TDF Drug Health Risks and Injuries
Health risks and injuries associated with Truvada and other TDF drugs are the subject of a growing number of product liability lawsuits across the country. Truvada - one in a group of HIV/AIDS medications containing a compound called tenofovir disoproxil fumarate, or TDF for short - is linked to serious, life-threatening side effects.
TDF-based medications (also sometimes used to treat hepatitis B) are very powerful, but also highly toxic. Unlike the later-released TAF-medications, TDF drugs are poorly-absorbed by the body, so must be taken at high doses to be effective. These high toxicity levels can result in serious complications in patients.
As noted by the U.S. Department of Health and Human Services, TDF medications, can cause:
- Lactic acidosis (buildup of lactic acid in the blood)
- Severe liver problems
- New or worsening kidney problems, including kidney failure
- Bone problems, including bone pain, softening or thinning, which can lead to fractures
Discontinuation of these medications is also associated with a condition called immune reconstitution inflammatory syndrome, or IRIS.
Florida Truvada injury lawyers know the basis of litigation against Gilead Sciences, Inc., the pharmaceutical company that manufactures both TDF and TAF drugs, is is that Gilead allegedly knew about these dangerous side effects, but downplayed them and mislead consumers. The U.S. Food and Drug Administration has warned the company against this numerous times over the years. Some plaintiffs further allege the company shelved development of safer alternative drugs containing a compound called tenofovir alafenamide (TAF) while running down the clock on TDF drug patents to maximize profits.
In addition to Truvada, TDF drugs manufactured by Gilead include:
Two generic TDF drugs, Symfi Lo and Cimduo, were released by drugmaker Myan in 2018, once Gilead’s patents expired.
Meanwhile, Gilead released several TAF drugs, including Descovy, Genvoya, Odefsey and Vemlidy.
Understanding the nature and severity of the health risks and injuries purportedly caused by these drugs is essential for anyone considering legal action against Gilead.TDF Drugs and Lactic Acidosis
Although lactic acidosis is listed as a possible side effect of Truvada and other TDF drugs, the assertion by plaintiffs in Truvada injury lawsuits is that drug makers have downplayed the risks.
Lactic acidosis is a condition caused by a buildup of lactic acid in the blood due to kidney failure. It’s relatively rare, but a known and serious side effect of TDF HIV/AIDS medications classified as nucleoside reverse transcriptase inhibitors (NRTIs).
It tends to build up gradually, with early signs including nausea, vomiting, weight loss and fatigue. These symptoms don’t seem severe, but once the condition takes hold, it can progress rapidly. Indications that the condition has become life-threatening include:
- Rapid breathing
- Above-normal heart rate
- Jaundice (yellowing of the skin and whites of the eyes)
As the DHHS’s AIDSInfo resource notes, “lactic acidosis is less likely to occur with newer NRTIs than with NRTIs used in the past.”
Medical studies very early on identified lactic acidosis as a potential side effect of TDF drugs like Truvada. For instance, in a 2004 clinical trial published in the Journal of the American Medical Association found little difference on a patient’s kidneys when comparing TDF drugs to a similar drug, stavudine (brand name Zerit), with which 8-21 percent of patients suffered hyperlactamia (the precursor to lactic acidosis) and 1-2 percent suffered full-blown lactic acidosis.
Despite the fact that lactic acidosis is contained in black box warnings (the most severe required by the FDA) for TDF drugs, Gilead was warned by federal regulators more than once to refrain from downplaying these risks.TDF Drugs and Other Kidney Ailments
Lactic acidosis is one kidney condition associated with TDF-based HIV/AIDS drugs like Truvada. However, numerous studies show these medications may also cause decreased kidney function, kidney damage and kidney failure (also known as renal failure).
These are among the most serious side effects associated with TDF medications. Severe damage to one’s kidneys may require regular kidney dialysis or a kidney transplant.TDF Drugs and Bone Loss
The risk of bone density loss - including osteoporosis - has been shown to rise sharply with the use of TDF-based NRTI HIV drugs. One study published in the Journal of Clinical Risk Management in 2010 revealed a strong correlation between loss of bone density among HIV-infected patients taking TDF medications. This was particularly true for young children and adolescents whose bones are still developing.
This can lead to an uptick in bone fractures, broken bones, broken/lost teeth, bone pain and weakness.
Although bone loss generally isn’t a fatal condition, the long-term increased risk of fractures can be very dangerous the older a patient gets.TDF Drugs and Liver Disease
There have been a few cases of reported liver failure among patients who have been prescribed TDF-based drugs, but typically while they were taking other medications.
In one 2016 study published in the journal AIDS, researchers concluded long-term use of TDF-based drug Viread was associated with an increased risk of end-stage liver disease and liver cancer among patients who had HIV.
If you have suffered any of these adverse effects of Truvada or other TDF-based drugs and would like more information about whether you may have a legal claim against Gilead Sciences Inc., our Fort Lauderdale product liability attorneys can help.
Contact Florida Truvada injury lawyers at The Ansara Law Firm by calling (954) 761-4011 or toll-free at (888) ANSARA-8.