Drug manufacturers are needed to ensure that the drugs are safe for human use before releasing their products to the market. If there are possible side effects of these drugs, the law requires the manufacturers to warn patients and users of the harmful effects. Even if drugs might have side effects, manufacturers cannot create products that have adverse effects on users and get away with murder.
Several drugs, for example, Elmiron, have had severe effects on so many people. When many people suffer injuries after taking a dangerous drug, they are allowed to file lawsuits against the manufacturer, and that’s where we come to rescue. We are established mass tort lawyers who can represent you among many other plaintiffs against Elmiron’s manufacturer.
Consumer Alert Now has, for many years, now helped patients who have incurred severe injuries after the use of Elimron across the US. If you need representation or compensation, discuss with our attorneys about your effects, and you will get the best legal counsel.
Elmiron, also known as Pentosan Polysulfate Sodium (PPS), is a sodium salt of a heparin-like glycosaminoglycan. According to the manufacturer – Janssen Pharmaceuticals, Elmiron works as a weak blood thinner to replenish an inflamed bladder lining.
The US Food and Drug Administration (FDA) approved the sale of Pentosan Polysulfate in 1996 under the Orphan Drug Act (ODA). Until now, Elmiron has been the only approved drug for treating interstitial cystitis (IC) associated problems. Since its release, several patients have used the medications according to the US Department of Health and Human Services. Adults and children the age of 16 and above can use PPS.
How to Use Elmiron
Elmiron is an oral prescription drug coming in 100mg capsules. Patients can take up to 300 mg daily – that is three 100mg capsules per day. Doctors advise people to take medicine about two hours after or an hour before meals.
Contact your physician regularly when taking PPS for an assessment of how you are responding to the drug. Your doctor could prolong the dosage if there is no significant improvement, and you show no side effects. Usually, pentosan Polysulfate treatment takes three to six months, with patients getting examined after three months. Patients could have their medications, and dosages extend for decades too.
Vital Safety Information
Janssen Pharmaceuticals offers precautions and safety information vis-à-vis PPS, which include:
As a weak anticoagulant, Pentosan makes your blood not clot as normal. Experts have mentioned that this drug has heparin-like properties, and if you suffer bruises, you could bleed for a longer time. You are advised to notify your healthcare provider when scheduled for a surgical procedure.
No studies have been done on people with hepatic insufficiency. However, caution is advised for such patients because studies show that hepatic impairment can disrupt pharmacokinetics of Elmiron.
Pregnancy and Lactation
Expectant mothers are advised to take Elmiron if only vital per physicians’ prescriptions. Since prior studies of the drug have not been done on lactating mothers, there is no clear information stating whether it is extracted in human milk. However, precaution is always advised.
Drug researchers warn that there are drugs you cannot use together with PPS. If you are under other medications, you are needed to notify your healthcare practitioner before they can prescribe Elmiron. Examples of medicines that are known to show side effects if they interact with Pentosan are Urokinase, Warfarin, Sertraline, Rofecoxib, and many others.
Prior Medical Conditions
You want to notify your physician about previous medical problems before they can prescribe Elmiron. If you take this drug with underlying issues other than IC, you could endanger your life. Examples of conditions that doctors need to know before recommending PPS include stomach ulcers, spleen conditions, liver disease, blood vessel conditions, and polyps.
What is the Work of Elmiron?
A word from researchers has it that Elmiron works by protecting the urinary bladder from irritating substances present in your urine. IC damages the wall of the bladder, allowing irritants in the urine to cause inflammation. Pentosan properties create a barrier along the wall of the bladder to stop inflammation and irritation.
Does Elmiron Cure Interstitial Cystitis?
Unlike other approved painkillers and anti-inflammatory drugs, for example, Tylenol and ibuprofen, respectively, Pentosan Polysulfate Sodium does not heal inflammation.
To debunk misconceptions, Elmiron is not an interstitial cystitis cure. The drug relieves pain and discomfort that IC causes to the inner lining of the bladder. The National Institute of Diabetes and Digestive and Kidney Diseases states that bladder pain syndrome affects from three to eight million women and up to four million men across America. What the researchers don't know is the primary cause of IC.
Conditions that Elmiron is known to treat are:
- Bladder pain
- Inflammation of the bladder lining
- Urinary tract irritation
How Well Does Elmiron Work?
