Drug, Medical Device Recalls Increase in Third Quarter

Drug, Medical Device Recalls Increase in Third QuarterThe number of food, drug and medical device recalls continued to ascend in the third quarter, according to data from the quarterly ExpertRECALL Index, which was released in early November.

The index found that food recalls in the third quarter caused problems for nearly six times as many units as the previous quarter, while the FDA reported a 54 percent increase in drug recalls from the second quarter of 2011. In 150 of the recalls, manufacturers oversaw the return of as many as 30 million units of pharmaceuticals.

Enforcement reports from the FDA documented 290 medical device recalls, increasing roughly 5 percent against the average in the first two quarters of 2011. Medical device recalls affected markets both in the U.S. and abroad, although 95 percent remained in the U.S. The callbacks affected two times as many units as in the second quarter, and were initiated by more than 130 companies at least once. Forty companies reported initiating more than one recall in the quarter.

The quarterly index compiles recall activity and trends across five categories, including medical devices, pharmaceuticals, food, consumer products and children's products. Medical device recalls reported a 25 percent increase from the previous quarter, based on data from the Food and Drug Administration. The report categorizes the severity of recalls in the same way as the FDA, as Class I, II, and III.

Of all drug recalls, less than 7 percent were labeled as class I, which involve situations where there is "a reasonable probability that the product will cause serious adverse health consequences or death," according to the FDA.

Another 60 percent were Class II recalls, which present situations in which a product could cause temporary adverse health consequences, while the remaining were labeled Class III, in which the product is unlikely to cause health problems.

In the pharmaceuticals category, the index found there were 150 drug recalls. Although the number increased, 16 percent fewer units were affected. Of the total number of drug recalls, 132 had far reaching effects into international markets.

In Japan, problems with the drug Actos have brought profits from Japanese pharmaceutical company Takeda tumbling down, according to Reuters.

Takeda, the largest drugmaker in Japan, reported a 4.8 percent decline in operating profits due to concerns over its top selling Actos product. The company booked operating profit between April and September as $2.7 billion.

While the profits were slightly dented by the strengthening yen, the biggest blow came from a request by European medical authorities to include warnings on all Actos pills stating the drug had been linked to bladder cancer.

Problems with the drug led Takeda, which is almost 30 percent owned by foreign investors, to slash its profit expectations for the business year ending March 2012 to 270 billion yen from initial estimates of 390 billion yen.

Shares of the company have dropped roughly 13 percent in 2011.

According to The Scientist magazine, the increasing number of recalls is likely due to more intense oversight of the FDA at drug manufacturing plants.

"Regulatory oversight has been increasing and we do expect this trend to continue," says Mike Rozembajgier, VP for Recalls at Stericycle ExpertRECALL. "With the U.S. Government Accountability Office’s recent call for the agency to intensify its efforts to track and regulate overseas pharmaceutical manufacturing, we can expect the FDA to intensify its oversight even more."