The hypertension drugs (alpha blockers and

alpha-2 agonists) increases the death risk –

findings from American College of Cardiology

(ACC)

High blood pressure, or hypertension, is a major risk factor for heart disease,

and considered as a leading cause of death in the United States. But a new

study has found that two classes of medication that are commonly used to

lower blood pressure could present a death risk all on their own. Study results

confirm that individuals with hypertension who used alpha blockers and

alpha-2 agonists to control their blood pressure showed an increase in blood

pressure variability, which could increase mortality risk.

Blood pressure is the force of blood that pushes against the wall of the

arteries. A person is considered to have hypertension if their systolic blood

pressure is 130 millimeters of mercury (mmHg) or higher, and their diastolic

blood pressure is 80 mmHg or higher. Systolic blood pressure is the force of

blood against the artery walls when the heart is beating, while diastolic blood

pressure is the force of blood when the heart is at rest, or between heartbeats.

According to updated guidelines mean that almost half of adults in the United

States have high blood pressure, which puts them at greater risk of heart

attack, stroke, and heart disease, among other health problems. Treating

hypertension, the goal is to lower blood pressure. This may be achieved

through lifestyle changes such as adopting a healthful diet and increasing

physical activity medication, or both.

VOLUME 36 ISSUE 1

Medical News

––

January – March 2018

In this issue .. ..

Medical News ------------- 1

Pharmaceutical

Authorities News --------4

Medication Safety

Updates -------------------- 5

7 ---------------- الصفحة العربية

Scientific Books: New

Release -------------------- 8

College of Pharmacy

Drug and Poison Information Center

Now The bulletin is available online at: https://pharmacy.ksu.edu.sa/ar/node/1397

Low dopamine may

indicate early

Alzheimer's

A new study found link between

the loss of dopamine-firing cells in

the brain and the brain's ability to

form new memories .The

researchers used a type of MRI

scan called 3Tesla, to scan the

brains of 51 healthy adults, 30

with mild cognitive impairment,

and 29 with Alzheimer's disease.

Analyzing the results, they found a

link between the sizes of two key

brain areas the ventral tegmental

and hippocampus and the ability

of the participants to learn new

information. Findings suggested

that ventral tegmental area, does

not produce the right amount of

dopamine for the hippocampus, a

small organ located within the

brain's temporal lobe, it will not

work efficiently.

Source;

https://www.medicalnewstod

ay.com/articles

Drug & Poison

Information Center

BULLETIN

January – March 2009

Drug and Poison Information Bulletin 2

Medical News (cont..)

Previous research, however, has discovered that consistency is key for blood pressure levels. A study published

in The BMJ reported that associated higher variability of systolic blood pressure with a 15 percent increase in all-

cause mortality.

Two medications should be avoided

The study revealed two classes of blood pressure medication that were linked to higher blood pressure variability

in subjects: alpha blockers and alpha-2 agonists. Alpha blockers which include doxazosin mesylate and prazosin

hydrochloride work by dilating the blood vessels. Alpha-2 agonists, such as methyldopa, work by targeting

sympathetic nervous system activity, thereby reducing blood vessel constriction.

Based on the study results, these two medications should not be used to treat hypertension. Patients should know

what their blood pressure is and if it's up and down all the time, the patient should work with their physician to

explore options for the best blood pressure medications that will reduce variances.

Where possible, the two types of medications that show an increase in variances should be avoided

ACE inhibitors, angiotensin receptor blockers, calcium channel blockers, and thiazide diuretics may be safer

treatment options for people with hypertension. People who are on other types of blood pressure medications have

an increased risk of death . However, blood pressure variability is not solely down to medication the author’s notes

that the way in which blood pressure is measured can have a significant effect on readings. Because of the

variables that affect blood pressure measurements. Results shows more accurately measure blood pressure can

better identify effective treatments for patients who have hypertension."

For accurate blood pressure readings, it is recommended sitting or lying down for 15 minutes before measurements

are taken. Avoiding stressful situations and using a well-fitting blood pressure cuff may also help.

