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    WELLNESS HEALTH - Why Was BuSpar Taken Off The Market? Drug Genius

    Why Was BuSpar Taken Off The Market? Drug Genius

    By Wisdom BasseyUpdated:July 4, 2024
    Why Was BuSpar Taken Off The Market_ Drug Genius
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    Buspirone, formerly marketed under the brand name BuSpar®, is among the medications employed in the treatment of anxiety. Produced and distributed by the global pharmaceutical company Bristol-Myers Squibb, it gained FDA approval in 1986 and is frequently prescribed as an alternative to conventional anxiety medications for managing anxiety disorders or providing short-term relief from anxiety symptoms.

    This medication can contribute to clearer thinking, relaxation, reduced worry, and enhanced participation in daily life. It may also alleviate jitteriness, decrease irritability, and address symptoms like insomnia, excessive sweating, and rapid heartbeats.

    Originally developed in the 1960s and 70s as a medication for psychosis, buspirone, despite the discontinuation of the BuSpar brand name over a decade ago, is still informally referred to by this name when discussing the generic form.

    BuSpar received FDA approval for treating anxiety disorders and providing short-term relief from anxiety symptoms. Additionally, it is employed off-label as an augmentation agent, used in conjunction with another medication, to address specific types of depression and mental health issues.

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    While demonstrated to be effective in alleviating anxiety symptoms, BuSpar was typically not the primary treatment choice. Instead, it was often prescribed when other anxiety medications, such as selective serotonin reuptake inhibitors (SSRIs) or benzodiazepines, proved ineffective or resulted in severe or persistent side effects.

    Why Was BuSpar Pulled From The Market?

    Despite its widespread use and effectiveness, the abrupt removal of BuSpar from the market surprised many users. While the exact reasons remain unclear, the FDA confirmed that the decision was not prompted by safety concerns, formulation issues, or a lack of efficacy. Instead, it appears to be linked to the expiration of its patent in 2001, leading to the complete discontinuation of the brand in 2012.

    Another conceivable factor contributing to BuSpar's discontinuation is the increased availability of generic versions of buspirone, a trend observed with various drugs and medications. Importantly, Bristol-Myers Squibb, the pharmaceutical company behind BuSpar, did not withdraw the medication due to safety or effectiveness concerns.

    Nevertheless, the FDA continues to permit the use and sale of generic buspirone, which is considered safe and effective when used in accordance with a doctor's instructions.

    Health Benefits Of Buspirone

    Buspirone falls within the category of medications known as azapirones, and although its precise mechanism of action remains unknown, experts suggest a strong affinity for serotonin receptors throughout the body.

    Serotonin, a neurotransmitter, functions as a natural chemical facilitating communication between neurons and other cells, playing a crucial role in regulating moods, arousal, and feelings of happiness and anxiety. Low serotonin levels are associated with various psychiatric disorders, including depression and anxiety.

    Research indicates that buspirone may elevate serotonin levels and activity in brain regions related to fear and anxiety, such as the amygdala and certain prefrontal areas. It has been identified as more effective as an anxiolytic drug than an antipsychotic, and its limited side effect profile has made it a popular alternative to other anxiety medications.

    In the treatment of Generalized Anxiety Disorder (GAD), healthcare providers typically initiate therapy with SSRIs and SNRIs, as they have proven effective for a broad spectrum of anxiety disorders. However, when results are not as anticipated, supplementing with medications like buspirone has demonstrated enhanced efficacy.

    Studies indicate that combining buspirone with an existing SSRI antidepressant often yields better outcomes than using the SSRI alone. Nevertheless, conflicting results are noted in other studies, indicating that the addition of buspirone may not consistently produce more significant effects.

    Overall, research suggests buspirone's effectiveness in treating anxiety disorders. A study published in the Journal of Clinical Psychiatry, involving a six-week buspirone treatment for individuals with GAD, revealed improvements in both anxiety and depression symptoms.

    Notably, compared to many anti-anxiety medications, buspirone distinguishes itself by not functioning as a muscle relaxant, avoiding major sedative effects. Additionally, it is associated with milder side effects and a lower risk of withdrawal symptoms.

    How to Use Buspirone

    Standard Dosage

    Buspirone is presented in oral tablet form with varying doses, including 5 mg, 7.5 mg, 10 mg, 15 mg, and 30 mg per tablet. Typically, the recommended starting dose for patients with Generalized Anxiety Disorder (GAD) is 15 mg daily (either two 7.5 mg or three 5 mg tablets), with a maximum daily dose of 60 mg. Your healthcare provider may gradually adjust the dosage until the optimal level is reached. It's crucial not to alter the dosage or discontinue buspirone abruptly without your healthcare provider's guidance, as the medication is not associated with physical dependence or withdrawal symptoms.

    Frequency

    Administer this medication orally 2 or 3 times a day, as directed by your doctor. It can be taken with or without food, but consistency in administration is important for optimal absorption. Many individuals find taking buspirone with food helpful, as it aids in remembering and may reduce nausea, a common side effect. After taking a dose, refrain from activities requiring alertness, such as driving or operating heavy machinery, until you can safely do so to prevent accidents.

