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Drug Information Bulletin
Drug Information Centre (DIC)
Indian Pharmaceutical Association
Bengal Branch
Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com
Web Site: http://www.ipabengal.org
Contact: 09830136291
&
Regulatory Affairs Division (RAD), IPA
Content
• Editorial
• New Drug: Silodosin for benign prostatic hypertrophy
• Lamivudine Risk of hearing loss
• Amarasate extract Anaphylaxis
• Obeticholic acid Risk of serious liver injury
• Over 40 Techs in Pharma up for grabs for Gujarat companies
•
Editorial
Oxytocin-an essential drug is used widely for inducing labour. But unfortunately it is being misused in several means. Medical experts point out
that sustained use of the drug can cause hormone imbalance in humans and harms the reproductive system of animals, reducing their life
span. Similarly, it was reported that minor girls were given repeated and unregulated shots of oxytocin injection to speed up their sexual
maturation. Moreover, consuming this hormone unknowingly through Milk, vegetables, which causes several dysfunctions in human body. It is
very harmful for humans who unwittingly are made to consume this hormone. Humans face all the harmful effects of this drug. Children are
most susceptible to its effects and it is known to have caused imbalanced hearing and weak eyesight. Common symptoms are exhaustion and
loss of energy. Govt. of India has taken several steps to curb this menace, through a notification vide no. 29 E dated 17.01.2014 and a recent
circular dated 22.10.2014. They has adopted further restrictions on movement of Oxytocin vide G.S.R.411(E) dtd. 27.04.2018, which are-
The manufacture of Oxytocin formulations for domestic use shall be by public sector undertakings or companies only and the label of the
product shall bear barcodes.
(i) The manufacture of Oxytocin formulations for export purposes shall be open to both public and private sector companies and the
packs of such manufacture for exports shall bear barcodes.
(ii) The manufacturers of active pharmaceutical ingredient of Oxytocin shall supply the active pharmaceutical ingredient only to the
public sector manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug
for domestic use.
(iii) The manufacturers of active pharmaceutical ingredient of Oxytocin shall supply the said active pharmaceutical ingredient to the
manufacturers in public and private sector licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations
of the said drug for export purpose.
(iv) The Oxytocin formulations manufactured by the public sector companies or undertakings licensed under the Drugs and Cosmetics
Rules, 1945 for domestic use shall supply the formulations meant for human and veterinary use only,- (a) to the registered
hospitals and clinics in public and private sector directly; or (b) to the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)
and Affordable Medicines and Reliable Implants for Treatment (AMRIT) outlets or any other Government entity which may be
specified by the Central Government for this purpose in the country which shall further supply the drug to the registered
hospitals and clinics in public and private sector.
(v) The Oxytocin in any form or name shall not be allowed to be sold through retail Chemist.
Subsequently it was further amended to make Oxytocin available from retail outlets and for further regulation Oxytocin was included in the
Schedule H1vide G.S.R. 795(E) dtd.21.08.2018.
Dr. Subhash C. Mandal
Editor
E mail: subhash.mandaldr@gmail.com
Mob. 9830136291
New Drug: Silodosin for benign prostatic
hypertrophy
Approved indication: benign prostatic
hypertrophy
Urorec
4 mg and 8 mg capsules
Benign prostatic hyperplasia can cause lower
urinary tract symptoms such as slow urine flow,
nocturia and incomplete emptying of the bladder.
If these symptoms are sufficiently bothersome as
to require treatment, selective alpha-blockers
such as alfuzosin and tamsulosin are one option.
These drugs block alpha1 adrenoreceptors in the
smooth muscle of the prostate and bladder to
reduce resistance and so improve urinary flow.
Silodosin is another selective alpha-blocker. It has
much greater affinity for the alpha1A receptor
than the alpha1B receptor found in vascular
smooth muscle.
Silodosin is taken once a day with food. The dose
is halved if the patient has moderate kidney
impairment (creatinine clearance 30–59 mL/min)
and silodosin is not recommended for those with
severe impairment (creatinine clearance <30
mL/min). Most of the dose is metabolised, but no
data are available on the effect of severe hepatic
impairment. The terminal half-life of silodosin is
about 11 hours. As the metabolism of silodosin
involves cytochrome P450 3A4, it should not be
used with strong inhibitors of this enzyme system,
such as ketoconazole and ritonavir. Silodosin is
also a substrate of P-glycoprotein so using it with
strong inhibitors (amiodarone, verapamil) of this
transporter is not recommended.
The Australian approval of silodosin is mainly
based on three randomised trials. Two of them
compared silodosin with placebo in a total of 923
men.1 These patients had an average baseline
score of 21.3 on the 35-point International-
Prostate Symptom Score (I-PSS). After 12 weeks
of treatment this had reduced by 6.4 points in the
466 men who took silodosin 8 mg daily and by 3.5
points in the 457 who took placebo. There was
also a significant difference in urine flow rate.
