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Friday, May 28th, 2010 - One comment

A technical perspective on women’s liberation through the Pill

How can we ensure that every woman who chooses can access the Pill or other appropriate contraceptive options? There are many technical factors to consider.

Health-Care System, regulations, manufacturing, and distribution

There are many factors that should be considered before distributing Oral Contraceptives. As with any “drug product”, safety should be the concept when considering a new population (3), and, when considering distribution of a safely manufactured product, this requires a literate population with a dedicated health-care system. Still, we must remember the manufacturing process as well, because errors and illegal activity occurs.

Health: More than oral contraceptives

Although oral contraception is a valuable tool, I believe we should concentrate on other forms as well. For example, HIV and other Sexually Transmitted Diseases are prevalent in many countries, and adolescents, as well as adults, should be educated on the proper use of other contraceptives. Although there are many married and single people in relationships with “trustworthy” partners, we know that many women and men are infected because of untrustworthy relationship as well; therefore, some societies may be harmed by distribution of oral contraception.

Brief statistics and a health-Care network

The number of women using contraception in the USA is 12 million while the world-wide number is estimated to be 100 million. Since many medical conditions-thrombophlebitis, pulmonary embolism, cerebrovascular disease, diabetes, etc-cause problems when taking contraceptives, women should be evaluated by a Physician (1,2,3,4). In addition, age and smoking can cause problems as well. For this reason, the immediate impact will be communities where physicians, pharmacists, and other health-care practitioners can advise women about potential health concerns, perform proper physicals, and provide medical care. In addition, a consumer should have a literacy level that allows an understanding of complications associated with the oral contraceptive. Once accomplished, a network can be created to distribute oral contraception according to suggested protocols, which includes proper storage.

Drug interactions

Drug interactions are important for any consumer. In truth, a consumer may benefit from an “idea” of “chemical interaction” instead of “drug interaction”. Why? Pharmaceuticals, food, and herbal products can affect drugs.

For instance, grapefruit is known to affect liver metabolism of certain drugs, which affects the distribution within the body. In addition, there are other drugs and herbal products that may affect the efficacy of oral contraceptives as well. For example, St. John’s Wort (hypericum perforatum) is considered as a possible negative herbal product (14) because it may reduce the effectiveness of contraceptive steroids. In some continents and countries with high HIV prevalence, the HIV-infected consumer should know the effect of anti-HIV protease inhibitors on oral contraceptives. Furthermore, antibiotics, anticonvulsants, and other drugs may increase the metabolism of contraceptive steroids, which will reduce the effectiveness as well.

Complications and adverse events

In truth, “The Pill” can cause some serious complications and, like any pharmaceutical, a system should be available that allows continuous data gathering of “adverse events” (12). As data is gathered, professionals can perform an analysis and determine new trends. An important process in societies that use pharmaceuticals because a drug is approved on a “benefits” versus “risks” profile, and the profile is very dependent upon data and human “population” statistics (3,4).

As with any drug, pharmaceutical companies create the analytical method, collect data, decide upon appropriate statistical methods, and provide a regulatory agency with information for a regulatory and scientific review (6). The pharmaceutical evaluation process is expensive and limited. The greater the population number, the better the evaluation but time and cost is drastically increased. Therefore, many pharmaceuticals are approved on an analysis of extremely small human population profiles. For this reason, there should be continuous monitoring (13). We humans need to remember the complexities of our bodies when distributing pharmaceuticals or evaluating any data associated with humans. Different ethnic populations will have different genetic disease profiles, and we know this because of medical and scientific research. As a drug is introduced into new areas where, on-average, the population may have a different genetic profile, health-care researchers, pharmaceutical companies, and others have to prepare for complications that may be related to a new genetic profile. As you can appreciate, this requires a society with advanced medical and scientific capabilities.

Sadly, some corporations may not provide the means to ensure safety. In truth, corporations are a business and, as an organization, have a survival based upon monetary gain. This is the reason some corporate employees or consultants don’t make the best decisions, and, at times, engage in illegal activity. As a recent example, I provide the latest tobacco industry product where nicotine was added to candy. Although the industry argues the candy was created to help adults quit smoking, we adults know children will “experiment”. As proof of child curiosity, I provide medicine cabinet pharmaceuticals as an example. I’m sure the tobacco employees are aware of dangers associated with potentially deadly pharmaceuticals in their home. By the way, the risk profile of pharmaceuticals can be affected by illegal manufacturing practices as well. Therefore, it is imperative that consumers, health-care professionals, and others report “adverse events” associated with any medical device or pharmaceutical product (13). At the bottom of this article, I provide links to many US Food and Drug Administration‘s databases.

