Last March, news from the United Kingdom raised some concerns about the safety of pregabalin, a drug often used to treat chronic pain and anxiety. British newspaper investigation Sunday Times He linked the drug to the deaths of 3,400 people in recent years and described the problems of abuse and addiction it can cause.
Given the severity of the sociomedical crisis plaguing the United States due to opioid addiction, the safety concerns that may arise with the use of drugs such as pregabalin are of particular interest.
Beyond epilepsy and neuropathic pain
Pregabalin is a drug whose chemical structure is similar to that of the neurotransmitter GABA (gamma-aminobutyric acid), a substance that inhibits brain activity. Together with gabapentin, it forms a group of drugs called gabapentinoids.
In Spain, the first drug of pregabalin was launched on the market by the Pfizer pharmaceutical laboratory under the trade name Lyrica. It was initially approved for the treatment of epilepsy and neuropathic pain and was later licensed for the treatment of generalized anxiety disorder.
Over time, the use of Lyrica has been expanded to treat other conditions that do not have public health approval, such as chronic pain, low back pain, post-surgical pain prevention, fibromyalgia, and migraine prevention. This application is known as not on purpose or outside the technical sheet. Sometimes such use may be medically justified if there are no approved therapeutic alternatives, and in any case it is regulated by law.
Only advertising is prohibited, and this doomed Pfizer to pay millions in fines. It is worth remembering that the use not on purpose The use of drugs may pose safety concerns, increase treatment costs, or be outright ineffective because their therapeutic benefit has been shown to be insufficient.
However, various studies have concluded that more than half of gabapentinoid prescriptions are for off-label indications; mainly for the treatment of various types of pain, although scientific research does not recommend its use.
Its consumption has increased sharply
Today we have 168 drugs containing pregabalin, including so-called generics. Consumption data can be found on the website of the Spanish Agency for Medicines and Health Products (AEMPS), in particular in the report on the use of non-opioid analgesics.
This information is expressed in DHD, that is, a defined daily dose (DDD) per 1000 inhabitants per day. So we know that pregabalin consumption has increased by 66% over the past 10 years, as the GDV increased from 3.56 to 5.92 between 2012 and 2022. These latest data mean that every day on average 5.92 people out of every 1000 receive DDD of pregabalin. It is currently the third most consumed non-opioid analgesic in Spain after paracetamol and metamizole.
Is it safe to take pregabalin?
Pregabalin, like all medications, is not without side effects, that is, effects that we do not want, but which in many cases cannot be avoided. Luckily, the most common ones, affecting at least one in 10 people, are mild. These include dizziness, drowsiness and headache.
Others may also occur less frequently. All of them can be found in the technical data sheet on the AEMPS information center website, in the public domain or in the package insert for the drug. It is important to note that side effects are more likely to occur with chronic use of high doses of pregabalin. And in any case, this type of use does not provide the best pain relief.
Among the most serious effects is the risk of decreased breathing as they affect the area of the brain that controls this function. This is important to consider if the patient is already taking other drugs that have the same effect, since their combination in high doses can paralyze breathing and cause death.
Other depressants include opioid analgesics (such as morphine), which we use to relieve severe pain, and benzodiazepines (such as Orfidal), which we take to help us fall asleep or calm our nerves. Various studies show that 60% of patients taking gabapentinoids are also taking other depressants. A fatal combination may be responsible for the increased mortality associated with pregabalin use described Sunday Times.
The same depressant effect of pregabalin, but acting on the limbic system of the brain, produces feelings of euphoria and well-being, which can lead to abusive and addictive behavior. The concept of addiction refers to the need to continue taking a substance in order to experience the desired effect or to relieve the discomfort caused by stopping its use (withdrawal).
If the drug is not taken orally, symptoms appear that cause discomfort and encourage you to continue taking it, despite possible negative consequences; This is what we colloquially call “getting hooked.” People who have previously suffered from addiction problems are especially vulnerable.
Always under medical supervision
The risks associated with pregabalin abuse can be minimized with adequate monitoring of the treatment regimen and periodic assessment of the need to continue or discontinue treatment according to criteria of effectiveness, tolerability, side effects and adherence. If the assessment recommends stopping treatment, this will be done gradually and under medical supervision.
In any case, pregabalin is approved for the treatment of neuropathic pain caused by nerve damage, epilepsy and anxiety because research shows that the benefits of treatment outweigh the risks. In this context, the risk-benefit assessment of pregabalin treatment is appropriate for healthcare professionals and is supported by AEMPS.
Finally, we cannot forget the role of citizens in actively managing their health: it is important to follow medical instructions and report if we suffer from side effects and notice that treatment is not working. Communicating all of this information during consultation visits is key to ensuring that the physician correctly assesses the usefulness of the treatment and its safety.