Truvada is a medication that prevents HIV and Hepatitis B virus infection. However, it has been linked to chronic kidney disease, reduced bone density, kidney injuries, and bone damage.
The FDA has received reports of patients experiencing complications such as osteonecrosis (bone death) and proximal renal tubulopathy (kidney failure). We realize that standing up to a massive pharmaceutical corporation that sells HIV drugs might appear frightening and futile.
At Rosenfeld Injury Lawyers, LLC., our personal injury attorneys are legal advocates protecting victims’ rights against companies and individuals causing them harm.
Call our drug injury lawyers at (888) 424-5757 (toll-free phone number) or use the contact form today to schedule a free consultation. All confidential or sensitive information you share with our legal team remains private through an attorney-client relationship.
HIV/AIDS Prevention – Truvada Medication
Truvada is a pill 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.
FDA Approval for HIV Drugs
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 (tenofovir disoproxil fumarate) 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.
Gilead Sciences and Truvada Lawsuits, HIV Treatment & Kidney Failure
Truvada lawsuits claim that Gilead withheld a safer alternative to maximize profits from Truvada and other TDF drugs including Viread, Atripla, Complera, and Stribild.
An AIDS Healthcare Foundation lawsuit alleges that Gilead Sciences Inc., the drug manufacturer 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 a virus infection.
Antiretroviral Therapy Drugs
Gilead’s failure left many gay men at risk for contracting HIV/AIDS because they did not use condoms the TDF medication, 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 identifies PrEP among the safer HIV antiviral medications when people at very high risk of getting HIV take daily medicine to prevent HIV infection.
The FDA approved Truvada in 2004 as a safer alternative than other HIV medications. It was one of the first antiretroviral medications in a single-tablet regimen to treat HIV.
The drug company said it was approved as a safer TDF drug to reduce the serious health risks of sexually acquired HIV-1 in adults 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 tenofovir disoproxil fumarate, including Viread, Atripla, Complera, and Stribild.
Filed in the Northern District of California Federal Court by Jesse Mitchell of Nevada, the suit claims that Truvada has potential side effects, including bone injuries, kidney damage, bone density loss, 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 jawbone osteonecrosis.
Drug Manufacturer Aware of Side Effects
The pharmaceutical manufacturer knew or should have known that TDF was not an appropriate drug to prevent osteoporosis (bone loss) or 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 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.
FDA Sends Warning Letters To The Drug Maker
Many believe that Gilead Sciences is aware of the risks of taking HIV but does nothing to let consumers know about them. Gilead Sciences already received warning letters from the FDA in 2014 concerning its failure to adequately warn doctors and patients about the serious illnesses associated with the long-term use of TDF.
No class action lawsuit has been filed seeking legal action against the pharmaceutical company. All legal dangerous drug claims have been filed in civil court as individual cases from multiple law firms resolving Truvada lawsuit settlements.
The FDA notified Gilead Sciences over its representative statements to healthcare providers at a scientific conference, claiming its antiretroviral drugs were not toxic. The representatives presented the medication as a safer drug that did not pose a risk of kidney damage or bone issues.
However, pending lawsuits allege a significant risk of damage to kidneys and bones and possibly fatal damage to patient health. The legal claims over patient safety have resulted in TDF lawsuits filed against Gilead Sciences Inc.
Truvada Lawsuits Filed Claiming TDF Linked to Osteoporosis, Bone Disease
Recently, a man filed a complaint against Gilead Sciences Inc. for failing to warn patients about the potentially harmful side effects of Truvada.
The plaintiff claims that he suffered from bone disease, reduced bone mineral density, and other conditions after taking Truvada as prescribed by his doctor, not to treat HIV infection 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 accuses the drug manufacturer of not warning him of the potential risks of taking HIV medication, including kidney or bone injury.
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 US District Court for the Northern District of California (CACD) for injuries he allegedly suffered kidney injuries, bone problems, and Fanconi syndrome after taking Truvada as PrEP medication.
Fanconi syndrome is a rare kidney disorder affecting tubule function resulting in excess urine-excreated glucose, bicarbonate, uric acid, phosphates (phosphorus salts), potassium, and amino acids.
Truvada Lawsuit Filed by Man With Osteonecrosis Allegedly Caused by PrEP Drug
A man 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 drug manufacturer 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 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)
- A drug called Atripla (efavirenz 600mg/emtricitabine 200mg/tenofovir)
Viread (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 figure out what is happening. The FDA has been actively looking into this, and are trying to determine the true risk factors.
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 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 and heterosexually active adults who 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 bone pain, which were then discovered to be a lack of calcium.
No Controls For Monitoring Bone Injuries
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 to enable people to adhere to their PrEP regimen.
For 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 is that sexually transmitted infections — particularly herpes — are also associated with bone loss.
Some think some of these sexually transmitted infections could play 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. 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 daily and sticking to their adherence.
The PrEP Medication Cimduo (Cobicistat 150mg / Tenofovir 300 mg / Emtricitabine 200mg)
It is important for individuals who are already on medications to understand this issue so they can talk with their doctor about the possible risks and how to mitigate them.
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 diagnosed with bone diseases like achondroplasia (dwarfism).
According to the Aids Healthcare Foundation, 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 for it to remain in your system and reach the levels necessary where it can prevent a breakout of the HIV virus.
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 conducted by the FDA and CDC.
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 you should share this information with your healthcare provider.
They may want to monitor how Truvada affects your bones while you take them for PrEP purposes and 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 TDF medications such as PrEP, is still being researched, and several states do not yet allow it as a form of HIV prevention.
However, the information available about TDF medications for PrEP suggests that they can be an effective way to prevent serious injury and HIV and do not pose a direct threat to bone health.
Osteoporosis Development Risk
The risk of developing osteoporosis is believed to be related to other conditions such as smoking, excessive drinking, and family history. Overweight individuals are also at a higher risk.
Regarding 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 Vitekta (elvitegravir), have been ruled out by some researchers because it is a more potent version of TDF that could cause more harm than good when taken for PrEP purposes.
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 attorneys who have previously handled defective drug cases and Truvada lawsuits involving malfunctioning medical devices.
Hiring a Truvada lawyer helps the injured party financially while taking the stress off of other life trauma that can arise from dealing with this kind of lawsuit alone.
Our defective drug lawyers are available for a free case review to help determine whether your case qualifies for a lawsuit. These evaluations are free, and if it is determined that you have a viable Truvada case, 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.
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?
Call a Truvada lawsuit lawyer at (888) 424-5757 (toll-free phone number) or use the contact form to schedule a free case evaluation. If you have been diagnosed with osteoporosis after being on PrEP or experiencing renal-related side effects, you may be eligible for compensation through our drug injury lawsuit.
Representatives are available 24/7, including nights and weekends, to answer questions on how to file a Truvada lawsuit.
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 bad drug cases and wrongful death lawsuits through contingency fee agreements, meaning you pay us nothing until your case is resolved.
