Learning that a drug is approved by the FDA may give the impression that the drug is safe to use, but this isn’t necessarily the case. Find out what it means for a drug to be FDA approved, why certain medications require the label, the risks that accompany FDA approved products, and how homeopathic medications differ.
What Does It Mean to Be FDA Approved?
When a drug is FDA approved, it does not mean that the medication does not have potential and serious harmful side effects. It simply means that the benefits can outweigh the risks for the intended population. There are several phases of FDA approval that must occur throughout the process.1 These include:
- Analysis: FDA reviewers evaluate the current treatment landscape in order to properly weigh the drug’s risks and benefits. Sometimes these risks are serious, but if benefits outweigh the risks, especially for life-threatening conditions, then the approval process moves on to the next phase.
- Clinical data assessment: FDA reviewers then evaluate clinical benefit and risk information submitted by the drug maker, analyzing any uncertainties that may result from imperfect or incomplete data. Though two clinical trials are preferred, sometimes one clinical trial is enough if an illness is rare and multiple trials are not feasible.
- Strategies for managing risks: According to the FDA, all drugs have risks. These risks and management strategies are gathered at this point to be included on the drug’s label.
Why Certain Medications Need to Be FDA Approved
New drugs must be proven safe and effective to FDA’s satisfaction before companies are allowed to market them in interstate commerce.2 However, it is important to note that the FDA does not conduct these safety and efficacy tests themselves. The FDA merely reviews the results of laboratory, animal, and human clinical testing completed by manufacturers. FDA approval is mandatory for drugs that might pose a significant risk of injury or illness, but can also benefit your health.
FDA Approved Benzodiazepines for Anxiety
Benzodiazepines are a class of medicines that are designed to treat anxiety disorders such as generalized anxiety disorder (GAD), insomnia, social phobia, and panic disorders. Benzodiazepines listed on the FDA website for the treatment of anxiety include:3
- Alprazolam (Xanax)
- Clonazepam (Klonopin)
- Diazepam (Valium)
- Lorazepam (Ativan)
- Chlordiazepoxide (Librium)
- Clobazam (Onfi)
- Temazepam (Restoril)
Though these drugs are listed on the FDA website because their benefits are said to outweigh their risks, the FDA released updated labeling in 2020 to include abuse, addiction, and other serious risks associated with benzodiazepines.4 This included withdrawal reactions, seizures, and contraindications with other drugs.
Other documented side effects of benzodiazepines include: dizziness, nausea, restlessness, muscle pain, sexual dysfunction, drowsiness, inattention, nightmares, memory impairment, suicidal ideation, paranoia, and appetite changes.5
Understanding the Risks of FDA Approved Stimulants
Stimulants are prescribed to treat conditions like ADD and ADHD because they are said to have a calming or “focusing” effect. They boost certain chemicals in the brain like dopamine and norepinephrine to induce these effects. Stimulant drugs listed on the FDA website include:
- Methylphenidate (Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR)
- Dexmethylphenidate HCl (Focalin, Focalin XR)
- Dextroamphetamine sulfate (Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat)
- Lisdexamfetamine dimesylate (Vyvanse)
- Amphetamine, mixed salts (Adderall, Adderall XR)
- Methamphetamine (Desoxyn)
Risks associated with these stimulant drugs include: headaches, upset stomach, increased blood pressure, dizziness, dry mouth, decreased appetite, nervousness, and insomnia.6
No harmful side effects.
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Though drugs must undergo clinical trials to be approved by the FDA, reports show that one third of new drugs have safety issues after approval.7 Sometimes drugs are granted “accelerated approval” or were only tested on a small number of patients. When the drugs are released to the public new risks and side effects often emerge as the sampling size dramatically increases.
Homeopathic Options & Their Benefits
Homeopathic medication like Brillia offers a gentle and impactful approach to reducing anxiety, irritability, and hyperactivity while improving attention and focus. The active ingredient in Brillia is not a synthetic chemical; it consists of antibodies to the brain-specific S100 protein (S100B), an important regulator of various different intracellular and extracellular brain processes. This protein works like a key, binding to targets in the brain to unlock symptoms of anxiety and ADHD. Brillia works by attaching to the S100B protein and stopping it from unlocking these undesirable symptoms with absolute specificity so that no other systems in the body are affected and no harmful side effects are triggered.
Because there are no harsh chemicals used in Brillia and there are clinical studies that support its safety and efficacy, the FDA has categorized Brillia as a non-prescription homeopathic medication. According to FDA rules, homeopathic medications must back up their health claims with scientific evidence or admit on their labels that no such scientific evidence exists. This is not the case with Brillia, which has documented scientific evidence to support the claims that it makes.
Why Homeopathic Medications Aren't FDA Approved
Homeopathic non-prescription over-the-counter products such as Brillia are regulated differently than other drug products. Homeopathic drugs are required to provide substantive documentation with clinical trials and studies of the claims that the product makes, abide by FDA standards and regulations (e.g., for quality and labeling), and go through a proper registration process detailing active ingredients and inactive ingredients in order to be allowed to be sold in the U.S. In this instance, Brillia has been used in Europe for almost 10 years with great success and history supporting its efficacy as well as its safety. When a shipment arrives, there is another FDA review process of a sample of the products that they take from the shipment to test. The boxes cannot be sold until FDA clearance is issued. So Brillia has met all requirements and completed all procedures to be reviewed by FDA and secure permissions to be sold in the U.S.
Because of the special formulation of Brillia, many families have been able to avoid or stop using prescription medications, thus dodging their harmful side effects and finding greater success with Brillia. Simply because a product has FDA approval does not make it the better choice. While prescription medications have their unique place in a treatment plan, it’s recommended to use them when more gentle and holistic options have been exhausted.
Knowing the risks of FDA approved drugs will help you make an informed decision when it comes to addressing symptoms of anxiety, inattention, or hyperactivity for you or your child. Find more resources about homeopathic medication and Brillia’s unique 5-Pillar methodology, which combines antibody science with healthy living habits for long-lasting results.
Erica Garza is an author and essayist from Los Angeles. She holds an MFA from Columbia University and a certificate in Narrative Therapy. Her writing has appeared in TIME, Health, Glamour, Good Housekeeping, Women's Health, and VICE.