 million in damages.

Symptoms

Inflammatory bowel disease, manifested most commonly as Crohn’s disease or ulcerative colitis both involve inflammation in the lining of the digestive track, particularly in the large intestine and rectum. These afflictions may be disabling, life-threatening, and without cure. Symptoms include:

• Abdominal pain
• Cramping
• Severe and/or painful diarrhea (In extreme cases, up to 20 movements per day)
• Blood in bowel movements
• Vomiting
• Loss of appetite and weight
• Intestinal and/or anal abscesses

Other symptoms, unrelated to IBD, which have been associated with the use of Accutane include:

• Joint pain
• Arthritis
• Anemia/fatigue
• Growth retardation in children
• Damage to the eyes
• Liver failure and liver damage
• Celiac disease
• Severe depression
• Suicide

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If you or a loved one have taken Accutane and experienced any side effects, please contact 

Daniel P. Kondos today.

 About $3 billion dollars worth of Avandia is sold each year by the pharmaceutical company GlaxoSmithKline. It’s the biggest-selling diabetes medication in the world, despite its dangers.

Heart Attacks, Strokes, and Heart-Related Deaths

Heart attacks, strokes, and deaths due to heart problems have been linked to Avandia in studies that indicate a significant association between the drug and cardiovascular events. A meta-analysis of 42 Avandia studies showed that diabetic patients treated with Avandia have a 37% greater likelihood of developing heart problems compared to patients treated with another medication or a placebo.

The lead author of the meta-analysis, published in the New England Journal of Medicine in May 2007, is Dr. Steven Nissen, the cardiologist and prominent drug safety advocate who was an early critic of the painkiller Vioxx, a drug removed from the U.S. market in 2004.

Thousands of Patients Injured

In a New York Times report regarding the analysis, Dr. Nissen estimated that “tens of thousands of people” have had heart attacks as a result of taking Avandia. What’s even worse is that Glaxo appears to have known about the increased cardiovascular risks of Avandia, but chose not to make that information widely known to consumers.

Drug Maker Knew the Risks

When Glaxo declined to take part in Dr. Nissen’s meta-analysis of Avandia studies, Nissen and his co-author scoured the Glaxo website and found the company’s own study confirming a 31% increase in heart attack risk. He noted, “I just built this piece by piece until I had enough…then I stumble upon the company’s own meta-analysis deeply buried on their website, and it shows the same thing. It was a eureka moment for sure.”

Symptoms of Cardiovascular Emergencies

If you have been treated with Avandia and you experience any of the following symptoms, consult a physician immediately:

• Shortness of breath
• Unusual fatigue
• Swelling
• Liver disease
• Heart failure

There are less dangerous treatments for diabetes than Avandia, and there are less expensive generic alternatives, too. Glaxo spent hundreds of millions of dollars on advertising claiming that Avandia is an effective and safe treatment, but their own data belies that claim.

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If you or a loved one have taken Avandia and experienced any side effects, please contact 

Daniel P. Kondos today.

Have you or a loved one taken Nexium, Prilosec, Prevacid or another Proton Pump Inhibitor (PPI) and have suffered kidney damage or another serious injury?

Has someone in your family died due to kidney-related complications?

Individuals take PPI’s to alleviate symptoms of acid reflux, or they make take them to treat stomach ulcers and/or other injuries to the digestive tract that is caused by acid reflux.

Nexium, Prilosec & Prevacid are medications used to decrease the amount of stomach acid produces by the glands in your stomach’s lining or also known as Gastroesophageal Reflux Disease (GERD)

Recent studies have linked Nexium, Prilosec or Prevacid to life-threatening complications such as:

• Interstitial Nephritis Chronic Kidney Failure
• Acute Kidney Disease
• Renal Failure
• Acute Kidney Injury
• Kidney Surgery
• Kidney Transplant
• Heart Attack
• Liver Disease
• Bone Fractures
• Unusual Bleeding
• Death

Kidney Disease (CKD) or Chronic Kidney Failure occurs gradually as the kidneys begin to lose their ability to function normally. When your kidneys lose their ability to function, waste products and excessive fluid can build up in your body. If this conditions continues to progress, kidney dialysis or a kidney transplant may be necessary. If left untreated or treatment is not successful, this condition may be fatal.

