Qianxi Wang RGA 6201 Professor Schalago 4 June 2016 Drug: Thalidomide Brand Name: THALOMID Trade Name: THALOMID Drug Class: Immunomodulatory Agent FDA Application Number:(NDA)020785 Sponsor/Company:Celgene Corporation INTRODUCTION THALOMID(thalidomide) is “an immunomodulatory agent”[1]. Thalidomide was first put into marker in 1957, which trade-name is Contergan under a German drug company-Chemie Grünenthal. The aim of this drug is used as a sedative or hypnotic, Chemie Grünenthal also claimed that this drug cured "anxiety, insomnia, gastritis, and tension"[2]. Meanwhile, this drug was found efficiently on contraception. People in that time believed THALOMID as a drug without risks, however, after few years, about 10,000 cases on worldwide "were reported of infants with phocomelia due to thalidomide; only 50% of the 10,000 survived"[2]. "Those subjected to thalidomide while in the womb experienced limb deficiencies in a way that the long limbs either were not developed or presented themselves as stumps. Other effects included deformed eyes and hearts, deformed alimentary and urinary tracts, blindness and …show more content…
It is hard to collect exactly number of victims of THALOMIDE because of the difficulty of collecting data, however the range is believed from 10,000 to 20,000 to 100,000. The most powerful evidence of lacking of international regulatory is thalidomide was sold in Canada until 1962. The other examples of lacking international regulatory is in the United Kingdom, the drug was licensed in 1958 and withdrawn in 1961. Around United Kingdom, nearly 2,000 babies were reported born with defection, half of them died in following months. In Spain, thalidomide was widely available throughout the 1970s, now there is a center of caring victims suffering THALOMADE in the captical of
Even now, after over half a century later, many aftereffects remain: leukemia, A-bomb cataracts, and cancers of thyroid, breast, lungs, salivary glands, birth defects, including mental retardation, and fears of birth defects in their children, plus, of course, the disfiguring keloid
Methaqualone, is also referred to as Disco Biscuits, Down And Dirties, Jekyll-and-Hyde, Joe Fridays, Lemmon 714, Lemons, Lennon's, Lovers, Ludes, Mandies, Mandrake, Q, Qua, Quack, Quad, Quaaludes, Soaper, Supper, Vitamin Q, The Love Drug, Wallbangers, Whore Pills, and Sopor. This list of street names for the drug goes on and on.
In the late 1950s, the Thalidomide drug was used in Europe to treat morning sickness in pregnant women among other things. This study involved manufacturing company providing samples of this drug to physicians and compensating them to study the benefits and results of this drug. Although allegedly this drug did not cause any harm to the mother the fetus suffered severe damage as a result. There were thousands of children born with
Depression is the fourth leading cause of disease burden worldwide and is expected to show a rising trend over the next 20 years. Depression is associated with a marked personal, social and economic morbidity, loss of functioning and productivity, and creates significant demands on service providers in terms of workload. Although pharmacological and psychological interventions are both effective for major depression, antidepressant drugs remain the mainstay of treatment. During the last 20 years, selective serotonin reuptake inhibitors (SSRIs) have progressively become the most commonly prescribed antidepressants. Sertraline, one of the first SSRIs introduced in the market, is a potent and specific inhibitor of serotonin uptake into the presynaptic
Depression is one of the most common mental disorders in the United States today. Fortunately, due to advanced technology and research about this disorder and its effects on the brain, there are many different kinds of medication to help treat those who are depressed. One of these medications includes Amitriptyline.
• Pregnant women – the drug is in category C according to the FDA listing, it should be avoided unless the expected benefits justifies the potential risks to the unborn
Controlled substances, including methamphetamine, marijuana, cocaine and other drugs, are illegal in the state of Texas. The penalties for possessing such substances can be serious, with life changing effects. When people stand accused of manufacturing these drugs, however, the potential consequences are even more severe.
