The blood thinners included in this announcement include Arixtra (fondaparinux sodium) Solution for subcutaneous injection; Fragmin (dalteparin sodium injection) for Subcutaneous Use; Innohep (tinzaparin sodium) injection; and Lovenox (enoxaparin sodium) injection for subcutaneous and intravenous use.

The new warning states that epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Health care professionals are asked to consider these risks when scheduling patients for spinal procedures.

Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

• Use of indwelling epidural catheters
• Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants.
• A history of traumatic or repeated epidural or spinal punctures
• A history of spinal deformity or spinal surgery

Health care providers are encouraged to monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Benefits and risks should be weighed before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

SOURCE: Heparin Recall › Revised boxed warning placed on blood thinners

Anticoagulants are often administered to patients before undergoing some surgeries and medical procedures to reduce the risk of life-threatening blood clots. Lovenox has been touted as an effective replacement for the blood thinner heparin in patients undergoing abdominal surgery.

Heparin carries a laundry list of side effects such as nausea, vomiting, abdominal pain, diarrhea and low blood pressure. Concerns about heparin flooded the media last year with cases of accidental overdoes and shipments of tainted batches of the blood thinner imported from China. Both incidences caused patients serious injury or death.

The contaminated heparin scandal in particular created an urgency among consumers, the medical community and pharmaceutical companies to find safer alternatives to the commonly used blood thinner.

Momenta chief executive officer Craig A. Wheeler said in the conference call that the FDA continues to review its Abbreviated New Drug Application (ANDA) process for M-Enoxaprin. ANDA is the FDA’s Center for Drug Evaluation and Research Office of Generic Drugs review and ultimate approval process of a generic drug.

Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. “We are in regular communication with the agency and responding to their questions as they arise,” Wheeler said.

Wheeler referred to the “global contamination issue” with the heparin supply and the FDA’s plant inspections of Chinese suppliers of heparin, adding that the companies who supply heparin to Momenta’s partner distributor Sandoz for the manufacture of M-Enoxaprin have all been inspected by the FDA.

While the company has no indication that the inspections raised concerns with the FDA, Wheeler said “Any disruption in the heparin supply has the potential to impact our supply chain.” As a result, the company will diversify its sources of heparin and closely monitor the supply chain.

Momenta hopes to launch M-Enoxaparin in 2009 provided the ANDA is readily approved by the FDA.

Source:
Seeking Alpha

SOURCE: Heparin Recall › FDA approval for marketing generic Lovenox expected

Rivaroxaban, a pill marketed in Europe as Xarelto, showed to be more effective than the anticoagulant heparin, while presenting no more side effects than heparin. Side effects of heparin and rivaroxaban include the risk of internal bleeding. Another benefit of rivaroxaban is that it does not need constant monitoring like another popular blood thinner, warfarin. Heparin is administered intravenously while warfarin is a pill taken orally.

Pharmaceutical companies have long been working on safer and easier alternatives to heparin and warfarin, especially since the tainted heparin scandal last year where more than 80 Americans died and hundreds more were made sick after receiving injections of batches of heparin that had been laced with oversulfated chondroitin sulfate (OSCS), a contaminant that mimics heparin but can cause serious allergic reactions in humans.

The FDA is expected to make a decision whether to approve rivaroxaban by May 28. If approved, rivaroxaban would be the first oral blood thinner approved since the FDA approved warfarin in 1954, according to Forbes.

“We appreciate the thoroughness of the advisory committee’s review, and we will continue to work with the FDA as they finalize their review,” Dr. Peter DiBattiste, vice president of Johnson & Johnson Pharmaceutical Research and Development, said in a prepared statement.

SOURCE: Heparin Recall › FDA panel recommends agency approval of heparin alternative

Last March, after more than 100 people died and hundreds more were sickened after being given the tainted heparin, an investigation found that heparin manufactured in Baxter’s China plant had been contaminated with oversulfated chondroitin sulfate (OSCS). OSCS mimics heparin and can cost substantially less to produce – $9 compared to $900. However, OSCS can cause serious allergic reactions which can lead to death.