Source; https://accscientificsession.acc.org/

The researchers analyzed the data of over 10,500 adults with

high blood pressure. The participants had their blood

pressure measured at least seven times between January

2007 and December 2011, and the type of blood pressure

medication they were using was monitored. The team used

these data to assess whether certain classes of blood pressure

medication were associated with variability in blood

pressure levels.

Medical News (cont..)

Stomach acid drugs (proton pump inhibitors) may cause

depression

A study published in the journal Psychotherapy and Psychosomatics has found a link between a common class of

stomach drugs called proton pump inhibitors and depression. The investigated results suggested that the pills

might lead to major depressive disorder by disrupting the gut's bacteria

For instance, researchers have found that germ-free mice that had been deprived of beneficial gut bacteria

displayed symptoms of anxiety, depression, and cognitive impairment. Since the bacteria in our gut can alter the

function of our brain by producing certain hormones or neurotransmitters and emotional responses can, in turn,

affect our gut bacteria it should come as no surprise that some studies have found a link between post-traumatic

stress disorder and certain strains of bacteria. Other studies have not only pinpointed specific bacteria whose

absence can trigger symptoms of depression in rodents, but they have also shown that supplementing said bacteria

can reverse signs of depression.

An observational study suggests that proton pump inhibitors which are a class of drugs typically prescribed to treat

acid-related stomach conditions such as gastroesophageal reflux disease increase the risk of developing major

depressive disorder. This is the leading cause of disability both in the United States and worldwide.

Stomach acid pills may disrupt gut-brain axis

A study examined data on 2,366 individuals who had been taking proton pump inhibitors and went on to develop

depression, and compared them with 9,464 people who also took the drugs but did not develop depression. The

latter group of participants was "matched for age, sex, enrollment time, end point time, and follow-up period. The

study used logistic regression analysis and adjusted for various demographic factors, as well as for psychiatric

comorbidities such as anxiety and substance abuse disorders.

The study revealed that, compared with those who did not develop major depressive disorder, patients with major

depression had a greater prevalence of higher cumulative defined daily dose of proton pump inhibitors.

Specifically, the risk of clinical depression increased for those who took the drugs pantoprazole, lansoprazole, and

rabeprazole, while in those who used omeprazole and esomeprazole, only a trend significance was noted. This was

the first study to investigate the association between [proton pump inhibitor] exposure and the risk of major

depression.

Source: https://www.medicalnewstoday.com/articles/321164.php

3 Drug and Poison Information Bulletin

Drug and Poison Information Bulletin

Pharmaceutical Authorities News

Dietary supplement shows potential for reversing cardiovascular

related aging - results from pilot study

People consume a natural dietary supplement called nicotinamide riboside (NR) daily, it mimics caloric restriction.

Supplementation also tends to improve blood pressure and arterial health, particularly in those with mild

hypertension, the study found. This was the first ever study to give this novel compound to humans over a period

of time, it is well tolerated and appears to activate some of the same key biological pathways that calorie

restriction does.

For the study, published in the journal Nature Communications, which included 24 lean and healthy men and

women ages 55 to 79 from the Boulder area. Half were given a placebo for six weeks, then took a 500 mg twice-

daily dose of nicotinamide riboside (NR) chloride (NIAGEN). The other half took NR for the first six weeks,

followed by placebo collected blood samples and other physiological measurements at the end of each treatment

period. Participants reported no serious adverse effects. The researchers found that 1,000 mg daily of NR boosted

levels of another compound called nicotinamide adenine dinucleotide (NAD+) by 60 percent. NAD+ is required

for activation of enzymes called sirtuins, which are largely credited with the beneficial effects of calorie

restriction. It's involved in a host of metabolic actions throughout the body, but it tends to decline with age.

