FDA Action Regarding TDF HIV Drugs

HIV Litigation Attorneys™ are concerned that patients taking TDF drugs to treat or prevent HIV may not have received adequate warnings of certain health risks. The TDF-based antiretroviral medications, particularly Truvada, have been the subject of lawsuits filed by plaintiffs who allege serious complications including bone density loss and kidney damage.

Personal injury actions filed in courts across the country raise allegations of failure to warn, design defect, strict product liability, and breach of warranty. According to the lawsuits, TDF drug maker Gilead knew as far back as 2001 that their HIV drugs were “highly toxic in the doses prescribed,” with risks of “permanent and possibly fatal damage to the kidneys and bones.”

Despite the growing litigation, the FDA remains silent on the matter, forcing patients to conduct their own research and seek justice through the court system. 

When Did Truvada Receive FDA Approval?

The timeline of Truvada FDA approval spans more than 15 years:

  • Gilead first submitted applications for fixed dose coformulation of Viread and Emtriva on March 15, 2004.
  • The FDA granted priority review on May 17, 2004.
  • The FDA approves Truvada as treatment for HIV-1 infection in adults on August 2, 2004.
  • On July 16th, 2012, the FDA approved Truvada for reducing the risk of sexually-acquired HIV infection in adults.
  • On May 15, 2018, the FDA expands approval for reducing the risk of HIV infection in adolescents.

When the FDA approved Truvada for prophylactic use in 2012, the drug was the first of its kind, used in HIV prevention.

Are There Any FDA Warnings on the Truvada Package Insert?

The original Truvada package insert warned patients that users have reported “lactic acidosis and severe hepatomegaly with steatosis, including fatal cases” with the use of nucleoside analogs alone or in combination with other antiretrovirals. Furthermore, Truvada is not approved for the treatment of chronic Hepatitis B, the insert adds. Users discontinuing Emtriva or Viread have experienced “severe, acute exacerbations of Hepatitis B.” Hepatic function monitoring for several months for Hepatitis-B patients discontinuing Truvada use.

Doctors are cautioned against prescribing Truvada alongside other drugs like Emtriva, Viread, Combivir, Epivir, Epivir-HBV, Epzicom, or Trizivir in order to avoid causing immune system disorders, lactic acidosis, dyspnea, abdominal pain, pancreatitis, renal disorders, and urinary issues. The insert acknowledges that the long-term effects are unknown.

Under “possible side effects,” patients may experience: fat redistribution, immune reconstitution syndrome, lactic acidosis, serious liver problems (hepatoxicity), flare-ups of Hepatitis B, kidney problems, and changes in bone density.

Though certain bone and kidney-related issues are mentioned in the insert, the seriousness of the side effects are understated and somewhat vague. “Bone monitoring should be considered for patients who have a history of pathologic bone fracture or are at risk for osteopenia.” They suggest Vitamin D supplementation and calcium “may be beneficial for all patients,” though it hadn’t been studied. Bone mineral density “may” need to be checked or monitored, along with regular blood tests to check kidney function. 

In 2012, when the FDA expanded the use of Truvada for preventative measures, the boxed warning was expanded to alert health care professionals that PrEP use of Truvada is only for “individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use.” The FDA strongly recommends against using Truvada preventatively in patients “with unknown or positive HIV status.” No new side effects were added – the usual diarrhea, nausea, abdominal pain, headache, and weight loss appeared on the insert. Serious adverse events related to kidney or bone toxicity were “uncommon.”

No FDA Recall of  HIV Drugs

To date, there have been NO safety recalls on FDA-approved HIV medicines. However, the number of adverse events reported to the FDA continue to increase. Patients filed 1,167 complaints in the FDA Adverse Event Reporting System in 2018. All told, Truvada users reported more than 9,000 adverse events since 2005, including 7,575 “serious” cases and 657 deaths. Many of those reports were related to maternity and fetal risks, but acute kidney injury was reported by 453 patients and Fanconi Syndrome by 111. Another 119 patients reported osteonecrosis and 58 patients reported osteopenia. Of course, the FDA database does not include the total number of affected individuals – just the ones who took the time to report.  

To date, there have been NO safety recalls on FDA-approved HIV medicines. However, the number of adverse events reported to the FDA continue to increase. Patients filed 1,167 complaints in the FDA Adverse Event Reporting System in 2018. All told, Truvada users reported more than 9,000 adverse events since 2005, including 7,575 “serious” cases and 657 deaths. Many of those reports were related to maternity and fetal risks, but acute kidney injury was reported by 453 patients and Fanconi Syndrome by 111. Another 119 patients reported osteonecrosis and 58 patients reported osteopenia. Of course, the FDA database does not include the total number of affected individuals – just the ones who took the time to report.  

What do FDA Warnings Mean for Dangerous Drug Lawsuits?

Sometimes we never see an FDA warning regarding a dangerous drug. While FDA safety communications, black box warnings, recalls, and other actions are helpful to a lawsuit, they are not necessary. An expert legal team works hard to uncover internal documents and test data that reveal knowledge of the drug’s flaws. We work with expert scientists and medical professionals to build our case. Independently conducted research can be used to prove a drug’s inherent dangers. 

Sometimes we never see an FDA warning regarding a dangerous drug. While FDA safety communications, black box warnings, recalls, and other actions are helpful to a lawsuit, they are not necessary. An expert legal team works hard to uncover internal documents and test data that reveal knowledge of the drug’s flaws. We work with expert scientists and medical professionals to build our case. Independently conducted research can be used to prove a drug’s inherent dangers. 

Contact HIV Litigation Attorneys™

If you or a loved one suffered serious bone or kidney injuries as a result of TDF HIV medication, contact HIV Litigation Attorneys™ to connect with experienced attorneys who are already investigating the case. We are filing lawsuits on behalf of plaintiffs nationwide.

With support and resources from the AIDS Healthcare Foundation, our trailblazing firm was the first to file legal action against Gilead for their defective HIV drugs. We provide you with the best possible representation, without charging you a penny until we win compensation on your behalf. You may be eligible to receive compensation for past, present, and future medical bills; lost wages and lost earning capacity; as well as pain and suffering. Contact us for a free evaluation of your potential claim.

Additional Resources:

  1. U.S. Food & Drug Administration – Truvada Label Insert, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021752s000_Truvada_Prntlbl.pdf
  2. MD Magazine – FDA Expands Indication for Truvada to Lower Risk of HIV in Adolescents, https://www.mdmag.com/medical-news/fda-approves-expanded-indication-for-truvada-to-lower-risk-of-hiv-in-adolescents
  3. Forbes – Gilead Said PrEP To Prevent HIV Was Not A Commercial Opportunity; Not It’s Running Ads For It, https://www.forbes.com/sites/michelatindera/2018/08/07/gilead-said-prep-to-prevent-hiv-was-not-a-commercial-opportunity-now-its-running-ads-for-it/#4452735d781b
  4. FDA Adverse Events Reporting System – Truvada, https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/45beeb74-30ab-46be-8267-5756582633b4/state/analysis
  5. AIDS Info – FDA-Approved HIV Medicines, https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/19/58/fda-approved-hiv-medicines