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Newsletter No.3-2014
Newsletter No.3-2014
Iraqi pharmacovigilance center(IQPHVC)
Iraqi ministry of health Baghdad –Iraq
[email protected]
[email protected]
mobile:00964-7807820490
1
Newsletter No.3-2014
Iraqi pharmacovigilance center(IQPHVC)
Iraqi ministry of health Baghdad –Iraq
[email protected]
[email protected]
mobile:00964-7807820490
2
Newsletter No.3-2014
Iraqi pharmacovigilance center(IQPHVC)
Iraqi ministry of health Baghdad –Iraq
[email protected]
[email protected]
mobile:00964-7807820490
Table of contents
1- Introduction……………………..
2- Risk of arterial thromboembolic events Thalidomide………
3- Valproate sodium, divalproex sodium, valproic acid Contraindicated in pregnant
women for prevention of migraine headaches …….
4- heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and
Kombiglyze XR)………………
5- Doripenem Risk when used to treat pneumonia on ventilated patients ……………
6- cancer drug docetaxel may cause symptoms of alcohol intoxication after
treatment…………….
7- FDA requires label changes to warn of rare but serious neurologic problems after
epidural corticosteroid injections for pain………………..
8- FDA clarifies Warning about Pediatric Use of(sildenafil) for Pulmonary Arterial
Hypertension…………….
9- FDA evaluating risk of stroke, heart attack and death with FDA-approved
testosterone products………….
10- FDA and Pharmacovigilance Committee recommends not using lidocaine to treat
teething pain and requires new Boxed Warning………
11- New restriction and label update of domperidone-containing medicines…………
3
Newsletter No.3-2014
Iraqi pharmacovigilance center(IQPHVC)
Iraqi ministry of health Baghdad –Iraq
[email protected]
[email protected]
mobile:00964-7807820490
Introduction
Medicines have significant benefits to our lives and lead to significant reduction in
morbidity and mortality. However, even though they are generally seen as having
beneficial effects, all medicines (including their excipients e.g. coloring agents,
lubricants, preservatives, etc), have a potential for producing adverse or unwanted
effects no matter how skillfully they are used With the increasing use of medicines
for the management and control of diseases, there has been a mounting need to
monitor adverse drug reactions (ADRs), as ADRs have been shown to rank among
the top 10 leading causes of mortality in some countries despite the fact that most of
the ADRs are preventable. In addition suitable services to treat ADRs impose a high
financial burden on health care due to the hospital care of patients with drug related
problems. It is therefore of major importance to set up a Pharmacovigilance system to
control the increasing in the use of medicines through continuous monitoring for the
ADRs and other drugs related problems to insure the safety of medicines at all times
and at all levels of the health care system
What is Pharmacovigilance?
According to the WHO,Pharmacovigilance is the science and activities
relating to the detection, assessment, understanding and prevention of adverse events or any other
possible drug-related problems.
Iraqi pharmacovigilance center deal with any serious adverse drugs events, decrease or lack of
effectiveness , any medication errors lead to serious ADR.
The potential risks of medicines
came into sharp focus during the
story of thalidomide tragedy in the
late of 1950‟s and early 1960‟s in
western Europe and North America ,
the mothers had taken the drug for
morning sickness , babies born with
phocomelia (shortening of the
limbs), among other birth defects.
Following this tragedy till now, all
the governments have tried
formulating legislations and
regulations that ensure the safety,
efficacy and quality of medicines
used in their countries.
4
Newsletter No.3-2014
Iraqi pharmacovigilance center(IQPHVC)
Iraqi ministry of health Baghdad –Iraq
[email protected]
[email protected]
mobile:00964-7807820490
Iraqi Pharmacovigilance Data Base (IPDB)
national database containing side effects of drugs, vaccines in Iraq has reached
1432 case.
the number of reports for the period from 01/01/2013 up to 01/07/2014 showed in( graphic 1 )
1200
no.of rep.
1000
800
600
400
200
0
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Newsletter No.3-2014
Iraqi pharmacovigilance center(IQPHVC)
Iraqi ministry of health Baghdad –Iraq
[email protected]
[email protected]
mobile:00964-7807820490
Adverse Drug reactions Development with Direct IV Push of
antibiotics drug
On the background of the appearance of significant number of cases that was
label as drug allergy to certain antibiotic item most belong to third generation
cephalosporin received from medical centers; the following recommendations is
issued:
 Allergy test must be done to all patient give third generation
cephalosporin by the nursing staff to avoid latent allergy and don’t depend
on medical drug history obtained from patient .
