New Study Links Long-Term Elmiron Use to Increased Risk of Vision Loss
A new study published in the scientific journal Retina suggests long-term exposure to Elmiron – pentosan polysulfate sodium (PPS) – may increase a person’s risk of vision loss and other vision problems.
Elmiron, a drug that treats pain associated with interstitial cystitis (IC), has been the target of numerous lawsuits filed by victims who claim the medication caused them vision problems – including pigmentary maculopathy, a condition that affects the part of the eye (macula) responsible for central vision.
The latest study published in Retina adds to growing scientific literature establishing a link between Elmiron and retinal eye damage, and provides more evidence for plaintiffs filing suit against Elmiron manufacturer Janssen Pharmaceuticals.
About the Study
As part of the study, researchers distributed surveys to individuals diagnosed with interstitial cystitis (IC), a bladder condition characterized by recurring pelvic pain, discomfort in the bladder and pelvic region, and urinary frequency and urgency.
An estimated 4 to 12 million Americans may have IC, and Elmiron (PPS) is the only oral prescription medication approved by the FDA to treat IC and associated bladder and pelvic pain.
Here are some of the study’s findings:
- The survey was completed by 912 respondents, 96.4% of whom were female, with a median age of 55.
- Among respondents who used Elmiron (PPS), the median exposure was 547.5 grams.
- Survey respondents with the highest levels of PPS exposure were more likely to report vision problems (including difficulty reading small print) and have a diagnosis of pigmentary maculopathy and/or macular degeneration than those who did not use Elmiron.
New Research Adds to Growing Scientific Literature
The Retina study is only one of many in a long list of research that shows a link between Elmiron – and particularly long-term use – and vision loss/vision problems.
Other notable studies include:
- An Emory Eye Center study (2018) found patients taking Elmiron for 15 years developed unusual changes in the part of the retina responsible for clear central vision (macula). Researchers behind the study warned long-term Elmiron use may cause retinal damage.
- Research presented at the American Academy of Ophthalmology (AAO) Annual Meeting (2019) revealed links between Elmiron and vision-threatening eye conditions. According to the study, 25% of patients with significant Elmiron exposure (taking Elmiron for six months or more) showed clear signs of eye damage, a figure that may actually be higher as Elmiron-related eye damage may be misdiagnosed as macular degeneration or pattern dystrophy.
- A study published in The British Journal of Ophthalmology (2019) found PPS patients had significantly increased odds of having a new diagnosis of macular disease / pigmentary maculopathy after 7 years of taking Elmiron.
- A study from ophthalmologists at Kaiser Permanente (2020) noted Elmiron toxicity may increase with the amount of medication taken, from 11% for patients who take between 500 to 1,000 grams to 42% for patients taking 1,500 grams or more.
Despite years of research suggesting links between PPS and vision problems, Janssen Pharmaceuticals did not update Elmiron’s product labeling to warn about vision problems until June 2020.
The label now states Elmiron can cause retinal pigmentary changes, blurred vision, reading problems, and sensitivity to low light, and recommends patients taking Elmiron regularly have their vision tested.
Elmiron Litigation Gains Steam
In light of the growing scientific evidence behind PPS and vision problems, thousands of patients diagnosed with pigmentary maculopathy, vision loss, and other vision problems after taking Elmiron have started to file lawsuits against Janssen Pharmaceuticals.
These suits claim Janssen failed to ensure the safety of its medication and seek damages for permanent vision loss, pain and suffering, lost income, and medical bills – including expenses associated with increased medical monitoring.
On December 15, 2020, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all Elmiron lawsuits to be consolidated in the District of New Jersey. MDL consolidation allows related federal lawsuits to be grouped together under one judge, and can help increase efficiency in the lawsuit process.
Discuss Your Rights & Legal Options with an Elmiron Injury Attorney
Bailey Cowan Heckaman PLLC has been closely tracking research into Elmiron’s risks and ongoing litigation against Janssen Pharmaceuticals.
As an award-winning trial practice recognized for our work representing plaintiffs in complex cases involving product liability and dangerous drugs, we are available to victims and families who would like to learn more about Elmiron lawsuits and their legal options.
