Truvada and other antiretroviral drugs containing the active ingredient tenofovir disproxil increase the risk of bone density loss, fracture, renal impairment, and kidney failure. Truvada is one of the most popular HIV drugs in the world. However, the manufacturers hid serious side effects that cause permanent damage to people suffering from HIV. Especially since there are safer versions available that do not pose the same risk for kidney problems and bone density loss.
Truvada is a prescription medication used for HIV-1 treatment and prevention. The FDA approved Truvada in 2012 as the first drug to reduce the risk of HIV infection. Those with HIV take Truvada daily and use the medication for pre-exposure prophylaxis (PrEP) in combination with safer sex practices. This will also help reduce the risk of a partner acquiring HIV-1.
HIV, short for human immunodeficiency virus, is a potentially deadly virus that weakens an individual’s immune system. HIV does this by destroying white blood cells. These cells are important in helping fight off disease and infections. Without medication, the virus will eventually destroy an individual’s immune system. Truvada contains two antiretroviral components: tenofovir and emtricitabine. This combination of drugs is intended to help slow the disease progression and prolong life. However, it cannot cure HIV.
Truvada and other antiretroviral drugs containing TDF can cause dangerous complications. This includes an increase in the risk of bone density loss, bone fractures, renal impairment, and also kidney failure. In the most critical cases, these complications can lead to death. Other common side effects include:
Chronic Kidney Disease Injuries
Nearly 20,000 people taking Truvada reported kidney damage. Kidneys are normally resilient to damage, however, when symptoms start, it is hard to reverse them. Kidneys filter wastes from the bloodstream into the urine and out the body. However, those taking TDF reported chronic kidney disease. This prevented the kidneys from effectively filtering the bloodstream.
Symptoms of this include:
- Loss of appetite
- Poor concentration
- Swelling of feet and ankles
- Itchy skin
- Need to urinate frequently
- High blood pressure
- Abnormal protein levels in the urine
- High creatinine levels diagnosed by a physician or other healthcare provider
- Abnormal glomerular filtration rate (GFR) levels (15 to 90) as determined by tests and blood work
- Death due to renal failure
Aside from chronic kidney disease, individuals taking Gilead’s TDF drugs are at risk of developing several other kidney-related conditions, including:
- Acute kidney injury (AKI) or acute renal failure (ARF): A kidney disorder in which the kidneys suddenly have difficulty filtering waste from the blood.
- Fanconi syndrome: A kidney tubule disorder that causes excessive levels of glucose, potassium, and bicarbonate to be excreted in the urine.
- Renal tubular acidosis: A kidney condition involving the build-up of acid in the bloodstream due to the kidneys failing to filter it out.
Bone Density Injuries
Those taking Truvada reported nearly 10,000 reports of bone density loss. In fact, a 2010 study found:
A strong correlation between loss of bone density in HIV-infected individuals, particularly in conjunction with the antiretroviral drug tenofovir.
Another study from 2016 found that Gilead’s TDF has a 1-3 percent greater bone mineral density loss than other anti-viral drugs. Without new bone tissue replacing the older one, osteoporosis sets in it. This is a condition in which bones are so weak that minor falls or stresses can cause them to fracture.
Common symptoms for osteoporosis and osteopenia include:
- Back pain
- Stooped posture
- Loss of height
- Bone fractures with physician or healthcare provider diagnosis of bone weakening or demineralization
- Bone density loss, bone demineralization, or weakening of the bones diagnosed by a physician or other healthcare provider
Gilead Hid Dangers
Gilead is the leading manufacturer of HIV drugs worldwide. The company generated $11 billion in sales in 2017 alone. The FDA warned Gilead that was misleading the public of the seriousness of Truvada’s side effects. In fact, the government agency sent multiple letters to Gilead criticizing the company’s statements on the medication.
IThe FDA even sent multiple warning letters starting in 2002, each for minimizing the known risks of Truvada and making false claims in regards to its efficacy. Sales representatives were saying it was a “miracle drug without toxicities”. Kidney failure is a side effect, however, representatives never told doctors.
FDA Truvada Warning 1, March 14, 2002: Gilead sales representatives were observed making false claims about the Truvada, stating it was “extremely safe”, “extremely well-tolerated”, and a “miracle drug” that had “no toxicities”. Truvada kidney failure, which was listed as a potential side effect on the warning label, was not mentioned by the representatives. Then, in 2014, the FDA sent another letter. This time the agency called out Gilead’s online advertising that neglected to mention kidney and bone risks with the drug.
Nothing changed and in July 2003 the FDA sent a second letter. Yet, nothing happened. Finally, in July 2014 the FDA asked Gilead Sciences to remove a sponsored web link that misrepresented the safety of TDF drugs. It also failed to mention the known risks of kidney problems and bone issues.
Gilead Purposely Withheld Safer Medication
Gilead had a safer medication (TAF) for well over a decade but never released it to maximize profits. Those with HIV need TDF meds to stay alive. They have no choice, and Gilead knew this. But, instead of addressing the kidney and bone density issues, the company decided to keep selling the medication until the patent was up. Then, they “claimed” to find a safer alternative.
Thus far, there have been two lawsuits filed against the company over its promotion of HIV medication. Victims filed in the Superior Court of the State of California for the County of Los Angeles. These individuals suffered bone and kidney damage as a result of taking Gilead medications containing the active ingredient tenofovir disoproxil fumarate (TDF). This substance is highly toxic in large doses when taken over a long period of time.
Those lawsuits led to a JCCP 5043 litigation in California under Judge Cheng. Judge Cheng already denied Gilead’s motion to dismiss. Due to COVID-19, the litigation has stalled a bit. However, case management orders are being filed.
Speak to an Attorney Today
If you or a loved one has been harmed by Gilead’s TDF, you need an attorney with experience helping people who have been harmed by pharmaceutical drugs. The attorneys at the Michael Brady Lynch Firm know what it takes to go up against drug manufacturers to get clients what they need.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
Therefore, if a jury finds the conduct of a drug company to be highly reckless, they may award punitive damages to deter similar conduct in the future. If you developed bone issues or kidney failure after taking a TDF drug, please speak to us to learn more about your rights.
Also, case evaluations are free of cost and without obligation. Therefore, call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.