There are numerous studies out there, proving that PPS does the work it was manufactured to perform. Other publications exist showing severe effects of the same drug after usage. Look at the figures below.
Two thousand six hundred twenty-seven participants underwent treatment using Elmiron in two clinical trials. Of these patients, 22 were unknown, 263 were male, and 2343 were female. During the second clinical trial, the manufacturer found 1307 (52%) of the trial participants ineligible for analysis.
Another group of scientists conducted a study on a few IC patients and discovered that Pentosan had little benefits to the patients.
Side Effects/ Potential Risks of Using Elmiron
Patients who ingest therapeutic dosages of Elmiron could experience common side effects, but these vary from patient to patient.
Common Side Effects
Common side effects include but not limited to:
Nausea — Many Elmiron users complain of feeling the urge to vomit. Nausea is a common side effect of drugs with heparin content. PPS contains a fifteenth of heparin components.
Indigestion — Drugs with pain-relieving properties like Pentosan and ibuprofen stimulate the secretion of acid in the stomach. Excessive acid reflux back into the esophagus, causing inflammation because the food pipe has no internal protective lining.
Headache — Using Elmiron could cause slight to a mild headache, especially after a few hours of taking the drug. Many patients complain of cluster headaches on either side that lasts for many hours.
Skin rash and itching — Elmiron can cause itching and skin rash as an unwanted side effect. Many patients have reported experiencing hives after using Pentosan.
Vomiting — Even though not common, patients who suffer nausea experience vomiting as a side effect after taking Elmiron. Researchers link vomiting to stomach acid reflux.
Dizziness — Vertigo is the primary cause of dizziness where you feel like things around you are spinning. Other patients could feel like they are being pulled downwards.
Diarrhea — Patients have experienced diarrhea after taking Pentosan for long. They complain of abdominal pain, and after a few hours, they diarrhea.
Mild to Serious Elmiron Side Effects
In addition to the common side effects of Elmiron, there are mild ones that could get serious in some circumstances. these are:
Hair loss — Also known as alopecia, hair loss is another Elmiron drug side effect. 90% of patients experience hair loss, but their hair regrows after the drug cessation. The typical hair loss suffered is telogen effluvium.
Hemorrhage — As mentioned earlier, Elmiron is a blood thinner; hence, it could cause excessive bleeding if you suffer bruises. Apart from this, you could experience blood in the stool or renal hemorrhage in extreme cases.
Swallowing difficulties — Many patients have reported problems in eating food after the use of IC medication for a long time.
Severe Effects After Taking Elmiron
So many have reported mild side effects, but new studies from Emory Eye Center reveal Elmiron could damage the retina. The retina is the tissues at the back of the eye that acts as a light sensor.
In a manufacturer’s study, 33 out of 2627 developed adverse side effects after using Pentosan Polysulfate sodium. Six people who had underlying conditions died, while approximately two percent of the patients showed common side effects.
Through the use of advanced technology like retinal imaging, researchers have discovered that prolonged use of Pentosan causes retinal pigmentary endothelial injury (RPE). Retinal maculopathy is a condition that causes the change of color in pigment cells found inside the retina.
Changing of color in the cells instigate vision difficulties akin to those the aging experience due to macular degeneration.
Symptoms of RPE are:
- Difficulty recognizing faces
- Increased blurriness of printed words
- Visual distortion like seeing straight line as wavy
- Diminished central vision in one or all eyes
- Trouble seeing under dim light. That means the person need brighter light to read
- Difficulty adapting to low light conditions
- The decreased intensity in the brightness of colors
Documented Cases of Elmiron Eye Disease
In 2018, A publication from the Journal of Ophthalmology revealed a case series consisting of six women who suffered IC and sought treatment between May 2015 and October 2017. These women developed pigmentary maculopathy after taking Elmiron as IC treatment.
According to the National Center for Biotechnology Information, maculopathy is a condition that affects the retina’s center. These patients experienced difficulties in reading and adapting to dim light. Two of the women had dimmed vision, two others had problems reading, and one experienced loss of vision (paracentral scotomas) in part of their eye. The last patient suffered metamorphosis – distorted vision where straight lines become wavy.
