Health ensures that all products, whether they are medicines, food, or beauty products comply with regulations. The Spanish Agency for Medicines and Health Products, AEMPS, has received information from the Customs Surveillance Service of Madrid-Barajas Airport about the marketing of Powers-X tablets. They have decided to ban their marketing and to demand that all copies of these tablets be pulled from the market. This was because the tablet contained sildenafil, the active ingredient in Viagra, in sufficient quantities to cause a pharmacological effect, which confers legal status of medicine.
Powers-X tablets are being marketed as a food supplements, despite it not having been notified to the relevant authorities. This is in violation of the current regulations.
The product is found to contain sildenafil, according to official laboratory analysis. This substance is not listed on the labeling. It misleadingly suggests a variety of products of plant origin. According to its labeling, this product could have been manufactured by the company VITAMAC SAS, Bogota D.C. (Colombia) and marketed by @Powersexcolombia.com.
Sildenafil (or PDE-5), is used to improve erectile function. It selectively inhibits phosphodiesterase 5 (5 (PDE-5), which causes increased penile blood flow). Patients with unstable angina, exertional and heart failure, acute myocardial injury, unstable angina, heart attack, heart failure, hypertension, history or ischemic stroke, severe liver disease, retinitis pigmentosa, non-arteritic optic neuropathy, or genetic disorders of phosphodiesterases are not recommended to take PDE-5 inhibitors. The retina.
There are many interactions between select PDE-5 inhibitors and other medications. It is worth considering adverse reactions of varying severity, such as cardiac problems, heart attacks, unstable angina, ventricular arrhythmia, palpitations, cerebrovascular accident, and sudden cardiac death. These effects have been more common in patients who have a history of cardiovascular disease.
The product is presented as natural and hides its real composition. It also gives misleading information about safety. Particularly, sildenafil can pose a risk to those who are more susceptible to adverse reactions from PDE-5 inhibitors. These individuals may resort to these products, which are supposedly natural and based on plants, to replace prescription drugs. This product also emphasizes its safety, misleadingly based upon its natural composition.
Because Powers-X tablets were not subject to AEMPS approval and evaluation prior to being released, the AEMPS has ordered their withdrawal.
You can find the most current information about all medicines that are authorized or controlled by AEMPS on the Agency’s website www.aemps.gob.es under the Online Information Center for Authorized Medicines – CIMA section.