Truvada is a medication used to prevent HIV infections. However, it has been linked to chronic kidney disease and bone damage. The FDA has received reports of patients experiencing complications such as osteonecrosis (bone death) and proximal renal tubulopathy (kidney failure).
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Truvada is a pill that people take every day as HIV prevention to block an enzyme that the virus uses when it tries to infect healthy cells in your body. When the company first developed HIV medications, it was only used in combination with other drugs for treating HIV patients.
In 2012, the FDA approved Truvada to be used as a preventative medication in combination with other safe sex practices for people without HIV who are at risk of getting infected with the virus.
This preventive use of Truvada is known as PrEP or pre-exposure prophylaxis treatment.
Truvada and similar TDF drugs are recommended for people who are in a sexual relationship with someone who is HIV-positive, for those who have multiple sexual partners without using condoms, and for individuals whose partners refuse to wear condoms.
Truvada Lawsuits, HIV Treatment & Kidney Failure
Truvada lawsuits claim that Gilead withheld a safer alternative to maximize profits from Truvada and other drugs containing TDF including Viread, Atripla, Complera, and Stribild.
An AIDS Healthcare Foundation lawsuit alleges that Gilead Sciences Inc., the maker of Truvada®, failed to warn consumers about the risks associated with taking its anti-HIV drug when prescribed for pre-exposure prophylaxis (PrEP), which involves HIV negative people taking PrEP in hopes of avoiding infection.
Gilead's failure led many gay men who were at risk for contracting HIV/AIDS because they did not use condoms, to take the TDF drug, which led to HIV infections and required them to be treated with antiretroviral therapy drugs for life, costing $900 per month or more.
Truvada is produced by Gilead Sciences Inc., based in Foster City, Calif. According to the federal Centers for Disease Control and Prevention (CDC), Truvada is the only drug approved for PrEP. The government agency's website describes PrEP as a safer HIV drug when people at very high risk for getting HIV take daily medicine to prevent HIV infection.
The FDA approved Truvada in 2004 as a safer HIV drug than other HIV medications. It was one of the first antiretroviral medications available in a single tablet regimen to treat HIV.
The drug company said that it was approved as a safer drug to reduce the health risks of sexually acquired HIV-1 in adults who are at high risk for sexual acquisition.
Truvada Lawsuit Filed, Claiming Bone Disease Among Other Complications
A lawsuit involving Truvada has been filed recently by an individual who claims to have suffered through harmful side effects like bone injuries after taking the medication to treat HIV. According to the plaintiff, Gilead Sciences Inc., withheld risks associated with Truvada and other drugs containing TDF including Viread, Atripla, Complera, and Stribild.
Filed in California Federal Court by Jesse Mitchell of Nevada, the suit claims that Truvada has potential side effects, which could include bone disease, kidney damage, and injury to other bones.
According to Mitchell's complaint against the defendant, he took Truvada for several years as prescribed by doctors to treat HIV until 2012 when it was discovered that he suffered from osteonecrosis of the jawbone.
The pharmaceutical manufacturer knew or should have known that TDF was not an appropriate drug for the prevention of osteoporosis or to prevent fractures.
Reports show that Gilead hid the material facts regarding its product by disseminating false and misleading information through various channels, including medical journals, false advertisements to doctors who prescribed Truvada as PrEP for off-label uses, to health insurers, to the medical community, and to Plaintiffs' doctors," Mitchell stated in his complaint.
A similar lawsuit was filed last year by a group of individuals currently taking Truvada for PrEP who claim that using the drug has led them to suffer from bone damage and other conditions such as bone injuries, kidney damage, kidney failure, or other kidney problems, which are not the same risks when taking other HIV medications.
Many believe that Gilead Sciences is aware of the risks involved with taking HIV drugs, but that they are doing nothing to let consumers know about them. Gilead Sciences has already received warning letters from the FDA in 2014 concerning its failure to warn doctors and patients about the serious illnesses associated with long-term use of TDF.
