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Concerns About FDA Approved Drugs
Posted on by Paula Gallagher
Last week findings published in the Journal of the American Medical Association (JAMA) found that nearly one-third of FDA approved drugs from 2001 through 2010 had major safety issues years after the medications were made widely available to patients.
The study identified 123 drugs that had safety issues arise after FDA approval. Of those:
• 3 were withdrawn due to safety concerns.
• 61 had received boxed warnings about serious side effects (the strictest warning put in the labeling of prescription drugs or drug products by the FDA when there is reasonable evidence of an association of a serious hazard with the drug).
• 59 had been flagged in FDA communications for safety issues.
Although the post-FDA approved side effects varied from minor to serious, this study points out the need for ongoing monitoring of newly approved drugs. Currently, the FDA is under pressure to accelerate drug approvals, however the study findings also showed that the FDA's process of accelerating drug approvals has the potential to compromise patient safety.
Adverse Drug Reactions (ADRs), are the fourth leading cause of death in the US ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents and automobile deaths. If you are on medications and are concerned about side effects, here are five tips to help you be more informed about what you are taking.
- Read the labels of any medication you take, both prescription and over-the-counter, and don’t take them until you are clear about the potential risks.
- Consult with your doctor and make sure your doctor explains exactly why they are prescribing you a drug, how it works, and any risks.
- Ask questions. Don’t assume anything. Medications affect people differently, and they can also react with other meds you are taking. Talk to your pharmacist, who has a wealth of knowledge and can let you know about interactions and side effects.
- Get a second opinion from another doctor if you don’t feel comfortable. In some cases, there may be a natural-health solution that can complement or even replace the prescription.
- Be honest and open with your doctor and pharmacist. Inform your doctor about anything you are taking, prescription, including over-the-counter and natural products. There can be potential side effects or contraindications that you may not be aware of and that your doctor or pharmacist can identify.
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