Truvada has been found to cause a decrease in bone density resulting in osteoporosis, brittle bones, and broken bones. Critics say the drugmaker, Gilead, withheld a safer version of the Truvada to maximize profits, causing patients to suffer from Truvada broken bones for an extra decade. Attorneys handling Truvada osteoporosis lawsuits believe persons and the family members of persons who have suffered from Truvada bone problems may be eligible for significant compensation. This page provides a comprehensive look at Truvada bone problems and other side effects of Truvada.
Truvada (tenofovir or TDF), first approved in 2001, is considered a front-line drug for HIV positive patients. An integral component in HAART (highly active antiretroviral therapy), tenofovir is used by more than 600,000 Americans and 9 million more patients worldwide. Tenofovir drugs fall in the nucleoside reverse transcriptase inhibitor (NRTI) class and include Truvada, Viread, Stribild, Atripla, Symfi Lo, AccessPak for HIV PEP Expanded with Kaletra, AccessPak for HIV PEP Expanded with Viracept, Complera, Cimduo, and Genvoya. As the most prescribed HIV drug on the world, tenofovir sales exceed $11 billion annually; Truvada was the most prescribed of these drugs.
Truvada osteoporosis is a risk faced by anyone who has taken Truvada or another tenofovir drug. The skeletal system is made of more than 200 bones and provides essential support, stability, and protection to the entire body and its vital organs. Osteoporosis is a disease that affects the entire system, causing a weakening in the bones that results in fragility and frequent fractures -- particularly in the wrists, spine, and hips. Osteoporosis is essentially when bone degradation is occurring more rapidly than bone regeneration, resulting in lower overall bone mineral density. This condition occurs naturally with age but is markedly accelerated in patients taking Truvada.
Loss of bone mineral density is known as a typical side effect of HIV, but tenofovir drugs such as Truvada have been found to accelerate the problem. A significant study analyzed rates of bone problems in patients taking Truvada and a host of other common HIV drugs, finding patients who had ever taken Truvada had a significantly higher risk of fracture than their counterparts who had never taken Truvada or a similar tenofovir drug. The research showed that bone mineral density (BMD) declines by 2-6% in the first two years of Truvada treatment.
Truvada bone problems can be detected through a bone mineral density test, which measures the strength of bones through a simple and noninvasive procedure. However, in most cases Truvada osteoporosis is detected when a patient breaks a bone or suffers a fragility fracture from Truvada.
On at least three occasions, Gilead Scientific has received a FDA Truvada warning letter for downplaying the risk of osteoporosis and broken bones from Truvada:
First, on March 14, 2002, the FDA chastised the drugmaker when its representatives were observed making false and misleading statements. The sales representatives stated the drug had "no toxicities", was "extremely safe", "extremely well-tolerated", and a "miracle drug" - making no mention of Truvada bone problems. In fact, Truvada bone fractures risks were well documented and included on the warning label.
The company received another FDA Truvada warning letter on July 29, 2003, essentially citing recurrence of the same problem: sales representatives were downplaying Truvada bone risks and promoting the drug for a broader-than-approved indication or use.
On June 27, 2014, a third Truvada FDA warning was issued, this time requiring the drug maker to remove a sponsored link that omitted Truvada bone warning information. In each of these cases, the company was chastised for omitting Truvada osteoporosis warning information and for making false claims about the uses or effectiveness of the drug.
A 2017 study compared patient outcomes for Truvada ad Viread (TDF) and a new tenofovir drug (tenofovir alafenamide or TAF) and concluded that taking Truvada is accompanied by a higher risk for decreased bone mineral density, putting patients at risk for osteoporosis and bone fractures. In comparison, the newer drug, which has higher absorption rates and is thus prescribed in lower doses, does not cause osteoporosis and is generally believed to be safer.
TAF was first tested in the early 2000s and showed promising results. However, Gilead executives made a decision to halt clinical test of the drug. Critics say this safer version of Truvada sat on a shelf until 2010, and was dusted off just in time to be approved in 2016, before the Truvada patent expired in 2018. By delaying the development and release of TAF, the drug company extended its global dominance of the tenofovir market -- and caused patients to suffer serious Truvada bone side effects for a decade longer. In 2016, the AIDS Healthcare Foundation filed a Truvada lawsuit against Gilead for "blocking affordable access to a lifesaving HIV drug".
When TAF was finally released, it became available only in concert with other drugs and not as a stand-alone -- which critics again say was a strategic move to protect Gilead's multi-billion dollar annual earnings for tenofovir.The new version of the drug would not have been deemed unique enough to warrant a new patent on its own, which would have enabled other companies to offer generic versions much sooner. As it stands, Gilead has a patent on TAF products such as Genvoya, Odefsey, and Descovy through 2032.
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