Acute Kidney Injury (AKI) or Acute Renal Failure is an abrupt loss of kidney function that develops within 7 days. Its causes are numerous. Generally it occurs because of damage to the kidney tissue caused by decreased renal blood flow (renal ischemia) from any cause (e.g. low blood pressure), exposure to substances harmful to the kidney, an inflammatory process in the kidney, or an obstruction of the urinary tract which impedes the flow of urine. AKI is diagnosed on the basis of characteristic laboratory findings, such as elevated blood urea nitrogen and creatinine, or inability of the kidneys to produce sufficient amounts of urine. AKI may lead to a number of complications, including metabolic acidosis, high potassium levels, uremia, changes in body fluid balance, and effects on other organ systems, including death. People who have experienced AKI may have an increased risk of chronic kidney disease in the future. Management includes treatment of the underlying cause and supportive care, such as renal replacement therapy.

Roughly about one-third of people diagnosed with AKI will also suffer from related cardiovascular complications, including heart failure, heart attack, arrhythmia or cardiac arrest. In addition to that, more than half of people diagnosed with AKI will experience lung-related cmplications, which is the most common cause of death for AKI patients.

Interstitial Nephritis is a kidney disorder in which the spaces between the kidney tubules become swollen (inflamed). This can cause problems with the way your kidneys work. Interstitial nephritis may be temporary (acute), or it may be long-lasting (chronic) and get worse over time. Interstitial nephritis can cause mild to severe kidney problems, including acute kidney failure. In about half of cases, people will have decreased urine output and other signs of acute kidney failure.

Symptoms of this condition may include:

• Blood in the urine
• Fever
• Increased or decreased urine output
• Mental status changes (drowsiness, confusion, coma)
• Nausea, vomiting
• Rash
• Swelling of the body, any area
• Weight gain (from retaining fluid)

Liver Disease

is any disturbance of liver function that causes illness. The liver is responsible for many critical functions within the body and should it become diseased or injured, the loss of those functions can cause significant damage to the body. Liver disease is also referred to as hepatic disease. Liver disease is a broad term that covers all the potential problems that cause the liver to fail to perform its designated functions. Usually, more than 75% or three quarters of liver tissue needs to be affected before a decrease in function occurs.

Liver Disease Symptoms:

• Nausea
• Vomiting
• Abdominal pain on the upper right side and Jaundice (a yellow discoloration of the skin )
• Fatigue, weakness and weight loss may also be occur.

Evidence is mounting that certain PPI manufacturers might have been aware of some major risks associated with PPIs, but did not disclose those risks to doctors or users.

In 2016, a plaintiff filed a lawsuit against Astra Zeneca in U.S. District Court, after he claimed PPI led to his kidney failure and the need for a lifesaving kidney transplant. The suit claims that Astra Zeneca knew of the risks to Nexium users’ kidneys, yet continued to market the drug without warning of these dangers.

As researchers discover more PPI-related medical problems, attorneys expect more lawsuits against manufacturers who knew about these risks, yet put profits before people.

Daniel Kondos Law Offices is evaluating Prescription Nexium, Prilosec and Prevacid lawsuits for those who have suffered injuries after taking these medications.

While the U.S. Food and Drug Administration (FDA) has issued a number of safety warnings regarding proton pump inhibitors, such as their potential to cause increased risk of bone fractures, association with low magnesium levels, and association with a specific type of gastrointestinal inflammation caused by a bacteria known as C. diff, it has not specifically addressed the very real and dangerous possibility of irreparable kidney damage.

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If you or a loved one have taken Nexium and experienced any side effects, please contact 

Daniel P. Kondos today.

 Invokana ( Canagliflozin ) is an oral diabetes medicine that helps control blood sugar levels. Canagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Invokana is used together with diet and exercise to treat type 2 diabetes.

Invokana – Kidney Damage, Ketoacidosis, Amputations

Invokana increases the risk of amputations. On May 16, 2017, the U.S. FDA confirmed that a black box warning must be included in the Invokana label. The revised label will state that Invokana raises the risk of people needing to have their legs or feet amputated. Invokana also appears to increase the risk of ketoacidosis, potentially fatal kidney failure.