The new study also found that in 13 participants with elevated blood pressure or stage 1 hypertension (120-139/80-

89 mmHg), systolic blood pressure was about 10 points lower after supplementation. A drop of that magnitude

could translate to a 25 percent reduction in heart attack risk. If this magnitude of systolic blood pressure reduction

with NR supplementation is confirmed in a larger clinical trial, such an effect could have broad biomedical

implications. The information found in this research is really good stepping stone for future work. The researchers

have applied for a grant to conduct a larger clinical trial looking specifically at the impact of NR supplementation

on blood pressure and arterial health. Researchers also launching a separate trial looking at the impact NR has on

older adults with mild cognitive impairment, a precursor to Alzheimer's disease.

The study was partially funded by grants from the National Institutes of Health and the American Federation for

Aging Research. ChromaDex, the maker of NIAGEN provided supplements and some financial support.

1. Reference ; Christopher R. Martens, Blair A. Denman, Melissa R. Mazzo, Michael L. Armstrong, Nichole Reisdorph, Matthew B. Mcqueen, Michel Chonchol, Douglas R. Seals. Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD in healthy middle-aged and older adults. Nature Communications, 2018; DOI: 10.1038/s41467-018-03421-7

4 Drug and Poison Information Bulletin 4

Medication Safety Updates

5 Drug and Poison Information Bulletin

FDA Drug Safety Communication: FDA review finds additional data

supports the potential for increased long-term risks with antibiotic

clarithromycin (Biaxin) in patients with heart disease

The U.S. Food and Drug Administration (FDA) is advising caution before prescribing the antibiotic

clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or

death that can occur years later. Our recommendation is based on our review of the results of a 10-year follow-up

study1 of patients with coronary heart disease from a large clinical trial2 that first observed this safety issue.

Clarithromycin is not approved to treat heart disease. The drug has been used for more than 25 years, and is sold

under the brand name Biaxin and as generics by many different drug companies. It works by stopping the growth

of bacteria. Without treatment, some infections can spread and lead to serious health problems

Health care professionals should be aware of these significant risks and weigh the benefits and risks of

clarithromycin before prescribing it to any patient, particularly in patients with heart disease and even for short

periods, and consider using other available antibiotics. Advise patients with heart disease of the signs and

symptoms of cardiovascular problems, regardless of the medical condition for which you are treating them with

clarithromycin. Patients should tell your health care professionals if you have heart disease, especially when you

are being prescribed an antibiotic to treat an infection. Talk to them about the benefits and risks of clarithromycin

and any alternative treatments. Do not stop taking your heart disease medicine or antibiotic without first talking to

your health care professionals. Doing so could be harmful without your health care professionals’ direct

supervision. Seek medical attention immediately if you experience symptoms of a heart attack or stroke, such as

chest pain, shortness of breath or trouble breathing, pain or weakness in one part or side of your body, or slurred

speech.

The large clinical trial, called the CLARICOR trial2, observed an unexpected increase in deaths among patients

with coronary heart disease who received a two-week course of clarithromycin that became apparent after patients

had been followed for one year or longer. There is no clear explanation for how clarithromycin would lead to

more deaths than placebo. Some observational studies also found an increase in deaths or other serious heart-

related problems, while others did not. All the studies had limitations in how they were designed. Of the six

observational studies published to date in patients with or without coronary artery disease, two found evidence of

long-term risks from clarithromycin3,4, and four did not 5,6,7,8. Overall, results from the prospective, placebo-

controlled CLARICOR trial provide the strongest evidence of the increase in risk compared to the observational

study results. Based on these studies, we were unable to determine why the risk of death is greater for patients

with heart disease.

Medication Safety Updates

Apadaz (acetaminophen and benzhydrocodone hydrochloride) Tablets -

formerly KP201

( February 23, 2018 ) U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for

Apadaz for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid

analgesic and for which alternative treatments are inadequate. Apadaz is an immediate release (IR) combination of

KemPharm’s prodrug, benz hydrocodone, and acetaminophen (APAP).

