The medical net on July 6 was the serious adverse reaction of the disabled, 124 best-selling drugs were modified instruction manual! Thousands of drug companies.
Yesterday (July 5), the state administration of food and drug administration issued a notice on the revision of the general use of fluoroquinolones for the whole body (no. 79 of 2017). The general administration decided to add a black box warning to the "whole-body fluoroquinolones" specification, and to modify the indications [indications], [adverse reactions], [cautions], etc.
Administration also announced the "whole body with fluoroquinolone drugs" list of norfloxacin capsule and levofloxacin hydrochloride injection, etc. The most commonly used, the best-selling drug in it, a total of 124 (see attachment).
More than 3,000 batches of such drugs have been approved by the general administration database, involving thousands of pharmaceutical companies.
124 drug administration requirements in this prospectus, increase the "black box" warning: serious adverse events, including tendinitis and tendon rupture, peripheral neuropathy, the influence of the central nervous system and myasthenia gravis.
In 【 side effect 】 : seriously, and other important adverse reactions, including "disabling and potentially irreversible serious adverse events, including tendinitis and tendon rupture, peripheral neuropathy, and the influence of the central nervous system", etc. 11.
And in the [notes], they correspond to each other. Such as: the use of fluoroquinolone drugs, reports have different organs in the body of patients with the same system at the same time disabling and potentially irreversible serious adverse reaction, usually includes: tendinitis and tendon rupture, arthralgia, myalgia, peripheral neuropathy and central nervous system responses (hallucinations, anxiety, depression, insomnia, severe headache and disorder). (see annex for details)
In the announcement, the general administration requested that the relevant pharmaceutical companies of 124 drugs be submitted to the provincial food and drug administration for filing before August 31, 2017. In the next six months, the manufacturer's instructions and labels will be replaced.
From April 2003 to now, the general administration has issued a revision notice of 152 pharmaceutical instructions. This time, there are more medicines and pharmaceutical companies than ever before.
The side effects of quinolones have been attracting attention for some time. The revision is also gradual. On August 2, 2013, the administration has released on the alert to serious adverse reaction of levofloxacin injection in the bulletin, June 30, 2016, forwarding the FDA "to limit the fluoroquinolone indications and warning disability risk". Today, a quick fix, a decisive revision.
Only, in the revised manual, are the "black box warning" and "serious adverse reactions to disability", which doctors also prescribe? Do patients dare to use it?
1. Revised general requirements
1. This manual amendment applies only to the whole body with fluoroquinolone drugs preparations and injections (oral), the entire body shall be applicable to the specific revision opinion with fluoroquinolone drugs under each specific varieties.
2. The whole body with fluoroquinolone drugs preparations and injections (oral) manual revision is aimed at the black box warnings 】 and 【 side effect 】 and 【 notes 】 three part, should follow the following principles: such as the revision content has been approved by the state food and drug supervision and management of administration related content more strict and comprehensive, the description should be modified according to this revision opinion. The relevant content approved by the state administration of food and drug administration shall not be removed in principle. If the original approval content is more comprehensive or more rigorous than this revision, the original approval shall be retained.
Add black box warning
Should include at least the following:
Warning: severe adverse reactions, including tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects and myasthenia gravis.
· the use of fluoroquinolone drugs (including XXXX) has been reported at the same time both disabling and potentially irreversible serious adverse reactions (see [note]), including:
Tendonitis and tendon rupture (see note)
Peripheral neuropathy (see note)
Effects of the central nervous system (see note)
When these serious adverse reactions occur (see [note]), XXXX should be discontinued immediately and the use of fluoroquinolones should be avoided.
· fluoroquinolones may exacerbate myasthenia in patients with myasthenia gravis. Patients with a known history of severe myasthenia should avoid using XXXX (see article).
, due to the use of fluoroquinolone drugs (including XXXX) has been reported serious adverse reaction (see [note]), for patients with belong to the following indications, should be used when no other drug treatment can XXXX:
Acute bacterial sinusitis (see indications and usage)
Acute episodes of chronic bronchitis (see indications and usage)
Simple urinary tract infection (see indications) and [usage]
Acute non-complicated cystitis (see indications and usage)
Note: 1. For the above indications, only the approved indications are listed according to the drug specification.
The "XXXX" is the generic name for the drug.
Three, [indications] increased content
As approved drugs manual containing indications 】 【 "acute bacterial sinusitis," "chronic bronchitis acute" "simple urinary tract infection (uti)" "acute non complexity cystitis," to be in the corresponding indications after increasing restrictions on the use of hints respectively, specific content as follows: "due to the use of fluoroquinolone drugs (including XXXX) has been reported serious adverse reaction, and for some patients, acute bacterial sinusitis/chronic bronchitis acute/simple/acute urinary tract infection of complexity cystitis have self-limiting, should be used when no other medication can XXXX."
