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According to the results of adverse drug reaction assessment, in order to further protect the safety of public drug use, the State Medical Products Administration decided to uniformly revise
the instructions of alendronate sodium preparations (including alendronate tablets, alendronate enteric-coated tablets, alendronate sodium vitamin D3 tablets and alendronate sodium vitamin D3 tablets (II.
)).
The relevant matters are hereby announced as follows:
1.
The marketing authorization holders of the above-mentioned drugs shall, in accordance with the Measures for the Administration of Drug Registration and other relevant regulations, report to the Drug Evaluation Center of the State Medical Products Administration or the provincial drug regulatory department for the record
before January 27, 2023 in accordance with the requirements for amending the instructions of alendronate preparations (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 instructions
.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
2.
Drug marketing authorization holders shall conduct in-depth research on the mechanism of occurrence of new adverse reactions, take effective measures to publicize and train on drug use and safety issues, and guide physicians and pharmacists in rational drug use
.
3.
Clinicians and pharmacists should carefully read the revised content of the above drug instructions, 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 medication, and should strictly follow the doctor's advice when using prescription drugs
.
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 in 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: Alendronate preparation instructions revision requirements
NMPA
October 28, 2022
Alendronate preparation instructions revision requirements
1.
The following content should be included under [Adverse Reactions].
Post-IPO experience
The following adverse reactions/events of this product were monitored after marketing (the incidence is unknown):
Systemic reactions: peripheral edema
.
Musculoskeletal: arthralgia, back pain, atypical fractures of
the femoral shaft.
Nervous system: dizziness, vertigo, insomnia
.
Respiratory system, chest: chest pain, chest discomfort, dyspnea, acute asthma exacerbation
.
Cardiovascular: palpitations
.
Immune system: hypersensitivity
.
Digestive system: loss
of appetite.
Urinary system: hematuria, frequent urination, renal
impairment.
Skin: alopecia
.
Ocular symptoms: ocular uveitis, scleritis, or superficial scleritis
.
Ear disorders: rare reports
of cholestetoma of the external auditory canal (osteonecrosis of the lesion).
2.
The following content should be included under [Precautions].
Osteonecrosis of the jaw
Osteonecrosis of the jaw has been reported in cancer patients treated with bisphosphonates, usually associated with
tooth extraction and/or local infection with delayed healing.
Known risk factors for osteonecrosis of the jaw include invasive dental treatment (e.
g.
, tooth extraction, dental implants, orthopedic surgery), cancer diagnosis, concomitant therapy (e.
g.
, chemotherapy, radiation therapy, corticosteroids, angiogenesis inhibitors, smoking), poor oral hygiene, concomitant conditions (e.
g.
, periodontal and/or pre-existing dental disease, anemia, coagulopathy, infection, misaligned dentures).
The longer you are exposed to bisphosphonates, the higher the risk of osteonecrosis of the jaw
.
In patients who require invasive dental procedures, stopping bisphosphonate therapy may reduce the risk of osteonecrosis of the
jaw.
The clinical judgment of the treating physician and/or oral surgeon should guide each patient's treatment plan
based on individual benefit/risk assessment.
Patients who develop osteonecrosis of the jaw while receiving bisphosphonates should be treated
by an oral surgeon.
In these patients, major dental procedures to treat osteonecrosis of the jaw can aggravate the condition
.
Based on individual benefit/risk assessment, discontinuation of bisphosphonate therapy
should be considered.
While receiving bisphosphonate treatment, patients are encouraged to maintain good oral hygiene, undergo a routine oral examination, and report any oral symptoms such as loose, painful, or swollen
teeth.
Atypical femoral shaft fracture
Atypical fractures
of the femoral shaft have been reported in patients treated with bisphosphonates.
These fractures can occur in either of the femoral shafts below the trochanter to the condyle, and are transverse or oblique with no significant comminutement
.
Because these fractures also occur in osteoporosis patients who are not treated with bisphosphonates, there is no causal relationship
between these fractures and bisphosphonates.
Patients with a history of bisphosphonate therapy who present with thigh or groin pain may have an atypical fracture and should be evaluated to rule out incomplete femoral fracture
.
Patients presenting with atypical fractures should also be evaluated for fracture signs and symptoms
of the contralateral limb.
Discontinuation of bisphosphonate therapy
should be based on individual benefit/risk assessment.
3.
The following content should be included under [Drug interactions].
aspirin
In clinical studies, patients simultaneously receiving alendronate and aspirin-containing drugs at doses higher than 10 mg per day experienced an increased
incidence of adverse events in the upper gastrointestinal tract.
(Note: If the safety content of the original approval specification is more comprehensive or stricter than the content required by this amendment, the original approval content
shall be retained.
) If other contents of the specification are inconsistent with the above revision requirements, they shall be revised
together.
）
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