In contrast, a peer may argue the following: “The Pill” can be distributed in a manner similar to HIV drugs, and health-care practitioners are not “necessary” . In contrast, I argue the latter assumption sets a dangerous precedence in new distribution populations. Although many women may argue the contraceptive pill provides a means for women’s liberation, I believe there are safer and more effective liberation methods. When dealing with humans and pharmaceuticals, we need to adhere to previously established safety protocols. In fact, the safety protocols are “dynamic” and should be changed to meet the needs of new consumer populations (3).

Cost and distribution

As we know, many US people are attempting to get the pill covered by insurance. Why? Because it is an expensive drug, and women of industrialized nations cannot always afford the product. As such, women of other countries will benefit from the philanthropic interaction of corporations. Therefore, another “Conversation Starter” may have more networking connections than I, and find the following databases useful. In addition, all consumers should be aware of this valuable information. Why? Because they can research a drug, it’s interactions and complications, possible distribution problems, and make informed decisions.

Conclusion:

Women of developed countries have come a long way, and their struggle for equality should have been decreased by many years. As a chemical engineering student, I valued the intelligent thought process of female peers and many were the top students. I can say the same for the period of my biological science degree. As the son of a single mother, I can understand my female peers desire to assist other women with liberation. As we attempt to “liberate” others, we need to ensure proper protocols exist. As previously mentioned, these protocols are dynamic and will save the lives of many, reduce costs associated with manufacturing and distribution, and ensure a safe distribution of properly manufactured pharmaceuticals. With that said, later, I provide an example of United States Food and Drug Administration Resources. Resources that will assist with potential distribution of “The Pill”.

For further information on oral contraceptives

United States National Library of Medicine and the National Institutes of Health. MedlinePlus. Drugs and Supplements. Oral Contraceptives. MedlinePlus[online]. 2010. Available from: Oral Contraceptives. Search MedlinePlus”.

Next, Enforcement Reports, Recalls, US Food and Drug Administration Database Information, and how to obtain such important information:

References and FDA Databases

Enforcement reports and recalls

A “recall” (7) or “enforcement report” may not denote illegal activity. As we know, humans and equipment error. As such, we should expect some deviation from “accepted” processing norms and work to regain control, which is the power of statistical process control. Therefore, some corporate employees will honestly report errors and may face US FDA action after an inspection. Usually an FDA action will occur if the process is not meeting current Good Manufacturing Practices. Many corporate employees, including corporate management, view this “constructive criticism” negatively. In truth, corporations, like humans, need “constructive criticism” because it allows production of safe and efficacious product.

In addition, I would like to share some important information that is based on personal “a priori” knowledge. Although normal manufacturing errors occur, some pharmaceutical manufacturing scientists and engineers would rather endanger consumers than admit to errors. As such, they will cover up errors, mislead others, and knowingly place adulterated product on the market for consumption. Since they cover-up errors, a US FDA inspection may not reveal improper manufacturing. As a pharmaceutical chemical engineer, I had peers who regularly engaged in this activity, which is an activity I wouldn’t follow. Therefore, many companies may not have US FDA enforcement reports on file but engage in illegal activity. The latter reason emphasizes the importance of reporting “adverse events” (13), which could lead to “recalls” of product (7).

Sadly, Wall Street looks at these reports as well and make decisions based on FDA action. In turn, a company’s stock can be affected, which affects the investments of many. Although I say “sadly”, this process is important because it should force a company to manufacture safe product. In truth, many corporations and employees of corporations, care more about the “symbol”, which equates to money, than the health of consumers. As such, they may cover up data.

Searching

Searching for United States Food and Drug Administration on Birth Control Pills: United States Food and Drug Administration Class II Drugs:

The Search for Information!

A note on Errors: A possible mode of frustration

As with any database of information, consistency is important. In my opinion, this is a serious problem with much Internet Information. During my searching of the US FDA databases, I noticed the organization of drug names varied between databases, and some generic names don’t produce any search results. For example, one database will include a hyphen between names, which causes problems when using drug names. In addition, I noticed numerous errors in the National Drug Code Directory. Although the database is “maintained” by the US FDA, companies provide the data to be entered. What can we “consumers” do to help improve the accuracy? Well, we are all consumers, and we should all take the time and report errors, which is similar to “peer” review.