Patient satisfaction was higher with silodosin,
with 32% of the men who took it being ‘delighted,
pleased or mostly satisfied’ compared with 22.5%
of the placebo group.1
The third trial compared silodosin with
tamsulosin, as well as placebo.2 In this trial the
baseline I-PSS was 19.1. After 12 weeks of
treatment it had reduced by a mean of 7.0 points
in the 371 men taking silodosin 8 mg daily and by
6.7 points in the 376 taking tamsulosin 0.4 mg.
The average reduction for the 185 taking placebo
was 4.7 points. The proportions of patients who
had an improvement of at least 25% in the I-PSS
were 66.8% with silodosin and 65.4% with
tamsulosin. These results were significantly better
than the 50.8% response rate to placebo. While
44–45% of the men were ‘delighted, pleased or
mostly satisfied’ with the active treatments, only
34% of the placebo group agreed.2
Silodosin was generally well tolerated, but caused
more adverse effects than placebo. In the placebo
controlled trials, 6.4% of the silodosin group
withdrew because of adverse events compared
with 2.2% of the placebo group. Problems that
were more frequent with silodosin included
dizziness, orthostatic hypotension, diarrhoea and
headache. A major difference between silodosin
and placebo was the adverse effect of retrograde
ejaculation (28.1% vs 0.9%).1 This abnormal
ejaculation is thought to be a consequence of the
selective blockade of the alpha1A receptors. This
specificity should reduce cardiovascular adverse
effects, but in the comparative study silodosin did
not have significantly different effects from
tamsulosin on pulse and blood pressure.2 Alphablockers
may cause floppy iris syndrome so the
patient’s ophthalmologist should be informed
when cataract surgery is being planned.
There can be a high placebo response when
treating symptoms associated with benign
prostatic hyperplasia. The trials controlled for this
by only randomising patients who had not
responded during a placebo run-in phase. Despite
this the differences between silodosin and
placebo were small. Although it is statistically
significant, a difference of 2–3 points in the I-PSS
is only a slight advantage. The mean difference in
maximum urine flow rates was 1
mL/second.1 Such a small advantage over placebo
is of questionable value.3 The overall efficacy of
silodosin is non-inferior to tamsulosin, but
silodosin is more likely to cause retrograde
ejaculation (14.2% vs 2.1%).2
References:
1. Marks LS, Gittelman MC, Hill LA, Volinn W,
Hoel G. Rapid efficacy of the highly selective
alpha1A-adrenoceptor antagonist silodosin in
men with signs and symptoms of benign
prostatic hyperplasia: pooled results of 2
phase 3 studies. J Urol 2009;181:2634-40.
2. Chapple CR, Montorsi F, Tammela TL, Wirth
M, Koldewijn E, Fernández Fernández E;
European Silodosin Study Group. Silodosin
therapy for lower urinary tract symptoms in
men with suspected benign prostatic
hyperplasia: results of an international,
randomized, double-blind, placebo and activecontrolled
clinical trial performed in Europe.
Eur Urol 2011;59:342-52.
3. Dawson A. The price of urine. Aust Prescr
1995;18:26-7.
Source: Australian Prescriber
Lamivudine Risk of hearing loss
NCC-PvPI, IPC has made a recommendation to
CDSCO requesting that the drug safety label for
lamivudine is revised to include hearing loss as an
adverse reaction. Lamivudine is used for the
treatment of HIV infection in combination of at
least two other antiretroviral drugs. Between July
2011 and March 2018, NCC-PvPI received eight
ICSRs that reported hearing loss with lamivudine
use. A review of cases by the Signal Review Panel
(SRP)-PvPI, IPC suggested a strong causal
relationship between lamivudine and hearing
loss. Reference: Based on the communication
from IPC, NCC-PvPI, India (http://ipc.nic.in)
Propofol Contraindication in pregnant women
removed
MHLW and PMDA have announced that
precautions of propofol preparations (Diprivan®)
should be revised to remove the contraindication
of use during pregnancy. Propofol can be used by
pregnant women or women who may be
pregnant provided the potential benefits
outweigh the risks. Propofol is indicated for
induction and maintenance of general anesthesia.
