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An Indiana dangerous drug attorney can help individuals who have been harmed by dangerous medications. The drugs that doctors prescribe often undergo exhaustive approval processes by the U.S. Food and Drug Administration (FDA) to ensure that they are as safe as possible for consumers. However, many approved drugs later turn out to cause problems that were previously not apparent or that went unreported. Patients who have been harmed by dangerous drugs may be eligible to seek compensation for their injuries with the assistance of an Indiana bad drug attorney.
Drug Approval Process
The drug approval process in the United States consists of the FDA, through its Center for Drug Evaluation and Research, and documentation from clinical trials. The company developing the drug typically performs tests on animal subjects first, and then moves on to human subjects. Once initial trials have been conducted by pharmaceutical companies, professionals, such as chemists and physicians, working under the purview of the CDER, perform reviews of clinical trial results. They identify effective and ineffective drugs alike, and they also identify the best ways for consumers to take medication. This is accomplished by analyzing possible side effects and conditions that consumers may have, which makes taking a particular drug unwise. If the CDER team decides that the disadvantages of a drug do not counteract its benefits, the drug will most likely be cleared for use.
Potential Problems with Approving Drugs
The process of drug approval may be met with potential pitfalls. For example, the reaction of a person to a drug can change as time passes. Furthermore, people who take a drug may be on other drugs for a mix not studied (or not studied enough) in clinical trials. Also, while common side effects manifest themselves in clinical trials, the case may not be the same with unusual side effects.
The FDA uses a system called MedWatch for consumers to log reports of negative reactions to medications after their approval, but the process is voluntary. Many dangerous reactions can slip through the health care system. Once a reaction comes to light, however, the FDA may choose to add safety information to a drug’s warning label or even remove the drug from the market.
Withholding Negative Information
According to a Newsweek report, another potential problem may arise when drug companies hold back critical negative data, even sometimes with the knowledge of the FDA. This seems to have been the case with the flu drug Tamiflu, also called oseltamivir, which caused delirium in some consumers taking it. Suicide was the end result for some of these people.
Indiana Dangerous Drug Attorney
Many people and their families believe that they have felt the effects of drugs they did not realize were dangerous. For instance, in an October 2015 lawsuit filed against AstraZeneca over the diabetes drug Onglyza, the plaintiff said that the drug led to her mother’s death. Information had recently come to light showing that Onglyza could be linked to an increased risk of heart problems in people who take it. The FDA voted to strengthen the drug’s safety label.
Another diabetes drug, Invokana, has been the focus of lawsuits, including class-action lawsuits, in both the United States and Canada. Some plaintiffs allege that Janssen Pharmaceuticals, part of Johnson & Johnson, knew about the possibility of bad reactions but failed to adequately warn people such as doctors and the public.
In any case, potentially dangerous drugs can cross many companies and treat many conditions. Consumers and doctors can do a lot of research before taking or prescribing a drug, but if a company has withheld important information or if a side effect appears later, a huge part of the picture is missing.
How an Indiana Dangerous Drug Attorney Can Help
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by bad drugs may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.