Yaz, Yasmin and Ocella are combination birth control pills that contain a chemical progestin called drospirenone. Drospirenone has been associated with a number of very dangerous and potentially fatal side effects.
Drospirenone is a diuretic with antimineralocortoid properties that can cause hyperkalemia and lead to thrombosis. Drospirenone can make the potassium levels in your blood go to dangerous levels and cause potentially life-threatening blood clots, stroke, pulmonary embolism (PE), deep vein thrombosis (DVT), gallbladder disease, liver or kidney failure, sudden cardiac death, and a number of other serious medical problems.
The drospirenone contained in Yaz, Yasmin and Ocella is not used in any other combination oral contraceptive on the market in the United States.
Should Health Insurance Cover Medical Marijuana Costs?Cannabis News
Should you HMO or PPO cover medical marijuana prescriptions, read this https://cannabis.net/blog/opinion/should-health-insurance-cover-medical-marijuana
Should Health Insurance Cover Medical Marijuana Costs?Cannabis News
Should you HMO or PPO cover medical marijuana prescriptions, read this https://cannabis.net/blog/opinion/should-health-insurance-cover-medical-marijuana
Yaz, Yasmin and Ocella are combination birth control pills that contain a chemical progestin called drospirenone. Drospirenone has been associated with a number of very dangerous and potentially fatal side effects.
Drospirenone is a diuretic with antimineralocortoid properties that can cause hyperkalemia and lead to thrombosis. Drospirenone can make the potassium levels in your blood go to dangerous levels and cause potentially life-threatening blood clots, stroke, pulmonary embolism (PE), deep vein thrombosis (DVT), gallbladder disease, liver or kidney failure, sudden cardiac death, and a number of other serious medical problems.
The drospirenone contained in Yaz, Yasmin and Ocella is not used in any other combination oral contraceptive on the market in the United States.
September, 2009 presentation for 130 local nonprofit organizations sponsored by the Knight Foundation and the Community Foundation of Northwest Florida.
An excellent tool to create Database search quickly, with high performance and scalability, easy to maintain, flexible result rendering, api or javascript integration, etc.
3 News Uptoday
35 New Guidance
42 Audit Findings
483 Observations
- Top Drug 483 Observations
46 EMA Non-Compliance Reports
- Wockhardt Limited, Aurangabad
- AGEPHA, Austria
- North China Pharmaceutical Group Semisyntech Co., Ltd, China
48 Regulations of the Month
- § 211.188 Batch production and control records
- § 211.192 Production record review
- § 211.194 Laboratory records.
Qui Tam: Off Label Drug Marketing [Data Snapshot]lawsuitlegal
When does the promotion of a pharmaceutical become illegal?
Learn what is considered off-label use for popular drugs and when it becomes unlawful in this data snapshot.
We share the most common types of off-label uses, where it happens most often, and what exceptions provide 'safe haven' protection.
Most doctors and hospitals are prescribing doctors as they should be, with the patients in mind.
However, off-label prescriptions are important when considered in relation to the False Claims Act. The issue of insurance reimbursement takes center stage when drugs are being used unlawfully and these healthcare organizations are receiving insurance payments for improper use.
So take a moment to review the data with us on Off-Label Marketing relating to qui tam actions, today.
Yaz, Yasmin and Ocella are combination birth control pills that contain a chemical progestin called drospirenone. Drospirenone has been associated with a number of very dangerous and potentially fatal side effects.
Drospirenone is a diuretic with antimineralocortoid properties that can cause hyperkalemia and lead to thrombosis. Drospirenone can make the potassium levels in your blood go to dangerous levels and cause potentially life-threatening blood clots, stroke, pulmonary embolism (PE), deep vein thrombosis (DVT), gallbladder disease, liver or kidney failure, sudden cardiac death, and a number of other serious medical problems.
The drospirenone contained in Yaz, Yasmin and Ocella is not used in any other combination oral contraceptive on the market in the United States.
September, 2009 presentation for 130 local nonprofit organizations sponsored by the Knight Foundation and the Community Foundation of Northwest Florida.
An excellent tool to create Database search quickly, with high performance and scalability, easy to maintain, flexible result rendering, api or javascript integration, etc.
3 News Uptoday
35 New Guidance
42 Audit Findings
483 Observations
- Top Drug 483 Observations
46 EMA Non-Compliance Reports
- Wockhardt Limited, Aurangabad
- AGEPHA, Austria
- North China Pharmaceutical Group Semisyntech Co., Ltd, China
48 Regulations of the Month
- § 211.188 Batch production and control records
- § 211.192 Production record review
- § 211.194 Laboratory records.
Qui Tam: Off Label Drug Marketing [Data Snapshot]lawsuitlegal
When does the promotion of a pharmaceutical become illegal?
Learn what is considered off-label use for popular drugs and when it becomes unlawful in this data snapshot.