Currently, no class action lawsuit has been filed seeking legal action against the pharmaceutical company. All legal claims have been filed in civil court as individual cases from multiple law firms resolving Truvada lawsuit settlements.
Truvada Lawsuits Filed Claiming TDF Linked to Osteoporosis, Bone Disease
Recently, a man filed a complaint against Gilead Sciences Inc., for their failure to warn patients about the potentially harmful side effects of Truvada. The plaintiff claims that he suffered from bone disease and other conditions after taking Truvada as prescribed by his doctor, which was not for treatment of HIV, but rather to prevent the contraction of the virus.
Claiming that Truvada's side effects include bone disease which can lead to osteoporosis and other injuries, the plaintiff says he lost his ability to walk after taking the medication for three years. He is accusing the drug manufacturer of not warning him of the potential risks involved with taking HIV medications.
Truvada Lawsuit Filed by Man Allegedly Damaged by Bone Disease After Taking PrEP Medication
A man has filed a complaint against Gilead Sciences, Inc., in the U.S. District Court for the Central District of California (CACD) for injuries he allegedly suffered kidney injuries, bone problems and Fanconi syndrome after taking Truvada as PrEP medication.
Truvada Lawsuit Filed by Man With Osteonecrosis Allegedly Caused by PrEP Drug
A man who was recently diagnosed with osteonecrosis, a bone disease which [usually] affects people taking bisphosphonate drugs used to treat osteoporosis, has filed a lawsuit against Gilead Sciences Inc., the maker of the PrEP medication Truvada.
Gilead's own prescribing information describes osteonecrosis as a rare side effect of using bisphosphonates.
Truvada is used for people who are at high risk for HIV and is the only FDA-approved HIV treatment in pill form to help prevent HIV. Besides Truvada, doctors can also prescribe an injectable drug called Viread (tenofovir), another formulation of tenofovir disoproxil fumarate (TDF) called Eviplera (tenofovir 1.5mg/emtricitabine 200mg) or another drug called Atripla (efavirenz 600mg/emtricitabine 200mg/tenofovir).
The PrEP injectable medication Viread (tenofovir) is an alternative to Truvada and has the same side effects including osteonecrosis. Other medications associated with an increased risk of osteonecrosis include Procrit (epoetin alfa), Aredia (pamidronate), and Zometa (zoledronic acid).
Medical scientists are seeing an uptick in the result of taking this dangerous drug, which is to be expected when Truvada has been out in the marketplace for a couple of years. When these things happen, we investigate and try to figure out what is going on. The FDA has been actively looking into this and we're trying to find out what the true risk factors are.
Depending on the severity of the side effects, doctors will usually discontinue Viread (tenofovir), Atripla (efavirenz 600mg/emtricitabine 200mg/ tenofovir), Cimduo, Complera, Stribild, Symfi-Lo, or other TDF drugs and individuals may not be able to use PrEP in the future.
The CDC (Centers for Disease Control and Prevention) Had HIV Drug Companies
In a report published last year, the CDC said that there were no cases of osteoporosis or bone fractures in any of their clinical trials on PrEP efficacy. Their study included men who have sex with men as well as heterosexually active adults, both of whom used Truvada as PrEP.
However, the CDC also reported that bone fractures were seen among those looking at TDF use across all trials involving more than 1,000 people taking the dangerous drug. The side effects include a lack of energy and pain in bones, which were then discovered to be a lack of calcium.
The CDC acknowledged that there were no controls for monitoring bone health during its studies, but said that the results are being used to figure out how best to prevent, identify and treat these types of side effects in order to enable people to adhere to their PrEP regimen.
For the men who have sex with men, there is a slightly higher risk of fracture, but it's still very small. And the other thing about men who have sex with men, we know that sexually transmitted infections — and particularly herpes — are also associated with bone loss. So we think that some of these sexually transmitted infections could be playing a role in the different fracture risks for this population.