All six women underwent background checks to determine if there was a history of eye conditions in their families. Results showed that the conditions were not a hereditary retinal loss, but they had one common thing! They used Elmiron for many years.
In May 2019, the Emory Eye Center presented a study at the American Urology Association Annual Meeting that entailed ten IC patients. All patients had taken Elmiron and suffered macular disease. The patients, who ranged from 38 to 69 years of age, reported experiencing difficulty in reading and seeing in darkness after taking approximately 2062 grams of Pentosan within 15 years. Results of eye assessments reveal symmetric pigmentary changes in the retina.
In October 2019, researchers at Kaiser Permanente discovered that out of 140 people who had taken Pentosan for over five years, 91 volunteered for an eye examination. Results showed that 24 percent of the patients (22 patients) suffered eye damage, and it was more significant in patients who had taken higher quantities of Elmiron.
The Fourth Documented Study
In November 2019, the Department of Ophthalmology at Harvest Medical School published research of one patient who had taken 200mg of Elmiron each day for 18 years. The patient complained of blurry vision in their left eye and difficulty seeing in darkness.
According to the eye studies, there were pigmentary changes in the retina. After six years, the same patient returned with a worse vision in all eyes. After another two years, the case worsened. The doctors ruled out hereditary causes and other possible infections.
The Harvard clinic reported that the patient ceased using Elmiron six years before the extensive retinal atrophy. This study shows progressive maculopathy even after discontinuing the use of Pentosan.
Lawsuits/ Mass Torts Against Manufacturer in Media
Several patients who claimed to have suffered permanent vision loss after using Elmiron said that Janssen failed to offer sufficient warning about the severe side effects linked to the drug.
On 26th March 2020, a patient was diagnosed with long life retinal damage and loss of vision paint to high levels of toxics in Elmiron. The plaintiff filed a claim alleging that Janssen Pharmaceuticals, in conjunction with Teva Branded Pharmaceuticals, did not provide warning that Elmiron is associated with retinopathy and maculopathy. The drug manufacturer also did not want users to visit their physicians regularly when under prescription to have eye examinations.
Tens of thousands of users, including the accusers, were at risk of harm because the defendant decided to withhold information from the medical community, FDA, and the general public. The plaintiff wanted compensation for emotional trauma and physical damage. Injuries incurred include retinal macular dystrophy and vision loss.
In November 2019, many patients were reported to have used Elmiron for long and later diagnosed with maculopathy that led to partial vision loss.
How a Mass Tort Case Works
Mass tort litigations come from dangerous drugs like Elmiron in the market after several people incur injuries. You could find many of these cases in the media, while others don’t make it to the headlines. Like a class action lawsuit, mass torts entail many accusers and one or a few defendants.
The main difference between a mass tort claim and a class action lawsuit is that with the former, plaintiffs have different complaints against one defendant, and these mainly involve defective medical products and dangerous drugs.
So many victims are not aware of how mass tort cases work. Below is an anatomy of a mass tort.
Reviewing records is the primary step. Here, your mass tort lawyer examines claims from plaintiffs and their medical history to determine the drug that caused harm after use. This step in the discovery stage allows the attorney to establish harm consistencies and other factors that help build substantial litigation.
Next step, your attorney identifies the similarity of injuries that the drug users incur. These injuries act as evidence for the claim and categorize litigations to understand any shared characteristics between them. The categorization of the cases makes it easy for the lawyers to know what compensation is suitable for the claimants.
Federal Court Filing
Here, the lawyer consolidates injury claims from different plaintiffs to accelerate the evidence gathering and litigation process.
The jury selected a smaller group of lawsuits from a large one for trial. The smaller group acts as the litmus test since the results can offer insights concerning the possible outcomes of future litigations.
Settlement happens when the plaintiffs and defendant(s) enter negotiations to settle the claims. Also, the claimants receive proposed agreements and they choose whether to accept the offer or to proceed to a trial.
Note that because of the several accusers involved, mass tort claims usually take longer than personal injury claims.
How to Join a Mass Tort
When a drug like Elmiron causes harm to many people, they can come together and create a mass tort. As a group, the claimants can pursue financial compensation with the help of legal experts.
