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.
OZEMPIC - 10,000 FDA Adverse Reports
New lawsuits are being filed against compounded versions of Ozempic and Wegovy. As demand skyrockets for drugs that are throught to cause significant weight loss, unauthorized versions of the treatments have started to fill pharmacies, and consumers are reporting serios side effects.
The exact number of people currently using Ozempic for diet purposes is unknown. However, Ozempic (generic name semaglutide) is a medication primarily prescribed for managing type 2 diabetes, but it is also used "off-label" for weight management. Ozempic popularity has been growing due to claimed potential benefits in reducing appetite and promoting weight loss. To get accurate and up-to-date information, please consult your medical provider.
US Food & Drug Administration (FDA) "Adverse Event Reports" About Ozempic
Over 10,000 FDA "adverse events" have been reported to U.S. FDA Adverse Reporting System (FAERS) regarding Ozempic, Rybelsus, and Wegovy. Many of the adverse reports have been coded as serious adverse events. A question exists whether Ozempic manufacturer Novo Nordisk knew about the health risks associated with Ozempic, and if doctors were warned to inform patients of any known Ozempic risk.
Lawsuits will likely determine if Ozempic tests disclosed all of the drug's potential risks. Also, lawsuits will likely determine if the Ozempic drug manufacturer failed to provide all of their evidence and data to the FDA, or failed to disclose all adverse events or any study protocol violations.
- OZEMPIC SIDE EFFECTS
Studies may link Ozempic to health problems inclduing gallbladder diseases, such as cholelithiasis (known as gallstones) and cholecystitis (known as inflammation of the gallbladder).
Side effects associated with gallstones include:
If you used OZEMPIC and suffer side effects, promptly consult you doctor.
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If you have had serious complications 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!