Every year, drug companies introduce new life-saving medications to the market. In fact, a study by Health Affairs reported that prescription drugs accounted for $328.6 billion of national health-related spending in the United States in 2016. According to the Centers for Disease Control and Prevention (CDC), within any given 30 day period, over 45% of the US population used prescription drugs. Despite new drugs going through a rigorous Food & Drug Administration (FDA) approval process, serious side effects may go undetected in clinical trials. In fact, many FDA-approved drugs have been linked with serious medical complications. Off-label uses prescribed by physicians can also result in dangerous consequences.
Patients might think that the US FDA's stamp of approval means that a product is completely safe, but almost a third of drugs approved by the FDA between 2001 and 2010 have been involved in some kind of safety event after reaching the market. They key message with all new drugs and technology is that there is an ongoing learning process that will continue through the lifetime of the drug. When drugs are used in real-world circumstances in a wider patient population, problems can happen.
Drugs are tested only in a limited number of studies before being approved for the market. As a result, it is critical for patients and physicians to report medication adverse events to the FDA as soon as they occur. In 2018, a 9-year research study of the United States FDA Adverse Events Reporting System database showed 902,323 severe events were reported to the FDA, including 244,408 fatalities and 72,141 disabilities. It is evident that pharmaceutical medications cause hundreds of thousands of fatalities and millions of hospitalizations each year.
What is a drug?
The FDA defines the term “drug” as a substance:
- Recognized by an official pharmacopoeia or formulary
- Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
- Intended to affect the structure or any function of the body (other than food)
- Intended for use as a component of a medicine but not a device or a component, part or accessory of a device
How are drugs approved?
In order to be approved by the FDA, pharmaceutical companies must undertake certain laboratory, animal, and clinical testing to evaluate how new drugs function and if they are safe for human use. A team of doctors, chemists, and other scientists from the FDA's Center for Drug Evaluation and Research (CDER) examine the evidence from these restricted experiments. If the team find that the test results demonstrate a level of safety and a measurable health benefit, the FDA may approve the drug. In rare circumstances, the FDA may approve a drug on the condition that additional postmarketing testing is undertaken.
Potential risks posed by medications
Sometimes the initial tests might not disclose all of a new drug's potential risks. Furthermore, in some circumstances, drug manufacturers fail to provide all their evidence, submit erroneous or fabricated data, fail to disclose adverse events or other study protocol violations or fail to protect the safety of clinical trial patients. Drug manufacturers may also not communicate the risks of a drug to the public, even if the FDA discovers a problem at a clinical trial site during an inspection or after a medical journal publishes the results of a clinical trial.
Adverse effects of medicines have spawned thousands of lawsuits in recent years.
Belviq is a prescription medication that was approved for weight management when used with increased physical activity and a low caloric diet. Its extended-release formulation was approved as Belviq XR. Both are prescription medications. Belviq was approved by the FDA in mid-2012 and Belviq XR in mid-2016.
Belviq was intended to be used as a 'satiety promoter' - to help patients feel less hungry. However, both Belviq and Belviq XR have been removed from the market in the United States due to patients facing an increased risk of developing certain forms of cancer. It is thought to increase your risk of lung cancer, pancreatic cancer and colorectal cancer.
Taking Belviq and Belviq XR can also cause a number of additional serious side effects, including the following:
- Vulvar heart disease
- Cognitive impairment
- Psychiatric disorders
- Hypoglycemia in those with diabetes
- Seratonin syndrome
The most commonly reported side effects from Belviq and Belviq XR include:
- Dry cough
- Back pain
The FDA has advised patients to stop taking Belviq and talk to their health care professionals about other possible weight-loss drugs and weight-management programs. The FDA further requested health care professionals to notify their patients currently taking the drug to inform them about the increased occurrence of cancer linked to this weight-loss medication demonstrated in the clinical trial.
Elmiron is approved by the FDA to help relieve bladder pain or discomfort in patients who have been diagnosed with interstitial cystitis. Interstitial cystitis is a chronic condition affecting the bladder and pelvis - affecting mostly women. Symptoms may include:
- Urinary urgency
- Frequent urination, often in small amounts
- Painful sexual intercourse
- Chronic pelvic pain
- Bladder pain or discomfort
However, recent studies have linked the use of Elmiron to a unique type of eye damage affecting the retina, which may lead to vision-threatening medication toxicity. This damage is described as a type of pigmentary maculopathy. Researchers have reported that the findings are "alarming for both physicians and patients, and highlight the importance of annual ophthalmic examinations for all patients." The vision-threatening pigmentary maculopathy identified is irreversible and vision loss of this nature is not recoverable. The symptoms of pigmentary maculopathy include:
- Blurred vision
- Metamorphopsia - a type of perceptual distortion
- Difficulty reading
Some people who have taken Elmiron in the past are now reporting having problems with their vision. They may have been diagnosed with:
- Pigmentary maculopathy
- Retinal pigment epithelium atrophy
- Macular retinopathy
If you have taken Elmiron and developed vision problems, you may be entitled to compensation for your injuries.
In 2019, nearly 50,000 people in the United States died from opioid-involved overdoses. The misuse of and addiction to opioids is a serious national crisis that affects public health as well as social and economic welfare. To read more about this, please click here.
How we can help
If you have had serious complications or were hospitalised as a result of an adverse drug event, or if a family member died as a result of prescribed drug-related complications, you may be entitled to financial compensation for medical expenses, lost income, pain and suffering, and other costs incurred due to these devastating side effects. It is important to contact a qualified attorney with experience in defective drug claims in order to ensure you get the compensation you deserve. Our Los Angeles based law firm invites you to contact us for a free, confidential, no-obligation consultation to review your case!