Truvada FDA Actions

Truvada FDA History

Truvada FDA history is complicated. Though the boxed warning was expanded in 2012 and the FDA’s adverse event database has received more than 11,000 complaints, there has been no recall of the popular HIV drug.

If you or a loved one have suffered serious side effects of Truvada, such as bone loss or kidney damage, you do not have to wait for the U.S. Food and Drug Administration, to take action. You may be eligible to file a Truvada lawsuit with the help of the attorneys of Rutter Mills, even if there has been no recall issued.

A Brief FDA History of Truvada

Gilead’s Truvada has been on the market for more than 15 years.

• The FDA granted priority review on May 17, 2004.
• The FDA approved Truvada for the treatment of HIV-1 infection in adults on August 2, 2004.
• Eight years later, on July 16, 2012, the FDA approved the use of Truvada for PrEP– the prevention of HIV infection in adults. Though there is another option for PrEP now, Truvada was the first of its kind.
• On May 15, 2018, the FDA allowed Truvada use for reducing the risk of HIV infection in adolescents.

FDA Receives Thousands of Truvada Side Effect Reports

Only about 1 percent of all adverse medical events are reported to the Food and Drug Administration Adverse Event Reporting System (FAERS), according to findings from the Institute for Safe Medicine Practices. So you can imagine the scope of the problem when you realize that the FDA database has received more than 11,000 complaints. It should be noted that some of these numbers may be overlapping, with a case containing more than one complaint. However, the sheer volume suggests unaddressed issues.

Though pain, anxiety, and fetal injury are the most commonly reported problems, there have also been:

• 76 cases of end-stage renal failure
• 122 cases of acquired Fanconi Syndrome
• 221 cases of renal impairment
• 366 cases of chronic kidney disease
• 497 instances of acute kidney injury and
• 503 reports of renal failure.

Furthermore, there has been:

• 46 fractures
• 76 reports of bone loss
• 142 cases of osteopenia (bone pain and weakness)
• 436 osteoporosis (bone density loss)

Bone loss and kidney damage continue to be the adverse events leading to Truvada lawsuits, as these potential risks were not listed anywhere on the original FDA warning label.

FDA Warnings

When it was first approved, Truvada came with a black box warning that users have reported “lactic acidosis and severe hepatomegaly with steatosis, including fatal cases” when using nucleoside analogs alone or in combination with other antiretrovirals. This warning was removed from the boxed section and placed in a general warnings section in April 2017.

The most modern Truvada package insert emphasizes in a boxed warning that Truvada is not approved for the treatment of chronic hepatitis B. “Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and HBV who have discontinued TRUVADA,” the label states. Therefore, hepatic function should be closely monitored in HBV-infected patients discontinuing the drug. Patients who wish to use Truvada for PrEP must be confirmed HIV-negative prior to treatment.

Drug interactions include didanosine, which may produce pancreatitis or neuropathy when co-administered, and HIV-1 protease inhibitors, which can cause tenofovir toxicity.

Adverse reactions affecting greater than 10% of users include abnormal dreams, depression, diarrhea, dizziness, fatigue, headache, insomnia, nausea, and rash. When used for PrEP, headache, abdominal pain, and weight decreases have been reported.

Under “warnings and precautions,” we now see notice of:

• “New onset or worsening renal impairment”– which may include acute renal failure and Fanconi syndrome. Gilead recommends additional testing before starting patients at risk for renal dysfunction on the drug and avoiding the co-administration of Truvada with nephrotoxic drugs.

• “Decreases in bone mineral density”– for which Gilead urges doctors to “consider assessment of BMD in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss.”

These warnings were even vaguer when the label insert was first FDA-approved in 2004. The information had been buried in the “precautions” section, simply stating that “the clinical significance of the changes in BMD and biochemical markers is unknown,” with “follow-up continuing to assess long-term impact.” Doctors may consider bone monitoring in “patients with a history of fractures” and possible “supplementation with calcium and vitamin D,” though it has not been studied.

In 2004, renal impairment was listed more prominently as a “warning,” but Gilead merely suggested that the dosing interval be adjusted in patients with creatinine clearance between 30 and 49 mL/min. Truvada should not be administered to patients with creatine clearance below 30 or to patients who require hemodialysis. “Some” cases of Fanconi Syndrome occurred in patients with no underlying risk factors, but Gilead claimed the majority of kidney injuries occurred in patients with underlying renal disease or who were taking other nephrotoxic drugs.

Did the warnings go far enough? Attorneys for injured patients say, “no.” Worse yet, is the evidence supporting Gilead’s suppression of a less-toxic, lower-dose drug until Truvada’s patent expired. How many patients were hurt over the years due to Gilead’s greed for profit and market control are unimaginable.

No FDA Recall for Truvada

To date, the FDA has issued no Truvada Recall, nor has the company initiated a voluntary recall of their own. Often, we never see FDA warnings or recalls of dangerous drugs. Though these market removals and safety communications can be helpful to a case, they are not necessary to pursue litigation against manufacturers.

An experienced and sophisticated legal team can obtain internal documents, test data, scientific reviews, and independent expert testimony to assist with your claim to compensation for injury. Contact Rutter Mills for your free Truvada case review.