The withdrawal of more than 300 formulations of contaminated valsartan has been reported in 26 countries in Europe, including Spain, reopening the debate on the safety of generic drugs.
Valsartan is a medicine for the treatment of high blood pressure, and this is no other case. In recent years, many drugs that have been used in the treatment of cardiovascular disease have been withdrawn from the market. A clear example is atorvastatin, candesartan, irbesartan.
On the other hand, the European Congress of Cardiology (ESC Congress 2018), which takes place in Munich from 25 to 29 August, has taken a broad approach to the safety of generic medicines in one of its sessions.
According to Juan Luis Tamargo, member of the Spanish Society of Cardiology (SEC) and ESC working group for drug therapy and pharmacotherapy, "in Spain they account for 40 percent of the market, while in Europe 60 percent of the market Medications are generic. "
"Theoretically, generic drugs have the same active ingredient, the same dose and the same route of administration as branded medicines, so the effectiveness should be exactly the same." Tamargo states, "the problem comes with so-called excipients and possible impurities. ingredient, other ingredients such as diluents, disintegrants, preservatives, sweeteners or colorants, and are also referred to as inactive components, although perhaps mistakenly because the American Heart Association (AHA) has recognized that some of them are not inert, "confirms the expert of the SEC that also adds that these components "can cause unwanted reactions".
What is a generic medicine?
Generic drugs are medicines that use exactly the same active ingredients as their brand counterparts. According to the law, generic drug companies can legally produce the drug once the patent has expired, usually 12 to 15 years after the first release of the drug. This is because brand medicines have been prescribed for many years before they can be copied, their clones being considered "proven"
The Food and Drug Administration (FDA) requires generic prescription drugs and over-the-counter medicines to contain exactly the same active ingredients at the same concentration as the brands they copy. It also requires that they have the same purity and stability, that their presentation is the same, for example tablets, patches or liquid, and that they are administered in the same way (for example pills to swallow or administered as an injection). .
One fact to emphasize is that the manufacturers of a generic drug with studies have to prove that the drug is "bioequivalent" to the corresponding brand, showing that it delivers the same amount of active ingredients into a person's bloodstream at the same time as the original brand
"These studies are only performed on young, healthy people, usually men and without associated comorbidities, who receive the drug for a short period of time," the SEC emphasizes.
That's why the specialist Tamargo says about bioequivalence research: "Doctors do not prescribe drugs to healthy subjects, but to elderly people with physiological worsening of liver and kidney functions, one or more co-morbidities and, as a consequence, taking different medications."
For the expert, however, it is worrying that there are few comparative studies between generic medicines and branded drugs in terms of efficacy and safety. "There are no studies in which generic comparisons are compared.As a result, a generic or another unequivocal is delivered in the pharmacy without informing the physician, so that a patient part of the effectiveness of the treatment. can lose or have an adverse reaction "adds the member of the SE.