To speak personally with an attorney from BCH, call us or contact us online. Consultations are free and confidential, and available to victims nationwide.
Ranitidine in Zantac Can Trigger NDMA Formation, Causing Cancer
Zantac and its manufacturer Sanofi are under harsh scrutiny and potentially facing a wave of lawsuits, perhaps through multidistrict litigation (MDL), after it was announced that the popular heartburn medication could cause cancer with regular use. Zantac can be purchased off-the-shelf, over-the-counter (OTC), or with a prescription to treat heartburn and chronic indigestion. The drug relies on ranitidine as an active ingredient, but studies show ranitidine could lead to stomach, bladder, kidney, and intestinal cancers.
When ranitidine comes into contact with water, such as the naturally-occurring water inside the human digestive tract, it can undergo a chemical compound change, forming N-nitrosodimethylamine (NDMA). It is NDMA that has been linked to various types of cancers. The Food and Drug Administration (FDA) considers NDMA a possible carcinogen.
If you are taking prescription Zantac, please see your doctor before discontinuing use. There may be alternative medicines without ranitidine to treat your heartburn and indigestion symptoms.
How Dangerous is Zantac?
A standard strength Zantac tablet is 75 milligrams. Maximum strength tablets are twice that amount, up to 150 milligrams per dosage. In 2016, a Stanford University study found that consuming just 150 milligrams of Zantac could produce around 47,000 nanograms of NDMA in the urine within the same day. To put that into perspective, the FDA warns there may be a cancer risk for anyone exposed to just 96 nanograms of NDMA in a 24-hour period.
The problem of the ranitidine in Zantac producing NDMA is so significant, a 2017 study found evidence that suggests wastewater – i.e. flushed urine from Zantac users – could be contributing to an NDMA increase in municipal potable water due to soil contamination and inefficient wastewater treatments.
People who have used Zantac frequently and for years have an inordinate number of cancer diagnoses, including:
- Bladder cancer
- Stomach cancer
- Kidney cancer
Is Sanofi Liable for Cancers Caused by Zantac?
A medication’s cancer risk does not make that drug’s manufacturer automatically liable for damages caused to users. The problem with Zantac and Sanofi is the lack of transparency and information given to consumers about ranitidine and NDMA. Studies dating back to 2004 concluded that Zantac use can cause bladder cancer due to ranitidine producing large quantities of NDMA in the body. However, there has been no widespread effort from Sanofi to bring this information to the public’s attention.
Even as word spreads throughout news headlines about Zantac’s dangers, the product’s own official website does not address the cancer risk. It lists some side effects like “vomiting with blood” and alludes to a “serious condition,” but says nothing more. As a result, Sanofi is being targeted by lawsuits not for making a dangerous drug, but for knowingly selling one without warning consumers appropriately.
How to File a Lawsuit After Using Zantac
Not everyone who has used Zantac will be eligible to file a claim against Sanofi in pursuit of damages. The strongest claims will come from people who have been diagnosed with bladder, stomach, kidney, or similar cancers, and who have evidence of long-term Zantac use, like a prescription.
At Bailey Cowan Heckaman PLLC, our team of trial attorneys is currently hearing from Zantac users from around the country to help determine if they are eligible to file a claim. Depending on how the story develops, a mass tort or class action could soon develop against Sanofi by thousands of people nationwide. As highly experienced injury lawyers with a focus on multidistrict litigation and major cases, we can help you get ready to file your own Zantac lawsuit, too.
Please call us or contact us online to take the first step in demanding justice from Zantac for causing your cancer and hardships.
Pharmaceutical Company Connected to NDMA Impurity Placed on Import Alert
Active pharmaceutical ingredient (API) manufacturer Zhejiang Huahai Pharmaceuticals was placed on import alert on Friday, September 28 by the U.S. Food and Drug Administration (FDA). The company will determine how its products, used in valsartan-containing drug products became affected by N-nitrosodimethylamine (NDMA).
The FDA has been updating its list of valsartan products under recall, which can be found here (accurate as of September 28, 2018) (PDF).