When you incur harm because of a dangerous drug that a doctor prescribed, you feel safe in the care of your physician. However, if the drug has severe effects, you will incur physical injuries and emotional trauma. Here, your doctor gets involved in the damage.
Tort Case Explained
If you want to join mass tort litigation, you should talk to attorneys handling a situation similar to yours. An interview is conducted to determine if the details of your injury are relevant to the mass tort at hand.
Evidence is vital for a dangerous drug tort to win in the court. The mass tort attorney must prove beyond a reasonable doubt that the drugs cause harm to the plaintiffs.
The lawyer representing the victims demonstrates how the drug caused injuries through prescribed or standard use.
Statutes of Limitations
Drug injury litigations, like other cases, are subject to statutes of limitations. You should consult your lawyer to know the specific statute of limitations for your state. These limitations allow a particular time before which you must file your claim in court.
Statutes of limitations involving drug injuries are complicated as it is hard to know the exact time your medication began to cause you harm. It is recommendable that you understand the time limits imposed and file your case before expiry.
Different states have different statutes of limitations, for example:
- You have three years to make an injury claim against a drug manufacturer in Rhode Island
- In Massachusetts, you have up to three years to offer file a lawsuit against a manufacturer
- New Hampshire statute of limitations law needs you to file you drug injury claim before three years
The clock begins to tick the date that the injury-causing action occurred. When talking about dangerous drugs, it is impossible to cap the time you are allowed to make a claim. Different patients react differently to medications. While some may develop medical problems within a year after using Elmiron, others could suffer side effects after decades of using the same medicine. Because of this, the statute of limitations for Elmiron – a dangerous drug starts the moment you discover your injuries.
How to Not Miss the Statute of Limitations
Here are things you need to do not to miss the statute of limitations. These are:
- Visiting your physician, the instant you start noticing signs and symptoms of injury or side effects. When seeking help from your healthcare practitioner tell them about your medication history -the name of the medicines, the dosage prescribed, starting date, and the date you ceased taking the drugs
- Adhering to your doctor's treatment plan. Following the treatment plan helps not only your health but also your legal litigation should there be an association between your symptoms and the drug you took. Your doctor could help document your medical history to identify causation and prove that you stuck to your treatment
- Hire an injury lawyer. Your attorney should offer expert legal counsel and tell you if you can file a lawsuit and when the statute of limitation started and when it is set to expire
What Happens When the Statute of Limitations Expires Before Filing Your Lawsuit?
The defendant motions the jury to drop your case if you miss the statute of limitations. If the jury drops the case, you cannot receive any compensation, and the pharmaceutical firm cannot negotiate a settlement with your attorney as there is no recourse existent in the court.
You cannot afford to miss the statute of limitations and fail to recover compensation. Contact a mass tort attorney the moment you notice an adverse side effect after taking prescribed drugs.
Compensation for A Mass Tort
Per federal and state laws, if dangerous drugs cause harm to you or people you know, you have the right to receive compensation for various losses. These losses include:
- Current and future medical bills
- Lost work time related to your injury
- Disability and disfigurement
- Pain and suffering
- Mental and emotional damages
How Long Does a Mass Tort Claim Take?
Expect to have your compensation after a long time if your case is under a mass tort. The lengthy process is because of the massive number of claimants involved. Mass tort lawyers spend a lot of time investigating and gathering significant proofs for each plaintiff’s case.
Factors that lead to a lengthy mass tort claim are the several state conferences, motions, bellwether trial selections, and case management. Adding to these factors are other dynamics that also affect the timeline for compensation, and these are:
- Finding and talking to expert witnesses like scientists, drug developers, doctors, and marketers. Lawyers could have challenges getting appointments and meeting with expert witnesses
- Investigations and evidence collection call for a lot of traveling; hence, lawyers could spend many months moving from one state to another or other countries
Find a Mass Tort Near Me
If you or someone you know has suffered severe side effects like vision loss after taking Elmiron under prescription, you want to hire a mass tort attorney. The Consumer Alert Now mass tort and dangerous drug litigation team is your go-to legal source. We have helped many victims of dangerous drugs across the country to hold negligent pharmaceutical companies responsible and recover financial compensation for damages and injuries incurred. We are on standby around-the-clock to discuss your case. Call us now at 800-511-0747 to set up a no-cost consultation!