Recently, the alarm went off when at least 20 cases of hypertrichosis* were detected in babies from the Spanish regions of Cantabria, Andalusia and the Valencian Community.
The children were diagnosed with gastroesophageal reflux in their respective health centres, where they were prescribed a master formula made with Omeprazole, which they ingested for several days. The problem is that this formula did not contain Omeprazole, but Minoxidil, a vasodilator that is usually prescribed for alopecia, usually for topical use.
The Spanish Agency for Medicines and Health Products (Aemps) withdrew a total of 23 batches of Omeprazole from Farma-Química del Sur S.L., the packaging company, after receiving notification of 14 cases of hypertrichosis in children. On July 11, Aemps launched a pharmaceutical alert and ordered the withdrawal of the first batch of this medication. On August 6, it issued a new alert and, as a preventive measure, extended the withdrawal to 22 batches more from the same company, 45 batches at least.
Following this incident and the inspections carried out at its facilities, the company Farma-Química del Sur S.L. It has suspended its registration to carry out the activities of manufacturing, importing and distributing pharmaceutical active ingredients since last July.
Children are recovering favourably from hypertrichosis, thanks to the suspension of the intake of the “false” medication.
Analyzing this case, some questions come to our mind. How was it possible? How could these active principles be confused? Could it have been avoided?
The active ingredients intended to make master formulas are carried out in authorized pharmacies, which must check the traceability of the batches and their labelling and proceed to the formula. Sometimes, the active ingredients are similar to the human eye, so without a compositional analysis, it would be impossible to distinguish. If the labelling is incorrect, the result of the product and the health of the consumer are being compromised.
Therefore, since we are imperfect beings and making mistakes is intrinsic in our DNA, having analytical tools to ensure that traceability is more than recommended, it should be almost imperative.
PAT (Process Analytical Technologies) systems based on IR Spectroscopy such as VISUM allow:
- Quality inspection in different points of the factory.
- Analysis in seconds and real-time of the physical-chemical composition of the product.
- The quality assurance of the analyzed product, confirming that it matches the specifications of its label.
- Analytical traceability.
- Reliability in the results.
- The protection of the company’s brand image.
If you want to know how our VISUM devices can help you to assure the quality of the product and to convey to the consumer the security that they are acquiring what is specified on the label, do not hesitate to write to firstname.lastname@example.org and we will answer your questions.
Ambras-type congenital hypertrichosis, also known as the werewolf syndrome, is a genetic disorder that affects hair growth. It is a very rare disease of which 40 documented cases are known worldwide, according to a periodic report by Orphanet. Those who suffer from it see how their hair grows in a lot and thickness in areas of the body where they normally do not, such as the face. Although it can occur in localized areas of the body, its best-known manifestation is that in which the entire body surface is covered with hair, except the soles of the feet and the palms of the hands.