TTP Blood Disorder a Possible Plavix Side Effect

<"">Plavix, a popular blood-thinning drug used to prevent heart attacks and strokes, could cause a life-threatening blood disorder in some users. The condition, known as thrombotic thrombocytopenic purpura, or TTP, is marked by the formation of blood clots in small blood vessels throughout the body. Untreated, TTP blood clots block the blood vessels and limit blood flow to the brain, kidneys, or heart.

TTP was not observed in clinical trials of more than 17,500 Plavix-treated patients prior to its approval in 1997. The drug was only first linked to TTP in an article published on June 15, 2000 in the New England Journal of Medicine (NEJM), which identified 11 cases of the disorder in Plavix patients. According to a report published by The New York Times in April 2000, two others were identified by the paper’s authors after it was submitted to the journal.

According to The New York Times, the NEJM article stated that TTP usually appeared within two weeks after victims started Plavix and required aggressive treatment with plasma exchange. The majority of Plavix TTP patients needed 6 to 12 exchanges, while one needed 30. One of the patients died.

Dr. Charles J. Davidson of Northwestern University, one of the paper’ co-authors, told the Times that doctors “need to think strongly before we use this medication as a replacement for aspirin in patients in whom we are looking to prevent heart attack and stroke.” He added that Plavix appeared to “be more toxic than aspirin”

In April 2005, the U.S. Food & Drug Administration (FDA) updated the Plavix label to warn that rare reports of TTP had been associated with its use, sometimes after only a short exposure (less than two weeks). According to the FDA, worldwide postmarketing reports revealed a TTP incidence of approximately four cases per million patients exposed to Plavix.

TTP may first present with a skin rash made up of purplish spots that are the result of bleeding under the skin. This rash will appear on the skin, as well as the mucus membranes. Plavix patients who experience such a rash must call see a doctor immediately and undergo a blood test to determine if their platelet level is low.

Other TTP symptoms include:

• Pale skin
• Weakness
• Fever
• Increased heart rate
• Shortness of breathing
• Headache
• Speech changes
• Confusion
• Stroke
• Seizure
• Coma
• Decrease in the amount of urine
• Increase in the amount of blood or protein present in the urine.

TTP results in death in 10 to 20 percent of cases, according to a 2005 study published in the journal “Heart.”

This entry was posted in Pharmaceuticals, Plavix. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.