We share the most common types of off-label uses, where it happens most often, and what exceptions provide 'safe haven' protection.
Most doctors and hospitals are prescribing doctors as they should be, with the patients in mind.
However, off-label prescriptions are important when considered in relation to the False Claims Act. The issue of insurance reimbursement takes center stage when drugs are being used unlawfully and these healthcare organizations are receiving insurance payments for improper use.
So take a moment to review the data with us on Off-Label Marketing relating to qui tam actions, today.
FDA Regulation of Promotion & Advertising-- Part 6A: Draft Guidance on Medica...Michael Swit
November 9, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
In our post about the nutraceuticals industry, dietary supplements as a category of nutraceuticals are subject to compliance with FDA regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
In our post about the nutraceuticals industry, dietary supplements as a category of nutraceuticals are subject to compliance with FDA regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
In our post about the nutraceuticals industry, dietary supplements as a category of nutraceuticals are subject to compliance with FDA regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
CDSCO and Phamacovigilance {Regulatory body in India}
2009 Yaz Warning
1. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
Silver Spring, MD 20993
TRANSMITTED BY FACSIMILE
Fadwa Almanakly
Associate Director, Global Regulatory Affairs
Bayer Healthcare Pharmaceuticals, Incorporated
6 West Belt-W13
Wayne, NJ 07470
RE: NDA No. 21-400 LEVITRA® (vardenafil HCl) Tablets
NDA No. 21-676, 21-873, 22-045 YAZ® (drospirenone and ethinyl estradiol)
Tablets
NDA No. 21-225 Mirena® (levonorgestrel-releasing intrauterine system)
MACMIS ID # 17307
Dear Ms. Almanakly:
This letter notifies Bayer Healthcare Pharmaceuticals, Incorporated (Bayer), and, by copy,
Schering Corporation (Schering), which markets Levitra on behalf of Bayer, that, as part of its
monitoring and surveillance program, the Division of Drug Marketing, Advertising, and
Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed
Bayer’s sponsored links on internet search engines (e.g., Google.com) for the following
products: LEVITRA® (vardenafil HCl) Tablets (Levitra), YAZ® (drospirenone and ethinyl
estradiol) Tablets (YAZ), and Mirena® (levonorgestrel-releasing intrauterine system) (Mirena).
The sponsored links cited in this letter are misleading because they make representations
and/or suggestions about the efficacy of Levitra, YAZ, and Mirena, but fail to communicate
any risk information associated with the use of these drugs. In addition, the sponsored links
for YAZ and Mirena inadequately communicate the drugs’ indications, and the sponsored
links for Mirena overstate the efficacy of the drug. Furthermore, all of the sponsored links fail
to use the required established name. Thus, the sponsored links misbrand the drugs in
violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing
regulations. See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 201.10(g)(1), 202.1(b)(1), (e)(3)(i),
(ii) & (e)(6)(i).
Background
Levitra
According to its FDA-approved product labeling (PI), Levitra is indicated for the treatment of
erectile dysfunction.
Levitra is associated with a number of risks, as reflected in the Contraindications, Warnings,
Precautions, and Adverse Reactions sections of its PI.
2. Fadwa Almanakly Page 2
Bayer Healthcare Pharmaceuticals Incorporated
NDA#21-400, 21-676, 21-873, 22-045, 21-225
MACMIS#17307
YAZ
According to its FDA-approved PI, YAZ is indicated for the prevention of pregnancy in women
who elect to use an oral contraceptive.
YAZ is also indicated for the treatment of symptoms of premenstrual dysphoric disorder
(PMDD) in women who choose to use an oral contraceptive as their method of contraception.
The effectiveness of YAZ for PMDD when used for more than three menstrual cycles has not
been evaluated.
YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS).
YAZ is also indicated for the treatment of moderate acne vulgaris in women at least 14 years
of age, who have no known contraindications to oral contraceptive therapy, and have
achieved menarche. YAZ should be used for the treatment of acne only if the patient desires
an oral contraceptive for birth control.
YAZ is associated with a number of risks, as reflected in the Boxed Warning,
Contraindications, Warnings, Precautions, and Adverse Reactions sections of its PI.
Mirena
According to its FDA-approved PI, Mirena is indicated for intrauterine contraception for up to
5 years. Thereafter, if continued contraception is desired, the system should be replaced.
Mirena is recommended for women who have had at least one child.
Mirena is associated with a number of risks, as reflected in the Contraindications, Warnings,
Precautions, and Adverse Reactions sections of its PI.