A suggested Method for Searching and Gathering Information on “The Pill” or any other Drug:

Commercial Medical Websites:

In truth, many of us will seek information from one of many medical websites. As a professional, I suggest a site that provides references and information verification methods. Once we have information, we can use the US Food and Drug Administration Databases to discover useful details regarding drugs, recalls, and enforcement reports.

Although I appreciate many sites, I have a tendency to use WebMD. When I searched webMD, I discovered the following list of birth Control Pills:

º Seasonale; • Enovid; º Alesse; • Brevicon; º Demulen; • Desogen; º Nordette; • Loestrin; º Norinyl; • Ortho-Cept; º Ortho Cyclen; • Ortho Novum; º Yasmin; • Yasmin.

After discovering some pills, I went to the US FDA website and began gathering data. Specifically, I was interested in recalls and enforcement reports, but I decided to collect the following data:

º FDA New Drug Application Number, “NDA”; • Active Ingredients; º Company; • Marketing Status; º National Drug Code, “NDC”; • Recalls; º Reason for Recall; • Date of Recall.

Next, some definitions:

New Drug Application, “NDA“, Number:

A six digit number that is assigned by the United States Food and Drug Administration to each application for approval to market a new drug in the United States. If a drug has different dosage forms or routes of administration, it may have another application number.

Active Ingredient:

An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals.

Company:

The company (also called applicant or sponsor) submits an application to FDA for approval to market a drug product in the United States.

Marketing Status:

Indicates how a drug is sold in the United States, and given the following identification in the Drugs@FDA database. Prescription, Over-the Counter, Discontinued, and None.

Prescription: A prescription drug product requires a doctor’s authorization to purchase.

Over the Counter: A safe and effective drug for use by the general public without a doctor’s prescription.

Discontinued: Products listed in Drugs@FDA as “discontinued” are approved products that have never been marketed, have been discontinued from marketing, are for military use, are for export only, or have had their approvals withdrawn for reasons other than safety or efficacy after being discontinued from marketing.

National Drug Code, “NDC”, Number:

A three-segment number that is a universal identifier for human drugs.

Recalls: Class I, I, and III:

• Class I Recall: A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

• Class II Recall: A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences are remote.

• Class III Recall: A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Enforcement Report Definitions

After an Understanding of Terms:

Once we have an understanding of the definitions, we can search US FDA databases with a better understanding of the data. As I was searching, I used the Drugs@FDA and the Orange Book to obtain much of my information. I used my list of named “Pills” from WebMD, and searched the Drugs@FDA database to obtain New Drug Application, “NDA”, number. Once I discovered the NDA number, I searched the Orange Book, National Drug Code Directory, and any other database that allowed use of the NDA number. As I mentioned previously, the drug name often changed within the US FDA databases, which produced different results. In addition, some drug names didn’t produce a result, while the NDA did produce. In most situations, it seems the generic name caused a nil search. After obtaining and verifying the NDA number, drug name, active ingredients, company, etc with the Drugs@FDA and Orange Book databases, one can search for the National Drug Code, “NDC”, number.

A Search Based on NDA Number:

An NDA search allows one to find the greatest number associated with active ingredient “Strength”. Once I had a table of Label Code and Product Code values, I returned to the National Drug Code Directory and searched according to my newly discovered label and product codes. The NDC number is created with several numbers, and the labeler and product code numbers are a part of the NDC number.

National Drug Code Directory: Labeler and Product Code Search.

After selecting “Search by NDC Number”, “Search by NDC Number by Labeler Code and Product Code”, and entering the labeler and product codes, the National Drug Code Directory produces a nice table with the following:

º Trade Name; • Strength; º Complete NDC; • Packtype; º Packsize; • Firm Name.

Next, you can use your new information to understand the “Enforcement Report” or “Recall” search. Although an enforcement report or recall search can be completed independently, the latter procedure assists with an understanding of technical search knowledge. In turn, this may facilitate discussions with potential philanthropic suppliers, since the process can lead to generic names as well.