Propofol is used for therapy in pregnant women
in Europe and the United States. For this reason
the MHLW requested the PMDA to conduct an
investigation into the use of propofol during
pregnancy. As a result, PMDA concluded that the
above-mentioned revision to safety precautions
of propofol is acceptable. Reference: Revision of
Precautions, MHLW/PMDA, 27 March 2018
(www.pmda.go.jp/english/)
Amarasate extract Anaphylaxis
The Medicines and Medical Devices Safety
Authority (Medsafe) has issued a warning about
the risk of anaphylaxis with the use of amarasate
extract (Calocurb®). Amarasate extract is a dietary
supplement marketed to support weight loss and
appetite control. Medsafe continues to monitor
reports of adverse reactions for this product and
all other dietary supplements. Reference: Safety
Information, Medsafe, 9 May 2018
(www.medsafe.govt.nz/)
Obeticholic acid Risk of serious liver injury
The MHRA has issued advice to healthcare
professionals about the risk of serious liver injury
in patients with pre-existing moderate or severe
liver impairment, taking obeticholic acid
(Ocaliva®). Health-care professionals are
reminded to adjust dosing according to liver
function. Obeticholic acid is indicated in the
treatment of primary biliary cholangitis in
combination with ursodeoxycholic acid. An EU
review assessed reports of serious liver injuries
and deaths in patients with primary biliary
cholangitis with preexisting moderate or severe
liver impairment who were not adequately doseadjusted.
Liver-related adverse events have
occurred both early in exposure and after months
of treatment. The review concluded that no
changes to the product information are required
but suggested that health-care professionals
should be reminded of the dosing
recommendations. The MHRA has received two
Yellow Card reports of hepatobiliary disorders in
the UK associated with obeticholic acid. One case
was lifethreatening and required hospital
admission. Obeticholic acid is subject to
additional monitoring, allowing quick
identification of new safety information.
Reference: Drug Safety Update, MHRA, 24 April
2018 (www.gov.uk/mhra) (See WHO
Pharmaceuticals Newsletters No.5, 2017: Risk of
serious liver injury in USA)
Over 40 Techs in Pharma up for grabs for Gujarat
companies
Over 40 technologies developed by the National
Research Development Corporation (NRDC) in
drugs and pharmaceuticals have huge potential to
be commercialised by Gujarat-based companies,
a senior NRDC official said on Tuesday. With a
share of about 20%, Gujarat is one of the largest
recipients of technologies developed by NRDC.
NRDC has over 80 technologies in
pharmaceuticals and drugs, for which it is seeking
partners, through Transfer of Technology (ToT)
for commercialisation. "Of these, over 40 licenses
have high potential to be used by Gujarat based
companies," said Amitabh Mishra, senior
manager of biotechnology in NRDC, while
interacting with media persons on the sidelines of
a seminar on NRDC Industry Meet on Technology
Transfer Opportunities in Pharma, Biotech and
Health in Ahmedabad on Tuesday.
"Non-invasive diagnostic technologies targeted
and new-borns, solutions for control of diseases
like Hepatitis-B, as well as herbal medicines need
to be adapted by private companies," said
Mishra.
Jaimin Vasa, president of Gujarat Chamber of
Commerce and Industry (GCCI), said that small
businesses do not have the financial or human
resource to conduct research, during the seminar.
"SMEs need hand-holding during
commercialisation of technologies and to
minimise risks. We need more interactions of
industries with research institutions," said Vasa.
Arvind Kukreti, Deputy Drug Controller of Central
Drug Standard Control Organization (CDSCO)
called for better coordination between
regulators, Research and Development (R&D)
institutions and industry to ensure that the
interests of the consumers are met. Anil Jain, MD
of Ascent Finechem Private Ltd said that R&D is
also needed to bring down the cost and improve
affordability. Experts feel that there is a strong
need to develop technologies to cater to the
future needs of the society. With Gujarat being a
hub of pharmaceuticals and chemicals, it has an
important role to play, said Mishra.
With Maharashtra and Gujarat being one of the
most industrialised states, they are also the
largest recipients of technologies developed by
NRDC. While Gujarat companies are seeking
licenses in drugs and pharmaceuticals,
Maharashtra-based companies are also major
recipients of technologies in agriculture and food
sector.
Source: DNA Money
DISCLAIMER:
The Newsletter intends to provide updated and reliable information on medicines and other related issues in an
attempt to equip healthcare professionals to take informed decision in recommending medicines to the patients.
However, they are encouraged to validate the contents. None of the people associated with the publication of the
Newsletter nor the organization shall be responsible for any liability for any damage incurred as a result of use of
contents of this publication. The brand names of medicines, if mentioned, are for illustration only and the Newsletter
does not endorse them.
Please write to :
The Co-ordinator DIC & Editor DIB
Drug Information Bulletin
Drug Information Centre
Indian Pharmaceutical Association, Bengal Branch
Tel /Fax: 91 33 2461 2776 (Monday to Saturday from 5.00 pm to 8.00 pm)
Email: ipabengal.dic@gmail.com
Mobile: +91-9830136291