Medical science believes that the pill burden with Truvada, which is one pill once daily, could be contributing to bone mineral density problems. We know that if you're on an injectable form of PrEP there are three shots to take every month. That's another burden for people taking medications every day and sticking to their adherence. So we see this as two things that could be contributing together.
The PrEP Medication Cimduo (Cobicistat 150mg / Tenofovir 300 mg / Emtricitabine 200mg)
For individuals who are already on medications, it is important to understand this issue so you can talk with your doctor about the possible risks and how to mitigate those risks.
In addition, it is important to understand that there are certain risk factors for developing osteoporosis from taking TDF drugs, such as smoking or those who have been diagnosed with bone diseases like achondroplasia (dwarfism).
As soon as you start using PrEP, your body will attempt to fight off the drug by flushing it out in your urine. You need to take in enough TDF in order for it to remain in your system and reach the levels necessary where it can prevent a breakout of HIV.
The recommended dosage is usually Truvada (tenofovir/emtricitabine) once a day, however, the CDC is still investigating whether this dosage will also pose a risk. As of now, no official recommendation has been made for an alternative to Truvada as PrEP due to the investigation being conducted by the FDA and CDC.
PrEP Medication Complera (Emtricitabine 200mg / Rilpivirine 25mg / Tenofovir 300mg)
The FDA has suggested in the past that taking TDF drugs or other HIV medications for treatment may not pose a risk to one's bones, depending on how it is being administered. However, if you are receiving TDF for PrEP purposes then there are still questions about the long-term effects of taking these drugs.
As mentioned, the CDC is still working with the FDA to figure out an alternative dose that would not negatively affect one's bones while still offering protection against HIV. Researchers are also looking for ways to investigate whether there is a direct link between TDF medications and bone health.
It's important to note that research has shown that men who have sex with men but are not on PrEP, also face a greater risk of bone loss. This is related to their higher rates of sexually transmitted infections.
So it is important that men who have sex with men talk to their healthcare providers about how the condition might affect them if they choose to take TDF drugs for PrEP purposes.
Family History of Bone Loss and Kidney Problems
If you are on bone health medication or have a history of bone issues in your family, then it's important that you share this information with your healthcare provider. Not only will they want to monitor how Truvada affects your bones while you take them for PrEP purposes, but also the long-term effects after stopping the dangerous drug. It's also important to tell your doctor if you have a family history of bone issues.
Truvada with no safe or alternative substitutions as PrEP is still being researched and several states do not yet allow it as a form of HIV prevention. However, the information that is available about TDF drugs for PrEP suggests that they can be an effective way to prevent serious injury and HIV and that they do not pose a direct threat to bone health.
Osteoporosis Development Risk
The risk for developing osteoporosis is believed to be related to other conditions such as smoking, excessive drinking, and family history of the condition. Overweight individuals are also at a higher risk.
As far as alternatives, researchers are still investigating whether the drug Isentress (raltegravir) will be a viable alternative for PrEP purposes. Other alternatives, such as the drug marketed under the name of Vitekta (elvitegravir), have been ruled out by some researchers due to it being a more potent version of TDF that could cause more harm than good when taken for PrEP purposes.
So until dangerous drugs are deemed safe enough to be used for PrEP, there are several steps that you can take for protecting your bones from developing osteoporosis:
In addition to taking part in physical activity and eating a healthy diet, talk with your healthcare provider about whether or not Truvada is right for you.
For example, if you are receiving treatment for HIV or hepatitis B virus (HBV) then Truvada will not be approved as PrEP due to the risk of cross-resistance between TDF drugs and lamivudine (otherwise known as 3TC). A drug named Hepsera (adefovir) is approved for HIV treatment but has not yet been approved for use with PrEP.
Other drugs that are available (lamivudine and tenofovir disoproxil fumarate) work to prevent HBV, but this will only be considered if Truvada is found to pose a direct threat to bone health.