Enforcement Reports:

Finally, one may want to discover if enforcement reports or recalls exist. If they do, why did the recall occur and on what date. The latter allows a development of trends. Remember, some company’s may receive an enforcement report because of honesty, while others may hide “bad data” and appear as good manufactures. Also, politics does exist and some FDA investigators can be biased or corrupt as well, which can lead to biased reporting. In contrast, a recall is usually based on consumer or health-care data. The data of the report is pretty clear, and the US FDA provides explanations if needed.

A Brief Example of Available Information: Some Birth-Control Pill.

º Name: Enovid, Enovid-E, and Enovid-E 21 • Company: GD Searle LLC • Marketing Status: Discontinued

• Active Ingredients: Mestranol; Norethynodrel • NDA: 010976

• NDC: None

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Seasonale; Jolessa • Company: Duramed RES • Marketing Status: Prescription

• Active Ingredients: Ethinyl Estradiol; Levonorgestrel • NDA: 021544

• NDC: none

• Recall #: No Recalls on file • Reason: n/a • Date: n/a

º Name: Alesse • Company: Wyeth Pharms Inc • Marketing Status: Discontinued

• Active Ingredients: Ethinyl Estradiol; Levonorgestrel • NDA: 020683

• NDC: none

• Recall #: D-443-2007; NDC 0008-2576-03 • Reason: Impurity (18 month stability) • Date: 2006

º Name: Brevicon 21-Day • Company: Watson Labs • Marketing Status: Discontinued

• Active Ingredients: Ethinyl Estradiol; Norethindrone • NDA: 017566

• NDC: None

• Recall: No Recalls on file • Reason: n/a • Date: n/a

º Name: Brevicon 28-Day • Company: Watson Labs • Marketing Status: Prescription

• Active Ingredients: Ethinyl Estradiol; Norethindrone • NDA: 017743

• NDC: 53808-*071, 63285-*203; 52544-*254 (Watson Pharma Inc)

• Recalls: No Recalls of file • Reason: n/a • Date: n/a

º Name: Demulen 1/35-21 • Company: GD Searle LLC • Marketing Status: Discontinued

• Active Ingredients: Ethinyl Estradiol; Ethynodiol Diacetate • NDA: 018168

• NDC: 00025-0151 (GD Searle LLC)

• Recalls: No Recalls of file • Reason: n/a • Date: n/a

º Name: Demulen 1/35-28 • Company: GD Searle LLC • Marketing Status: Discontinued

• Active Ingredients: Ethinyl Estradiol; Ethynodiol Diacetate • NDA: 018160, other

• NDC: 65427-*161 (NDA: other; Pfizer); 00025-0161-09(NDA: other; GD Searle LLC); 55154-3612 (Cardinal Health); 60491-*181(Pharmaceutical Utilization Management Program VA Inc); 65084-*219 (RX PAK Div of McKesson Corp); 54868-0404 (Physicians Total Care Inc); 55154-3612 (Cardinal Health)

• Recalls: # D-501-5; NDC 00025-0161-09 • Reason: Subpotent; Ethinyl Estradiol • Date: 2005

º Name: Demulen 1/50-21 • Company: GD Searle LLC • Marketing Status: Discontinued

• Active Ingredients: Ethinyl Estradiol; Ethynodiol Diacetate • NDA: 016927

• NDC: None

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Demulen 1/50-28 • Company: GD Searle LLC • Marketing Status: Discontinued

• Active Ingredients: Ethinyl Estradiol; Ethynodiol Diacetate • NDA: 016936

• NDC: 60491-*183 (Pharmaceutical Utilization Management Program VA INC); 65427-*081 (Pfizer)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Desogen; Solia • Company: Organon USA Inc • Marketing Status: Oral-21, Discontinued; Oral-28, Prescription

• Active Ingredients: Desogestrel; Ethinyl Estradiol • NDA: 020071

• NDC: 53808-*072 (Dept Health Central Pharmacy); 66993-*611 (Prasco Laboratories); 60889-0261 (Organon Ireland LTD); 54868-3863 (Physicians Total Care Inc.); 00052-0261 (Organon USA Inc.)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Nordette-21; Levelen-21 • Company: Duramed RES • Marketing Status: Discontinued

• Active Ingredients: Ethinyl Estradiol; Levonoregestrel • NDA: 018668

• NDC: 50419-*410 (Levlen 21, Bayer Healthcare Pharmaceuticals Inc.)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Nordette-28; Levlen-28 • Company: Duramed • Marketing Status: Prescription

