The approval process for a new medicine is far from simple. On average, it takes 12 years and $350 million to move a new drug from the laboratory to the pharmacy.
Once a company develops a pharmaceutical, it undergoes approximately three and a half years of laboratory testing before an application is made to the U.S. Food and Drug Association (FDA) to begin human testing—and only 0.001 percent of the compounds pass the test.
Even though the FDA holds drug manufacturers to such rigorous testing and high standards, there could still be dangerous side effects and other risks. A $1.8 million report, created in 2006 by the Institute of Medicine, found significant deficiencies in the current FDA system for ensuring the safety of drugs on the American market.
The law requires manufacturers to disclose any known issues or severe symptoms that could come from taking their medicine. And while most drugs are safe and effective, some are not.
Each year, thousands of people are injured and die because of a defective drug or adverse side effects. In recent years, medicines like Onglyza, Invokana, and Taxotere have been added to the “dangerous” list.
- Onglyza is manufactured by Astro-Zeneca and is used to treat Type 2 Diabetes. It’s alleged to result in an unsafe cardiovascular risk, including heart failure, congestive heart failure, cardiac failure, and death from heart failure complications.
- Invokana is manufactured by Janssen Pharmaceuticals, Inc. and is another Type 2 Diabetes drug. Supposedly, the manufacturer failed to adequately warn users of diabetic ketoacidosis and other acute kidney damage, which can lead to death as well as leg and foot amputations.
- Taxotere is a chemotherapy drug used to treat breast cancer, manufactured by Sanofi, and has reportedly caused Alopecia (permanent hair loss) in users. The manufacturer failed to tell patients that their hair may not grow back.
Foley & Small is now accepting and litigating cases on behalf of clients who have suffered injuries or illness as a result of defective drugs. To learn more, call 574-288-7676, or visit them online at www.foleyandsmall.com.