 The drug should be given as slow intravenous infusion ameliorated in to
50cc to 100cc of suitable fluid .
 Avoid mixing more than on antibiotic agent in the same syringe when
administrating medications
 Its recommended that physicians and clinical pharmacist are meant to be
responsible for calculating the optimal dose for patient with renal and
hepatic impairment as this step is important in addressing and minimizing
the possible side effect .
no. of reports
80
60
40
no. of reports
20
0
ceftriaxone
cefotaxim
cefixim cap
ceftazidim
the most common drug that Couse allergy in Iraq shown in( graphic 2)
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Newsletter No.3-2014
Iraqi pharmacovigilance center(IQPHVC)
Iraqi ministry of health Baghdad –Iraq
[email protected]
[email protected]
mobile:00964-7807820490
Thalidomide Risk of arterial thromboembolic events
thromboembolic events have been added to the Product Monograph for thalidomide
capsules (Thalomid®).
Thalidomide is an immunomodulatory agent indicated for the treatment of patients
who are 65 years of age or older with previously untreated multiple myeloma, in
combination with melphalan and prednisone.
The following points summarize the updated Product Monograph safety information:
1• Cases of arterial thromboembolic events (ATEE), sometimes fatal ,have been
reported in patients treated with thalidomide. Events reported included myocardial
infarction, cerebrovascular accident and transient ischemic attack, among others. The
risk of thromboembolism (including ATEE) appears to be greatest during the first 5
months of therapy.
2• Risk factors associated with ATEE (in addition to the underlying malignant disease,
age S 65 years, and being male) include hyperlipidemia, hypertension, diabetes,
obesity, renal disease and tobacco use.
3• Health-care professionals are advised to be observant for the signs and symptoms of
ATEE. Patients should be instructed to seek medical care if they develop symptoms
related to stroke or heart attack.
Thromboprophylaxis should be recommended especially in patients with additional
thrombotic risk factors. The decision to take antithrombotic prophylactic measures
should be made after careful assessment of an individual patient's underlying risk
factors
-Valproate sodium, divalproex sodium, valproic acid Contraindicated in
pregnant women for prevention of migraine headaches .
The US FDA advised health-care professionals and women that valproate sodium and
related products, valproic acid and divalproex sodium, are contraindicated and should
not be taken by pregnant women for the prevention of migraine headaches.
These valproate products include valproate sodium (Depacon®), divalproex sodium
(Depakote®, Depakote® CP, and Depakote® ER), valproic acid (Depakene® and
Stavzor®), and their generics.
Valproate products are approved for the treatment of certain types of epilepsy, the
treatment of manic episodes associated with bipolar disorder, and the prevention of
migraine headaches. They are also used off-label for other conditions, particularly
other psychiatric conditions.
7
Newsletter No.3-2014
Iraqi pharmacovigilance center(IQPHVC)
Iraqi ministry of health Baghdad –Iraq
[email protected]
[email protected]
mobile:00964-7807820490
This alert is based on the final results of the Neurodevelopmental Effects of
Antiepileptic Drugs (NEAD) study showing that children exposed to valproate
products while their mothers were pregnant had decreased IQs at age 6 compared to
children exposed to other anti-epileptic drugs Stronger warnings about use during
pregnancy will be added to the drug labels, and valproate’s pregnancy category for
migraine use will be changed from "D" (the potential benefit of the drug in pregnant
women may be acceptable despite its potential risks) to "X" (the risk of use in
pregnant women clearly outweighs any possible benefit of the drug). Valproate
products will remain in pregnancy category D for treating epilepsy and manic
episodes associated with bipolar disorder
heart failure risk with diabetes drug saxagliptin (marketed as Onglyza
and Kombiglyze XR)
The U.S. Food and Drug Administration (FDA) has requested clinical trial data
from the manufacturer of saxagliptin to investigate a possible association between use
of the type 2 diabetes drug and heart failure.
