Taiwan’s FDA orders recall of Norvasc high blood pressure drug

The Taiwan Food and Drug Administration (FDA) on Saturday announced an order recalling two batches of a high blood pressure drug, tablets from which have been found to contain iron wires.

The recall involves two batches totaling 6 million Norvasc tablets/5 mg produced by U.S.-based drug developer Viatris Inc. with the designations FR3135 and FT2343. The company has been ordered to complete the recall by Jan. 29, the FDA said.

The major ingredient in Norvasc is amlodipine besylate, which is used to treat high blood pressure or angina as it inhibits the movement of calcium ions across cardiac muscle and the smooth muscle lining of blood vessels.

In December, Taiwan’s Consumers’ Foundation held a news conference where it detailed complaints from long-term local Norvasc users, claiming they found iron wires inside the drug when they cut the tablets in half, according to Hung Kuo-teng (???), head of the FDA’s Medicinal Products Division.

After the news conference the FDA launched an investigation, asking Viatris to provide information about the drug, and then identified the batch of problematic Norvasc tablets as designated FR3135, Hung said.

The FDA concluded that another batch, designation FT2343, could also be affected by the same problematic production process and so ordered it recalled as well.

According to Hung, Norvasc, of which about 210 million tablets were sold in Taiwan in 2022, accounts for about 60 percent of the local high blood pressure drug market, in terms of the same form of drug and dosage, so it is unlikely the recall of 6 million tablets will have a major impact on the medication’s sales in the country.

In addition to being ordered to recall the problematic Norvasc tablets, Hung said Viatris has also been instructed by the FDA to submit a report on the incident as well as detailed measures to prevent a re-occurrence of the problem.

High blood pressure patients affected by the recall who want to use alternative drugs should consult with their doctors before doing so, the FDA said.

Source: Focus Taiwan News Channel