The company said it took action to withdraw its products from sale on behalf of the Bristol-Myers Squibb/Sanofi-Aventis partnership because of a potential variability in levels of the less-soluble form of the active ingredient in Avalide, irbesartan, which could result in slower dissolution.
Christina Trank, a spokesperson for B-MS, told in-PharmaTechnologist: “A thorough review of the global post-marketing safety database has not revealed evidence of a signal suggesting reduced efficacy in any lots. However we cannot definitely exclude this possibility at this time.”
Possible reduced efficacy in lots
The voluntary recall involves Avalide containing 150mg of irbesartan, marketed as Avapro, and 2.5 mg of the generic diuretic, hydrochlorothiazide (HTC,) as well as other affected lots of 300/12.5 mg, 300/25 mg and blister sample packs of 300/25 mg.
Trank said the decision to initiate the recall came after the company developed more sensitive testing methods to identify a less soluble form of the active ingredient and found that the lots in question were not in full compliance with the filed product registration dossiers.
Though there have been no reports from patients of adverse events, Trank confirmed that “a cross-functional investigation is in progress to prevent recurrence of the less soluble form of irbesartan being produced during the drug product manufacturing process.”
In September last year, B-MS recalled 62 lots - equivalent to 60m tablets - of the hypertension drug which is manufactured in Puerto Rico. The company said the latest recall involved 65 lots of Avalide manufactured in sites in Humacal, Puerto Rico and Evansville, Indiana.
Puerto Rico less attractive to drugs manufacturers
B-MS’ latest recall comes shortly after the publication of a new report that suggests Puerto Rico may be losing its appeal to drugmakers.
The study cites problems with the quality of output from some plants on the island, increased operating costs for pharma and biotech firms, and the October passing of a tax law that imposes a four per cent tax on non-resident companies operating in the country as the main factors behind the island’s fall from favour.
Predicting that Puerto Rico may lose some of its drug manufacturing sites to Brazil and Mexico, which are investing heavily in developing export industry and boast huge domestic demand, the report indicates that this would irrevocably impact on scientific innovation and could lead to further plant closures in the territory. This would affect the island’s export potential.
A spokesperson for Business Monitor International, explained that regardless of such outcomes, Puerto Rico still remains one of the highest-ranking markets in the market research firm’s latest Business Environment Rankings (BER) for the Americas region, trailing only the US and Canada.
They said: “The US healthcare reform should boost public finances in Puerto Rico, with the Commonwealth’s Medicaid funding set to jump 182 per cent to $8.62bn over the next nine years, which should preserve some of the territory’s attractiveness to pharmaceutical players.”