The lawsuit states, “The recalled heparin was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses. Baxter placed tens of thousands of patients, including the Plaintiffs, at unnecessary risk of serious injury and/or death.”

It also claims Baxter wrongfully allowed the heparin to be placed on the market and “breached its express warranties that heparin had no dangerous side effects and that its ingredients were manufactured in a plant in accordance with FDA regulations,” according to the report.

The six-count suit seeks a judgment of more than $300,000 plus costs and other relief.

SOURCE: Heparin Recall › Class action lawsuit filed against Baxter over tainted heparin scandal

Blood thinners are routinely given to patients before certain types of surgery and treatments such as kidney dialysis to prevent blood clots from forming. Clots that do not naturally dissolve can travel through the blood stream and end up in the brain, causing a stroke, or in the lungs, causing a pulmonary embolism. Blood clots, also known as thrombosis, is a serious problem affecting nearly a million Americans each year and killing nearly 300,000 annually.

Two more common types of blood thinners are heparin and warfarin. Heparin is administered intravenously, requiring medical supervision, whereas warfarin is given orally. Both drugs have been used medically for decades. Both have side effects that doctors and patients find bothersome, including easy bruising, excessive bleeding, lower back pain, weakness or light-headedness, and flu-like symptoms. Thus physicians are eager to find safer alternatives.

Furthermore, heparin has been in the spotlight continuously over the past several months for confusing labeling that has resulted from overdoses that have sickened and killed patients, as well as batches of contaminated heparin that made its way into hospitals, causing more illnesses and deaths in patients who received the bad lots.

SOURCE: Heparin Recall › Drug makers rush to produce new blood thinners

Dr. Deborah Cook, academic chair of critical care medicine at St. Joseph’s, is leading a study to determine whether the newer and more expensive version of the blood thinner is more effective for patients in intensive care than the older one. Fifty-six ICUs in Canada, Australia, Brazil, U.S. and Saudi Arabia will participate in the study. Patients will be chosen at random from each of the participating ICUs.

The study also will look at each drug’s side effects, which can include excessive or unusual bleeding.

Heparin, which is used to prevent blood clotting, is routinely given to most ICU patients. The newer version has been touted as being stronger and thus is used most often. The newer heparin costs about $9 per day per patient compared to $2 per day per patient for the older version.

The study, which is called PROTECT and stands for Profhylaxis of Thromboembolism in Critical Care Trial, is funded by the Canadian Institutes of Health Research. No results have yet been posted for the study, which is currently halfway through the 2 ½-year research process.

SOURCE: Heparin Recall › Study compares brands of heparin given to ICU patients

Heparin is routinely used before certain types of surgery or other procedures are preformed to prevent clotting. Afterward, doctors will often remove the blood thinner to avoid unwanted bleeding by using the medication protamine.

Protamine is a weak anticoagulant drug that is administered intravenously and acts as a heparin antagonist. But protamine carries a risk of serious side effects such as difficulty breathing; swelling of the mouth, face, lips or tongue; wheezing; muscle pain; confusion; fainting; fast or irregular heartbeat; mood changes; seizures; slurred speech; headache; loss of consciousness; unusual hunger; unusual sweating; and weakness.

Many people also experience allergic reactions from heparin, including organ failure, heart problems and shock. Batches of the drug also have been recalled or seized by the federal government after more than 80 people died and hundreds more were sickened by heparin that was found to have been contaminated during manufacturing.

In an effort to find a safer product to remove heparin from the bloodstream, Krzysztof Szczubialka and his team of researchers have developed a new product made of microscopic polymer beads from modified chitosan, a product of shellfish. Lab tests show that the new material reduced heparin concentrations to nearly zero within 10 minutes. The product will be detailed in the December issue of American Chemical Society’s monthly journal, Biomacromolecules.

SOURCE: Heparin Recall › Scientists develop heparin antagonist medication

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.

SOURCE: Heparin Recall › doctors favor drug safety litigation