News

Recall for valsartan drugs: The following drugs and manufacturers are affected


What hypertension patients need to know about the recall

As early as July 4, 2018, the Federal Institute for Drugs and Medical Devices (BfArM), as a precautionary measure, recalled the batches of valsartan-containing medicines from the Chinese manufacturer "Zhejiang Huahai Pharmaceutical" because carcinogenic contaminants were found in various blood pressure-lowering preparations. The exact extent is not yet known. The affected batches are currently being determined in cooperation with pharmaceutical companies and the state authorities. The first results are now available.

The BfArM assumes that the list of the drugs concerned will be completed shortly. This will then be available in all pharmacies. Furthermore, a constantly updated list can be viewed on the website of the Medicines Commission of the German Medical Association (AkdÄ). At the moment (July 11, 2018), the list includes 17 different valsartan-containing preparations for high blood pressure. In a statement, the BfArM provides information about the current events regarding the recall of medicines.

What medicines do valsartan contain?

According to the BfArM, valsartan is a class of active substances that expand blood vessels and can thus control high blood pressure. Valsartan is not an independent medication, but the active ingredient that is processed into finished medicinal products and can be contained in various capsules or tablets, for example.

The drug manufacturer is usually not the drug manufacturer

The BfArM warns that the manufacturer specified in the package insert does not have to be the manufacturer of the active substance. The contamination was caused by the active ingredient manufacturer "Zhejiang Huahai Pharmaceutical". This active ingredient was then supplied to various manufacturers for further processing, who then only produce the preparations. The package insert often only states the manufacturer who is responsible for the overall production.

Why are the preparations being recalled?

According to the BfArM, contamination with the substance N-nitrosodimethylamine was found in certain batches of the active substance. According to the International Agency for Research on Cancer from the WHO and the EU, this substance is considered to be likely to be carcinogenic.

How can those affected find out whether their preparations are contaminated?

On the one hand, pharmacies and doctors receive up-to-date information about the products concerned at regular intervals. In addition, the Medicines Commission of the German Medical Association (AkdÄ) publishes a freely accessible and constantly updated list of medicinal products affected by the recall with the active ingredient valsartan on its website.

Where can I exchange the contaminated medication?

The German High Pressure League also responds with a current statement. This shows that it will probably not be possible to exchange the medication in a pharmacy. In previous recall campaigns, those affected had to have a new prescription issued by the appropriate doctor. However, this means that the patient may have to pay another co-payment, which according to the previous statements they have not been reimbursed.

Is it advisable to do without the active ingredient valsartan?

No. Both the German Hypertension League and the Federal Institute for Drugs and Medical Devices warn of an arbitrary waiver. From a medical point of view, there is no reason to forego the active ingredient valsartan from harmless batches and from harmless manufacturers. The problem was not due to the active ingredient itself, but to the production-related impurities, which the Chinese manufacturer recognized and reported to the authorities.

Temporary exposure is also not recommended

"Patients who take medicinal products containing valsartan should not stop taking the medicinal products without consulting their doctor, because the health risk of discontinuation is many times higher than the potential risk of contamination," is the current recommendation from the BfArM . There is currently no acute patient risk. (vb)

These preparations are currently affected

The list of AkdÄ is current as of July 9, 2018 and includes the following drugs that are 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 pack sizes, film-coated tablets; Valsartan comp. AbZ film-coated tablets 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg All pack sizes, film-coated tablets; Valsartan CT 120 and 160 mg all pack sizes, film-coated tablets; Valsartan comp.-CT 80 / 12.5, 160 / 12.5, 160/25 and 320 mg / 25 mg All pack sizes, film-coated tablets
  • Valsartan AAA 40, 80, 160 and 320 mg all pack sizes, film-coated tablets Valsargamma 80 mg, all pack sizes, 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; Valsarten / 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 comp 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 pack sizes, film-coated tablets; Valsartan Hennig plus HCT 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg All pack sizes, 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 pures 40, 80, 160 and 320 mg all pack sizes, film-coated tablets; Valsartan Puren 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg All pack sizes, film-coated tablets
  • Valsartan ratiopharm® 40, 80, 120, 160 and 320 mg all pack sizes, film-coated tablets; Valsartan-ratiopharm® comp. 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg All pack sizes, 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 pack sizes; Valsartan Zentiva comp. 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg, all pack sizes
  • Author and source information


Video: Your drug has been recalled what do you do? (August 2020).