Apadaz is unique among prescription opioids in that it contains a prodrug that is chemically inert, or inactive, on

its own. When ingested, enzymes in the gastrointestinal tract cleave the ligand from the prodrug

(benzhydrocodone) and release the parent drug (hydrocodone), which can then exert its therapeutic effect. The

final approved product labeling for Apadaz includes these and other data points but concludes that the overall

results of the clinical program did not demonstrate abuse-deterrence by current measurement standards.

Source https://www.drugs.com

FDA Approves Firvanq (vancomycin) for Treatment of Clostridium

Difficile Associated Diarrhea and Staphylococcus Aureus Colitis

( January 26, 2018 ) US Food and Drug Administration (FDA) has approved Firvanq (vancomycin hydrochloride)

for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by

Staphylococcus aureus, including methicillin-resistant strains. Firvanq will be commercially available in 25

mg/mL and 50 mg/mL strengths in convenient 150 mL and 300 mL sizes. Firvanq is designed to be easy to use and

has the potential to be a cost-effective alternative to existing vancomycin therapies.

Firvanq used in Treatment of native valve or prosthetic valve endocarditis caused by susceptible Staphylococcus

aureusor S. epidermidis, including oxacillin-resistant (methicillin-resistant) strains. Also useful in native valve or

prosthetic valve endocarditis caused by viridans streptococci or Streptococcus bovis. Treatment of native valve or

prosthetic valve enterococcal endocarditis; used in conjunction with gentamicin or streptomycin Empiric treatment

of culture-negative endocarditis. For culture-negative native valve endocarditis, regimen of ampicillin-sulbactam

and gentamicin recommended by AHA and IDSA; regimen of vancomycin, gentamicin, and ciprofloxacin

recommended for those unable to tolerate penicillin.

Source ; https://www.drugs.com

6 Drug and Poison Information Bulletin

العربية الصفحة

Drug and Poison Information Bulletin 7

الهيئة العامة للغذاء والدواء . المصدر:

(Clopidogrel) مستحضرات تحتوي على المادة الفّعالة 4تلغي تسجيل الغذاء والدواء" "

8201-Feb-18

ألغت الهيئة العامة للغذاء والدواء تسجيل أربعة مستحضرات، لعدم تكافؤ اثنين منها حيوياً

.مع المستحضر المرجعي، وعدم تسويق آخَرين لمدة تزيد على سنتين

وقال المدير التنفيذي للتوعية واإلعالم في الهيئة الصيدلي عبدالرحمن السلطان: "ضمن

الدراسات التي تقوم بها الهيئة العامة للغذاء والدواء بشكل سنوي لمتابعة المستحضرات

بعد التسويق بهدف التحقق من فعالية األدوية الجنيسة مقارنة بالمستحضرات المرجعية،

,(Clopidogrel) راجعت الهيئة المستحضرات الجنيسة المسجلة المحتوية على المادة الفعالة

المعتمدة سابقاً لدراسات التكافؤ الحيوي،المسجل منها بناًء على طريقة التحليل تحديد

ونظراً لتغيّر طريقة التحليل لهذه المستحضرات، وورود عدد من البالغات التي تفيد بعدم

أُجريت دراسة تكافؤ حيوي له وفقاً للطريقة الحديثة المعتمدة، (Pedovex) فعالية مستحضر

" وأوضحت نتائج هذه الدراسة عدم تكافؤها مع المستحضر المرجعي

وأضاف أن لجنة تسجيل شركات ومصانع األدوية ومنتجاتها بالهيئة قررت إلغاء تسجيل المستحضرين لعدم تكافؤهما حيوياً مع

المستحضر المرجعي وسحبهما من األسواق، إضافة إلى إلغاء تسجيل مستحضري لعدم تسويقهما لمدة تزيد على سنتين.

الهيئة خاطبت وكالء المستحضرات لسحبها من الجهات المستفيدة، كما خاطبت الجهات المعنية لتوجيه من يلزم بسحب المستحضرات وتطرق السلطان إلى أن

.في حال وجودها لديها

وأكد على مستخدمي المستحضرات األربعة مراجعة الطبيب المعالج بشكل فوري.

