Liometacen Side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling:
•Cardiovascular Thrombotic Events
•GI Bleeding, Ulceration and Perforation
•Heart Failure and Edema
•Renal Toxicity and Hyperkalemia
•Serious Skin Reactions
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 clinical practice.
In a gastroscopic study in 45 healthy subjects, the number of gastric mucosal abnormalities was significantly higher in the group receiving Liometacen immediate-release capsules than in the group taking Liometacen suppositories or placebo.
In a double-blind comparative clinical study involving 175 patients with rheumatoid arthritis, however, the incidence of upper gastrointestinal adverse effects with Liometacen immediate-release capsules or suppositories was comparable. The incidence of lower gastrointestinal adverse effects was greater in the suppository group.
The adverse reactions for Liometacen immediate-release capsules listed in the following table have been arranged into two groups: (1) incidence greater than 1%; and (2) incidence less than 1%. The incidence for group (1) was obtained from 33 double-blind controlled clinical trials reported in the literature (1,092 patients). The incidence for group (2) was based on reports in clinical trials, in the literature, and on voluntary reports since marketing. The probability of a causal relationship exists between Liometacen capsules and these adverse reactions, some of which have been reported only rarely.
The adverse reactions reported with Liometacen immediate-release capsules may occur with use of the suppositories. In addition, rectal irritation and tenesmus have been reported in patients who have received the capsules.
Table 1 Summary of Adverse Reactions for Liometacen Capsules
|Inci d ence greater than 1%||In cidence l e ss than 1%|
|GAST ROINTE STINAL|
|na u sea* wi th orwi thout v o mi ti ng |
d y sp ep s ia* ( inc lud ing
ind igest io n, hear tb urn a nd e p ig astr ic p a in)
di arr h ea
ab d o minal dis tr ess or pa in co n s tip ati on
|a norexia |
b loat ing ( inc ludes d is te ns ion)
flatul e nce
pep tic ulcer
gas tro e n ter it is
rectal b leeding
p roc ti tis
s in g le or m u lti ple ulc erat io ns,
i nc lu d i ng p e rforat i on and h em or r h ageof t he es o ph ag us, s tomach,d u od en um or smallandlargeintestines
disturbances,includingthoseofthemacula,havebeenreportedin somepatientsonprolongedtherapy with
flushing or sweating
|None||acute anaphylaxis |
acute respiratory distress
rapid fall in blood pressure resembling
a shock-like state
|*Reactionsoccurringin3%to9%ofpatients treatedwithindomethacin capsules.(Thosereactionsoccurringinless than3%ofthepatientsareunmarked.)|
Causal relationship unknown: Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, the possibility cannot be excluded. Therefore, these observations are being listed to serve as alerting information to physicians:
Hematologic: Although there have been several reports of leukemia, the supporting information is weak
Genitourinary: Urinary frequency
A rare occurrence of fulminant necrotizing fasciitis, particularly in association with Group Aβ hemolytic streptococcus, has been described in persons treated with nonsteroidal anti-inflammatory agents, including Liometacen, sometimes with fatal outcome.
Known hypersensitivity to Liometacen, aspirin or other NSAIDs. Neonates w/ congenital heart disease when patency of the ductus arteriosus is needed for adequate pulmonary or systemic blood flow (e.g. neonates w/ pulmonary atresia, severe tetralogy of Fallot or severe coarctation of the aorta). Neonates w/ proven or suspected untreated infection, necrotising enterocolitis, impaired renal function, active bleeding (e.g. intraventricular haemorrhage or GI bleeding), thrombocytopenia or underlying coagulation defect. Patient w/ history of proctitis or recent rectal bleeding. History of asthma, urticaria, allergic-type reactions. Treatment of perioperative pain in the setting of CABG surgery. Concurrent use w/ diflunisal.
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Information checked by Dr. Sachin Kumar, MD Pharmacology