Unsafe drugs can do much more than delay your recovery. They can cause a host of health complications you otherwise would not have suffered. Uloric (febuxostat) by the manufacturer Takeda Pharmaceuticals is currently the center of a possible multidistrict litigation for allegedly withholding the known risks of Uloric. If Uloric has injured you or a loved one, speak to an attorney about the developments in the case.
What Is Uloric?
Uloric is a drug physicians commonly prescribe to treat gout. It lowers uric acid levels in the body to relieve symptoms. Patients take Uloric once per day to remove extra uric acid. It may take several months for patients to feel the effects of Uloric. Uloric is one of the only Food and Drug Administration (FDA) approved drugs for treating gout.
Unfortunately, it could come with serious health risks.
The Risks of Taking Uloric
When the FDA approved Uloric in 2009, it required Takeda Pharmaceuticals to conduct a safety study of the drug. Uloric contained a Warning and Precaution about potential cardiovascular problems starting in 2009. When Takeda completed its safety trial on more than 6,000 patients, it found that Uloric can increase the risk of heart-related deaths compared to other gout medications. About 15 cardiovascular-related deaths occurred for every 1,000 patients taking Uloric.
The most common adverse outcomes in patients during the trial were heart-related death, non-deadly stroke and heart attack, and unstable angina (lack of proper blood flow to the heart). If a patient notices symptoms such as shortness of breath, chest pain, rapid heartbeat, numbness or weakness in the body, dizziness, or severe headache, they should see their doctors. Physicians should warn patients of the heart-related risks of Uloric before prescribing.
The Emerging Uloric Litigation
Cases against Takeda Pharmaceuticals allege that the company knew or should have known about the risks of Uloric, yet failed to warn patients. The litigation is seeking (took out multidistrict – it hasn’t been filed yet as an MDL) financial compensation for patients who suffered heart complications and other harms while taking Uloric. Patients may be eligible for payment for medical bills, pain and suffering, lost wages, and other damages from Takeda for its negligence.
What to Do If You Think You Have a Case
If you or a loved one has taken Uloric for at least 30 days and is experiencing cardiovascular problems, speak to an attorney about joining the potential litigation concerning Uloric.
An attorney can investigate your situation, help you gather evidence, and take care of confusing paperwork to investigate your possible claim. Contact Gallon, Takacs, Boissoneault & Schaffer Co. for assistance with your Uloric lawsuit.
Initial consultations are free.
Valsartan is a drug used to treat high blood pressure and heart failure. In June 2018, the FDA announced a voluntary recall of Valsartan due to the discovery of carcinogenic chemicals in the drug. Anyone who has taken Valsartan needs to know what this recall entails and what to do if they currently take this medication.
FDA Guidance on Valsartan
Valsartan’s main intended uses include the treatment of high blood pressure and heart failure conditions. However, the manufacturer issued a voluntary recall after identifying an impurity detected in this medication. The impurity is the presence of N-nitrosodimethylamine (NDMA), a substance classified as a potential human carcinogen. The manufacturer identified recent changes in the production process as the probable cause of this impurity.
The FDA recommends that despite this recall, patients currently taking Valsartan do so for very serious health conditions, and interruptions in their medication dosage schedule can be disastrous for some individuals. The FDA advises continuing to take Valsartan until replacement doses become available. The manufacturers affected by the recall are taking appropriate steps to remove this impurity from their Valsartan products.
Patients can identify recalled drug products by checking their prescription labels and manufacturer information. Patients taking Valsartan made by Major Pharmaceuticals, Solco Healthcare, or Teva Pharmaceuticals, Ltd. should note these products have been recalled. The recall also applies to Valsartan/Hydrochlorothiazide (HCTZ) produced by Solco Healthcare and Teva Pharmaceuticals, Ltd.
What to Do if You Currently Take or Have Taken Valsartan
Any person who confirms that he or she has taken or is taking any Valsartan medications affected by the recall should confirm the manufacturer of their medication and check the company’s recall information. Every company handles recalls differently, but most will encourage patients to continue taking their medications as prescribed until a safe replacement becomes available.
If you have concerns about your exposure to potentially harmful NDMA, speak with your primary care physician as soon as possible to learn more. A doctor may be able to prescribe a replacement or substitute product so the patient experiences minimal interruption in his or her medication schedule.
NDMA is a possible carcinogen, so it is unclear if there is any possibility of short-term cancer risk after taking Valsartan. The long-term health implications also remain unclear. Despite the possible risk of carcinogenic exposure, patients who take Valsartan do so for serious medical conditions that require consistent doses of these medications, and interruptions may cause serious health problems. Ultimately, patients taking recalled Valsartan medications should consult with their physicians and refer to manufacturers’ recall information in the meantime.