    Interactions

    Buspirone may interact with various medications, including certain antidepressants, antihistamines, anti-seizure medications, and antibiotics. Noteworthy interactions should be discussed with your healthcare provider before using buspirone. Drinking large amounts of grapefruit juice should be avoided, as it can elevate buspirone levels and increase the risk of side effects.

    Missed Doses

    If you miss a dose, take it as soon as you remember. However, if it's close to the next scheduled dose, skip the missed one. Avoid doubling the dose to compensate.

    Storage

    Store buspirone in a tightly closed container at room temperature below 86 degrees F (30 degrees C), away from light and moisture. Keep it out of the reach of children and pets.

    Read Also: The Process of Obtaining a Medical Marijuana Prescription Explained

    Other Precautions

    Avoid alcohol consumption while using buspirone, as it can intensify sedative effects. Pregnant women should seek their doctor's approval before taking buspirone due to insufficient studies on its effects during pregnancy. Inform your doctor or pharmacist of your medical history, particularly if you have kidney problems, liver problems, bipolar disorder, or Parkinson's disease.

    If discontinuing buspirone is contemplated, consult your healthcare provider for guidance on dosage adjustments or potential alternative anxiety medications.

    Pros and Cons of Buspar

    Pros of Buspirone (Buspar)

    • Low Dependency and Withdrawal Risk:
    • Mild Side Effects:
    • Non-Sedative Nature:
    • Limited Potential for Abuse

    Cons of Buspirone (Buspar)

    • Delayed Onset of Action:
    • Less Effective for Panic Attacks
    • Requires Regular Dosing

    Differences Between Buspar and Vienva

    Buspar (Buspirone)

    Buspar is primarily prescribed for the treatment of anxiety disorders, including generalized anxiety disorder (GAD). It is not intended for the management of other psychiatric conditions.

    Vienva

    Vienva is a combination hormonal contraceptive, commonly known as a birth control pill. It is used to prevent pregnancy.

    Alternative to Buspar

    Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)

    Venlafaxine (Effexor) and duloxetine (Cymbalta) are examples of SNRIs that can be effective for anxiety. They enhance the levels of both serotonin and norepinephrine.

    Does Buspirone Cause Side Effects?

    While buspirone is generally considered less likely to induce side effects compared to other anxiety medications, occasional mild side effects can still occur.

    Dizziness is the most frequently reported side effect associated with buspirone, and it may be more pronounced when initiating the medication or increasing the dose.

    Other commonly experienced side effects of buspirone include:

    • Drowsiness
    • Headaches
    • Lightheadedness
    • Nausea
    • Nervousness
    • Trouble sleeping

    Though rare, the occurrence of serotonin syndrome is a possibility when buspirone is combined with other antidepressants. Seek immediate medical attention if you notice any of the following symptoms:

    • Agitation or restlessness
    • Insomnia
    • Irritability
    • Confusion
    • Concentration problems
    • Rapid heart rate
    • Chest pains
    • Dilated pupils
    • Vision problems
    • Loss of muscle coordination
    • High blood pressure
    • Twitching muscles
    • Muscle rigidity
    • Elevated body temperature

    In contrast to more widely used anti-anxiety medications like Xanax, buspirone typically does not lead to severe withdrawal symptoms.

    If you experience any uncomfortable side effects while taking buspirone, it is advisable to discuss them with your healthcare provider. They can assist in determining whether to continue with the current treatment or explore alternative options.

    In some instances, buspirone may lead to elevated levels of liver enzymes. If you encounter severe or persistent adverse effects while using buspirone, it's essential to contact your healthcare provider promptly.

    Conclusion

    While buspirone is often considered a favorable option for managing anxiety with a lower likelihood of side effects compared to some alternatives, it is not without its occasional mild effects, with dizziness being the most common. Users may experience heightened symptoms initially or with dose increases. The medication's more typical side effects include drowsiness, headaches, lightheadedness, nausea, nervousness, and trouble sleeping. In rare instances, the combination of buspirone with other antidepressants can lead to serotonin syndrome, a condition requiring immediate medical attention.

    Unlike some widely-used anti-anxiety medications, buspirone tends not to cause severe withdrawal symptoms. Should individuals encounter discomfort with side effects, open communication with healthcare providers is crucial. Providers can guide decisions on whether to persist with buspirone or explore alternative treatments.

    It's important to note that, although infrequent, buspirone may result in elevated liver enzyme levels, emphasizing the necessity of promptly contacting healthcare providers if severe or persistent adverse effects arise during its use. As with any medication, an ongoing dialogue with healthcare professionals ensures a personalized and well-monitored approach to anxiety management with buspirone.

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    Wisdom Bassey

    My name is Wisdom Bassey, I’m a blog content writer and graphic designer who provides support and services for brands and different companies. I’m young and versatile, A tech enthusiast. I carry out deep research on every topic I choose to write about. You can reach me through my social media handles, I’m always available and ready to connect.

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