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According to the results of adverse drug reaction assessment, in order to further protect the safety of public medication, the State Medical Products Administration decided to uniformly revise
the content of the instructions of Ibandronate sodium injection.
The relevant matters are hereby announced as follows:
1.
The marketing authorization holders of the above-mentioned drugs shall report to the Drug Evaluation Center of the State Medical Products Administration or the provincial drug administration department for the record
before April 4, 2023 in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and in accordance with the revised requirements of the instructions of Ibandronate Sodium Injection (see Annex).
Where the revised content involves drug labels, they shall be revised together, and the instructions and other contents of the label shall be consistent
with the original approved content.
Drugs produced on the date of filing shall not continue to use the original drug insert.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
2.
Drug MAHs shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to do a good job in publicizing and training on drug use and safety issues, and guide physicians and pharmacists in rational drug
use.
3.
Clinicians and pharmacists should carefully read the revised contents of the above drug inserts, and when selecting drugs, they should conduct a full benefit/risk analysis
according to the newly revised instructions.
4.
Patients should carefully read the drug instructions before taking drugs, and if they use prescription drugs, they should strictly follow the doctor's advice
.
5.
The provincial-level drug regulatory departments shall urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job of revising the corresponding instructions and replacing labels and instructions as required, and strictly investigate and deal with
violations of laws and regulations in accordance with law.
This is hereby announced
.
Attachment: Revision requirements for the instructions of Ibandronate sodium injection
1.
The following should be included under [Adverse Reactions].
Post-market experience
The following adverse reactions/events (incidence unknown) of this product were monitored after marketing:
Systemic reactions: fatigue
.
Chest: chest discomfort, chest pain
.
Musculoskeletal pain: Bone, joint, or muscle pain (musculoskeletal pain).
Musculoskeletal and connective tissue disorders: osteonecrosis of the jaw and other oral and maxillofacial areas (including osteonecrosis of the external auditory canal), atypical femoral shaft fractures
.
Metabolic and nutritional abnormalities: hypocalcemia
.
Immune system disorders: case reports of immediate anaphylaxis/shock, including reports of fatal events
.
Allergic reactions, including angioedema, asthma exacerbations, bronchospasm, facial swelling/edema, rash
.
Severe skin adverse effects, including Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis
.
Respiratory system: dyspnea, shortness
of breath.
Vascular lesions: phlebitis, thrombophlebitis
.
Nephrotoxicity: acute renal failure
.
Ophthalmic diseases: ocular inflammatory events such as uveitis, episcleritis, and scleritis
have been reported in patients receiving bisphosphonates.
In some cases, adverse events did not resolve
until bisphosphonates were discontinued.
II.
The following content should be included under [Precautions].
Osteonecrosis of the external auditory canal
Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma
.
In patients receiving bisphosphonates, the possibility
of osteonecrosis of the external auditory canal should be considered if ear symptoms such as chronic ear infection develop.
Atypical femoral shaft fracture
Atypical femoral shaft fractures have been reported primarily in patients
with long-term bisphosphonates for osteoporosis.
These transverse or short oblique fractures can occur anywhere in the femur, from below the trochanteric minor to above
the supracondylar fissure.
These fractures occur with minimal or no trauma, and some patients present with thigh or groin pain weeks to months before a complete femoral fracture, often with imaging features
of stress fractures.
Fractures are usually bilateral, so the contralateral femur should be examined in patients with femoral shaft fractures treated with bisphosphonates
.
There have also been reports of poor healing of these fractures
.
Bisphosphonate therapy should be discontinued in patients at risk of atypical femoral fracture, based on the results of the individual benefit risk assessment
.
During bisphosphonate therapy, patients should be advised to report thigh, hip, or groin pain, and patients presenting with such symptoms should be assessed for risk of
incomplete femoral fracture.
(Note: If the safety content of the original approval manual is more comprehensive or stricter than the requirements of this revision, the original approval content
should be retained.
) If other contents of the manual are inconsistent with the above revision requirements, they shall be revised
together.
）
State Food and Drug Administration
January 5, 2023
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