The first bellwether trial against the drugmaker of AndroGel was recently concluded and the jury found the company AbbVie guilty of fraudulently misrepresenting its product. The jury awarded the plaintiff $150 million in punitive damages. Get the latest details.
In October 2016, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) issued warnings concerning the risk of infection associated with Stockert 3T heater-cooler units. These specialized devices are routinely used during open heart surgeries and other procedures. Federal agencies report that some of the devices may be contaminated with a bacteria that can be dangerous or fatal for heart patients. Patients should be aware of the risk and seek a medical diagnosis if they have recently undergone open heart surgery.
If you or a loved one were recently diagnosed with a bacterial infection after surgery, speak to one of our injury attorneys about your situation. You may be entitled to compensation. Call Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A. at 419-843-6663 for a free consultation.
What is the problem with Stockert 3T Heater-Cooler units?
Heater-cooler devices are an essential part of open heart surgery. More than 250,000 people under heart bypass procedures using heater-cooler devices every year, according to the CDC. Using cool water and fans, these machines help keep the patients’ blood, heart, and body at a safe, specific temperature during the procedure.
The problem is that some of the devices have been contaminated with Nontuberculous Mycobacteria (NTM) bacteria during the manufacturing process in Germany. NTM bacteria is a common organism often found in soil and tap water. They are usually harmless for healthy people, but can cause serious, life-threatening infections in patients with compromised immune systems.
“Samples of the water drained from the 3T devices and air samples collected while the devices were in operation were tested. The results strongly suggest the 3T heater-cooler units are the source of M. chimaera [a type of NTM] contamination,” reports the FDA. In contaminated devices, the fans can potentially blow the bacteria from inside the machine into the surgery room and into the patient’s body.
How do I know if I have been infected with NTM bacteria?
Roughly 60 percent of all heart bypass procedures performed use a heater-cooler device that has been associated with NTM bacterial infections. The FDA has received dozens of reports of patient infections associated with heater-cooler devices. In hospitals where at least one infection has been identified, the CDC estimates patients’ risk of getting an infection between one in 100 and one in 1,000.
Diagnosis is challenging because it can take months for the bacteria to cause symptoms. Plus, the symptoms are non-specific so neither patients nor doctors may first realize at first that the symptoms have anything to do with an NTM infection. CDC Deputy Director Dr. Michael Bell explains, “If you are a couple of years out from your surgery, and you aren’t having any symptoms, then you don’t need to worry about this particular issue.” However, if your surgery was more recent, you should go to your clinician if you are having any of the following symptoms which could be related to an NTM infection:
- Night sweats
- Redness, heat, or pus at the surgical site
- Muscle or joint pain
- Weight loss
- Nausea or vomiting
Where can I find more information about contaminated heater-cooler units?
Inform yourself of the risks of Stockert 3T heater-cooler device-related bacterial infection, and speak to your doctor if you have any concerns. Here are a few helpfuol resources with more information:
- Sample Letter for Patients to Give their Healthcare Provider
- CDC Video: Important information for heart surgery patients
- FDA Safety Communication: Infections Associated with Stӧckert 3T Heater-Cooler System
- CDC Q&A on heater-cooler device-related infections
How are NTM bacterial infections treated?
If you test positive for a NTM bacterial infection, your doctor will probably begin your treatment by giving you a round of strong antibiotics. This particular type of bacteria can be resistant to treatment, however, and some patients need prolonged treatment lasting months or even years. Although rare, some patients who contract an NTM infection after heart surgery may require additional surgery. If left untreated, NTM infection can be potentially fatal.
What remedies do patients have if they have developed a NTM infection?
Infected patients (and family members in fatal cases) have already begun filing personal injury and class action lawsuits against the manufacturer. If you have been diagnosed with an NTM infection after surgery that utilized a heater-cooler device, you may be eligible to file a claim and pursue compensation for your losses. There is strong evidence to support the link between the devices and NTM infections, so the chances of winning your case are excellent. Not only have the CDC and FDA issued warning reports on the device, but there has even been a national recall.
You may be able to recover damages for losses such as:
- Medical bills associated with the infection, both current and future
- Miscellaneous expenses related to your injuries
- Loss of wages
- Household services
- Pain and suffering
- Loss of quality of life
- Death benefits such as funeral expenses, loss of income, and loss of support (in fatal case)
How do I pursue compensation for a post-surgery NTM infection?
If you have a serious infection related to a surgery, your first step in pursuing compensation is to speak to an injury lawyer about your case. Our attorneys at Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A would be happy to assist you. We will review your case, investigate the facts, and let you know if your case meets the criteria to file a liability claim.
Our firm cares deeply about our clients’ situations. We know how devastating a serious infection can be, not only physically, but for financially and emotionally. If your illness was caused my a defective device or medical mistake, we can help you hold the appropriate party liable and fight for maximum compensation on your behalf.
Contact our office today at 419-843-6663 for a free consultation to learn more.