Invokana Linked to Amputations

On May 18, 2016, the FDA first announced Invokana and Invokamet are linked to amputations. The agency had announced May 15, 2015 that it was investigating reports of some type 2 diabetes drugs – including Invokana and Invokamet – for causing a serious medical condition known as ketoacidosis.

Invokana Linked to Kidney Failure

According to the American Diabetes Association, ketoacidosis – also known as acidosis or diabetic ketoacidosis (DKA) – causes one to produce dangerous levels of blood acids, or keytones, which can lead to diabetic coma and can be fatal. The FDA is now reviewing the safety of all SGLT2 inhibitors to determine if the risk of ketoacidosis should be noted on the drugs’ labels, and also whether Invokana raises the risk of amputations.

Free Legal Consultation

Daniel P. Kondos Law Offices is investigating potential Invokana lawsuits on behalf of anyone hospitalized due to ketoacidosis, diabetic ketoacidosis (DKA), ketosis, or acidosis while using Invokana or another Type 2 diabetes medication known as sodium glucose cotransporter 2 (SGLT2) inhibitors, and on behalf of anyone who may have lost a limb after taking Invokana.

If you were hospitalized with ketoacidosis while taking Invokana or a similar diabetes medication, or if you lost a limb or limbs after taking this drug, contact our legal staff today for a free legal case review regarding a potential lawsuit against the drug’s maker. By filing an Invokana lawsuit, you may be able to obtain compensation for medical bills, lost wages, pain and suffering, and other damages related to your injuries.

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If you or a loved one have taken Invokana and experienced any side effects, please contact

Daniel P. Kondos today.

 About $3 billion dollars worth of Avandia is sold each year by the pharmaceutical company GlaxoSmithKline. It’s the biggest-selling diabetes medication in the world, despite its dangers.

Heart Attacks, Strokes, and Heart-Related Deaths

Heart attacks, strokes, and deaths due to heart problems have been linked to Avandia in studies that indicate a significant association between the drug and cardiovascular events. A meta-analysis of 42 Avandia studies showed that diabetic patients treated with Avandia have a 37% greater likelihood of developing heart problems compared to patients treated with another medication or a placebo.

The lead author of the meta-analysis, published in the New England Journal of Medicine in May 2007, is Dr. Steven Nissen, the cardiologist and prominent drug safety advocate who was an early critic of the painkiller Vioxx, a drug removed from the U.S. market in 2004.

Thousands of Patients Injured

In a New York Times report regarding the analysis, Dr. Nissen estimated that “tens of thousands of people” have had heart attacks as a result of taking Avandia. What’s even worse is that Glaxo appears to have known about the increased cardiovascular risks of Avandia, but chose not to make that information widely known to consumers.

Drug Maker Knew the Risks

When Glaxo declined to take part in Dr. Nissen’s meta-analysis of Avandia studies, Nissen and his co-author scoured the Glaxo website and found the company’s own study confirming a 31% increase in heart attack risk. He noted, “I just built this piece by piece until I had enough…then I stumble upon the company’s own meta-analysis deeply buried on their website, and it shows the same thing. It was a eureka moment for sure.”

Symptoms of Cardiovascular Emergencies

If you have been treated with Avandia and you experience any of the following symptoms, consult a physician immediately:

• Shortness of breath
• Unusual fatigue
• Swelling
• Liver disease
• Heart failure

There are less dangerous treatments for diabetes than Avandia, and there are less expensive generic alternatives, too. Glaxo spent hundreds of millions of dollars on advertising claiming that Avandia is an effective and safe treatment, but their own data belies that claim.

Contact Us

If you or a loved one have taken Avandia and experienced any side effects, please contact

 Daniel P. Kondos today.

 Metoclopramide is an antiemetic and gastroprokinetic agent used to facilitate gastric emptying, as well as to treat nausea and vomiting. Though marketed under other trade names, metoclopramide is commonly known as Reglan, and is formulated in tablet, disintegrating tablet, oral solution, and injection form.

