HIV Medication
Gilead Sciences Inc., the American biotechnology company behind TDF drugs like Viread, Truvada, Atripla, Complera, and Stribild, is facing strong legal challenges. Court documents reveal that the FDA issued two warning letters related to Gilead’s marketing practices concerning TDF drugs in 2002 and 2003. The first letter called out the company for off-label marketing of Viread, promoting its use in patients with Hepatitis B co-infection, which lacked FDA approval, and as a first-line treatment for HIV before FDA approval was granted in late 2003.
Plaintiffs argue that Gilead misled doctors by claiming the drugs were “benign,” “extremely safe,” and devoid of toxicities. The FDA demanded an immediate halt to such communications. The second FDA letter required the retraining of sales professionals to provide more accurate safety information and raised concerns about unsubstantiated comparison statements and the omission of significant safety issues in Gilead’s marketing materials.
A class action lawsuit was filed in the Superior Court of Los Angeles County on behalf of California residents who suffered bone density loss or kidney damage and could have benefited from alternative drugs on the market. Claimants involved in the class action would receive a portion of a larger settlement sum. Additionally, individual lawsuits have been filed against Gilead, including one involving a middle-aged man who experienced significant bone density loss.
These cases may be consolidated into Multi-District Litigation (MDL) to streamline the early proceedings, with a petition for California State Coordination already filed. Furthermore, three early cases have been consolidated for pre-trial motions in the Northern District of California. Gilead’s motion to dismiss has been denied, indicating a promising outlook for plaintiffs seeking compensation.
Side Effects
Tenofovir, also known as TDF, is associated with several common side effects such as mild nausea, diarrhea, loss of appetite, headache, and occasional dizziness. However, it is the more severe side effects that have sparked concern, as evidenced by over 25,000 adverse event reports filed with the FDA by tenofovir users. Clinical studies have revealed that tenofovir use can lead to a gradual increase in bone loss, averaging 1-2% per year. In some instances, patients on HIV drugs, including tenofovir, experienced bone loss of up to 6% within the first two years of treatment.
Another serious side effect associated with TDF is acute kidney injury or acute renal failure. This condition occurs when waste products accumulate in the blood, disturbing the body’s fluid balance and necessitating immediate emergency care to prevent permanent kidney damage. Even after discontinuing TDF treatment, the effects on kidney function can persist for a year or longer.
These significant side effects reported by tenofovir users highlight the potential dangers associated with the use of TDF drugs, necessitating careful monitoring and timely medical intervention to mitigate the risks.
Contact GDS Law Group for a free consultation to determine your specific eligibility and legal options if you have been injured by use of the HIV drugs listed above.