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research when the recall was first announced.
If you or someone you love was seriously affected by tainted medication or defective drugs, our Houston personal injury lawyers at Bailey Peavy Bailey Cowan Heckaman are ready to provide you with the legal support you need. Give our firm a call to discuss your situation today, or send us the details of your situation through our online form and a member of our staff will reach out to you as soon as possible to set up a free consultation. Don’t wait to get the help you need, contact Bailey Cowan Heckaman PLLC today.
Valsartan Voluntarily Recalled by the FDA Over NDMA Impurity
The U.S. Food and Drug Administration (FDA) recently announced a voluntary recall of drugs that contain valsartan, an active ingredient in a number of products meant to treat heart failure and high blood pressure.
While not all products containing valsartan were recalled, those with the impurity N-nitrosodimethylamine (NDMA) were included in the list. According to reports, the recall includes valsartan/hydrochlorothiazide (HCTZ), which is sold by Teva Pharmaceuticals Industries Ltd. and Solco Healthcare, as well as versions of valsartan produced by Teva Pharmaceuticals Industries Ltd., Solco Healthcare, and Major Pharmaceuticals.
According to the FDA, the presence of this probable human carcinogen is unexpected, and is believed to be caused by how these drugs were manufactured. The FDA announced that it is reviewing this discovery and is investigating the NDMA levels in each recalled product, the potential effects it could have on patients who took the recalled products, and what can be done to prevent this issue from occurring again in the future.
“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA Commissioner Scott Gottlieb, M.D. “When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”
What is NDMA?
NDMA is a type of semi-volatile organic chemical that is present in very low levels in certain types of food, mostly in cured, smoked, or cooked meats. It can also be produced as a by-product in a number of industrial processes, and can be toxic to organs in great enough doses, most notably in the liver – it has been known to cause liver tumors, scarring, and liver fibrosis when tested on rats – and is a known human carcinogen.
NDMA is only intentionally produced in its pure form for research purposes. It used to be used in the production of a number of products, including copolymers softeners, lubricant additives, antioxidants, and liquid rocket fuel.
In the United States, it is classified as an extremely hazardous substance, and has even been used to intentionally poison people. The first reported case of NDMA being used as a poison occurred in 1978, when a teacher in Germany attempted to murder his wife by feeding her with jam laced with this chemical. He was sentenced to life in prison for his actions. That same year, an American man killed two people, a 30-year-old man and an 11-month-old child in Omaha, NE by spiking lemonade with NDMA. He was sentenced to death for his actions.
A key concern about NDMA is its solubility in water, and the fact that it has little to no odor or taste. It can be incredibly harmful at incredibly low levels of concentration that are difficult to detect, and is incredibly difficult to remove it from water it contaminates. Due to its composition, it cannot be removed by activated carbon, a common substance used to purify contaminated water.
This recall comes just one week after 22 countries across the globe issued recalls due to the potential cancer risk. Due to the severity of the conditions these drugs are used to treat, the FDA stated that patients taking these drugs should continue to do so until a replacement product is provided. However, patients taking any valsartan-containing medicine should contact their health care professional to determine whether or not their treatment is affected by the recall and if there is an alternative option available.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
Our Houston personal injury attorneys at Bailey Cowan Heckaman PLLC have dedicated their careers to providing injured victims with the knowledgeable and experienced legal representation they require. If you were seriously affected by defective drugs or tainted medication, give us a call to discuss your situation over the phone, or send us the details of your case through our online form today to set up a free case evaluation with a member of our firm. We understand just how devastating these situations can be to you and your entire family, and our attorneys are committed to fighting for and securing the compensation you deserve.
Study Shows PPIs Potentially Tied to Increased Risk of Stomach Cancer
People suffering from Helicobacter pylori, a type of stomach bacteria that increases the risk of stomach cancer and ulcers, may still be at risk of stomach cancer even after antibiotic treatment eliminates the bacterium.
A new study published by researchers at the University of Hong Kong found that prolonged use of proton pump inhibitors (PPIs) could lead to an increased risk of stomach cancer. The study covered 63,397 people in Hong Kong who were treated for H. pylori – 21,179 used H2-receptor antagonists, a type of acid-controller (Pepcid, Tagamet, etc.), and 3,271 used PPIs.