• Active Ingredients: Ethinyl Estradiol; Levonoregestrel • NDA: 018782

• NDC: 60491-*411 (Pharmaceutical Utilization Management Program VA Inc.); 60491-*456 (Pharmaceutical Utilization Management Program VA Inc.); 51285-*091 (Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Loestrin 21 1.5/30 • Company: Warner Chilcott • Marketing Status: Prescription

• Active Ingredients: Ethinyl Estradiol; Norethindrone Acetate • NDA: 017875

• NDC: 00071-0916 (Parke Davis Div Warner Lambert Co); 00047-0082 (Warner Chilcott Co INC); 51285-*082 (Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Loestrin 21 1/20 • Company: Warner Chilcott • Marketing Status: Prescription

• Active Ingredients: Ethinyl Estradiol; Norethindrone Acetate • NDA: 017876

• NDC: 51285-*079 (Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc); 00071-0915 (Parke Davis Div Warner Lambert Co); 00047-0079 (Warner Chilcott Co Inc)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Loestrin 24 FE • Company: Warner Chilcott • Marketing Status: Prescription

• Active Ingredients: Ethinyl Estradiol; Norethindrone Acetate • NDA: 021871

• NDC: 54868-6100 (Physicians Total Care Inc); 00047-0530 (Warner Chilcott Co Inc.); 00430-0530 (Warner Chilcott US LLC)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Loestrin FE 1.5/30 • Company: Warner Chilcott • Marketing Status: Prescription

• Active Ingredients: Ethinyl Estradiol; Norethindrone Acetate • NDA: 017355

• NDC: 51285-*083, -*084 (Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc); 00071-0917 (Parke Davis Div Warner Lambert Co.); 60491-*366 (Pharmaceutical Utilization Management Program VA Inc.); 00047-0083, -0534 (Warner Chilcott Co Inc); 54868-1512(Physicians Total Care Inc.)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Loestrin FE 1/20 • Company: Warner Chilcott • Marketing Status: Prescription

• Active Ingredients: Ethinyl Estradiol; Norethindrone Acetate • NDA: 017354

• NDC: 51285-*080, *081 (Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc.); 00071-0913 (Parke Davis Div Warner Lambert Co); 60491-*365 (Pharmaceutical Utilization Management Program VA Inc); 00047-0080, -0081(Warner Chilcott Co Inc.); 54868-0502(Physicians Total Care)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Norinyl • Company: Watson Labs• Marketing Status: Discontinued

• Active Ingredients: Mestranol; Norethindrone • NDA: 013625

• NDC: None

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Norinyl and Norinyl 1 +50 21-Day • Company: Watson Labs • Marketing Status: Discontinued

• Active Ingredients: Mestranol; Norethindrone • NDA: 013625

• NDC: None

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Norinyl 1 +35 21-Day and Norinyl 1 +35 28-Day; Genora • Company: Watson Labs • Marketing Status: Prescription

• Active Ingredients: Ethinyl Estradiol; Norethindrone • NDA: 017565

• NDC: 63285-*200 (Patheon Inc Toronto Region Operations); 52544-*259 (Watson Pharma Inc); 54868-0528 (Genora, Physicians Total Care Inc.)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: º Tri-Norinyl 21-Day and Tri-Norinyl 28-Day; Leena • Company: Watson Labs • Marketing Status: 21-Day, Discontinued; 28-Day, Prescription

• Active Ingredients: Ethinyl Estradiol; Norethindrone • NDA: 018977

• NDC: 53808-*070 (Dept Health Central Pharmacy); 63285-*201, -*208 (Patheon Inc Toronto Region Operations; -*208: Leena); 52544-*219 (Leena, Watson Pharma Inc); 60491-*654 (Pharmaceutical Utilization Management Program VA Inc)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Norinyl 1+35 21-Day; 1+35 28-Day; Genora • Company: Watson Labs • Marketing Status: Prescription

• Active Ingredients: Ethinyl Estradiol; Norethindrone • NDA: 017565

• NDC: 63285-*200 (28 Day, Patheon Inc Toronto Region Operations); 52544-*259 (28 Day, Watson Pharma Inc); 54868 -*0528 (Genora, Physicians Total Care Inc)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Norinyl 1+50 28-Day; Genora • Company: Watson Labs • Marketing Status: Prescription