The US FDA’s request resulted from a study published in the New England Journal
of Medicine (NEJM), which reported an increased rate of hospitalization for heart
failure, when the heart does not pump blood well enough, with use of saxagliptin
(marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment. The
study did not find increased rates of death or other major cardiovascular risks,
including heart attack or stroke, in patients who received saxagliptin.
At this time, we consider information from the NEJM study to be preliminary. Our
analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type
2 diabetes drug therapies and cardiovascular risk. Patients should not stop taking
saxagliptin and should speak with their health care professionals about any questions
or concerns. Health care professionals should continue to follow the prescribing
recommendations in the drug labels.
Saxagliptin is used along with diet and exercise to lower blood sugar in adults with
type 2 diabetes. It works by increasing the amount of insulin produced by the body
after meals, when blood sugar is high
8
Newsletter No.3-2014
Iraqi pharmacovigilance center(IQPHVC)
Iraqi ministry of health Baghdad –Iraq
[email protected]
[email protected]
mobile:00964-7807820490
Doripenem Risk when used to treat pneumonia on ventilated patients
The U.S. Food and Drug Administration (FDA) concluded that doripenem
(Doribax®), an antibacterial drug used to treat patients who develop pneumonia
while on ventilators, carries an increased risk of death and lower clinical cure rates
compared to use of imipenem and cilastatin for injection (Primaxin®). Doripenem is
not approved to treat any type of pneumonia.
Health-care professionals should consider whether the benefits of doripenem
treatment are likely to exceed its potential risks in patients who develop pneumonia
while on ventilators. Doripenem is still considered safe and effective for its FDAapproved indications - treatment of adults with complicated intra-abdominal
infections and complicated urinary tract infections, including kidney infections
(pyelonephritis).
cancer drug docetaxel may cause symptoms of alcohol intoxication
after treatment
The U.S. Food and Drug Administration (FDA) is warning that the intravenous
chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may
cause patients to experience intoxication or feel drunk during and after treatment.
. Health care professionals should consider the alcohol content of docetaxel when
prescribing or administering the drug to patients, particularly in those whom
alcohol intake should be avoided or minimized and when using it in conjunction
with other medications.
.Patients should be aware that docetaxel may cause them to become intoxicated
from the alcohol it contains.
. Patients should avoid driving, operating machinery, or performing other activities
that are dangerous for one to two hours after the infusion of docetaxel.
.Some medications, such as pain relievers and sleep aids, may interact with the
alcohol in the docetaxel infusion and worsen the intoxicating effects.
Docetaxel is a prescription chemotherapy drug used to treat different kinds of
cancer, including cancers of the breast.
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Newsletter No.3-2014
Iraqi pharmacovigilance center(IQPHVC)
Iraqi ministry of health Baghdad –Iraq
[email protected]
[email protected]
mobile:00964-7807820490
FDA requires label changes to warn of rare but serious neurologic
problems after epidural corticosteroid injections for pain
The U.S. Food and Drug Administration (FDA) is warning that injection of
corticosteroids into the epidural space of the spine may result in rare but serious
adverse events, including loss of vision, stroke, paralysis, and death.
The injections are given to treat neck and back pain, and radiating pain in the arms
and legs. The US FDA’s are requiring the addition of a Warning to the drug labels
of injectable corticosteroids to describe these risks. Patients should discuss the
benefits and risks of epidural corticosteroid injections with their health care
professionals, along with the benefits and risks associated with other possible
treatments.
FDA clarifies Warning about Pediatric Use of(sildenafil) for
Pulmonary Arterial Hypertension
Revatio is FDA-approved only to treat PAH in adults, not in children; however,the
purpose of the recommendation was to raise awareness of clinical trial results
showing a higher risk of mortality in pediatric patients taking a high dose of
Revatio when compared to pediatric patients taking a low dose. This
recommendation was not intended to suggest that Revatio should never be used in
children; however, some health care professionals have interpreted this information
as a contraindication, and have refused to prescribe or administer the drug. We
recognize there may be situations in which the benefit-risk profile of Revatio may
be acceptable in individual children, for example, when other treatment options are
limited and Revatio can be used with close monitoring.
The evidence behind our initial recommendation has not changed; we are simply
clarifying the strength of the warning communicated in the Revatio drug label.
