Hypertension: reminder of valsartan – these drugs for hypertension are currently affected

What hypertensive patients need to know about recall

As of July 4, 2018, the Federal Institute of Drugs and Medical Devices (BfArM) has recalled batches of drugs containing valsartan from Chinese manufacturer "Zhejiang Huahai Pharmaceutical "as carcinogenic impurities have been found in various antihypertensive preparations. The exact extent is not yet known. The affected lots are studied in collaboration with pharmaceutical companies and state authorities. Now, there are initial results.

BfArM expects that the list of affected drugs will be completed shortly. This will then be available in all pharmacies. In addition, a constantly updated list can be found on the website of the German Medical Commission (AkdÄ) Drug Commission. At present (July 11, 2018), the list includes 17 different preparations of valsartanhaltige for hypertension. In a statement, the BfArM informs about current events regarding the drug recall.

Which drugs contain valsartan

According to BfArM, valsartan is a clbad of drugs that can dilate blood vessels and thereby control high blood pressure. Valsartan is not an independent drug, but the active ingredient, which is then processed into ready-to-use drugs and can therefore be contained, for example, in various capsules or tablets.

The manufacturer of the drug is not usually the manufacturer of the drug

The BfArM warns that the manufacturer specified in the package leaflet need not be the manufacturer of the drug. The contaminants were caused by the drug manufacturer "Zhejiang Huahai Pharmaceutical". This active ingredient was then shipped to various manufacturers for further processing, which then manufactures the preparations. The leaflet often only mentions the manufacturer who is responsible for the overall manufacturing process.

Why are products recalled?

According to BfArM, N-nitrosodimethylamine has been found to be contaminated in some batches of the active substance. According to the International Agency for Research on Cancer (WHO) and the EU, this substance is considered carcinogenic.

How can people know if their products are contaminated?

On the one hand, pharmacies and doctors receive up-to-date information on the disease preparations affected. In addition, the Anti-Drug Commission of the German Medical Association (AkdÄ) publishes on its website a list of medicines related to the remedy, containing the active substance valsartan, freely accessible and constantly updated

a current position. From what follows, it seems that it will probably not be possible to exchange drugs in a pharmacy. In previous recalls, patients had to undergo a new order from the competent physician. However, this may result in another additional payment for patients who, according to previous statements, are not reimbursed.

Is it advisable to dispense with the active ingredient valsartan?

The German League Against Hypertension and the Federal Institute of Drugs and Medical Devices warn against an autonomous waiver. From a medical point of view, there is no reason to give up the active substance valsartan from harmless batches and harmless manufacturers. The problem would not concern the active substance itself, but the production-related contaminants identified by the Chinese manufacturer and reported to the authorities.

Temporary exposure is also not recommended

"Patients receiving drugs containing valsartan, Drugs should not be discontinued without consulting their doctor, as the risk to health related at weaning is several times greater than the potential risk of contamination, "is the current recommendation of BfArM.There is currently no acute risk to the patient. (vb)

These preparations are currently affected

AkdÄ list dated 09 July 2018 and includes the following drugs affected by the recall:

• Valsartan – 1A Pharma 40 mg, 28 film-coated tablets; Valsartan – 1A Pharma 80, 160 and 320 mg, 28 , 56 and 98 film-coated tablets; Valsartan 1a Pharma plus 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg, 28, 56 and 98 film-coated tablets
• Valsartan AbZ Film-coated tablets 40, 80, 120, 160 and 320 mg All presentations, film-coated tablets; Valsartan comp. AbZ 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg film-coated tablets All presentations, film-coated tablets; Valsartan CT 120 and 160 mg All the presentations, film-coated tablets; Valsartan Comp.-CT 80 / 12.5, 160 / 12.5, 160/25 and 320 mg / 25 mg All the presentations, film-coated tablets
• Valsartan AAA 40, 80, 160 and 320 mg All presentations, film-coated tablets Valsargamma 80 mg, all presentations, film-coated tablets
• Valsartan – Actavis 80 mg 28 film-coated tablets; Valsartan – Actavis 320 mg 28, 56 and 98 film-coated tablets
• Valsartan AL 80, 160 and 320 mg, 98 film-coated tablets; Valsart / HCT AL 160 / 12.5, 160/25 and 320 mg / 25 mg, 98 film-coated tablets
• Valsartan AL 40 mg, 28 film-coated tablets
• Valsartan Basics 80 / 12.5, 160 / 12.5 and 160 mg / 25 mg, 28, 56 and 98 film-coated tablets
• Valsartan Dexcel 80 and 160 mg, 98 film-coated tablets
• Valsartan Hennig 40, 80 , 160 and 320 mg All sizes of packaging, film-coated tablets; Valsartan Hennig plus HCT 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg All the presentations, film-coated tablets
• Valsartan Heumann 40, 80, 160 and 320 mg, 28, 56 and 98 film-coated tablets
• Valsartan Hexal® 80, 160 and 320 mg, 28, 56 and 98 film-coated tablets; Valsartan Hexal® comp 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg, 28, 56 and 98 film-coated tablets
• Valsartan-Hormosan comp 80 / 12.5, 160 / 12.5 and 160 mg / 25 mg, 28 and 98 film-coated tablets
• Valsartan Puren 40, 80, 160 and 320 mg All the presentations, film-coated tablets; Valsartan Puren 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg All the presentations, film-coated tablets
• Valsartan-ratiopharm® 40, 80, 120, 160 and 320 mg all presentations, film-coated tablets; Valsartan ratiopharm® comp. 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg All the presentations, film-coated tablets
• Valsartan Stada 40, 28 film-coated tablets; Valsartan Stada 80, 160 and 320 mg, 28, 56 and 98 film-coated tablets; Valsartan / HCT Stada 80 / 12.5, 160 / 12.5, 320 / 12.5 and 320 mg / 25 mg, 98 film-coated tablets; Valsartan / HCT Stada 160 mg / 25 mg, 28 and 98 film-coated tablets
• Valsartan Zentiva 40, 80, 160 and 320 mg, all sizes of packaging; Valsartan Zentiva comp. 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg, all sizes of packaging