Are FDA Approved Medications Safe?

Medications, personal injuryAccording to studies conducted by Yale University, as many as one in every three FDA approved medications may pose serious health and safety risks to users. The study highlights the fact that many of the drugs consumers consider safe may, in fact, have potentially devastating drug interactions and health risks that were not discovered prior to the drug’s approval for the market.

The FDA Approval Process

Any new drug that enters the US market is required to go through a multi-stage drug approval process. This process starts with drug development and testing which is followed by a detailed application for an Investigational New Drug (IND) is submitted to the FDA. If the IND is approved, the drug is put through a three-phase clinical trial drug testing process. Testing during these stages involves determining the drug’s effectiveness in treatment, the drug’s interactions with other drugs, as well as any side-effects and safety issues the drug presents.

Drugs that pass these three phases of testing then proceed to the fourth phase which involves releasing the drug to the open market. During this post-marketing phase, the drug is thoroughly investigated and reviewed to determine whether or not there are additional health and safety concerns not discovered during the clinical trial and testing phases.

Yale Uncovers Serious Concerns

Yale’s study determined that approximately 32% of new drugs raise red flags after they reach the market. A handful of these flags result in drug withdrawal from the market. For most, the flags result in additional warnings provided to physicians and patients regarding the drug’s safety and effectiveness. It’s important to note that the majority of drugs that raise additional safety concerns are those that have gone through the FDA’s accelerated approval process. These drugs are “fast-tracked” which means that they do not receive the thorough and detailed testing of drugs that go through the traditional approval process.

Liability for Unsafe Medications

Drug manufacturers, physicians, and pharmacists can be held liable for medications they produce and prescribe that harm patient safety. A Las Vegas personal injury attorney can help individuals seek compensation for the negative health effects these medications cause. Patients who experience negative drug interactions and side-effects from FDA approved drugs should cease taking the suspected medication to prevent further damage and potential long-term health consequences.