FDA evaluating risk of stroke, heart attack and death with FDAapproved testosterone products
The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke,
heart attack, and death in men taking FDA-approved testosterone products.
Patients should not stop taking prescribed testosterone products without first
discussing any questions or concerns with their health care professionals.
10
Newsletter No.3-2014
Iraqi pharmacovigilance center(IQPHVC)
Iraqi ministry of health Baghdad –Iraq
[email protected]
[email protected]
mobile:00964-7807820490
Health care professionals should consider whether the benefits of FDA-approved
testosterone treatment is likely to exceed the potential risks of treatment. The
prescribing information in the drug labels of FDA-approved testosterone products
should be followed.
Testosterone is a hormone essential to the development of male growth and
masculine characteristics. Testosterone products are FDA-approved only for use in
men who lack or have low testosterone levels in conjunction with an associated
medical condition. None of the FDA-approved testosterone products are approved
for use in men with low testosterone levels who lack an associated medical
condition. FDA-approved testosterone formulations include the topical gel,
transdermal patch, buccal system (applied to upper gum or inner cheek), and
injection.
FDA and Pharmacovigilance Committee recommends not using
lidocaine to treat teething pain and requires new Boxed Warning
The U.S. Food and Drug Administration (FDA) warns that
1-prescription oral viscous lidocaine 2% solution should not be used to treat infants
and children with teething pain.
2- We are requiring a new Boxed Warning, strongest warning, to be added to the
drug label to highlight this information. Oral viscous lidocaine solution is not
approved to treat teething pain, and use in infants and young children can cause
serious harm, including death.
3-Health care professionals should not prescribe or recommend this product for
teething pain. And recommendations for treating teething pain:
1- Use a teething ring chilled in the refrigerator (not frozen).
2-Gently rub or massage the child’s gums with your finger to relieve the
symptoms.
New restriction and label update of domperidone-containing
medicines


A review of the evidence confirms a small increased risk of serious cardiac
adverse drug reactions related to the use of domperidone, including QTc
prolongation, torsade de pointes, serious ventricular arrhythmia and sudden
cardiac death
The benefit-risk balance of domperidone remains positive in the relief of the
symptoms of nausea and vomiting. The available evidence of efficacy was not
sufficient to support its use for other indications.
11
Newsletter No.3-2014
Iraqi pharmacovigilance center(IQPHVC)
Iraqi ministry of health Baghdad –Iraq
[email protected]
[email protected]
mobile:00964-7807820490








Domperidone should be used at the lowest effective dose for the shortest possible
duration. The maximum treatment duration should not usually exceed one week.
The new recommended dose in adults (and adolescents ≥ 35 kg where licensed) is
10 mg orally up to three times daily (maximum dose of 30 mg daily). Adults may
also be given 30 mg twice daily rectally as suppositories.
Where suitable domperidone products are available for children, the
recommended dose is 0.25 mg/kg bodyweight up to three times daily by mouth.
In order to accurately measure doses to pediatric patients, oral suspensions should
be given using an adapted graduated oral syringe.
Domperidone products are contraindicated in patients with severe hepatic
impairment, conditions where cardiac conduction is, or could be, impaired or
where there is underlying cardiac disease such as congestive heart failure, and
when co-administered with QT-prolonging medicines or potent CYP3A4
inhibitors.
Formulations not consistent with the new dosage recommendations will be
withdrawn from the market, as will combinations of domperidone with
cinnarizine. The product information for domperidone-containing products will
be updated, and a letter will be sent to healthcare professionals explaining the
new recommendations.
Overall there was sufficient evidence to support the use of oral domperidone
10 mg up to three times a day in a general indication of treatment of nausea and
vomiting in adults. There were limited data to support paediatric use in
this indication, and although the mechanism of action is not expected to differ
between adults and children studies to provide further data to supportefficacy in
the paediatric population have been requested.
Data in support of other indications were extremely limited. In particular, there
was little evidence in support of the long-term efficacy of domperidone in
dyspepsia and gastro-oesophageal reflux disorder. The benefits in these
indications were therefore not considered to outweigh the risk.
Although the results of the thorough QT study with domperidone indicate that it
does not significantly prolong the QTc interval when administered to healthy
subjects at 10 mg and 20 mg four times daily, there are limitations in the study
that restrict the conclusions that can be drawn.
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