Primodos | |
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Purpose | Determine if pregnancy is present |
Primodos was a hormone-based pregnancy test, produced by Schering AG, and used in the 1960s and 1970s that consisted of two pills that contained norethisterone (as acetate) and ethinylestradiol. [1] [2] It detected pregnancy by inducing menstruation in women who were not pregnant. The presence or absence of menstrual bleeding was then used to determine whether the user was pregnant. [1] In South Korea it was also used, "perhaps as a double dose" to induce abortions. [3]
While first made available for sale in the UK in 1959, it was withdrawn from sale in the UK in 1978. [4] Primodos was produced by Schering AG, a German company taken over by Bayer AG in 2006.
Another hormonal pregnancy test called Duogynon was in use in Germany during the same general time period. [1]
In the 1960s, Dr. Isabel Gal conducted research at Queen Mary's Hospital for Children that showed a link between use of the drug and severe birth defects. [5] A review by the Committee on Safety of Medicines in the 1970s concluded that the product should not be used by pregnant women. [2] Litigation in the 1980s regarding these claims ended inconclusively, with proceedings being discontinued, with the court's approval. [1] [6] A review of the matter by the Medicines and Healthcare products Regulatory Agency in 2014 assessed the studies performed to date, and concluded that it found the evidence for adverse effects to be inconclusive. [1] [7]
The report of an expert working group of the UK Commission on Human Medicines published in November 2017 concluded there was no "causal association" between Primodos and severe disabilities in babies. The expert group recommended that families who took a hormone pregnancy test and experienced "an adverse pregnancy outcome" should be offered genetic testing to establish whether there was a different underlying cause. [8]
An independent review by Baroness Cumberlege, the Independent Medicines and Medical Devices Safety Review, reported in 2020 that "avoidable harm" resulted from the use of Primodos. It recommended that "the Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos". [9]
Dr Bill Inman, of the Committee on Safety of Medicines, who had investigated Primodos was referenced in a Schering memo stating "he has destroyed all the material on which his investigation is based, or made it unrecognizable, which makes it impossible to trace the individual cases taken into the investigation. I understood Dr. Inman that he did this to prevent individual claims from using this material." [9]
Baroness Cumberlege said, in relation to Bayer, "I think they should not only apologise; they should recognise what has happened and give ex-gratia payments to these people who have suffered." [10]
Emergency contraception (EC) is a birth control measure, used after sexual intercourse to prevent pregnancy.
Medical physics deals with the application of the concepts and methods of physics to the prevention, diagnosis and treatment of human diseases with a specific goal of improving human health and well-being. Since 2008, medical physics has been included as a health profession according to International Standard Classification of Occupation of the International Labour Organization.
Morning sickness, also called nausea and vomiting of pregnancy (NVP), is a symptom of pregnancy that involves nausea or vomiting. Despite the name, nausea or vomiting can occur at any time during the day. Typically the symptoms occur between the 4th and 16th week of pregnancy. About 10% of women still have symptoms after the 20th week of pregnancy. A severe form of the condition is known as hyperemesis gravidarum and results in weight loss.
Human chorionic gonadotropin (hCG) is a hormone for the maternal recognition of pregnancy produced by trophoblast cells that are surrounding a growing embryo, which eventually forms the placenta after implantation. The presence of hCG is detected in some pregnancy tests. Some cancerous tumors produce this hormone; therefore, elevated levels measured when the patient is not pregnant may lead to a cancer diagnosis and, if high enough, paraneoplastic syndromes, however, it is unknown whether this production is a contributing cause or an effect of carcinogenesis. The pituitary analog of hCG, known as luteinizing hormone (LH), is produced in the pituitary gland of males and females of all ages.
A pregnancy test is used to determine whether a female is pregnant or not. The two primary methods are testing for the female pregnancy hormone in blood or urine using a pregnancy test kit, and scanning with ultrasonography. Testing blood for hCG results in the earliest detection of pregnancy. Almost all pregnant women will have a positive urine pregnancy test one week after the first day of a missed menstrual period.
Levonorgestrel is a hormonal medication which is used in a number of birth control methods. It is combined with an estrogen to make combination birth control pills. As an emergency birth control, sold under the brand names Plan B One-Step and Julie, among others, it is useful within 72 hours of unprotected sex. The more time that has passed since sex, the less effective the medication becomes, and it does not work after pregnancy (implantation) has occurred. Levonorgestrel works by preventing ovulation or fertilization from occurring. It decreases the chances of pregnancy by 57–93%. In an intrauterine device (IUD), such as Mirena among others, it is effective for the long-term prevention of pregnancy. A levonorgestrel-releasing implant is also available in some countries.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
Levothyroxine, also known as L-thyroxine, is a synthetic form of the thyroid hormone thyroxine (T4). It is used to treat thyroid hormone deficiency (hypothyroidism), including a severe form known as myxedema coma. It may also be used to treat and prevent certain types of thyroid tumors. It is not indicated for weight loss. Levothyroxine is taken orally (by mouth) or given by intravenous injection. Levothyroxine has a half-life of 7.5 days when taken daily, so about six weeks is required for it to reach a steady level in the blood.
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A contraceptive implant is an implantable medical device used for the purpose of birth control. The implant may depend on the timed release of hormones to hinder ovulation or sperm development, the ability of copper to act as a natural spermicide within the uterus, or it may work using a non-hormonal, physical blocking mechanism. As with other contraceptives, a contraceptive implant is designed to prevent pregnancy, but it does not protect against sexually transmitted infections.
Julia Frances Cumberlege, Baroness Cumberlege, is a British Conservative Party politician and businesswoman. She was created a life peer on 18 May 1990 as Baroness Cumberlege, of Newick in the County of East Sussex.
Bayer AG is a German multinational pharmaceutical and biotechnology company and is one of the largest pharmaceutical companies and biomedical companies in the world. Headquartered in Leverkusen, Bayer's areas of business include: pharmaceuticals, consumer healthcare products, agricultural chemicals, seeds and biotechnology products. The company is a component of the EURO STOXX 50 stock market index.
William Howard Wallace Inman, MRCP, FRCP, FFPHM, also known as WHW Inman, was a British doctor and pioneer of methods and systems to detect risks of treatment with drugs. As well as holding positions in health institutions in the UK, he was active in international efforts to co-ordinate drug safety monitoring.
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Isabel Gal, was a Jewish Hungarian paediatrician who was responsible for highlighting the link between use of the hormonal pregnancy test Primodos and severe birth defects.