Several blockbuster drugs faced backlash after problems arose with their efficacy, safety, and quality that led to the removal of indications, prohibition of sale, and market withdrawal.
Government regulators withdrew insurance coverage for Dong-A ST’s gastritis treatment, Stillen, after reports concluded the drug’s efficacy was uncertain. Although the drug maintained its indication for gastritis, its sales fell into a downward spiral as regulators pulled out coverage for the drug.
Regulators also said Ursa, Daewoong Pharmaceutical’s most well-known product, was not useful for indigestion or appetite loss. The food and drug ministry’s re-examination showed that while it acknowledged the drug’s efficacy for physical fatigue caused by liver dysfunction, it could not see the same effectiveness for indigestion or appetite loss.
Multinational pharmaceuticals were not free from quality issues of their products, either.
Regulators slapped Abbot Korea with an import suspension that lasted from Feb. 1 to March 22 after discovering a metal object in Klaricid. Health regulators also stopped the sales of Klaricid products with a different serial number.
Pfizer Korea withdrew two drugs, one for dyslipidemia and one for anxiety, from the market this year. Reports detected microorganisms in the two doses of dyslipidemia treatment Lipitor. A closer inspection also showed the main ingredient in anxiety disorder treatment Xanax, alprazolam, decreased before the expiration date.
Sanofi-Aventis Korea also withdrew two diabetes injections, Apidra and SoloSTAR (also known as Lantus), in February after post-launch monitoring found an increase in an unknown substance in the injections’ batches at its German manufacturing plant.
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