In 1957, one of the worst chemical drugs was put on the market to result in a major tragedy in the Chemical field. This drug was Thalidomide. Thalidomide is a mutagen, studied in toxicology, in which it causes damage to the chemical material within an embryo when in development. This drug was created in West Germany by a pharmaceutical company, Chemie Grünenthal (Recognition of Thalidomide Defects, n.d.). During this time when Thalidomide was introduced to the market, it was classified as safe to use. This drug was originally prescribed to pregnant women to prevent morning sickness, insomnia, anxiety and upset stomachs (Breaking News., n.d.). However, it was later determined that this drug caused
The thalidomide disaster was another treatment found to be toxic. Thalidomide was used in pregnant women for morning sickness in the early 1950 's. This led to birth defects in hundreds of babies. Because of the birth defects in infants, the drug was banned from use in the United States. In 1906 a law was passed to set standards for drug purity and quality through the United States Pharmacopoeia and the National Formulary; however, there still was not a law regulating the safety profile
Chemotherapy began in the 20th century. Chemotherapy is a drug treatment used to get rid of diseases. Chemotherapy is intended to shrink the cancerous tumor and attempt to rid of any cancer in the body. Patients who undergo this treatment often have side effects including ; destroying their immune system,increasing their neurocognitive decline, it disrupts endocrine functioning and causes organ and metabolic toxicities.Well aware of these side effects, most cancer patients tend to not want to use chemotherapy. As a cancer patient under the legal age it can become difficult to refuse treatment, and even harder to use alternate treatment.
Valproate, a commonly worldwide drug treatment used since 1967 (in France,) to prevent a series of epilepsy or bipolar disorder symptoms during a women’s pregnancy or a woman was likely able to reproduce at age of her mid-thirties and mid-forties. French studies shown Valproate is “four times likelier” to cause disfiguration during the development of the babies. About 2,150 to 4,100 children were affected by the “link ‘of’ the drug” causing severe defects including malformations and autism. Many families spoke out about the crisis. APESAC, a French umbrella organization, (a large association of institutions, which coordinates the activities of its member organizations and works to protect their shared interests) sued Sanofi, the drug’s manufacturer
Amitriptyline is a tricyclic antidepressant displays a wide array of biological properties including several psychiatric disorders and neuropathic pain. Tricyclic antidepressants (TCAs) mediate their therapeutic effect by inhibiting the reuptake of both serotonin and norepinephrine, leaving more neurotransmitter in the synaptic cleft stimulating the
In a 1983 study, American researchers found that high doses of Red No. 40 administered to adult rats and their offspring resulted in “significantly reduced reproductive success, parental and offspring weight, brain weight, [and] survival” as well as behavioral abnormalities. Though the U.S. Food and Drug Administration approved its use over twenty years ago, there is enough uncertainty about the safety of Red No. 40 that it is banned in Austria, Belgium, Denmark, France, Germany, Sweden, and Switzerland.
Designer dugs were made because of the introduced laws that ban the use of hallucinogens and psychoactive drugs such as rehab drugs and ecstasy. They are known to also cause psychoactive effects that resemble those that already exist while some have unexperienced effects on the patients that use them.
Thalidomide is teratogen because it disrupts the growth of a fetus or an embryo. (K. L. Lerner & B. W. Lerner, 2014) The Placenta is an organ that supplies nutrients and oxygen to a fetus, and also protect the fetus from its mothers blood. Most harmful substances cannot cross the placenta so shouldn’t it be common sense to test a drug that is meant for morning sickness in pregnant women to see if it can cross the placental barrier. When the drug was taken off the market, Grünenthal used some radioactively tagged thalidomide and tested the drug in pregnant mice and found out that it does indeed cross the placental barrier. Doctors and scientists are still uncertain on how thalidomide actually disrupts the fetus. Their theory is that it prevents the blood vessels from forming, which would result in the shortened limbs. (N. Schlager, 2008) There are two types, or isomer, of thalidomide, a safe and a harmful version. The safer isomer is called (R)-thalidomide and the harmful isomer is (S)-thalidomide. You can’t just put the safer isomer of thalidomide in to the body because once thalidomide is in your body, it undergoes a process called racemization. This process is when both of the isomers of thalidomide are created in the body regardless of which one was originally administered. (Fatimathas, L., 2010) “Depending on when during the fetal