Their study found that PPI users were more than twice as likely to develop stomach cancer compared to H2 users.
“Even after the eradication of H. pylori, the risk of cancer persists with P.P.Is,” said the lead author, Dr. Wai Keung Leung, a professor of medicine at the University of Hong Kong. “But the absolute risk is not high, and I don’t want to discourage people from taking these drugs when necessary. There are people who benefit tremendously from them.”
At Bailey Cowan Heckaman PLLC, our Houston drug & medical device injury attorneys have spent their careers working with clients in order to provide them with the experienced and dedicated representation they require. Send us the details of your situation through our online form to request a free consultation, or give us a call to speak with one of our attorneys.
Trial Results Link Invokana Use to Foot and Leg Amputations
According to a new trial, Invokana has shown an increased risk of leg, foot, and toe amputations. The United States Food and Drug Administration is now releasing an alert to the public regarding the ongoing research involving the use of Invokana (canagliflozin) and lower-limb amputations. The type 2 diabetes drug is part of a drug class called sodium-glucose cotransporter-2 (SGLT2) inhibitors.
The FDA recommends health care professionals to follow recommendations when prescribing Invokana and to properly monitor their patients. They should look for signs that would indicate a possible amputation such as new pain, sores, tenderness, ulcers, or infections in the lower legs. Other potential problems associated with Invokana use can be dizziness, frequent urination, dry mouth, and light headedness.
The European Medicines Agency (EMA) conducted a safety review of Invokana 100-mg, Invokana 300-mg, and a placebo. They determined that 7 in every 1,000 people taking the Invokana 100-mg experienced a toe amputation within one year. In comparison, 5 in every 1,000 people taking Invokana 300-mg experienced a toe amputation. The study analyzed about 2,000 type 2 diabetes patients.
If you or someone you love had a lower limb amputated after taking Invokana, you may be able to take legal action.
Our defective drug lawyers at Bailey Cowan Heckaman PLLC can protect your rights in a legal matter. We know how difficult it can be to deal with an amputation. You may be able to seek compensation for the damages you’ve sustained. Call us today to learn more about your rights.
Research Shows Why PPIs Increase Risk for Heart Disease & Dementia
As we have noted before, the long-term use of proton pump inhibitors has been linked to an increased risk of serious conditions including heart disease, dementia, and more. Before now, however, researchers were not sure of why this was the case. Now, a publication in the journal Circulation Research brought to light some possible answers. According to researchers, “Vascular cells chronically exposed in vitro to PPIs led to a buildup of cellular garbage in cellular linings, thus accelerating blood vessel aging.”
Studies suggest that roughly one in every 14 Americans use some kind of PPI such as Prilosec to help with heartburn and acid reflux. The United States Food and Drug Administration approved the PPI for use up to four weeks at a time. Studies state that up to 70% of the use of PPIs may be for inappropriate reasons.
A 2013 study showed that PPIs helped to decrease the nitric oxide in the endothelial cells. Unfortunately, this can impact a person’s cardiovascular health. A 2015 study showed a 20% increase in the risk of heart attack in individuals who used PPIs for a longer period of time.
The most recent study placed Nexium and another PPI against an H2 blocker by exposing endothelial cells to the medications for a number of weeks. Those cells exposed to the PPIs had what researchers described as the “fried egg” look. As a result, researches claim that chronic PPI use can impair the lysosomes while the H2 blocker had no effect.
On one of our earlier blogs, we discussed the link between PPI use and kidney failure. This is just another study that supports the dangers involved with prolonged use of these types of medications and how they can impact a person’s body. According to the research, individuals using PPIs were 20% to 50% more likely to develop chronic kidney disease.
If you or someone you love has taken a proton pump inhibitor for a prolonged period of time and have developed heart disease, dementia, or chronic kidney failure, now is the time to take action and seek legal counsel.
