Venous Thromboembolism (VTE): DVT and PE on Labels
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Venous thromboembolism

Also called VTE, blood clot, deep vein thrombosis, DVT, pulmonary embolism, PE · Reviewed

Definition: Venous thromboembolism (VTE) is a blood clot that forms in a vein. NHLBI says it includes deep vein thrombosis (DVT), a clot usually in the lower leg, thigh or pelvis, and pulmonary embolism (PE), when a clot breaks loose and travels to the lungs. Up to 600,000 VTE events happen in the US each year.

Risk and signs

NHLBI says risk is highest after major surgery, major injury, or during infection and inflammation, and that not moving after surgery or on long trips raises it. Swelling, redness and pain are signs of DVT; a PE can cause sudden chest pain and shortness of breath. The NCI adds that medicines containing hormones are among the causes of PE.

Clot numbers on labels

Blood clots in label trials
LabelWhat it reports
Climara (WHI, estrogen alone)DVT 23 vs 15 per 10,000 women-years on placebo
Climara (WHI, estrogen plus progestin)Blood clots 35 vs 17; pulmonary embolism 18 vs 8 per 10,000 women-years
Evista (MORE trial)About 1 in 100 women over an average 2.6 years; hazard ratio 2.4, highest in the first months

Evista has a boxed warning for VTE. Its label says it is stopped at least 72 hours before and during long immobilization. Estrogen labels say estrogen is stopped right away if a clot is suspected, and, if feasible, 4 to 6 weeks before surgery linked to clots.

Why it matters for your log

Several labels tie clot risk to surgery and long periods without moving. A log that shows your current hormone or SERM doses makes it easy to tell a surgeon what you take and since when.

Read more on Dose Track: Blood clots on TRT · Estrogen patch vs pill blood clot risk · Evista side effects · Climara side effects

General education drawn from labels and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your product are the final word.
Women's Health InitiativeThe Women's Health Initiative (WHI) is a large set of studies in postmenopausal women aged 50 to 79 that… SERMA SERM (selective estrogen receptor modulator) is a drug that acts like estrogen in some tissues and… Boxed warningA boxed warning is a warning printed inside a border at the top of a US prescription drug label. FDA uses… Hazard ratioA hazard ratio (HR) compares how often an event happens over time in one group with how often it happens… HematocritHematocrit is the percentage of your blood volume made up of red blood cells. A result of 45 means about…

Frequently asked questions

Is a DVT the same as a pulmonary embolism?+
No. NHLBI says DVT is a clot in a deep vein, usually in the leg or pelvis, and a pulmonary embolism is when a clot breaks loose and travels to the lungs. Both are forms of VTE.
Which medicine labels warn about VTE?+
Estrogen labels and the raloxifene (Evista) label carry boxed warnings that include blood clots, with numbers from trials such as the Women's Health Initiative.

Sources

  1. NHLBI (NIH): What is venous thromboembolism?
  2. NCI Dictionary of Cancer Terms: pulmonary embolism
  3. Climara (estradiol transdermal system) US prescribing information, DailyMed
  4. Evista (raloxifene) US prescribing information, DailyMed

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