6.1 Clinical Trials Experience

Clinical trials are conducted under widely varying conditions, therefore, adverse reaction rates observed in the clinical studies 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.

In the two clinical trials with Depo-Provera CI, over 3,900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of Depo-Provera CI. The population studied ranges in age from 15 to 51 years, of which 46% were White, 50% Non-White, and 4.9% Unknown race. The patients received 150 mg Depo-Provera CI every 3-months (90 days). The median study duration was 13 months with a range of 1-84 months. Fifty‑eight percent of patients remained in the study after 13 months and 34% after 24 months.

Adverse reactions leading to study discontinuation in ≥2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2.0%).

6.2 Post-Marketing Experience

The following adverse reactions have been identified during post approval use of Depo-Provera CI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking Depo-Provera CI.

 

Table 3. Adverse Reactions Reported during Post-Marketing Experience

 

* Body System represented from COSTART medical dictionary.

 

† Injection site abscess and injection site infections have been reported; therefore, strict aseptic injection technique should be followed when administering Depo‑Provera CI in order to avoid injection site infections [see Dosage and Administration (2.1)].