At Bailey Cowan Heckaman PLLC, we are well aware of how individuals may be harmed by the use of certain drugs. Unfortunately, the results can be extremely serious and leave individuals facing serious hospital trips and more. It is our goal to help you hold the manufacturer of these drugs accountable if they cause harm as a result of PPI use. We encourage you to call our PPI injury lawyers today to discuss your rights in a free consultation and learn what rights and options you may have.
PPI manufacturers should not get away with causing harm to another party. Call today.
Xarelto Makers Withhold Information from Medical Journal?
Attorneys who are representing patients in lawsuits against two big drug markets are claiming that the makers of these drugs withheld important information from a leading medical journal. The companies, Johnson & Johnson and Bayer, are being called out by legal professionals because of an analysis performed by Duke researchers in which lawyers felt that key information that may have affected the clinical trials was left out.
A device that was used to test Xarelto’s effectiveness on blood clotting was recalled after concerns over the clinical trial’s faulty information to make the drug look more effective than warfarin.
Duke’s Clinical Research Institute ran their trial for three years using more than 14,000 patients and eventually led to FDA’s approval of Xarelto. They later reanalyzed results after the concerns were brought up regarding the faulty device. According to The New York Times, in the follow-up analysis, additional information was withheld that should have been published.
The medical journal that published the analysis claimed that they were unaware of additional lab data of roughly 5,000 blood samples that were sent to a central laboratory. The missing data raises some questions regarding whether the makers of the drug were hiding something about the blood-thinning drug.
Over the years, Xarelto has been linked to numerous side effects, including back pain, leg weakness, headaches, dizziness, and even paralysis. If you or someone you love is taking Xarelto and experiencing serious side effects, you may have a right to file a claim.
At Bailey Cowan Heckaman PLLC, we know how important it is for drug makers to make a safe prescription for patients. If they fail in this duty, they should be held accountable for their actions. If you believe you have a case, contact our firm today to discuss a potential lawsuit with our dangerous drug attorneys. We’re ready to help you!
Invokana Use Linked to Development of Ketoacidosis
In May of 2015, the Food and Drug Administration issued warnings regarding the Type 2 diabetes medication Invokana and its link to diabetic ketoacidosis. This condition can be very serious leading to high levels of ketones in the body. There are numerous cases already filed against the manufacturers of Invokana due to the development of ketoacidosis which resulted in some needing hospitalization.
The FDA required SGLT2 inhibitor manufacturers provide updates regarding their labeling to include the warnings of ketoacidosis and urinary tract infections.
When an individual takes Invokana, the kidneys release the excess blood glucose through urination. This is supposed to help with Type 2 diabetes, but in the first year of its release, there were over 450 adverse effects reported. These include reports of kidney failure, dehydration, urinary tract infections, abnormal weight loss, and kidney stones. There are some individuals who had allergic reactions to the drug as well with tongue, face, lips, and throat swelling, as well as skin irritation.
Some of the lawsuits against the makers of Invokana claim that the manufacturer were negligent in their production and testing, or that they failed to warn users of the potential dangers.
If you or someone you know took Invokana and experienced side effects, you may have a right to file a claim against the manufacturer. This lawsuit can help you recover compensation for the damages you may have incurred as a result of a condition you developed.
At Bailey Cowan Heckaman PLLC, our team of dangerous drug attorneys is dedicated to protecting those who have been affected by defective drugs. If you have suffered harm, we want to help you hold the manufacturer accountable for their actions. Call us today and learn if you have a claim, as well as what our firm can do to help you move forward without financial concern. We’re here to stand by your side every step of the way.
SCOTUS Upholds BCH's $124 Million Trial Victory
Last month, the United States Supreme Court upheld a $124 million trial victory that Bailey Cowan Heckaman PLLC achieved for our client, the State of South Carolina. Janssen Pharmaceuticals attempted to appeal the $124 million judgment, but the Supreme Court refused. Our law firm represented South Carolina in both the trial and appeals process, along with South Carolina co-counsel. The $124 million judgment was awarded for deceptive trade practices concerning Janssen's false and misleading marketing of its antipsychotic drug. The Attorney Fees & Expenses for this case totaled $23,101,269.
For more information, you can read the press release about the case here.