Prolonged exposure to Truvada results in diminished bone mineral density, which can lead to fragility fractures and frequent broken bones. A safer version of Truvada, which could have prevented a decade of Truvada broken bones, was held back for financial reasons. Now persons and families who have suffered the ill effects of Truvada osteoporosis are seeking compensation through filing Truvada osteoporosis lawsuits against Gilead. This section offers a comprehensive look at Truvada broken bones and osteoporosis.
Truvada (which contains tenofovir and is also known as TDF), is an integral component of HAART (highly active antiretroviral therapy), which is a front-line antiretroviral treatment for more than 600,000 Americans and another 9 million people worldwide who are HIV positive. Approved by the FDA in 2001, Truvada is among the most popular in its class, nucleoside reverse transcriptase inhibitors. Others include Viread, Stribild, Atripla, Symfi Lo, AccessPak for HIV PEP Expanded with Kaletra, AccessPak for HIV PEP Expanded with Viracept, Complera, Cimduo, and Genvoya. Together, these comprise an $11 billion market in global sales; Truvada was the leader until its safer alternative was released.
Diminished bone mineral density is an expected side effect of HIV, but patients taking Truvada have a higher risk for developing osteoporosis and suffering from broken bones. A major study analyzed rates of osteoporosis from Truvada and compared it to many other common antiretroviral drugs. The results showed that taking Truvada significantly increases a patient’s risk for osteoporosis and broken bones. Truvada bone damage occurs in a short time: the study showed that bone mineral density (BMD) declines by 2-6% in the first two years a patient takes Truvada.
The human skeleton is comprised of over 200 bones which provide vital stability, support, and protection to bodily organs and systems. Throughout life, bone cells are constantly dying and regenerating. Generally, osteoporosis can be thought of as a disease whereby degradation of the skeleton occurs more rapidly that bone regeneration, leading to an overall reduction in bone mineral density. When this takes place, the bones become weaker and are susceptible to brittleness and fragility fractures — particularly in the wrists, spine, and hips. While osteoporosis is a normal side effect of aging, bone degeneration is markedly accelerated in patients taking Truvada. Developing osteoporosis from Truvada is a danger faced by anyone taking the drug or who has taken it in the past.
To determine whether Truvada bone damage has occurred, patients can undergo a simple, on-invasive bone density test. Monitoring bone mineral density is an important part of health for HIV positive patients, yet in many cases Truvada osteoporosis is not detected until a patient breaks a bone.
On three different occasions, an FDA Truvada warning letter has been issued to Gilead Scientific for false or misleading marketing practices.
FDA Truvada Warning 1: March 14, 2002. The first FDA Truvada warning cited examples of drug company representatives orally making false claims about the uses and safety Truvada, omitting any mention of the risk of Truvada osteoporosis and broken bones.
FDA Truvada Warning 2: July 29, 2003. Again, Gilead was called out for false and misleading promotion of Truvada when its representatives were observed saying the drug was not toxic and again failing to mention any warning of the danger of osteoporosis and bone fractures from Truvada.
FDA Truvada Warning 3: June 27, 2014. In this case, Gilead was ordered to remove a sponsored web link that failed to mention known Truvada side effects such as broken bones and early osteoporosis. The web link, which was removed in response to the third FDA Truvada warning, made false claims about the safety of Truvada.
Shortly after Truvada was released in the United States, Gilead Scientific initiated testing of a new tenofovir formula. Truvada, or TDF, was known from the beginning to be toxic to the kidneys and to cause osteoporosis, and the new formula, showed promise for being a safer alternative. Yet in 2004, Gilead officials inexplicably halted development of this promising substance for many years, resuming in 2010 and finally releasing the drug just years before the TDF patent expired. Critics say this was a strategic delay, designed to prolong Gilead’s market dominance of widely-used tenofovir drugs. Gilead’s delay of the safer compound (TAF) led to an extra decade of preventable bone fractures.
In 2016, the AIDS Healthcare Foundation filed a Truvada lawsuit against Gilead for ‘blocking affordable access to a lifesaving HIV drug.’ Others have asserted that Gilead’s release of TAF only in combination with other drugs used in HAART therapy (and never as a standalone drug) is a further injustice. 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. By releasing the safer compound only as a combination treatment, Gilead ensures its market dominance into the coming decades and limits the flexibility physicians have to choose the most effective treatment for their patients. As it stands, Gilead has a patent on TAF products such as Genvoya, Odefsey, and Descovy through 2032.
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The most effective means individuals have for holding a pharmaceutical company accountable for public safety is filing a lawsuit for harm done to your family. Filing a Truvada osteoporosis lawsuit can yield real compensation for medical expenses, suffering and loss. Contact us today for a free consultation.