The Controversy

Metoclopramide is the most common cause of drug-induced tardive dyskinesia, a serious neurological disorder characterized by Parkinsonian symptoms such as involuntary and repetitive movements. Such movements are most commonly manifested by lip smacking and pursing, chewing, grimacing, rapid eye movements and blinking, impaired finger movement, and tongue protrusions. Unfortunately, evidence suggests that these effects may be permanent and irreversible.

The risk of tardive dyskinesia increases with prolonged therapy and at high doses. Moreover, evidence suggests that elderly populations are particularly at risk, especially among females. In response to these risks, the FDA issued a black box warning for the drug in 2009, indicating among other things that its use should not exceed 4-12 weeks. Despite these warnings, a recent FDA study showed that 20% of all patients, and 32% of elderly patients, were taking metoclopramine for more than three months at a time.

Metoclopramine has exhibited additional neurological and psychiatric symptoms such as depression, suicidal ideation, suicide, neuroleptic malignant syndrome, and tardive tremors.

Symptoms

Deleterious effects associated with metoclopramide include:

• Repetitive and involuntary movements
• Depression
• Tremors
• Impaired movement
• Suicidal thoughts

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If you or a loved one has been diagnosed with tardive dyskinesia and have used Reglan/metoclopramide in the past, please feel free to contact Daniel P. Kondos today.

 The drug Risperdal, which is prescribed to treat schizophrenia and bipolar disorder, has an unwanted and unpleasant side effect which can occur in young men and boys. It is called gynecomastia — the development of male breasts. But gynecomastia is not typical weight gain. It is breast tissue growth caused by an increase in the hormone prolactin.

According to Risperdal’s own manufacturer, the drug has been found to increase prolactin levels in:

• 82% to 87% of boys and young men with schizophrenia or bipolar disorder
• 49% of boys and young men suffering from autism and certain other ailments

By comparison, 7% or less of those given a placebo during the study experienced increased prolactin levels.

Effects Are More Than Just Physical

Risperdal, which contains risperidone, was approved in 1993 as an antipsychotic for use in schizophrenic adults. It was not until 2007 that it was approved for use in children and adolescents, who now make up more than 25% of Risperdal users.

The drug’s packaging warns of gynecomastia and other side effects in young males. Some young men taking Risperdal may mistake breast development for typical weight gain, which is possible with Risperdal and other medications.

But it is not typical. Surgery may be necessary to remove excess breast tissue, and the condition may cause pain. In some instances, however, the worst effects are psychological and emotional. This can lead to self-image issues and social problems.

Gynecomastia may also cause:

• Pain
• Swelling
• Tenderness
• Nipple discharge

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If you or a loved one suffered from male breast development after taking Risperdal, you need to speak with an attorney. You may be entitled to compensation for your ordeal.

 Contact Daniel P. Kondos today.  

 Drug companies that manufacture Testosterone have been actively marketing to men over 50, who are feeling tired, lack energy, experience bone density loss, loss of muscle strength or decreased sex drive, as if there is something wrong with them. Instead, these symptoms are a result of the natural aging process. As you age, the testosterone levels decline. The drug companies urge you to start Testosterone replacement therapy to erase side effects of the lowered testosterone levels that come naturally in the aging process. They state that the use of testosterone will increase muscle strength, energy levels, sexual activity BUT fail to mention the side effects the drug can have.

4 dangers have been noted in the PLOS and JAMA research studies:

1. DANGER - The younger you are when you use the testosterone therapy, the likelihood of experiencing dangerous side effects increases.
2. DANGER - That men younger than 65 with clear indications of heart disease also demonstrated a two- to three-fold increased risk of heart attack shortly after initiating testosterone therapy.
3. DANGER – The risk of suffering a heart attack more than doubled among men 65 and older after starting testosterone therapy.
4. DANGER - Older men with both mobility limitations and low testosterone levels suffered significantly more adverse events like cardiac, skin, tissue and respiratory disorders.

These prescriptions are expensive so they are very profitable for the drug companies that manufacture them. Currently this is a $2 billion market with an estimated 5.3 million prescriptions written in the U.S. The use of testosterone is rising partly due to the aggressive marketing tactics in commercials on TV. Nearly 25% of the patients never even have their testosterone levels checked before beginning the T-therapy.

