The warning label on Truvada and other TDF drugs lists the side effects that can happen to people who take the medication. These include lactic acidosis, broken bones and osteoporosis, and kidney failure. However, Gilead Sciences, Inc., the company that makes these drugs, has repeatedly been reprimanded for marketing Truvada without mentioning these side effects. As a result, hundreds of TDF lawsuits have been filed against Gilead, seeking compensation for:
- Medical expenses,
- Pain and suffering,
- Professional losses like lost wages and reduced earning capacity, and
- Loss of consortium for the family members of the victim.
- 1. Truvada's warning label
- 2. Truvada's warning label downplays risks
- 2.1 Truvada's warning label for bone density problems
- 2.2 Truvada's warning label for kidney failure
- 3. Gilead marketing contradicts warning label
- 3.1 Statements at conference trivialize boxed warning
- 3.2 Gilead's marketing team make bold claims at an AIDS conference
- 3.3 Gilead website pushes TDF drug for unapproved use
- 4. Why Truvada's warning label is significant
1. Truvada's warning label
Truvada's warning label is what doctors look at before making a decision about whether to prescribe Truvada to a patient. The accuracy of the information on the warning label, therefore, is crucially important to the health of the people who may or who may not be prescribed Truvada.
As of May 2018, Truvada's warning label mentioned a handful of the drug's serious side effects, including1:
- Kidney problems,
- Renal failure,
- Fanconi syndrome,
- Decreases in bone mineral density, and
- Lactic acidosis.
The warning label also mentioned a list of Truvada's more common side effects, as well:
- Abnormal dreams,
- Abdominal pain, and
- Decreased weight.
2. Truvada's warning label downplays risks
Disputes have arisen about the accuracy of the information that is included on Truvada's warning label. Even though Gilead Sciences, Inc. fought to avoid mentioning kidney problems and bone density concerns on the warning label, there are signs that they did not go far enough with the label's language.
Almost as soon as Gilead first released its TDF-based HIV treatment drugs in 2001, medical studies and clinical trials began to note the number of people who suffered bone fractures and kidney problems.2 Connections were quickly made to the low absorption rate of TDF in the body, which strained and damaged the kidneys, and the high toxicity of TDF, which decreased a patient's bone density, sometimes to the point of osteoporosis.
However, the warning labels on TDF drugs like Truvada used language that downplayed the connection.
2.1 Truvada's warning label for bone density problems
To notify doctors of TDF's tendency to decrease a patient's bone density, warning labels merely suggested that doctors “consider assessment of bone material density” in patients with a history of broken bones or who had other risk factors.3
However, the decreases in bone density that appeared in clinical trials were not contained only to people with a predisposition for broken bones. Studies had found lowered bone densities across the board. This made the warning inadequate, as it led doctors to believe Truvada or a TDF drug would not pose a bone density risk to someone with average density measurements.
2.2 Truvada's warning label for kidney failure
The warning on TDF labels also mentioned the potential for kidney damage and renal failure. However, the only guidance the warnings provided doctors was to assess a patient's kidney function and monitor patients at risk for developing kidney issues.4
Just like with the warning label's language for bone density issues, this language for kidney problems also makes it seem as if the only people who can develop kidney problems are those who were already at risk before taking Truvada. Doctors reading the warning label on Truvada would be led to believe that patients with healthy kidneys were completely safe from the side effects of TDF.
3. Gilead marketing contradicts warning label
Gilead Sciences, Inc. has also marketed Truvada and other TDF drugs in ways that have ignored or even contradicted the risks that are already downplayed on their warning labels. Three instances of this marketing in particular have gone so far that the U.S. Food and Drug Administration (FDA) has had to reprimand the company.
3.1 Statements at conference trivialize boxed warning
The first incident occurred at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago in December, 2001.
At that point, the only TDF-based HIV drug that Gilead had on the market was Viread. On Viread's warning label was a prominent boxed warning detailing the risks for lactic acidosis that Viread could cause.5
However, Gilead officials at the conference claimed that the TDF-based drug was a “miracle drug” that was “extremely safe,” and had “no toxicities.” Other representatives for the pharmaceutical company went out of their way to downplay the boxed warning, claiming that it was “a ‘wait and see' warning” and insinuating that the boxed warning was only a formality – a “class effect” warning – required by the FDA. Yet another Gilead representative overstated the types of medical conditions that called for TDF treatment.6
After confirming these statements, the FDA issued a warning letter to Gilead on March 14, 2002.7 This letter demanded the company stop making such bold statements about the drug's efficacy and stop downplaying its risks.
3.2 Gilead's marketing team make bold claims at an AIDS conference
The second incident happened at the National HIV/AIDS Update Conference in Miami, in 2003, where there were more than 1,500 people in attendance, including HIV safety advocates who were sure to relay the information to countless others not in attendance.
In spite of the earlier warning letter from the FDA, a Gilead representative once again referred to the boxed warning about the potential for developing lactic acidosis in Viread as a “class effect warning” that applied to all nucleoside analogues, not just Viread. The representative also described the side effects of TDF drugs as “fewer” than other HIV treatments, and as “benign,” and did not mention the fact that Viread had to be taken with other antiretroviral drugs, not on its own.8
On July 29, 2003, the FDA again issued a warning letter to Gilead, demanding that they stop downplaying the risks of their TDF drugs.9
3.3 Gilead website pushes TDF drug for unapproved use
The third incident happened when the FDA Googled the TDF drug, Viread, to find Gilead had bought an advertisement for the drug in the results page. That advertisement referred to Viread as a “Hepatitis B Prevention” pill. However, the FDA's approved use of Viread was as a hepatitis B treatment, not as a prophylactic that could prevent someone from contracting the disease.10
On June 27, 2014, the FDA again issued a warning letter to Gilead, demanding they stop the illegal promotion of its TDF drugs for off-label use.
4. Why Truvada's warning label is significant
The inadequate warnings on the labels for Truvada and Gilead's other TDF drugs are significant because they could amount to a legal failure to warn doctors and patients of the risks of the drugs.
Pharmaceutical companies like Gilead have a legal obligation to disclose the risks of taking their drugs. The law recognizes this legal obligation because it understands how much doctors and patients rely on them. However, drug companies recognize that fully disclosing the risks of their products will likely deter patients from using them.
The inadequacy of the warning labels could prevent them from satisfying Gilead's legal requirements to warn people of the dangers of its TDF drugs, like Truvada. If a court decides that Gilead failed to uphold its duty to warn doctors and patients of these risks, Gilead could be held liable for the injuries that their nondisclosures caused.
Many Truvada lawsuits have claimed that this is just what has happened:
All of these lawsuits seek compensation from Gilead for compensation, including:
- Medical expenses,
- Lost wages,
- Reduced earning capacity,
- Physical pain,
- Mental and emotional suffering, and
- Loss of consortium for the victim's family.
In addition to compensatory damages, these lawsuits seek to punish Gilead for their conduct by demanding punitive damages.
See, e.g., Falcó V, et al., “Severe nucleoside-associated lactic acidosis in human immunodeficiency virus-infected patients: report of 12 cases and review of the literature,” Clinical Infectious Diseases 34(6):838-46 (March 15, 2002) and Gallant JE, et al., “Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial,” Journal of the American Medical Association 292(2):191-201 (July 14, 2004).
See note 3.
See note 6.
See note 8.