Gilead Sciences manufactures Truvada (emtricitabine and tenofovir disoproxil fumarate, or TDF), a prescription medication used alongside other drugs to mitigate the adverse effects of HIV-1 infection in adults. Not only have TDF antiretroviral drugs like Truvada (others include Viread, Atripla, Complera, and Stribild) been linked with devastating bone and kidney injuries, but lawsuits allege that the manufacturer developed a safer version of the drug but withheld it from the market so as not to interfere with the profit-making potential of the riskier drug. Gilead sat on the safer tenofovir-based alternative to Truvada (TAF, or tenofovir alafenamide fumarate, which is sold as Odefsey, Genvoya, and others) for approximately 13 years after its initial clinical trials before finally releasing it to the pharmaceutical market in 2015, only a short time before the Truvada patent expired. Plaintiffs who suffered severe bone density loss and kidney problems after taking Truvada are suing Gilead, claiming the drug maker exposed them to needless suffering in order to protect its bottom line.
TDF drugs earned Gilead an estimated $11 billion in 2017 alone.
Plaintiffs in Truvada lawsuits not only seek damages for their individual losses, including medical expenses and loss of quality of life, but also to hold Gilead accountable for its allegedly unethical business practices.
At Showard Law Firm, we’ve been on the winning side time and time again when it comes to defective drug litigation. We are not intimidated by big drug companies, marketers, insurance companies, or corporate defense lawyers. If you believe you have been harmed as a result of taking Truvada, contact a Truvada lawyer at our firm to discuss your options for pursuing monetary damages for your losses, including past, present, and future medical costs. Call today for compassionate, yet aggressive, representation.
Truvada Side Effects
First approved by the FDA in August 2004, Truvada was later expanded in July 2012 to include PrEP, Pre-Exposure Prophylaxis of HIV infection in adults and in May 2018 to include PrEP for adolescents. Though it’s been on the market for more than 15 years, safety concerns remain, particularly involving bone mineral density loss and kidney failure.
Truvada side effects are tied to the presence of tenofovir disoproxil fumarate (TDF), which can also be found in drugs like Viread, Atripla, Complera, and Stribild. The most dangerous TDF side effects include:
- Bone Injuries – Patients in their thirties have suffered bone loss comparable to those in their eighties. Truvada users may suffer from osteopenia (weak bones), presenting with symptoms of pain, loss of height and posture, and increased susceptibility to fractures. Truvada users with osteoporosis have bones so porous that a sneeze or minor fall could cause one or more bones to break – often the first sign of bone mineral density loss.
- Kidney Injuries – Lawsuits against Gilead have also been filed alleging chronic kidney disease, acute kidney injury, Fanconi Syndrome, and tubular dysfunction. After three months of diminished kidney function, patients are diagnosed with chronic kidney disease, which can progress to end-stage kidney failure, spelling death without routine dialysis or transplant. Prior to that, patients may suffer from kidney stones, muscle weakness, fatigue, painful urination, vomiting, and electrolyte imbalances.
- Lactic Acidosis – A potentially fatal side effect occurs due to the build-up of lactate, causing the blood and tissues to become too acidic. Nausea, vomiting, cramping, fatigue, and shortness of breath occur before 75% of people with the condition die.
- Severe Liver Problems – Hepatomegaly (enlarged liver) and steatosis (fatty liver) have been reported in a small percentage of Truvada users. Symptoms include stomach pain, nausea, loss of appetite, light-colored stools, dark-colored urine, and yellowing of the eyes. These conditions can be fatal if untreated.
FDA Action & Recall History for Truvada Medication
The insert for Truvada medication originally included a warning that users have reported “lactic acidosis and severe hepatomegaly with steatosis, including fatal cases.” The drug is “not approved for the treatment of chronic Hepatitis B,” the insert adds. “Bone monitoring should be considered for patients who have a history of pathologic bone fracture or are at risk for osteopenia,” the insert suggests, adding that Vitamin D and calcium supplementation “may be beneficial for all patients.” Bone mineral density “may” need to be checked, along with routine blood tests to determine kidney function.
No new side effects were added in 2012, when the FDA expanded the use of Truvada for preventative measures. Serious adverse events related to kidney or bone toxicity were labeled as “uncommon.” The boxed warning advised that health care providers confirm that they are HIV-negative before starting therapy and undergo re-testing every three months.
FDA warnings are not necessary to sue drug manufacturers. To date, there have been NO safety recalls, even though the number of adverse events reported to the FDA top 9,000 since 2005. Of those, there are 7,575 serious cases and 657 deaths. Acute kidney injury was reported by 453 patients and Fanconi Syndrome by 111. Another 177 patients reported bone problems like osteonecrosis and osteopenia.
For Manufacturer Gilead, Truvada Is a Big Moneymaker
For Gilead, Truvada is a big money maker – bringing in over $2.6 billion in annual profits from American patients alone. Worldwide, Truvada earns $3 billion. Since the drug was approved for prevention, the price has more-than-doubled to $1,780 a month. Gilead has come under fire by the U.S. government for the exorbitant $21,000/year pricing at home; by comparison, a generic form of Truvada sold in Africa costs about $60 annually. They lobbied hard to keep Truvada equivalents from India out of the African market. Gilead has agreed to donate enough drugs to cover 200,000 U.S. patients each year until a generic version of the drug becomes available in 2020. Critics say this paltry amount covers just 20% of those who need it.
Contact Showard Law Firm to Learn About Truvada Lawsuits
If you or a loved one have suffered harmful side effects from Truvada, contact Showard Law Firm for a free consultation as soon as possible. If we agree to take your case, we cover the upfront cost of investigation and litigation; you pay nothing for our legal services unless a favorable resolution is reached.
- NY Times – Under Fire For Truvada US Pricing, https://www.nytimes.com/2019/05/09/health/gilead-truvada-hiv-aids.html
- National Osteoporosis Foundation – Fast Facts, https://cdn.nof.org/wp-content/uploads/2015/12/Osteoporosis-Fast-Facts.pdf
- Science Direct – Hospitalizations for osteoporosis-related fractures: Economic costs and clinical outcomes, https://www.sciencedirect.com/science/article/pii/S2352187216300298
- POZ – HIV Bones Basics, https://www.poz.com/basics/hiv-basics/hiv-bones
- Truvada: The Potentially Life Threatening Drug Recommended to Healthy Gay Men, https://www.bgdblog.org/2014/02/truvada-potentially-life-threatening-drug-recommended-healthy-gay-men/