A Medical Device Daily

U.S. marshals last week seized 11 lots of heparin from Celsus Laboratories (Cincinnati) as part of the FDA's ongoing efforts to ensure that heparin for patients remains safe.

The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request. The products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

Mike Chappell, acting associate FDA commissioner for regulatory affairs, said, "This action will help prevent this contaminated heparin from finding its way into the marketplace."

An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. Heparin Sodium USP is an API that may be incorporated into finished blood-thinning drug products.

Heparin Lithium is used in certain medical devices, including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes.

Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the U.S. and abroad.

OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS.

The seized Celsus heparin – which had entered the U.S. before the establishment of import controls for the drug – was tested for the presence of OSCS as part of the stepped-up FDA program.

To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

The FDA informed Celsus Laboratories during an April inspection and again in a May 8 letter that the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall.

The agency advised manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.

The FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.

Covidien, Wal-Mart in syringe recall

FDA is notifying healthcare professionals and patients that Covidien (formerly Tyco Healthcare; Mansfield, Massachusetts) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling.

The agency said use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall applies to lot number 813900 of Covidien/Tyco's ReliOn 1 cc, 31-gauge, 100 units for use with U-100 insulin. Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.

These syringes are distributed by Can-Am Care Corp. and sold only by Wal-Mart (Bentonville, Arkansas) at Wal-Mart stores and Sam's Clubs under the ReliOn name.

Wal-Mart has requested that all users of ReliOn 31-gauge, 1 cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product.

The FDA urged patients and healthcare professionals to check their syringe packaging carefully for syringes labeled as 100 units for use with U-100 insulin from that lot number.

During the packaging process for this lot, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin.

The manufacturer has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam's Clubs from Aug. 1-Oct. 8, 2008.

Affirmation, not a rebuke, says Andy

Writing in his blog, "Andy's Take," FDA Commissioner Andrew von Eschenbach, MD, hailed a contrary point of view expressed by a subcommittee of the FDA Science Board recently evaluating the scientific data on bisphenol A, or BPA.

"When I spoke with you in August about BPA," von Eschenbach wrote, "I mentioned that as a science-based regulatory agency we need the best science to make good public health decisions. And part of that process is seeking input from experts outside the agency. In this case the experts on the subcommittee presented a perspective that someone described as a 'stinging rebuke' of FDA.

"My take," he said, "is that this report presenting a contrary point of view is exactly what FDA needed to hear. Rather than a rebuke of our position, the report was a strong affirmation of our process a process to identify information that will better inform our regulatory decision-making."

He noted that FDA "asked for this report, asked for this critical analysis, and we will continue to do so. Input such as this as well as information from a variety of sources like analyses conducted by other regulatory agencies will be incorporated into our regulatory decision-making."

von Eschenbach added, "Regulatory decisions regarding the safety and effectiveness of a product must always be based on comprehensive knowledge of that product. This knowledge is derived from a rigorous and disciplined analysis of information about that product that is based in turn on accumulation of scientific data. That is why we say that FDA is a science-based regulatory agency.

"But science is always evolving, and in fact that evolution has become so rapid that we now describe it as a revolution in science. The agency seeks the new data coming from that revolution. But these new scientific data must be assembled into information and converted to knowledge upon which our regulatory decisions are based," he said.