In April of 2019, the Food and Drug Administration (FDA) approved its first HIV-related drug of the year. Marketed as Dovato, it is the first approved combination of dolutegravir and lamivudine. Both of these drugs have been commonly prescribed to HIV patients, but the combination of the two has not been thoroughly tested. Despite its FDA approval, Dovato has drawn some skepticism from doctors and medical experts. It is not the only HIV medication that has raised questions, however.
Another popular HIV medication, Truvada, has seen some additional warnings required by the FDA since its initial release. Despite these changes and the reported problems that brought them about, the FDA has done little to address the issues with this drug.
Showard Law Firm has begun its own investigation into these HIV drugs. Our skilled team has received reports of bone loss and kidney disease linked to Truvada and other TDF-based HIV meds. We are working diligently to establish if Big Pharma has put HIV patients at risk. A successful HIV medications lawsuit could result in significant financial compensation for a patient’s medical injuries. This compensation could include money to cover medical bills, pain and suffering, and emotional trauma. If you believe you have a claim related to HIV medication injuries, contact us immediately to schedule your free, no-obligation consultation.
FDA-Approved HIV Drugs
The FDA has steadily approved drugs designed to combat HIV since the late 1980s. Since that time, the options for HIV patients has only grown. In the early years, doctors began prescribing a number of medications to combat the spread of HIV. However, in recent years, pharmaceutical companies have focused on combinations of these medications. Today, the most commonly prescribed HIV medications include Truvada, Stribild, Viread, and Complera. A new drug known as Dovato has also been recently approved.
Truvada is an HIV medication manufactured by Gilead Sciences. This drug consists of a mixture of emtricitabine and tenofovir disoproxil fumarate, or TDF. TDF antiretroviral drugs are a common form of treating HIV. However, they also have been linked to cases of kidney and bone damage. TDF drugs are an important part of Gilead’s portfolio. In 2018, the drug maker earned $3 billion from Truvada alone.
Truvada FDA Approval
Truvada was first approved by the FDA in 2004 for treatment of HIV and again in 2012 for use as an HIV pre-exposure prophylaxis (PrEP). In 2018, the FDA expanded the allowed use of the drug again. This time, the regulator accepted the use of Truvada to reduce the risk of HIV among adolescents.
FDA Warnings About Truvada
The original insert warning informed users that cases of lactic acidosis and severe hepatomegaly with steatosis had been reported. In some cases, the use of Truvada had fatal consequences during testing. The warning also cautions users of the possibility of side effects, including:
- Fat redistribution
- Immune reconstitution syndrome
- Lactic acidosis
- Flare-ups of Hepatitis B
- Changes in bone density, and
- Kidney problems
The warnings included in Truvada’s packaging were expanded by the FDA in 2012. This was due to the drug’s approval for the use as a PrEP drug. The new warning informed consumers that Truvada for PrEP was only intended for patients confirmed to be HIV-negative. The warning also suggests additional testing every three months. The FDA issued a strong warning against the use of PrEP for anyone that is HIV positive or unsure of their status.
Released in early 2019, Dovato is the first two-drug complete regimen ever accepted by the FDA. Dovato contains dolutegravir and lamivudine, two drugs that have previously been used to treat HIV. The use of the drug is limited to patients who have never used antiretroviral treatments. It is also ineffective for anyone with a known resistance to either dolutegravir or lamivudine. Some doctors have voiced their skepticism about the drug given issues with resistance to the medication. There are additional concerns that the drug was approved despite the lack of long-term testing.
FDA Recall of TDF Drugs
Despite the serious medical issues linked to the use of Truvada and other HIV medications that contain TDF, the FDA has remained silent. To date, the regulator has declined to issue any form of recall or make a public statement. However, behind the scenes, the FDA has required some label changes to Truvada. Additionally, as discussed above, certain warnings have always been present on the Truvada package insert.
Contact Showard Law Firm
The research on the complications related to HIV medications is ongoing. However, given the reports of bone and kidney damage due to the use of TDF, our experienced HIV medications team is prepared to hold the pharmaceutical companies accountable. If you believe you have been injured by Truvada, Dovato, or other HIV medications, contact Showard Law Firm right away.
- FDA encourages additional Truvada research. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-continues-encourage-ongoing-education-about-benefits-and-risks-associated-prep
- National Institute of Health. https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/58/fda-approved-hiv-medicines