Truvada and Bone Injuries
Pharmaceutical companies are expected to provide patients with safe and effective medication to treat or prevent disease. However, there is a conflict of interest when profit takes precedence over a patient’s welfare. There are checks and balances at each drug development stage to ensure safety for the potential patient. Research and clinical trials are monitored by the U.S. Food and Drug Administration, which scrutinizes a new medication before it hits the open market. Evidence must show that it is safe and effective for use. Post-market safety monitoring can remove a drug from circulation if it shows a significant risk to public health. Yet, there remain drugs currently in use where the risks greatly outweigh the benefits.
A Harmful Antiretroviral Drug
Truvada is a drug that Gilead Sciences, Inc manufactures. It is part of a classification of antiretroviral drugs used to fight the human immunodeficiency virus (HIV). Truvada works by blocking an enzyme that prevents HIV from replicating. Truvada and other drugs containing tenofovir disoproxil fumarate (TDF) are known to be highly toxic in dosages that are usually prescribed. The use of these drugs poses the risk of permanent and possibly fatal damage to the kidney, liver, and bones. Gilead Sciences, Inc. claims that medications containing TDF are miracle drugs and they are very safe. But research as early as 1997 indicates otherwise.
The History of Truvada and the Food and Drug Administration
- The FDA reprimanded the manufacturer of Truvada multiple times, in 2002 and 2003, for false claims of safety in using the drug. But Gilead, Inc. continued to downplay the risks.
- In 2004, Truvada was approved by the FDA for the treatment of HIV-1 infections in combination with other antiretroviral drugs.
- The FDA approved Truvada for further usage as an HIV pre-exposure prophylaxis (PrEP) in 2012.
- In 2018, Truvada was approved for use in adolescents that weigh at least 77 pounds. It was approved earlier for adults and senior citizens.
- A generic brand of Truvada was approved for the U.S. market, manufactured by Teva Pharmaceuticals in October 2020. This generic drug carries the same safety concerns.
Adverse Symptoms associated with Truvada:
There are many short and long-term adverse symptoms associated with Truvada usage, especially for people with pre-existing kidney, liver, and bone density issues.
- Bone Mineral Density Loss or Bone Fractures: Evidence of these symptoms may be shown through a diagnosis of osteoporosis or Osteopenia, and through labs including Vitamin D, Calcium, Serum Alkaline Phosphate (ALP.) May also be visible on a DEXA Scan.
- Declining Kidney Function or Chronic Kidney Disease (CKD): Symptoms of declining kidney function may be proven using a renal biopsy (evidence preservation), GFR/eGFR, serum creatine, albuminuria, ultrasound tests, creatine clearance, BUN, and serum Cystatin C.
- Acute Kidney Injury (AKI) or Acute Renal Failure (ARF): Symptoms of acute kidney injury may be proven using a renal biopsy (evidence preservation), GFR/eGFR, serum creatine, albuminuria, ultrasound tests, creatine clearance, BUN, and serum Cystatin C.
- Tooth Loss Due to Bone Loss: For tooth loss alone, symptoms must be proven using a Cone Beam CT.
The risk of bone injuries are higher for individuals who:
- Are age 50 or older.
- Are overweight.
- Are frequent smokers/drinkers.
- Are on other medications including opioids, antacids, corticosteroids.
- Are combating other health conditions including thyroid disorder, GI disorder, or auto immune disorder.
The risk of kidney injuries are higher for individuals who:
- Have poorly controlled HIV.
- Have low CD 4/ High Viral Load.
- Have diabetes or high blood pressure.
- Have other medical conditions including Hepatitis C.
- Use other medications include NSAIDS, proton pump inhibitors, IV drugs, or antibiotics.
Truvada has been reported to decrease bone mineral density, redistribute fat, cause patients to develop inflammatory responses and more. There are also documented adverse reactions to Truvada during clinical trials, including lactic acidosis, severe acute exacerbations of hepatitis B, new onset or worsening renal impairment, and immune reconstitution syndrome.
Truvada Lawsuits Begin
In June 2016, the AIDS Health Foundation ran ads to inform the public about the dangers of Truvada and expose Gilead, Inc., for their disregard for patient safety. The first of many lawsuits against Gilead, Inc., was filed in California in May 2018. It was followed by a class-action lawsuit by the AIDS Health Foundation, the largest AIDS advocacy group in the United States. The lawsuits claim that the drug manufacturer disregarded the safety of its consumers to reap excessive profits. There was a safer alternative to this drug discovered. However, Gilead Inc. withheld its manufacturing and distribution to consumers to increase the company’s profit margin.
Drug Label Change and New Tablet Strengths
In March of 2016, the Truvada tablet label was updated to include pediatric patients weighing at least 37 pounds and new strengths of the tablet were introduced at 100/150 mg, 133/200 mg, and 167/250 mg. According to the Aids Education Center and Training Program (AETC), the adverse reactions observed in pediatric subjects who received treatment with the individual drug component Viread were consistent with those observed in clinical trials of Viread in adults. No pediatric clinical trial was conducted to evaluate the safety and efficacy of Truvada for children.
The Michael Brady Lynch Firm is a Consumer Advocate for Victims of Harmful Drugs
If you or a loved one has been harmed by a pharmaceutical drug, causing severe long-term side effects or wrongful death, we will hold the pharmaceutical company accountable for its actions. Drug companies must warn consumers of potential side effects. The Michael Brady Lynch Firm has taken effective legal action with proven results against many manufacturers for marketing dangerous prescription or over-the-counter medications. We are a complex national litigation law firm. Our legal team has more than two decades of trial and litigation successes, representing thousands of consumers who have been injured by defective drugs.
Contact the Michael Brady Lynch Firm to end the cycle of pharmaceutical sales taking precedence over your health. Contact us today for a no-obligation consultation with a pharmaceutical litigation attorney. Our office is located in Winter Park, Florida, and can be contacted at 888-585-5970.