Omission of Risk Information
Promotional materials, other than reminder pieces, which include the name of the drug
product but do not include indications or other representations or suggestions relative to the
drug product (see 21 CFR 200.200, 201.100(f), 202.1(e)(2)(i)), are required to disclose risk
and other information about the drug. Such materials are misleading if they fail to reveal
facts that are material in light of the representations made by the materials or with respect to
consequences that may result from the use of the drug as recommended or suggested by the
materials. The sponsored links present the following claims:
• Poor Blood Flow & ED
www.LEVITRA.com Blood Flow May Decrease With High Blood Pressure And May
Lead to ED.
• YAZ® Birth Control Pill
www.Yaz-US.com YAZ® Prevents Pregnancy, May Help Moderate Acne and
PMDD.
3. Fadwa Almanakly Page 3
Bayer Healthcare Pharmaceuticals Incorporated
NDA#21-400, 21-676, 21-873, 22-045, 21-225
MACMIS#17307
• Mirena® Birth Control
www.Mirena-US.com Mirena® - Effective Birth Control That Helps Keep Life Simple.
• Anticonceptivo Mirena
Descubre La Flexibilidad de Mirena Más Informacion en Espanol Aqui
www.SimplementeMirena.com
These sponsored links make representations and/or suggestions about the efficacy of
Levitra, YAZ, and Mirena, respectively, but fail to communicate any risk information. This
omission of risk information is particularly concerning as one of these products, YAZ, has a
Boxed Warning. For promotional materials to be truthful and non-misleading, they must
contain risk information in each part as necessary to qualify any claims made about the drug.
By omitting the most serious and frequently occurring risks associated with the drugs
promoted in the links above, the sponsored links misleadingly suggest that Levitra, YAZ, and
Mirena are safer than has been demonstrated. We note that these sponsored links contain a
link to the products’ websites. However, this is insufficient to mitigate the misleading
omission of risk information from these promotional materials.
Inadequate Communication of Indication/Overstatement of Efficacy
The sponsored link for YAZ provides a very brief statement about what the drug is for;
however, this statement is incomplete and misleading, suggesting that YAZ is useful in a
broader range of conditions or patients than has been demonstrated by substantial evidence
or substantial clinical experience. Specifically, the sponsored link for YAZ misleadingly
broadens the indication for YAZ by implying that all patients with moderate acne are
candidates for YAZ therapy (“YAZ® Prevents Pregnancy, May Help Moderate Acne and
PMDD”), when this is not the case. Rather, YAZ’s indication is limited to the treatment of
moderate acne vulgaris in women at least 14 years of age who have achieved menarche,
and it should be used for the treatment of acne only if the patient desires an oral
contraceptive for birth control.
The sponsored links for Mirena overstate the efficacy for Mirena by failing to reveal that
Mirena is only indicated for up to 5 years of use before replacement. By omitting this
information, the link suggests that the drug can be used indefinitely, when this is not the case.
Likewise, the sponsored links for Mirena provide very brief statements about what the drug is
for; however, these statements are incomplete and misleading in that they fail to convey the
recommended patient population for Mirena (women who have had at least one child), thus
suggesting that the drug is appropriate for any woman.
Failure to Use Required Established Name
None of the sponsored links present the full established name of the drugs being promoted,
despite the requirement to do so. See 21 CFR 201.10(g)(1) & 202.1(b)(1).
4. Fadwa Almanakly Page 4
Bayer Healthcare Pharmaceuticals Incorporated
NDA#21-400, 21-676, 21-873, 22-045, 21-225
MACMIS#17307
Conclusions and Requested Action
For the reasons discussed above, the sponsored links misbrand Levitra, YAZ, and Mirena in
violation of the Act and FDA regulations. See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR
201.10(g)(1), 202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).
DDMAC requests that Bayer immediately cease the dissemination of violative promotional
materials for Levitra, YAZ, and Mirena, such as those described above. Please submit a
written response to this letter on or before April 9, 2009, stating whether you intend to comply
with this request, listing all promotional materials (with the 2253 submission date) in use for
these drugs as of the date of this letter, identifying which of these materials contain violations
such as those described above, and explaining your plan for discontinuing use of such
materials. Finally, we encourage you to review your promotional materials for the other
prescription drug products that Bayer promotes in the United States and to discontinue or
revise any materials with the same or similar violations, and request that your response
address this issue as well.
Please direct your response to the undersigned at the Food and Drug Administration, Center
for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and
Communications, 5901-B Ammendale Road, Beltsville, MD, facsimile at 301-847-8444. In all
future correspondence regarding this matter, please refer to MACMIS # 17307 in addition to
the NDA numbers. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is
your responsibility to ensure that your promotional materials for Levitra, YAZ, and Mirena
comply with each applicable requirement of the Act and FDA implementing regulations.
Sincerely,
{See appended electronic signature page}
Shefali Doshi, M.D.
Regulatory Review Officer
Division of Drug Marketing,
Advertising, and Communications
cc: Casilda Luck-Barnes
Senior Manager, Global Regulatory Affairs
Schering Corporation
2000 Galloping Hill Road
Kenilworth, NJ 07033