• Active Ingredients: Mestranol; Norethindrone • NDA: 016659

• NDC: 63285-*209 (Patheon Inc Toronto Region Operations); 52544-*265 (Watson Pharma Inc); 54868-0529 (Genora, Physicians Total Care Inc.)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho Cept • Company: Ortho McNeil Janssen • Marketing Status: Oral-21, Discontinued; Oral-28, Prescription

• Active Ingredients: Desogestrel; Ethinyl Estradiol • NDA: 020301

• NDC: 53808-*042 (Dept Health Central Pharmacy); 60491-*906 (Pharmaceutical Utilization Management Program VA Inc.); 00062-1796 (Ortho McNeil Janssen Pharmaceuticals Inc Ortho McNeil Unit); 00107-1796 (Ortho Pharmaceutical Division of Janssen Ortho LLC)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho Cyclen-21 and Ortho Cyclen-21 28; Trinessa • Company: Ortho McNeil Janssen • Marketing Status: Ortho Cyclen-21, Discontinued; Ortho Cyclen-28, Prescription

• Active Ingredients: Ethinyl Estradiol; Norgestimate • NDA: 019697; 019653

• NDC: 53808-*043 (NDA: 019697, Dept Health Central Pharmacy); 59564-*221, -*233 (NDA: 019677, Innovative Manufacturing and Distribution Services Inc.); 52544-*248, -*247, -*526 (NDA: 019677, -*248; NDA: 019653, -*247 and -*526; Watson Pharma Inc. ); 00062-1903 (NDA: 019677, Ortho McNeil Janssen Pharmaceuticals Inc. Ortho McNeil Unit); 00107-1903 (NDA: 019677, -1903; NDA: 019653, -1901; Ortho Pharmaceutical Division of Janssen Ortho LLC ); 55045-2782 (NDA: 019697, ); 54868-4093, -5826 (NDA: 019697; -5826; Physicians Total Care Inc ); 54868-2606 (NDA: 019653; Physicians Total Care Inc); 00062-1901, -1907, -9350 (NDA: 019697, -9350; NDA: 019653, -1901, -1907; Ortho McNeil Janssen Pharmaceuticals inc Ortho McNeil Unit); 00107-1901, -9350, -5260 (NDA: 019697; -9350; NDA: 019653, -1901, -5260; Ortho Pharmaceutical Division of Janssen Ortho LLC)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Mononessa, A generic of Ortho Cyclen • Company: Ortho Pharmaceutical Division of Janssen Ortho LLC; Watson Pharma Inc. • Marketing Status: See above

• Active Ingredients: Ethinyl Estradiol; Norgestimate • NDA: 019653

• NDC: 00062-5260 [other], 00107-5260, (Ortho Pharmaceutical Division of Janssen Ortho LLC); 52544-*526, -*247 (Watson Pharma Inc)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho-Novum 1/35-21 • Company: Ortho McNeil Pharm • Marketing Status: Discontinued

• Active Ingredients: Ethinyl Estradiol; Norethindrone • NDA: 017489

• NDC: None

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho-Novum 1/35-28 • Company: Ortho McNeil Janssen• Marketing Status: Prescription

• Active Ingredients: Ethinyl Estradiol; Norethindrone • NDA: 017919

• NDC: 53808-*031 (Dept Health Central Pharmacy); 60491-*908 (Pharmaceutical Utilization Management Program VA Inc.) 59564-*149 (Innovative Manufacturing and Distribution Services Inc); 00179-1297 (Kaiser FDN Hosp); 00062-1761 (Ortho McNeil Janssen Pharmaceuticals Inc Ortho McNeil Unit); 00062-1761; 00107-1761 (Ortho Pharmaceutical Division of Janssen Ortho LLC)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho-Novum 1/50-21 • Company: Ortho McNeil Pharm • Marketing Status: Discontinued

• Active Ingredients: Mestranol Norethindrone • NDA: 012728

• NDC: None

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho-Novum 1/50-28 • Company: Ortho McNeil Pharm • Marketing Status: Discontinued

• Active Ingredients: Mestranol; Norethindrone • NDA: 016709

• NDC: 53808-*030 (Dept Health Central Pharmacy); 00062-1332 (Ortho McNeil Janssen Pharmaceuticals Inc Ortho McNeil Unit); 00107-1332 (Ortho Pharmaceutical Division of Janssen Ortho LLC)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho-Novum 1/80 21 • Company: Ortho McNeil Pharm • Marketing Status: Discontinued

