This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (5.1) ] . EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH See full prescribing information for complete boxed warning. EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. ( 5.1 ) EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. ( 5.1 ) If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. ( 5.1 )
Romosozumab is authorised for severe postmenopausal osteoporosis, on the basis of a trial in several thousand women that showed a slightly lower risk of clinical fractures than with alendronic acid. This slight gain must be weighed against a possible increase in the risk of cardiovascular events, with higher mortality among patients aged 75 years and older ( Prescrire Int n° 223). Miscellaneous. A number of other drugs used for specific types of pain or in rheumatology are best avoided.
Prescrire is a French independent review funded only by subscribers, with no industry money. Its annual "drugs to avoid" list (2026 edition, section: Haematology) names drugs it judges more harmful than useful in every authorised indication. Its view is one expert opinion, reached without a conflict of interest.
is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1 ) Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. ( 1.2 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture EVENITY is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. 1.2 Limitations of Use The anabolic effect of EVENITY wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered [see Dosage and Administration (2.2) and Clinical Studies (14.1) ] .
is contraindicated in patients with: Hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY [see Warnings and Precautions (5.3) , Adverse Reactions (6.1) and Use in Specific Populations (8.7) ]. A history of systemic hypersensitivity to romosozumab-aqqg or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . Hypocalcemia ( 4 ) Known hypersensitivity to EVENITY ( 4 )
Major Adverse Cardiac Events (MACE): Monitor for symptoms of MI and stroke and seek prompt medical attention if symptoms occur. ( 5.1 ) Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria. Discontinue EVENITY if a clinically significant allergic reaction occurs. ( 5.2 ) Hypocalcemia: Adequately supplement calcium and vitamin D during treatment with EVENITY. ( 5.3 ) Osteonecrosis of the Jaw: Monitor for symptoms. Consider discontinuation of therapy based on benefit-risk assessment. ( 5.4 ) Atypical Femoral Fracture: Evaluate new or unusual thigh, hip, or groin pain to rule out an incomplete femur fracture. ( 5.5 ) 5.1 Major Adverse Cardiac Events (MACE) In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY compared to those treated with alendronate [see Boxed Warning and Adverse Reactions (6.1) ] . EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consi...
The following adverse reactions are discussed in greater detail in other sections of the label: Major adverse cardiac events [see Boxed Warning and Warnings and Precautions (5.1) ] Hypersensitivity [see Contraindications (4) and Warnings and Precautions (5.2) ] Hypocalcemia [see Contraindications (4) and Warnings and Precautions (5.3) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Subtrochanteric and Diaphyseal Femoral Fractures [see Warnings and Precautions (5.5) ] The most common adverse reactions (≥ 5%) reported with EVENITY in clinical trials were arthralgia and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of EVENITY for the treatment of postmenopausal osteoporosis was evaluated in a multicenter, randomized, double-blind, placebo-control...
Dosage and Administration ( 2.3 ) 1/2026
Source: FDA SPL label for Evenity (Amgen, Inc), effective 20260716. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 14 | 25 | 50 | 54 | 60 | 160 | 165 | 136 |
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
Not in the Medicare Part D spending file (typically hospital-administered or very new drugs).
No same-class alternatives found in RxClass.