You can learn more about Truvada, which is a combination pill that combines the two drugs tenofovir disoproxil fumarate and emtricitabine (brand names: Atripla, Complera, Stribild, or Viread ) by visiting http://www.drugs.com/truvada.html
Do I Qualify for a TDF Lawsuit?
If you have been diagnosed with osteoporosis after being on PrEP or are experiencing renal-related side effects, then you may be eligible for compensation through our drug injury lawsuit.
Call us today at (888) 424-5757 (toll-free phone number) or use the contact form today to learn more about your rights and whether you qualify.
Representatives are available 24/7, including nights and weekends. We also encourage you to sign up for a free case evaluation through our site so that you will have the opportunity to speak directly with one of our team members who can help you understand your legal options.
Truvada Lawsuits: Holding the Pharmaceutical Company Accountable
People taking the HIV prevention drug and experiencing chronic kidney disease, kidney failure, kidney damage, or other Truvada side effects have the right to seek compensation from the pharmaceutical company citing negligence.
Mitigating Truvada injuries usually requires a keen knowledge of the defective drug and a team of legal professionals to help you through all stages of litigation. Pursuing a Truvada lawsuit starts with scheduling a consultation with experienced Truvada attorneys who have handled defective drug cases and lawsuits involving malfunctioning medical devices before.
The significant benefits of hiring a Truvada lawyer helps the injured party financially while taking the stress off of other life trauma that can arise from having to deal with this kind of lawsuit alone.
Personal injury lawyers are available a free case review to help you determine whether or not your case qualifies for a lawsuit. These evaluations are free, and if it is determined that you do have a viable Truvada case then legal representation will be provided for you without incurring any cost out of pocket.
Truvada Lawsuit FAQs
Our personal injury law firm understands that many families have unanswered questions about how to hold a pharmaceutical Company accountable and receive financial compensation through their insurance companies. A Truvada lawsuit attorney has answered some of those questions below.
Call our law firm at (888) 424-5757 (toll-free phone number) or use the contact form for additional information on Truvada lawsuit settlements.
How Much Can I Get From a Truvada Lawsuit?
The amount of money that you can receive from a drug injury lawsuit will depend on several different factors, including the severity of your condition and how long you have been taking HIV drugs. Other factors include any medical expenses incurred as well as compensation for things like missed time at work or reduced earning capacity.
What Are My Chances of Winning a Truvada Lawsuit?
Truvada lawsuits are still pending due to the severity of some of these cases. However, you should know that there is currently a Truvada lawsuit in California that has been won by the plaintiff. The judge ruled that Gilead Sciences failed to warn consumers about some of the dangerous drugs' risks and awarded $2.5 million in compensatory damages to the plaintiff.
How Long Do I Have to File a Truvada Lawsuit?
In Illinois, the statute of limitations for product liability is two years, but the time may vary from state to state. If you believe that you might have a viable lawsuit against Gilead Sciences due to your Truvada injuries then it's important that you don't wait too long before speaking with an attorney about your case.
How Will My Truvada lawsuit Be Resolved?
Typically, these types of lawsuits are settled out of court through negotiations between the parties involved. However, if no settlement is reached then your Truvada case will go to trial so that a judge or jury can decide how much money you should receive for your injuries.
Hiring an Experienced Truvada Lawsuit Lawyer to Prove a Defective Drug Claim
Are you experiencing devastating side effects after taking Truvada or other medication? Are you seeking financial compensation from the pharmaceutical manufacturer and holding them accountable?
Our product liability attorneys at Rosenfeld Injury Lawyers, LLC can serve as your legal advocate to ensure you receive maximum compensation for your damages. We accept all personal injury cases and wrongful death lawsuits through contingency fee agreements, meaning you pay us nothing until your case is resolved.
Call a competent Truvada lawsuit lawyer at (888) 424-5757 (toll-free phone number) or use the contact form to schedule a free case evaluation.