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Artiss (Fibrinogen / Thrombin Human) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Overall Adverse Reactions

Adverse reactions occurring in greater than 1% of patients treated with ARTISS were skin graft failure and pruritus.

Hypersensitivity/Allergic/Anaphylactic Reactions: Hypersensitivity or allergic/anaphylactoid reactions may occur (see WARNINGS/PRECAUTIONS, Hypersensitivity/Allergic/Anaphylactic Reactions ). No adverse events of this type were reported during clinical trials.

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 following adverse reactions have been reported from a clinical trial where ARTISS was used to affix split thickness sheet skin grafts to excised burn wounds (see CLINICAL STUDIES). A total of 8 non-serious adverse reactions were deemed related to the use of ARTISS by the investigator. Of the 8 related non-serious adverse reactions, 5 were incidences of skin graft failure: 4 were graft detachment/non-adherence and 1 was graft necrosis. The graft detachment in 2 patients may have been related to the maximum thawing temperature (40C) being exceeded during study product preparation. The 3 other non-serious adverse reactions considered related to ARTISS were 2 incidences of pruritus and 1 incidence of dermal cyst. The graft necrosis and the 2 cases of pruritus considered related to ARTISS each had an equivalent adverse reaction with the exact start date and severity reported at a control wound where skin grafts were affixed with staples. Therefore, these events are most likely not related to ARTISS, but instead are expected outcomes for any grafted wound regardless of the method of attachment.

Overall, the data collected and analyzed during this study demonstrated that ARTISS is safe for the attachment of sheet skin grafts in subjects with deep partial thickness or full thickness burn wounds.

The adverse reactions and their frequencies are summarized in Table 2:

Table 2.
Adverse reactions (Preferred Term) Number of events/
Number of patients treated
Dermal cyst 1/138
Pruritus 2/138
Skin graft failure 5/138

Post Marketing

The following adverse reactions reflect what has been reported in post marketing experience with Baxter's fibrin sealant that could reasonably be expected to occur with ARTISS:

Immune system disorders: anaphylactic responses, hypersensitivity
Cardiac disorders: bradycardia, tachycardia
Respiratory, thoracic and mediastinal disorders: dyspnea
Gastrointestinal disorders: nausea
Skin and subcutaneous tissue disorders: urticaria
General disorders and administration site conditions: flushing, impaired healing, edema, pyrexia
Injury, poisoning and procedural complication: seroma

Air embolism associated with misapplication of fibrin sealant using the spray device, Class Effect: A postmarketing fatality was reported in association with the use of another fibrin sealant when applied using a spray device. The case involved an attempt to stop active bleeding by applying the fibrin sealant using a spray device attached to a wall unit at a higher than recommended pressure for the spray device. In addition, the spray head was placed at a distance from the bleeding site that was closer than the recommended distance guidelines for the application of the sealant. The patient suffered a fatal air embolism.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.



REPORTS OF SUSPECTED ARTISS SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Artiss. The information is not vetted and should not be considered as verified clinical evidence.

Possible Artiss side effects / adverse reactions in 35 year old female

Reported by a physician from Germany on 2012-01-10

Patient: 35 year old female weighing 100.0 kg (220.0 pounds)

Reactions: FAT Necrosis, Inflammation

Adverse event resulted in: hospitalization

Suspect drug(s):
Artiss

Other drugs received by patient: Pantoprazole Sodium; Levothyroxine Sodium; Folic Acid; Ferro Sanol Comp



Possible Artiss side effects / adverse reactions in 58 year old female

Reported by a physician from Germany on 2012-01-10

Patient: 58 year old female weighing 62.0 kg (136.4 pounds)

Reactions: FAT Necrosis, Inflammation

Adverse event resulted in: hospitalization

Suspect drug(s):
Artiss



Possible Artiss side effects / adverse reactions in 37 year old female

Reported by a physician from Germany on 2012-01-10

Patient: 37 year old female weighing 73.0 kg (160.6 pounds)

Reactions: FAT Necrosis, Inflammation

Adverse event resulted in: hospitalization

Suspect drug(s):
Artiss



See index of all Artiss side effect reports >>

Drug label data at the top of this Page last updated: 2010-07-13

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