Doripenem adverse reactions: Difference between revisions
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==Adverse Reactions== | ==Adverse Reactions== | ||
===Adverse Reactions from Clinical Trial=== | ===Adverse Reactions from Clinical Trial=== | ||
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Adverse reactions due to DORIBAX® 500 mg every 8 hours that occurred at a rate ≥ 1 % are listed in Table 4. Hypersensitivity reactions related to intravenous study drug occurred at a rate of less than 1%. | Adverse reactions due to DORIBAX® 500 mg every 8 hours that occurred at a rate ≥ 1 % are listed in Table 4. Hypersensitivity reactions related to intravenous study drug occurred at a rate of less than 1%. | ||
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=== Postmarketing Experience=== | === Postmarketing Experience=== | ||
The following adverse reactions have been identified during post-approval use of doripenem. Because these reactions were 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. | The following adverse reactions have been identified during post-approval use of doripenem. Because these reactions were 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.<ref>{{Cite web | last = | first = |title =http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf| url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf | publisher =|date = | accessdate = }}</ref> | ||
* [[Anaphylaxis]] | * [[Anaphylaxis]] | ||
Latest revision as of 22:12, 5 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Adverse Reactions
Adverse Reactions from Clinical Trial
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice.
During clinical investigations, 1338 adult patients were treated with DORIBAX® (1076 patients received doripenem 500 mg administered over 1 hour every 8 hours and 262 patients received doripenem 500 mg administered over 4 hours every 8 hours); in some patients parenteral therapy was followed by a switch to an oral antimicrobial. [see Clinical Studies (14)]. The median age of patients treated with DORIBAX® was 54 years (range 18–90) in the comparative complicated urinary tract infections (cUTI) study, 46 years (range 18–94) in the pooled comparative complicated intra-abdominal infections (cIAI) studies, and 56 years (range 18–94) in the other Phase 3 trials. There was a female predominance (62%) in the comparative cUTI study and a male predominance (63% and 75%) in the comparative cIAI and other Phase 3 trials, respectively. The patients treated with DORIBAX® were predominantly Caucasian (79%) in the five comparator-controlled Phase 3 studies.
The most common adverse drug reactions (≥ 5%) observed in the five DORIBAX® comparator-controlled Phase 3 clinical trials were anemia, headache, nausea, diarrhea, rash, phlebitis, and elevated hepatic enzymes. During clinical trials, adverse events led to discontinuation of DORIBAX® in 4.1% (55 of 1338) of patients compared to 4.3% (58 of 1325) of comparator-treated patients.
Adverse reactions due to DORIBAX® 500 mg every 8 hours that occurred at a rate ≥ 1 % are listed in Table 4. Hypersensitivity reactions related to intravenous study drug occurred at a rate of less than 1%.
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In a Phase 1 study of healthy subjects receiving doripenem doses greater than the approved dose of 500 mg every 8 hours for 10 to 14 days, the incidence of rash was higher than that observed in subjects who received 500 mg every 8 hours. The rash resolved within 10 days after doripenem administration was discontinued.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of doripenem. Because these reactions were 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.[1]
- Anaphylaxis
- Leukopenia
- Neutropenia
- Seizure
- Thrombocytopenia
- Toxic epidermal necrolysis
- Stevens-Johnson Syndrome
- Interstitial pneumonia
References
- ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022106s014lbl.pdf" (PDF). External link in
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Adapted from the FDA Package Insert.