• Active Ingredients: Mestranol; Norethindrone • NDA: 016715

• NDC: None

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho-Novum 1/80 28 • Company: Ortho McNeil Pharm • Marketing Status: Discontinued

• Active Ingredients: Mestranol; Norethindrone • NDA: 016715

• NDC: None

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho-Novum 10-21 • Company: Ortho McNeil Pharm • Marketing Status: Discontinued

• Active Ingredients: Mestranol; Norethindrone • NDA: 012728

• NDC: None

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho-Novum 10/11-21 • Company: Ortho McNeil Janssen • Marketing Status: Discontinued

• Active Ingredients: Ethinyl Estradiol; Norethindrone • NDA: 018354

• NDC: None

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho-Novum 10/11-28 • Company: Ortho McNeil Janssen • Marketing Status: Discontinued

• Active Ingredients: Ethinyl Estradiol; Norethindrone • NDA: 018354

• NDC: 00062-1771 (Ortho McNeil Janssen Pharmaceuticals Inc Ortho McNeil Unit); 00107-1771 (Ortho Pharmaceutical Division of Janssen Ortho LLC)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho-Novum 2-21 • Company: Ortho McNeil Pharm • Marketing Status: Discontinued

• Active Ingredients: Mestranol; Norethindrone • NDA: 012728

• NDC: None

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho-Novum 7/14-21, Ortho-Novum 7/14-28;, and Jenest 28 Tablets • Company: Ortho McNeil Pharm • Marketing Status: Discontinued

• Active Ingredients: Ethinyl Estradiol; Norethindrone • NDA: 019004

• NDC: 00062-1790 (Ortho McNeil Janssen Pharmaceuticals Inc Ortho McNeil Unit)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Ortho-Novum 7/7/7-21 and Ortho-Novum 7/7/7-28 • Company: Ortho McNeil Janssen • Marketing Status: Oral-21, Discontinued; Oral 28, Prescription

• Active Ingredients: Ethinyl Estradiol; Norethindrone • NDA: 018985

• NDC: 54868-0508 (Physicians Total Care Inc); 53808-*032 (Dept Health Central Pharmacy); 59564-*148 (Innovative Manufacturing and Distribution Services Inc); 60491-*910 (Pharmaceutical Utilization Management Program VA Inc) 52544-*936 (Watson Pharma Inc.);00179-1298 (Kaiser FDN Hosp); 00062-1781(Ortho McNeil Janssen Pharmaceuticals Inc. Ortho McNeil Unit); 00107-1781 (Ortho Pharmaceutical Division of Janssen Ortho LLC)

• Recalls: No Recalls on file • Reason: n/a • Date: n/a

º Name: Yasmin; Ocella • Company: Bayer Hlthcare • Marketing Status: Prescription

• Active Ingredients: Drospirenone; Ethinyl Estradiol • NDA: 021098

• NDC: 50419-*402 (Bayer Healthcare Pharmaceuticals Inc); 12866-0402 (Bayer Schering Pharma); 54868-4590 (Physicians Total Care Inc); 54868-5922 (Physicians Total Care Inc); 00555-9131 (Barr Laboratories Inc); 64259-9131; 64259-0402 (Schering GMBH UND Co. Produktions KG)

• Recalls: 2) Ocella (drospirenone and ethinyl estradiol tablets) 3 mg/0.3 mg, Rx only;This package contains one blister of 28 tablets: 21 yellow tablets, containing 3 mg of drospirenone and 0.3 mg of ethinyl estradiol; and seven white inert tablets’, NDC 0555-9131-767. Recall # D-047-2010

• Reason: Current Good Manufacturing Deviations: Out of specification analytical value for chemical assays of drospirenone and ethinyl estradiol was averaged with another analytical value to provide a reported result that was within specification. • Date: 2009

º Name: Yaz • Company: Bayer Hlthcare • Marketing Status: Prescription

• Active Ingredients: Drospirenone; Ethinyl Estradiol • NDA: 021676

• NDC: 64259-0405 (Schering GMBH UND Co. Produktions KG); 54868-5535; 54868-5828; (Physicians Total Care Inc); 50419-*405 (Bayer Healthcare Pharmaceuticals Inc.); 12866-0405 (Bayer Schering Pharma AG)

• Recalls: Recall # D-046-2010

• Reason: Current Good Manufacturing Practices Deviations: Out of Specification analytical value for chemical assays of drospirenone and ethinyl estradiol was averaged with another analytical value to provide a reported result that was within specification.

