VENTAVIS SIDE EFFECTS
SIDE EFFECTS
Clinical Studies 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.
Pre-marketing safety data on Ventavis were obtained from 215 patients with pulmonary arterial hypertension receiving iloprost in two 12-week clinical trials and two long-term extensions. Patients received inhaled Ventavis for periods of from 1 day to more than 3 years. The median number of weeks of exposure was 15. Forty patients completed 12 months of open-label treatment with iloprost.
The following table shows adverse events reported by at least 4 Ventavis patients and reported at least 3% more frequently for Ventavis patients than placebo patients in the 12-week placebo-controlled study.
Table 1: Adverse Events in Phase 3 Clinical Trial
| Adverse Event | Ventavis n = 101 |
Placebo n = 102 |
Placebo subtracted % |
| Vasodilation (flushing) | 27 | 9 | 18 |
| Cough increased | 39 | 26 | 13 |
| Headache | 30 | 20 | 10 |
| Trismus | 12 | 3 | 9 |
| Insomnia | 8 | 2 | 6 |
| Nausea | 13 | 8 | 5 |
| Hypotension | 11 | 6 | 5 |
| Vomiting | 7 | 2 | 5 |
| Alk phos increased | 6 | 1 | 5 |
| Flu syndrome | 14 | 10 | 4 |
| Back pain | 7 | 3 | 4 |
| Tongue pain | 4 | 0 | 4 |
| Palpitations | 7 | 4 | 3 |
| Syncope | 8 | 5 | 3 |
| GGT increased | 6 | 3 | 3 |
| Muscle cramps | 6 | 3 | 3 |
| Hemoptysis | 5 | 2 | 3 |
| Pneumonia | 4 | 1 | 3 |
Pre-marketing serious adverse events reported with the use of inhaled Ventavis and not shown in Table 1 include congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure.
In a small clinical trial (the STEP trial), safety trends in patients receiving concomitant bosentan and Ventavis were consistent with those observed in the larger experience of the Phase 3 study in patients receiving only Ventavis or bosentan.
Adverse Events With Higher Doses
In a study in healthy subjects (n=160), inhaled doses of iloprost solution were given every 2 hours, beginning with 5 mcg and increasing up to 20 mcg for a total of 6 dose inhalations (total cumulative dose of 70 mcg) or up to the highest dose tolerated in a subgroup of 40 subjects. There were 13 subjects (32%) who failed to reach the highest scheduled dose (20 mcg). Five were unable to increase the dose because of (mild to moderate) transient chest pain/discomfort/tightness, usually accompanied by headache, nausea, and dizziness. The remaining 8 subjects discontinued for other reasons.
Postmarketing Experience
The following adverse reactions have been identified during the postapproval use of Ventavis. 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.
Cases of bronchospasm and wheezing have been reported, particularly in patients with a history of hyperreactive airways. Bleeding events most commonly reported as epistaxis and hemoptysis were observed on Ventavis treatment . Cases of thrombocytopenia, dizziness, diarrhea, mouth and tongue irritation, nasal congestion, dysgeusia, hypersensitivity, and rash have also been reported with the use of Ventavis.
SRC: NLM .