The most common products are:

• Androderm, Androgel, Testim, and Testoderm - applied in patches or gels
• Delatestryl and Depo-Testosterone - injections

In reality, the actual health benefits of such prescription drugs are largely unknown. The FDA has only approved testosterone therapy products for men who have low testosterone levels and an associated medical condition such as hypogonadism, a diminished functional level of the gonads. The FDA has specifically NOT approved use in younger men unless they suffer from the associated medical complications involving hormones.

Kondos Law Offices is currently investigating cases of heart attack, stroke and cardiac death in patients taking T-Therapy medications. If you or a family member was prescribed testosterone and was hospitalized from complications, contact our firm immediately. We can answer any questions you may have about the therapy and your legal options, completely free of charge.

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If you or a family member was prescribed testosterone and was hospitalized from complications, contact Daniel P. Kondos today. We can answer any questions you may have about the therapy and your legal options, completely free of charge

 Xarelto was released in 2011 as part of a new generation of anticoagulants, or blood-thinners. It is prescribed to prevent blood clots and related complications, like stroke, pulmonary embolism and deep vein thrombosis. It may also be prescribed to people receiving an artificial hip or thigh. Its prescribing information says the drug “may cause serious and fatal bleeding.

DANGEROUS SIDE EFFECTS

Potentially fatal risks if a person taking Xarelto develops serious internal bleeding, such as:

• Brain hemorrhaging
• Gastrointestinal (GI) bleeding
• Kidney bleeding
• Internal bleeding

Unlike Warfarin — a well-known blood-thinner in use for 60 years — Xarelto has no antidote to reverse its anti-clotting effects in the event of an emergency. Xarelto has only been on the market for three years, but already its linked to serious or fatal bleeding incidents appears clear.

This is not acceptable, and the makers of this drug must be held accountable for the harm it has caused.

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If you or a family member was prescribed Xarelto and was hospitalized from complications, contact Daniel P. Kondos today.

 Yaz, Yasmin, and Ocella all contain the same contraceptive drug, drospirenone. Developed and marketed by Bayer, Yasmin hit the market in 2001, and Yaz followed suit a few years later in 2006. Ocella, on the other hand, is the generic version of Yasmin, but still carries with it the same risks as both Yaz and Yasmin.

DANGEROUS SIDE EFFECTS

Yaz has been linked with serious adverse heart problems in women taking the drug. In a warning letter sent to the manufacturer of Yaz, the Food and Drug Administration (FDA) warns of blood clots, heart attack, stroke, and gallbladder disease in Yaz users.

The FDA goes on to say, “Yaz has additional risks because it contains the progestin, drospirenone [...] can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems. Women taking Yaz must be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives.”

The British Medical Journal (BMJ) released a report revealing that blood clots in Yaz and Yasmin are as frequent as with third generation birth control pills. Third generation pills had an established warning for blood clots, but Yaz and Yasmin did not yet have such a warning.

The FDA then released results from a study that included over 800,000 American women who were taking various forms of birth control between 2001 and 2007. The research revealed that women taking Yaz had a 75 percent higher chance of getting a blood clot than women taking older forms of birth control pills.

Yaz also has been linked to a condition known as hyperkalemia. Hyperkalemia is a condition that describes abnormal levels of potassium in the bloodstream, which can lead to fatal arrhythmias. Arrhythmias are disorders of the speed at which the heart beats.

Yaz and other oral contraceptives present an increased risk of heart attack in users, especially in smokers. In addition to heart attack, there is an established link between oral contraceptives and blood clots and stroke.

Bloomberg reports that lawsuits have been filed against the manufacturer of Yaz, claiming that Bayer unlawfully promoted the drug by concealing side effects, including blood clots, heart attacks, and pulmonary embolisms in Yaz users.

Despite the dangers, marketing violations, and manufacturing issues Yaz has been associated with, it is still on the market today.

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If you or a loved one have suffered from a blood clot, deep vein thrombosis, pulmonary embolism, stroke or heart attack while taking Yaz, Yasmin, or Ocella please contact 

Daniel P. Kondos today