• Date: 2009

º Name: Yaz • Company: Bayer Hlthcare • Marketing Status: Prescription

• Active Ingredients: Drospirenone; Ethinyl Estradiol • NDA: 021873; 022045

• NDC: None

• Recalls: No Recalls on file • Reason: n/a • Date: 2009

References:

1. WebMD. Birth Control Health Center. Birth Control Pills. WebMD[online]. 2010. Available from: Birth Control Pills, WebMD.

2. Watson, Stephanie; Hoffman, Matthew MD. WebMD. Women’s Health. Birth Control Overview. WebMD[online]. 2010. Available from: Women’s Health, WebMD.

3. Dinger, Juergen C.; Bardenheuer, Kristina, and Assmann, Anita. Taking Oral Contraceptives (INAS-OC Study). BMC Med Res Methodol[online]. 2009. vol.9(77). Available from: Entrez, The Life Sciences Search Engine. Search Entrez.

4. Katzung, Bertram G., MD, PhD. Basic & Clinical Pharmacology, ninth edition. Lange Medical Books/McGraw-Hill. 2004. Available from: Amazon. ISBN: 0-07-141092-9. ISBN: 0-07-144097-6. ISSN: 0891-2033.

5. United States Food and Drug Administration, “FDA”. Drugs. Drugs. Drug Approvals and Databases. FDA[online]. 2010. Available from: Drugs: Quick Links. Search US FDA.

6. United States Food and Drug Administration, “FDA”. Drugs. New Drug Application, “NDA”, Introduction. FDA[online]. 2010. Available from: Drugs. Search US FDA.

7. United States Food and Drug Administration, “FDA”. Safety. Enforcement Report Definitions. FDA[online]. 2010. Available from: Enforcement Reports. Enforcement Report, Information. Search US FDA.

8. United States Food and Drug Administration, “FDA”. Drugs. Drugs@FDA. FDA[online]. 2010. Available from: Drugs@FDA. Drugs@FDA Frequently Asked Questions: FAQ. Search US FDA.

9. United States Food and Drug Administration, “FDA”. Drugs. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA[online]. 2010. Available from: Orange Book. Orange Book Frequently Asked Questions: FAQ. Electronic Orange Book (EOB) Query data files Definitions. Search US FDA.

10. United States Food and Drug Administration, “FDA”. Drugs. National Drug Code Directory, “NDC”. FDA[online]. 2010. Available from: NDC. Definitions. Search US FDA.

11. United States Food and Drug Administration, “FDA”. Drugs. Drug Firm Annual Registration Status. FDA[online]. 2010. Available from: Drug Firm Registration Search. Drug Firm Annual Registration Status Information. Search US FDA.

12. United States Food and Drug Administration, “FDA”. Drugs. Adverse Event Reporting System, AERS”. FDA[online]. 2010. Available from: AERS Description. Search US FDA.

13. United States Food and Drug Administration, “FDA”. For Consumers, Your Guide to Reporting Problems to FDA: Animal & Veterinary; Cosmetics; Dietary Supplements; Drugs; Food; Medical Devices; Radiation-Emitting Products, and Vaccines, Blood & Biologics. FDA[online]. 2010. Available from: For Consumers. Search US FDA.

14. United States National Library of Medicine and the National Institutes of Health. MedlinePlus. Drugs and Supplements. St. John’s wort (Hypericum perforatum L.). MedlinePlus[online]. 2010. Available from: St. John’s wort. Search MedlinePlus”.

15. Public Broadcasting System. American Experience. The Pill. OPB[online]. 2010. Available from: Timeline: The Pill. Search PBS.

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The views expressed in this blog-post are solely those of the author.

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Guest Editor

Chris Harding

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First, I hope you are having a nice day. If not, I hope it gets better soon! Next, I have two BS degrees: Chemical Engineering and Biological Sciences, and I am medically retired. With that said, I am trying to relearn statistics and would like an opportunity to volunteer on some simple projects that require data Excel entry and Z, t-test, F-test, Mann-Whitney, etc analysis. If you suggest a test, I will try to learn it and apply it. It my provide a door prior to hiring a statistician. Although my greatest strengths are integrity, honesty, and overall ethics, I enjoy learning about new topics and meeting people from other parts of the world as well.

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