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Hypertension: Valsartan recall recall updates - what patients need to know


These contaminated antihypertensives are affected

Regulators across Europe have been calling back blood pressure lowerers containing the active ingredient valsartan since early July. The reason was contamination in certain batches of the active ingredient that were supplied by a Chinese manufacturer. The probably carcinogenic substance N-nitrosodimethylamine (NDMA) was found in the active substance. As a result of the recall, many patients are now unsettled and do not know whether their valsartan preparations are affected. Heart experts provide information about what those affected can do now.

"Patients should see their family doctor and ask for an alternative," advises the cardiologist and pharmacologist Professor Dr. Thomas Meinertz in a press release from the German Heart Foundation. In many cases, it is possible to switch to another equally dosed valsartan preparation that is not affected by the contamination. The switch to an unaffected valsartan should take place at the latest when a new recipe is due. The specialist mentions candesartan or telmisartan as an example of safe medicines. Under no circumstances should the blood pressure lowerers simply be discontinued. This could cause spikes in blood pressure that endanger the heart and circulation, the cardiologist says.

How dangerous is the pollution?

NDMA is classified by both the World Health Organization (WHO) and the EU as likely to be carcinogenic to humans. For example, NDMA can also be found in cigarette smoke and in cured or smoked meat. According to the German Heart Foundation, up to 22 micrograms of NDMA per tablet were measured in some contaminated valsartan tablets. For comparison: smokers who consume 20 cigarettes a day are exposed to 17 to 85 micrograms of nitrosamines a day. In contrast, NDMA taken from food is only estimated at 0.3 micrograms per day.

No fixed limits

So far, 17 different preparations in different versions have been withdrawn from the market. According to the German Heart Foundation, it is possible that other sartans are contaminated. There are currently no concrete limit values ​​as to the amount of NDMA that is harmful to health. The German Heart Foundation is calling for a scientific investigation to clarify whether patients who have taken contaminated valsartan products for years are at increased risk of cancer.

Gaps in control

As the German Heart Foundation reports, the Chinese manufacturer had registered a new synthetic process before the contamination. This has been checked by the European Supervisory Authority (EDQM) in accordance with the legal provisions. Both the manufacturer and EDQM state that there was no evidence that contamination could occur. "Legislators should therefore step up controls on generics, for example through entrance tests," demands Professor Meinertz. The introduction of nationally binding tests by a central federal authority is also conceivable as a suitable measure.

How should heart patients behave now?

The Federal Association of German Pharmacy Associations (ABDA) suggest in a press release that cardiac patients should contact their doctor or pharmacist. Valsartan is mainly used against high blood pressure and heart failure. "The competent federal authority currently assumes that there is no acute health risk for patients," explains Professor Dr. Martin Schulz, Chairman of the Drug Commission of the German Pharmacists (AMK). It continued to apply that preparations containing valsartan should not be discontinued without consulting a doctor.

Where can the contaminated preparations be returned?

"Pharmacists must not simply exchange a opened package for a new one - all medicines containing valsartan are subject to a prescription," says Professor Schulz. For insured persons who are not exempt from the additional payment, an additional payment will unfortunately be due. The pharmacies would have to pass this full payment on to the respective health insurance company, explains the chairman. Consultations with the health insurance company could be worthwhile, however, as a large nationwide health insurance company has already announced that it will cover the costs.

Which antihypertensives are currently affected?

"Patients who take a medicine with valsartan can get advice on the Internet on the ABDA website and in their pharmacy whether their drug is affected by the current product recalls," recommends Schulz. The following products are currently affected (as of August 8, 2018):

  • Valsartan - 1 A Pharma: 40, 80, 160 and 320 mg, 28, 56 and 98 film-coated tablets, Valsartan - 1 A 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 AAA: 40, 80, 160 and 320 mg, all pack sizes, film-coated tablets
  • Valsargamma: 80 mg, all pack sizes, film-coated tablets (supplement)
  • Valsartan AbZ: 40, 80, 120, 160, 320 mg, valsartan comp. AbZ 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5, 320 mg / 25 mg, Valsartan CT 120, 160 mg, Valsartan comp.-CT 80 / 12.5, 160/12 , 5, 160/25 and 320 mg / 25 mg, film-coated tablets
  • Valsartan Actavis: 80 mg, 28 film-coated tablets, valsartan Actavis 320 mg, 28, 56 and 98 film-coated tablets
  • Valsartan AL: 40 mg, 28 film-coated tablets, Valsartan AL 80, 160 and 320 mg, 98 film-coated tablets, Valsartan / HCT AL 160 / 12.5, 160/25, 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®: 40 mg, 28 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, 80, 160 and 320 mg, 28, 56 and 98 film-coated tablets, Valsartan / HCT Stada 80 / 12.5, 160 / 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 and Valsartan Zentiva comp. 80 / 12.5, 160 / 12.5, 160/25, 320 / 12.5 and 320 mg / 25 mg, all pack sizes

(vb)

Author and source information

Video: FDA expands recall on blood pressure drug valsartan due to probable carcinogen (August 2020).