Recall for valsartan medicines The following medicines and manufacturers are affected

What hypertension patients need to know about the recall

Already on July 4, 2018, the Federal Institute for Drugs and Medical Devices (BfArM) recalled as a precaution the batches of valsartanhaltigen drugs of the Chinese manufacturer "Zhejiang Huahai Pharmaceutical" recalled because carcinogenic impurities were found in various antihypertensive drugs. The exact extent is not yet known. The affected batches are being investigated in collaboration with pharmaceutical companies and the state authorities. Now there are first results.

The BfArM expects the list of affected drugs to be completed soon. This will then be available in all pharmacies. Furthermore, a constantly updated list can be viewed on the website of the Drug Commission of the German Medical Association (AkdÄ). At present (11th July 2018) the list includes 17 different valsartan-containing antihypertensive preparations. The BfArM informs in a statement about the current events concerning the drug recall.

Hypertensive patients are insecure. Already 17 preparations with the active substance Valsartan in different versions are recalled due to production-related impurities. More can follow. (Image: hafakot / fotolia.com)

Which medications contain Valsartan

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

The drug manufacturer is usually not the drug manufacturer

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

Why are the drugs being recalled??

According to the BfArM, contamination of the substance N-nitrosodimethylamine has been detected in certain batches of the active substance. According to the WHO and the EU's International Agency for Research on Cancer, this substance is thought to be a carcinogen.

How can people find out if their products are contaminated??

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

Where to exchange the contaminated drugs?

The German high pressure league reacts likewise with a current attitude. From this it appears that it will probably not be possible to exchange the drugs in a pharmacy. In earlier recall campaigns, sufferers had to have a new prescription issued by the appropriate physician. However, this may result in a new additional payment for the patients, which according to the statements made so far will not be reimbursed.

It is advisable to abstain from the active ingredient Valsartan?

No. Both the German High Pressure League and the Federal Institute for Drugs and Medical Devices warn of a self-reliant waiver. From a medical point of view there is no reason to renounce the active ingredient valsartan from harmless batches and harmless manufacturers. The problem would not be with the active substance itself, but with the production-related contaminants that were identified by the Chinese manufacturer and reported to the authorities.

Even a temporary suspension is not recommended

"Patients who take valsartan-containing medicines should not discontinue the medicines without consulting their doctor, as the health risk of weaning is many times higher than the potential risk from contamination," is the current recommendation of the BfArM , There is currently no acute patient risk. (Vb)

These preparations are currently affected

The list of AkdÄ's as of 09 July 2018 includes the following medicines 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; Vals / 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 Puren 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