When the FDA approves a drug, it’s meant to signal thorough testing for safety and effectiveness. Yet, despite this rigorous evaluation, some approved medications end up causing serious harm to patients. This paradox reveals the difficulties in foreseeing long-term side effects.
It also underscores the necessity for ongoing monitoring after a drug hits the market. Even with extensive trials, unforeseen issues can arise once a drug is widely used. This highlights why continuous vigilance is crucial in pharmaceutical safety.
In this article, we’ll examine several high-profile cases where approved medications have resulted in significant adverse effects.
Tepezza-Associated Hearing Loss
Tepezza, a drug approved for treating thyroid eye disease, has been linked to serious hearing issues in some users. Although it works well for managing thyroid eye disease symptoms, there have been reports of side effects like hearing loss and tinnitus. For some patients, this can range from subtle changes in hearing to complete loss, which can significantly affect their day-to-day life.
The connection between Tepezza and hearing loss underscores the necessity for ongoing vigilance and risk assessment when using medications that affect sensory functions.
Drugs.com notes that Horizon Therapeutics made headlines in January 2020 with the FDA’s approval of Tepezza. This is because it was the first and only drug specifically for Thyroid Eye Disease (TED). This approval was based on the OPTIC study, which showcased impressive results. Tepezza led to an 82.9% improvement in proptosis, or eye bulging, compared to just 9.5% with a placebo.
Additionally, the drug met secondary endpoints, including notable improvements in diplopia, or double vision. This breakthrough offered a new treatment option for those struggling with TED.
A Look at the Tepezza Litigation
According to TorHoerman Law, some patients who have suffered hearing issues from Tepezza are now taking legal action against its manufacturer. The lawsuits claim that the company didn’t properly warn users about the risk of hearing loss linked to the drug. Many plaintiffs argue that the hearing problems have greatly affected their daily lives, causing both physical discomfort and emotional distress.
Drugwatch’s August 2024 updates highlight that there are 150 Tepezza cases active in multidistrict litigation (MDL). These lawsuits are still in the early stages, with no trials or court-approved settlements scheduled.
Plaintiffs sought in March 2023 that these cases be consolidated into an MDL, which was created in June 2023. This is an attempt to simplify the Tepezza hearing loss lawsuit and resolve the various claims linked to the medicine’s negative effects more effectively.
Accutane and Severe Birth Defects
Accutane, a potent therapy for severe acne, has been associated with catastrophic birth abnormalities when used by pregnant women. While it is quite successful in treating acne, the medication has a warning due to the severe danger to developing fetuses. Women who become pregnant while using Accutane have a greater risk of having babies with severe abnormalities, including major neurological and cardiac disorders.
This warning underscores the critical importance of avoiding pregnancy while on the medication. The drug’s potential to cause such devastating effects underscores the importance of ongoing risk assessments for patients on this medication.
NIH reports that every pregnancy has a baseline risk of 3-5% for birth defects, known as the background risk. However, when the medication Accutane is taken during pregnancy, the risk of birth defects can soar to 35% or more. Even a short-term use of the drug can increase the likelihood of having a baby with significant issues. Most infants affected by Accutane exposure may experience defects such as small or absent ears, along with problems with hearing and eyesight.
The Cardiovascular Risks of Vioxx
Vioxx, a popular painkiller used for osteoarthritis and other conditions, was once hailed for its effectiveness in managing pain. However, it was later found to be associated with increased risks of heart attacks and strokes. Despite its benefits for pain relief, evidence emerged showing that long-term use of Vioxx significantly raised the risk of serious cardiovascular events.
Nolo notes that after numerous legal actions from affected patients, the drug was pulled from the market in 2004. This case highlights the crucial need for ongoing safety evaluations and the potential consequences when risks outweigh the benefits. This underscores the need for comprehensive long-term safety studies and highlights the potential consequences of inadequate post-marketing surveillance.
FAQs
Is Tepezza’s hearing loss reversible?
Tepezza-related hearing loss is generally considered irreversible. Patients experiencing hearing issues from Tepezza often report persistent symptoms, including tinnitus and diminished hearing ability. Currently, there are no established treatments to fully reverse hearing loss caused by the drug.
What happens if you give birth on Accutane?
If a woman becomes pregnant while taking Accutane, there is a high risk of severe birth defects. These can include neurological and cardiac abnormalities in the baby. The drug has a strict black box warning, emphasizing the need for effective pregnancy prevention.
What was wrong with Vioxx?
Vioxx was found to significantly increase the risk of heart attacks and strokes, particularly with long-term use. Despite its effectiveness in pain management, this cardiovascular risk led to its withdrawal from the market in 2004. The drug’s safety concerns prompted numerous legal actions and regulatory scrutiny.
The FDA approval process, while thorough, can’t predict all future risks. Tepezza, Accutane, and Vioxx all highlight the need for ongoing monitoring and stricter risk assessments, especially for medications impacting sensitive areas.
These cases show the importance of patient vigilance in reporting side effects and holding drug manufacturers accountable for potential harm.
