Recent studies have confirmed that Truvada and other similar drugs made by Gilead Science may increase the risk of kidney failure, osteoporosis, bone density loss, and bone fractures. Tenofovir disoproxil fumarate (TDF) drugs – including Truvada – are commonly used to treat HIV and hepatitis B. These drugs are also prescribed as a preventative measure to patients who are at a higher risk of exposure to HIV. Lawsuits are being filed across the nation because Gilead allegedly knew of the side effects of TDF drugs but delayed the release of a safer alternative.
The first TDF drug, Viread (also made by Gilead Science), was approved by the FDA in 2001 for treatment of HIV-1 infection. In 2004, Truvada was approved for HIV treatment, and then later approved to treat hepatitis B in 2008. In a groundbreaking move in 2012, Truvada became the first drug approved for reducing the risk of sexually-acquired HIV. Today, Truvada and other TDF drugs (listed below) are being used by over 80% of the people receiving HIV treatments in the United States. Gilead has earned more than $36.2 billion in Truvada sales alone since the drug was originally approved back in 2004.
Prioritizing Profit Over Patients
Allegedly, Gilead knew of the health risks associated with their TDF drugs as early as 2001. Instead of notifying the public, they began developing a similar, less toxic HIV drug called tenofovir alafenaminde (TAF). TAFs are given in lower dosages, have fewer side effects, and are just as effective as TDFs. Gilead tested its TAF formula with positive initial results, but the TAF drug was not rolled out until November of 2015.
TAF alternatives were not developed further until the patent on TDF drugs was due to expire, bringing into question the financial motivation of Gilead. The concern is that Gilead intentionally withheld the introduction of their safer TAF drugs, ultimately prioritizing profit over patient safety. Pharmaceutical patents ensure that drugs are not subject to price caps or competition for as many as twenty years (the patent of tenofovir expired in 2017, and the patent for Truvada expires in 2021). releasing the TAF drugs in 2015 effectively extended that patent for Gilead. The TAF drugs made by Gilead, including Genvoya, Desovy, and Odefsey have patents lasting from February 2022 to August of 2032.
Gilead manufactures and markets the following TDF drugs:
- Smyfi Lo
- AccessPak for HIV PEO Expanded with Kaletra
- Access Pak for HIV PEP Expanded with Kaletra
Studies have shown that prolonged use of TDF drugs can cause a decrease in bone mineral density (resulting in osteoporosis, broken bones, etc.) Additionally, TDF drugs may be associated with a decline in kidney functioning.
Specific health risks include:
- Bone fractures
- Chronic kidney disease
- Renal failure
- Fanconi syndrome
- Tubular dysfunction
Patients who have experienced kidney problems of osteoporosis/bone density problems since using Truvada or other TDF drugs may want to explore their legal options. There are lawsuits being filed across the country against Gilead Science, alleging that the pharmaceutical company did not adequately warn patients that these debilitating medical complications are linked to their products. Furthermore, the pharmaceutical company may have delayed the release of safer drugs to protect its patents and profit margins.
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Pharmaceutical companies have a legal obligation to disclose any known or potential health risks associated with their products. Contact the Louisville dangerous drugs lawyer at Brett H. Oppenheimer, PLLC if you or a loved one has suffered harm due to the actions of a negligent pharmaceutical company. Attorney Brett Oppenheimer can help you determine if your case warrants investigation, free of charge. Brett has successfully taken on the powerful pharmaceutical industry in other product liability cases and can use this experience to your advantage.