OSPHENA SIDE EFFECTS
- Generic Name: ospemifene tablets
- Brand Name: Osphena
- Drug Class: Selective Estrogen Receptor Modulators
SIDE EFFECTS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders
- Malignant Neoplasms
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 OSPHENA has been assessed in ten phase 2/3 trials (N=2209) with doses ranging from 5 to 90 mg per day. The duration of treatment in these studies ranged from 6 weeks to 15 months. The majority of women (N=1683) had treatment exposure up to 12 weeks; 847 had up to 52 weeks (1 year) of exposure.
The incidence rates of thromboembolic and hemorrhagic stroke were 1.13 per thousand women years (1 reported case of thromboembolic stroke) and 3.39 per thousand women years (3 reported cases of hemorrhagic stroke), respectively in OSPHENA 60 mg treatment group and 3.15 (1 case of thromboembolic stroke) and 0 per thousand women years, respectively in placebo. There were 2 reported cases of DVT among the 1459 women in the OSPHENA 60 mg treatment group and 1 case of DVT among the 1136 women in the placebo group.
Table 1 lists adverse reactions occurring more frequently in the OSPHENA 60 mg treatment group than in placebo and at a frequency ≥1% in the 12-week, double-blind, placebo-controlled clinical trials. Table 2 lists adverse reactions occurring more frequently in the OSPHENA 60 mg treatment group than in placebo and at a frequency ≥1% in all clinical trials up to 52-weeks.
Table 1: Adverse Reactions Reported More Commonly in the OSPHENA Treatment Group (60 mg Once Daily) and at Frequency ≥1.0% in the 12 Week Double-Blind, Controlled Clinical Trials with OSPHENA vs. Placebo
| Ospemifene 60 mg (N=1459) % |
Placebo (N=1136) % |
|
| Vascular Disorders | ||
| Hot flush | 6.5 | 2.6 |
| Reproductive System and Breast Disorders | ||
| Vaginal discharge | 3.8 | 0.4 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Muscle spasms | 1.8 | 0.6 |
| Skin and Subcutaneous Tissue Disorders | ||
| Hyperhidrosis | 1.1 | 0.2 |
Table 2: Adverse Reactions Reported More Commonly in the OSPHENA Treatment Group (60 mg Once Daily) and at Frequency ≥1.0% in All Clinical Trials up to 52 Weeks (Safety Population)
| Ospemifene 60 mg All Trials (N=847) % |
Placebo (N=165) % |
|
| Nervous System Disorders | ||
| Headaches | 2.8 | 2.4 |
| Vascular Disorders | ||
| Hot flush | 12.2 | 4.2 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Muscle spasms | 4.5 | 2.4 |
| Skin and Subcutaneous Tissue Disorders | ||
| Hyperhidrosis | 2.5 | 1.8 |
| Night sweats | 1.2 | 0.0 |
| Reproductive System and Breast Disorders | ||
| Vaginal discharge | 6.0 | 0.6 |
| Vaginal hemorrhage | 1.3 | 0.0 |
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ospemifene. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Neoplasms Benign, Malignant and Unspecified (incl. cysts and polyps): endometrial hyperplasia, endometrial cancer
Immune System Disorders: allergic conditions including hypersensitivity, angioedema
Nervous System Disorders: headache
Vascular Disorders: deep vein thrombosis, thrombosis, pulmonary embolism
Skin and Subcutaneous Tissue Disorders: rash, rash erythematous, rash generalized, pruritus, urticaria
SRC: NLM .