Iv. The following contents should be added to the item
Serious and other significant adverse reactions
L disabling and potentially irreversible adverse reactions, including tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects
L tendon disease and tendon rupture
L QT period is extended
L anaphylaxis
Other serious and sometimes fatal reactions
The effects of the l central nervous system
L was associated with diarrhea
Peripheral neuropathy
L's interference with blood sugar
L photosensitive/phototoxic
These adverse reactions are described in detail below.
Cardiovascular system: extended period of QT, tachycardia, ventricular tachycardia, ventricular arrhythmias
In the central nervous system: convulsions, psychosis, tremor, restlessness, anxiety, dizziness, confusion, hallucinations, delusions, nightmares, insomnia, depression, seizures, a small number of conditions can lead to patients with suicidal thoughts or actions
Peripheral neuropathy: touch feel confusion, insensitive, and physical pain, pain, burning sensation, tingling, numbness, weakness, or the light touch, pain, temperature sense, location and abnormal vibration sense, multiple neuritis
Skeletal muscle system: joint pain, muscle pain, muscle weakness, tension in tendonitis, tendon rupture, and myasthenia
Allergic reaction: hives, itching, and other serious skin reactions, such as toxic epidermal necrosis release, erythema multiforme), breathing difficulties, angioneurotic oedema (including the tongue, throat, pharynx, or facial edema/swelling), cardiovascular collapse, low blood pressure, loss of consciousness, airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), hypersensitivity pneumonitis, anaphylactic shock
Hepatobiliary system: hepatitis, jaundice, acute liver necrosis or liver failure
Urinary system: acute renal insufficiency or renal failure
Blood system: anemia, including hemolytic anemia aplastic anemia, thrombocytopenia, and thrombotic thrombocytopenic purpura, white blood cells reduce disease, granulocytopenia, complete blood disease and/or other blood diseases
Other: fever, vasculitis, serum disease, fuselage related diarrhea, blood glucose disorder, photosensitivity/phototoxicity
Note: if there is any specific clinical trial experience and post-marketing monitoring and other related content, please make the supplement.
5. The following contents are added:
1. Disabling and potentially irreversible adverse reactions, including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects
The use of fluoroquinolone drugs, reports have different organs in the body of patients with the same system at the same time disabling and potentially irreversible serious adverse reaction, usually includes: tendinitis and tendon rupture, arthralgia, myalgia, peripheral neuropathy and central nervous system response (hallucinations, anxiety, depression, insomnia, severe headache and disorder). These adverse reactions can occur hours to weeks after using XXXX. In any age group, there was no risk factor before, and there were reports of these adverse reactions.
2. Tendon disease and tendon rupture
Fluoroquinolones can increase the risk of tendinitis and tendon rupture in all age groups. This type of adverse reaction occurs most frequently in the Achilles tendon, which may require surgical repair. There are also reports of tendinitis and tendon rupture in the shoulders, hands, biceps, thumb and other tendons. Tendonitis and tendon rupture can occur within hours or days after the use of XXXX, or several months after treatment. Tendonitis and tendon rupture can occur on both sides. The risk was increased in patients aged 60 and older, with corticosteroid and kidney, heart or lung transplants. In addition to age and use of corticosteroids factor, the other factors that increase the risk of tendon rupture include independently strenuous physical activity, renal failure and previous tendon disease, such as rheumatoid arthritis. Tendinitis and tendon fractures also occur in patients with fluoroquinolones without these risk factors. Tendon rupture can occur after treatment or after treatment; There were also reports of a tendon rupture that occurred months after treatment ended. This product should be stopped after the patient has a tendon pain, swelling, inflammation or fracture. After showing signs of tendinitis or tendon rupture, the patient should be advised to rest and contact the doctor for a non-quinolone drug. Patients with a history of tendon disease or who have had tendinitis and tendon fractures should avoid using fluoroquinolones.
The myasthenia is weak
Fluoroquinolones, which have neuromuscular blocking activity, may exacerbate myasthenia in patients with myasthenia. Serious adverse events, including death and need for ventilation support, and myasthenia gravis are associated with the use of fluoroquinolones. Patients with myasthenia gravis should avoid XXXX.
The QT is extended
Some fluoroquinolones can extend the QT period of the ecg, and a few patients can have arrhythmia. The spontaneous report of patients receiving fluoroquinolone treated with fluoroquinolones in post-marketing surveillance is rare. Patients with known long QT, not correct hypokalemia patients and using IA class (quinidine, procainamide) and Ⅲ class (amiodarone, Mr. He parlour) anti-arrhythmic drugs patients should avoid to use XXXX. Older patients are more susceptible to drug-related QT interphase.
