Hypertension Updates to Valsartan Recall - What Patients Need to Know

These contaminated antihypertensives are affected

Regulators all over Europe have been claiming antihypertensive drugs containing valsartan since the beginning of July. The reason was impurities in certain batches of the active ingredient, which were supplied by a Chinese manufacturer. In the drug, the likely carcinogenic substance N-nitrosodimethylamine (NDMA) was found. Many patients are now unsure as a result of the recall and do not know if their valsartan preparations are affected. Heart experts provide information on what those affected can do.

"Patients should visit their family doctor and ask for an alternative," advises cardiologist and pharmacologist Professor. Thomas Meinertz in a press release of the German Heart Foundation. In many cases, it is possible to switch to another doses of the same dosage of valsartan, which is not affected by the contamination. At the latest when a new recipe is due, the switch to an unaffected Valsartan should be made. As an example of safe medicines the specialist calls candesartan or telmisartan. Under no circumstances should the antihypertensives be discontinued easily. This could cause blood pressure peaks that endanger the heart and circulation, the cardiologist said.

Antihypertensives with valsartan are currently causing anxiety in high blood pressure patients. The actual risk posed by the contaminants remains unclear. However, experts advise against simply selling off the funds. (Image: Zerbor / Fotolia.com)

How dangerous is the pollution?

NDMA is considered by both the World Health Organization (WHO) and the EU to be probably carcinogenic to humans. For example, NDMA can also be found in cigarette smoke and 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 have a load of nitrosamines from 17 to 85 micrograms per day. By contrast, dietary NDMA is estimated to be only 0.3 micrograms per day.

No set limits

So far, 17 different preparations in various designs have been withdrawn from the market. According to the German Heart Foundation, however, it is possible that even more sartans are contaminated. Concrete limits, from which amount NDMA is harmful to health, there is currently not. The German Heart Foundation calls for a scientific study to clarify whether patients who have taken contaminated valsartan products for years are at increased risk for cancer.

Gaps in the control

As the German Heart Foundation reports, the Chinese manufacturer had filed a new synthesis procedure before the contamination. This has been reviewed by the European Supervisory Authority (EDQM) in accordance with legal requirements. Both the manufacturer and the EDQM indicate that there was no evidence that contamination could occur. "The legislator should therefore strengthen the controls of generics, for example, by entrance checks," says Professor Meinertz. The introduction of nationally binding tests by a central federal authority could also be envisaged as a suitable measure.

How should heart patients behave now?

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

Where can the contaminated preparations be returned??

"Pharmacists are not allowed to simply replace an open pack with a new one - all valsartan-containing medicines are subject to the prescription requirement," says Professor Schulz. For insureds who have not been exempted from the additional payment, an additional payment will unfortunately be due again. The pharmacies would have to forward this additional payment in full to the respective health insurance company, explains the chairman. However, consultations with the health insurance could be worthwhile, as a large nationwide health insurance company had already announced that they would pay the costs incurred.

Which antihypertensives are currently affected?

"Patients who take a medicine containing valsartan can consult the ABDA website and their pharmacy for advice on whether their medicine is affected by the current recalls," Schulz recommends. Currently the following products are affected (as of August 08, 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 tablets, Valsartan AL 80, 160 and 320 mg, 98 tablets, Valsartan / HCT AL 160 / 12.5, 160/25, 320 mg / 25 mg, 98 tablets, Valsartan AL 40 mg, 28 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, 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 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, 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)