Biotech Values

[DewDiligence]

The main AE to Lovenox is heparin-induced
thrombocytopenia (HIT). Here are some
excerpts from the Lovenox FDA label:

http://www.fda.gov/cder/foi/label/2007/022138,020164s075lbl.pdf

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5) WARNINGS AND PRECAUTIONS

5.5 Thrombocytopenia

Moderate thrombocytopenia (platelet counts between 100,000/mm3 and 50,000/mm3) occurred at a rate of 1.3% in patients given Lovenox, 1.2% in patients given heparin, and 0.7% in patients given placebo in clinical trials.

Platelet counts less than 50,000/mm3 [severe thrombocytopenia] occurred at a rate of 0.1% in patients given Lovenox, in 0.2% of patients given heparin, and 0.4% of patients given placebo in the same trials. [I.e. these events were higher in placebo, presumably a statistical fluke—Dew]

Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm3, Lovenox should be discontinued. Cases of heparin-induced thrombocytopenia with thrombosis have also been observed in clinical practice. Some of these cases were complicated by organ infarction, limb ischemia, or death.

6) ADVERSE REACTIONS

6.1 Clinical Trials Experience

In a clinical trial in patients with acute ST-segment elevation myocardial infarction, the only additional possibly related adverse reaction that occurred at a rate of at least 0.5% in the Lovenox group was thrombocytopenia (1.5%). [The word “additional” means incremental to the AE’s seen in the Lovenox trials in DVT secondary to elective surgery.]

6.2 Post-Marketing Experience

Local reactions at the injection site (e.g., skin necrosis, nodules, inflammation, oozing), systemic allergic reactions (e.g., pruritus, urticaria, anaphylactoid reactions), vesiculobullous rash, rare cases of hypersensitivity cutaneous vasculitis, purpura, thrombocytosis, and thrombocytopenia with thrombosis have been reported.
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