الكالريتثروميسين لمرضى القلبهيئة الغذاء والدواء األمريكية تحذر بشأن وصف

23-Feb-2018

فبراير الماضي إلى أن وصف المضاد الحيوي كالريثروميسين قد يزيد من خطر المشاكل 22أشارت هيئة الغذاء والدواء األمريكية يوم الخميس

القلبية على المدى البعيد ويزيد من خطر الوفاة عند مرضى القلب.

هيئة األطباء بالموازنة بشكل دقيق بين فوائد ومخاطر المضاد الحيوي كالريثروميسين قبل وصفه للمرضى المصابين وبناًء على ذلك، فقد أوصت ال

بحاالت قلبية.

إلى وقد جاء ذلك التحذير بعد إعالن نتائج دراسة استمرت لعشر سنوات، قام الباحثون فيها بمتابعة مرضى مصابين بأمراض قلبية تاجية، وخلصوا

اط غير مفسر وغير متوقع بين تناول مرضى القلب للمضاد الحيوي كالريثروميسين لمدة أسبوعين وزيادة خطر الوفاة لديهم بعد سنة أو وجود ارتب

أكثر.

من الجدير ذكره بأن الهيئة أوصت مرضى القلب الذين يتناولون الدواء حاليًا على ضرورة عدم التوقف عن تناوله دون استشارة الطبيب.

الهيئة العامة للغذاء والدواء .المصدر:

مو و ة المل د د الع ي الع ية للم و ال .المصدر:

(Pedovex) و (Cardlet)

(Vidapart) و (Clopex)

Editor-in-chief:

Mohamed N. Al-Arifi, PhD

Professor of Clinical Pharmacy

Director of Drug & Poison Information Center

Editors:

Abdulaziz M. Alhossan, PharmD, MPH, BCPS

Sultan M. AL-Ghadeer, PharmD, BCPS

Yazed S. AL-Ruthia, BS.C Pharm, PharmD, PhD

Drug & Poison Information Specialist’s

Salmeen D Babelghaith, PhD

Syed Wajid Ali, M. Pharma,

Rayyan A AL-Mansour, Higher Diploma.

Address / Correspondence:

Drug & Poison Information Center, College of

Pharmacy, King Saud University. P.O. Box

2457 Riyadh 11451, Saudi Arabia. Tel:

4677352, 4677353, 4677354 Fax: 4676229

E-mail: copdpic@ksu.edu.sa

March 16-19, 2018. APhA2018 Leading

Our Communities in Patient Care, in the

Music City Center in downtown Nashville,

USA

20 March 2018- 21 March 2018. Current

Regulatory Trends & Updates in Parenteral

Drug Product Development.

12 April 2018- 13 April 2018 3rd Global

Bioequivalence Harmonization Initiative

GPHI meeting, Amsterdam, The

Netherlands.

19 May 2018- 20 May 2018. 6th World

Health Professions Regulation Conference.

Crowne Plaza Hotel, , Geneva, Switzerland

Upcoming Conferences

Peripheral brain for the pharmacist 2018- by Jeanine P. Abrons (Author)

Student pharmacists have jerry-built a pocket-sized

collection of figures and tables containing key clinical

information they look up frequently. Many graduates

carry their tattered resource along with them right into

practice. Peripheral Brain for the Pharmacist, APhA’s

new 2018-2019 edition, includes more than 90

individual core reference pages—including new content

on calculations; immunization schedules for infants to

adults; travel health immunizations; and updates based

on the most recent changes in guidelines on diabetes,

hypertension, cholesterol, and warfarin management.

This new edition also features an easy-to-use spiral

binding.

ISSN: 1319 – 4302 1319 – 4302: ردمد

Editorial Board

Scientific Books: New Release

Evidence-Based Practice for Infusion Therapy

If you want to receive the DPIC bulletin in your E-mail please contact us via: copdpic@ksu.edu.sa