The creation of new drugs to combat all kinds of diseases and disorders, both psychological and physical, is a dynamic process in which any drug can be withdrawn from the market almost as quickly as it was put on it. Whether it is for economic reasons or in relation to the company’s profits, or for safety reasons.
This is the case of viloxazine, an antidepressant that has been on the market for a little over twenty years and which we will talk about throughout this article. In the same way, we will analyze its uses and its form of administration, as well as its possible side effects and the precautions to be taken by those who consumed it.
What is viloxazine?
Viloxacin, commercially known as Vivalan, Emovit, Vivarint and Vicilan, was an antidepressant medication whose main active ingredient was a morpholine derivative and which was categorized within the group of selective norepinephrine reuptake inhibitors (SNRIs).
This drug was discovered and launched on the market in 1976. During its time on the market, it was used as an antidepressant in a large number of European countries, and became quite famous due to its stimulant effects similar to those of amphetamines , but without the addictive effects or signs of dependence of the latter.
Although it was never granted American Food and Drug Administration (FDA) approval, it was granted a designation for the treatment of narcolepsy and cataplexy. However, it was withdrawn from markets around the world in 2002 on commercial grounds.
Regarding its action as an antidepressant, it was observed that, in animal models, viloxazine inhibits norepinephrine reuptake in the hearts of rats and mice. As regards the inhibition of serotonin reuptake, this drug boosted the brain functions mediated by this neurotransmitter in the same way as other more potent antidepressants such as amitriptyline or imipramine; it also showed no anticholinergic effect.
Finally, it was also found that, in rats, it regulated very effectively the gabaergic receptors of the frontal cortex of these animals.
In what cases was this antidepressant used?
Viloxazine was administered, in some European countries, as the drug of choice for the treatment of depression or major depression disorder.
Depression or major depressive disorder is a mental or psychological condition characterised by the fact that the person suffering from it experiences a constant and acute feeling of negative emotions such as sadness and anguish.
Often, depression is accompanied by low self-esteem, loss of interest in activities that were usually enjoyable or appealing, decreased energy, and pain with no apparent cause.
While in milder cases depression may occur intermittently, alternating periods of depression and periods of emotional stability. In the most severe cases, the person may have permanent symptoms, including faulty beliefs or even visual or auditory hallucinations.
Major depressive disorder can interfere significantly and negatively with the patient’s day-to-day life; modifying their routines, eating habits, sleep cycles and general health. The person’s decline can be so severe that between 2 and 7% of people with depression resort to suicide as a way of eliminating the suffering suffered.
How was it administered?
Viloxazine was marketed in tablet form for oral administration. It was usually recommended that daily doses of 50 to 100 milligrams were taken once every 8 to 12 hours, preferably with a meal. In addition, the last dose should be ingested before 6 pm.
However, in the most severe cases, the dose could be increased to 400 milligrams of viloxazine per day.
It is necessary to specify that neither in this case nor in that of any other medicine, the patient should alter on his own the doses indicated by the medical professional, since these are adjusted to the needs or state of the patient. Otherwise, there is a possibility that the patient may experience serious side effects such as sudden mood swings, among many other symptoms.
Due to the way in which viloxazine acts, in most cases the drug treatment was started gradually , starting with lower doses which increased as the first weeks of treatment passed.
In addition, viloxazine should never be withdrawn abruptly, since the side effects of this drug interruption could cause withdrawal symptoms such as severe headaches, increased muscle stiffness, mood swings, dizziness or vertigo.
What were the side effects?
As with the vast majority of psychiatric medications, viloxazine also had a number of side effects that, while not always significant or serious, occurred quite frequently.
In most cases, the appearance of the side effects was due to a dilation of the pharmacological action of the medication and affected mainly the central and autonomic nervous system .
These adverse reactions could be divided into: frequent side effects appearing in 10-25% of cases), occasional side effects (1-9% of cases) and rare side effects (less than 1% of cases).
1. Common side effects
2. Occasional side effects
These are slightly rarer side effects of viloxacin.
- Constipation .
- Dry mouth.
- Urinary retention.
- Tachycardia .
- Accommodation disorders.
3. Rare side effects
In these rare but serious cases, treatment with viloxazine had to be stopped immediately and always under the supervision and monitoring of a doctor.
- Heart arrhythmias.
- Orthostatic hypotension.
- Worsening anxiety .
- Sleepiness or insomnia.
- Tremors .
- Mild hypertension .
- Skin rashes.
What precautions should be taken during consumption?
Before starting treatment, the patient had to inform his/her doctor of any special health condition he/she was in, especially if it included cardiovascular disorders, epilepsy, liver failure or kidney failure.
Similarly, there are a number of drugs that could interfere with the action of viloxazine. These included antiepileptic drugs, levodopa, theophylline or St. John’s wort.
Although no adverse effects of viloxazine consumption during pregnancy were found, it could be excreted in breast milk, so it was common to recommend not to administer this drug during the last weeks of pregnancy and during breastfeeding.
Finally, as with other antidepressant drugs, viloxazine could cause drowsiness and confusion , making it inadvisable to drive or operate heavy machinery during treatment.