Adverse reactions : תופעות לוואי

4.8      Undesirable effects
The safety of lanthanum carbonate for use in patients has been examined in a number of clinical studies. The most commonly reported adverse drug reactions, with the exception of headache and allergic skin reactions, are gastrointestinal in nature; these are minimised by taking Fosrenol with food and generally abated with time with continued dosing (see section 4.2).


The following convention was used for frequency of adverse drug reactions: Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥1/10,000 to < 1/1,000); Very rare (< 1/10,000), not known (cannot be estimated from the available data).

Infections and Infestations
Uncommon                                   Gastroenteritis, laryngitis Blood and lymphatic system disorders
Uncommon                                   Eosinophilia
Endocrine disorders
Uncommon                                     Hyperparathyroidism
Metabolism and nutrition disorders
Common                                       Hypocalcaemia
Uncommon                                     Hypercalcaemia, hyperglycaemia, hyperphosphataemia, hypophosphataemia,
anorexia, appetite increased
Nervous system disorders
Very Common                                  Headache
Uncommon                                     Dizziness, taste alteration Ear and Labyrinth disorders
Uncommon                                     Vertigo
Gastrointestinal disorders*
Very Common                                  Abdominal pain, diarrhoea, nausea, vomiting Common                                       Constipation, dyspepsia, flatulence Uncommon                                     Ileus, subileus, intestinal obstruction, irritable bowel syndrome, oesophagitis, stomatitis, loose stools, indigestion, gastrointestinal disorder (not otherwise specified), dry mouth, tooth disorder,
eructation
Rare                                         Intestinal perforation
Skin and subcutaneous tissue disorders
Uncommon                                     Alopecia, sweating increased Musculoskeletal and connective tissue disorders
Uncommon                                     Arthralgia, myalgia, osteoporosis General disorders and administration site conditions
Uncommon                                     Asthenia, chest pain, fatigue, malaise, peripheral oedema, pain, thirst.
Investigations
Uncommon                                     Blood aluminium increased, increase in GGT, increases in hepatic transaminases, alkaline phosphatase increased, weight decrease.
Not known                                    Product residue present1 1
See Lanthanum deposition in gastrointestinal mucosa warning in section 4.4 Special warnings and precautions for use
*In a clinical trial in healthy subjects, the incidence of gastrointestinal adverse events was higher after administration of the oral powder formulation of Fosrenol (13 subjects, 18.3%) than after chewable tablets (4 subjects, 6.6%).

Post marketing experience: During post-approval use of Fosrenol, cases of allergic skin reactions (including skin rashes, urticaria and pruritus) have been reported which show a close temporal relationship to lanthanum carbonate therapy. In clinical trials, allergic skin reactions were seen in both Fosrenol and placebo/active comparator groups at a frequency of very common (≥1/10).

Although there have been a number of additional isolated reactions reported, none of these reactions are considered unexpected in this patient population.
Transient QT changes have been observed but these were not associated with an increase of cardiac adverse events.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il