5. Allergic reactions
A severe allergic reaction has been reported in the use of fluoroquinolones. Some patients take the first dose, and some of the reactions can be accompanied by cardiovascular failure, loss of consciousness, tingling, pharynx or facial edema, dyspnea, urticaria, itching, etc. Severe allergic reactions require epinephrine emergency treatment. XXXX should stop using the rash or any other signs of allergy for the first time. If necessary, oxygen, intravenous steroid, airway management, including intubation, etc.
6. Other serious and potentially fatal reactions
Other serious and potentially fatal events have been reported using fluoroquinolones. Some of these events are due to allergies, and some are not. These events may be heavy and usually occur after multiple doses. Clinical manifestations may include one or more of the following symptoms: fever, rash, severe skin response (e.g., toxic epidermal necrolysis, stevenson-johnson syndrome); Vasculitis. Joint pain; Muscle pain; Serum sickness; Allergic pneumonia; Interstitial nephritis; Acute renal insufficiency or renal failure; Hepatitis, jaundice, acute liver necrosis or liver failure; Anemia, including hemolytic anemia and aplastic anemia; Thrombocytopenia, including thrombocytopenic purpura; Leukopenia; Granulocytic deficiency disease; Total blood cell loss and/or other hematological abnormalities. A rash, jaundice, or any other allergy should be stopped immediately and take action at the first time.
7. Effects of the central nervous system
Fluoroquinolone drugs are used, including XXXX, report to the central nervous system an increased risk for adverse reactions, including convulsion and increased intracranial pressure (including pseudo brain tumor) and poisoning caused by mental illness. The use of fluoroquinolone drugs may cause central nervous system reactions include anxiety, excitement, insomnia, anxiety, nightmare, paranoia, dizziness, confusion, tremor, hallucinations, depression and suicidal thoughts or behavior. These reactions may occur after the first use of the drug. If these reactions occur during the use of XXXX, the drug should be stopped and appropriate measures should be taken. With all the fluoroquinolone drugs, patients with known or suspected of the central nervous system diseases, such as severe cerebral arteriosclerosis, epilepsy), or there are other risk factors of patients (e.g., has a tendency to attack or seizure threshold) should be used when the risk benefit more than XXXX.
8. Peripheral neuropathy
Reports have patients with fluoroquinolone drugs, produce the rare feeling or motor axonal neuropathy, small impact and/or large axon, caused by abnormal skin feeling, insensitive, physical pain and weakness. For some patients, symptoms may occur quickly and may be irreversible after XXXX. If patients with peripheral neuropathy symptoms, including pain, burning sensation, tingling, numbness and/or unable to, or other feelings, including light touch, pain, temperature, location and the change of vibration sense, should be stopped immediately. Patients with a history of peripheral neuropathy should avoid using fluoroquinolones.
Difficult clostridium is associated with diarrhea
Almost all antimicrobial drugs have been reported in the case of the difficult clostridium (CDAD), which includes XXXX, which is severe from mild diarrhea to severe colitis. Antibacterial drugs change the normal microflora of the colon, leading to overgrowth of the clostridium difficile.
A and B, the toxins produced by c. difficile, are responsible for the associated diarrhoea of c. difficile. The morbidity and mortality associated with highly toxic clostridium are elevated, and these infections are ineffective and may require a colectomy. The possibility of CDAD should be considered after antibiotic treatment. Since the CDAD could be treated with antimicrobial drugs for two months, it is necessary to carefully consult the history.
If it is suspected or confirmed that c. difficile is associated with diarrhea, it may be necessary to stop the current antibiotic that is not used against the clostridium difficile. The liquid and electrolyte should be complemented and the protein should be supplemented, and the treatment of the antibiotic should be evaluated when the clinical indications are used.
10. Interference with blood sugar
Had fluoroquinolone antibiotics cause blood sugar disorders (such as symptoms of hyperglycemia and hypoglycemia) reports, this kind of situation happens at oral medications at the same time, such as glyburide/glyburide) use insulin or diabetes. Therefore, for such patients, it is recommended to closely monitor their blood sugar changes. If the patient has a hypoglycemic response during the treatment of XXXX, stop the drug immediately and take appropriate treatment measures.
Photosensitive/phototoxic
In the use of fluoroquinolone antibiotics after exposure to sunlight or ultraviolet light, moderate to severe photosensitive sex happens/light toxicity reaction, which may show excessive sunburn reaction (for example, a burning sensation, erythema, blisters, exudation and edema), often appear in the area of exposed to light (usually the neck area of the "V" type, the forearm extensor surface, hand back). Therefore, excessive exposure to the light source should be avoided. You should stop the drug when you have a phototoxic reaction.
(note: if the other contents of the specification are inconsistent with the above amendments, they shall be revised together.)
