FDA Reviews Blood Clot Drug Vorapaxar

Dangerous drug lawyers at Pintas & Mullins Law Firm report that U.S. regulators recently accepted a marketing application for a blood clot drug called vorapaxar. The experimental drug, manufactured by Merck, was sidelined in 2011 after it was shown to increase bleeding risks.

The drug was acquired by Merck in 2009 when the pharmaceutical giant bought out rival drugmaker Schering-Plough Corp. The fateful 2011 study was conducted on 26,000 patients, and was one of the largest heart-drug studies ever conducted. It was cut short, however, when the drug was deemed inappropriate for patients who had already suffered a stroke, as it increased the risk of bleeding.

The new trial, set to begin this year, will include patients who are in stable condition after experiencing a heart attack or after being diagnosed with clogged arteries. Not surprisingly, it will not include patients who have suffered strokes. The trial’s main goal will be to determine whether or not vorapaxar can prevent heart attack and stroke in patients at high risk and whether it could do so safely.

Vorapaxar is eagerly awaited because it works to prevent cardiac events through a different mechanism than other drugs currently on market. Some analysts, however, are cautioning that even if it is approved by the FDA, it would still only be used in a limited number of patients because of the increased bleeding risk.

In related news, the FDA recently rejected AbbVie’s bid for approval of Humira in treating nonradiographic axial spondyloarthritis. The overwhelming rejection (12-1 vote) was due to inadequacies in the clinical trial the manufacturer used to support approval. The FDA considered the trial to be skewed, and since Humira is already approved for treatment of rheumatoid arthritis, plaque psoriasis, and ulcerative colitis, among other ailments, `panel members decided the trial criteria were too loose to define a population that would benefit.

Humira comes with a black box warning, the most severe of the FDA’s warning labels, detailing the risk of certain malignancies and infections. The panel was left unconvinced that the drug would be entirely safe in the population that did not experience effective benefits from the medication. Humira works by blocking the tumor necrosis factor (TNF), which is a protein naturally released by the immune system regulating immune responses to defend against infectious diseases and foreign materials.

Blocking TNF helps relieve the symptoms of certain diseases, such as Crohn’s diseases and psoriatic arthritis, but it also compromises the immune system and its ability to fight other infections. As a result, Humira has been associated with a plethora of devastating, occasionally fatal side effects.

Despite this, when the drug was initially approved in 2002, its labels included very little information on the potential side effects. In fact, it only warned of the risk of tuberculosis infection. Over the last decade the label has changed more than 20 times, adding greatly expanded risks and warnings. Humira’s labels now include the possibility of developing serious infections, malignancies, nervous system disorders, and drug-interactions.

This fraudulent failure to warn led to a mass of lawsuits filed by patients seriously injured by Humira. One man sued AbbVie after his wife suffered a life-threatening fungal infection while taking Humira for arthritis. The jury found that the manufacturer did not properly notify doctors and hospitals of the dangers of the drug, and awarded the family $2.2 million.

The case focused primarily on the extraordinary lapse in time between when the FDA told AbbVie it needed to notify doctors and hospitals of the risks and when the company actually sent out letters. It took AbbVie more than 20 months to send out the notification after the FDA directive in 2008. The plaintiffs successfully argued that if AbbVie had notified doctors in time, the woman would have been diagnosed with the deadly infection much earlier, avoiding much pain, medical bills and lost wages.

Humira lawyers at Pintas & Mullins Law Firm have decades of experience advocating on behalf of those seriously injured by dangerous or defective drugs such as Humira. If you or a loved one suffered a severe reaction to a medication, you may be entitled to significant compensation for your monetary damages and loss of quality of life.


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