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Thalidomide - Chemie Grünenthal/Celgene Corporation

Identifier

014496

Type of spiritual experience

Hallucination

Background

The full article identified hallucinations as one side effect.

Erythema nodosum (EN) (commonly known as cicada bites) is an inflammatory condition characterised by inflammation of the fat cells under the skin, resulting in tender red nodules or lumps that are usually seen on both shins. It can be caused by a variety of conditions, and typically resolves spontaneously within 3–6 weeks. It is common in young people between 12–20 years of age.

Stevens–Johnson syndrome, a form of toxic epidermal necrolysis, is a life-threatening skin condition, in which cell death causes the epidermis to separate from the dermis. The syndrome affects the skin and the mucous membranes. The most well-known causes are certain medications.

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From Wikipedia - Thalidomide background

Thalidomide, currently marketed under the brand names Immunoprin, Talidex, Talizer, Thalomid, is an immunomodulatory drug and the prototype of the thalidomide class of drugs. It was first marketed in 1957 in West Germany under the trade-name Contergan. The German drug company Chemie Grünenthal (now Grünenthal) developed and sold the drug. Primarily prescribed as a sedative or hypnotic, thalidomide also claimed to cure “anxiety, insomnia, gastritis, and tension". Afterwards, it was used against nausea and to alleviate morning sickness in pregnant women. Thalidomide became an over the counter drug in Germany on October 1, 1957.

Shortly after the drug was sold in Germany, between 5,000 and 7,000 infants were born with phocomelia (malformation of the limbs). Only 40% of these children survived.  Throughout the world, about 10,000 cases were reported of infants with phocomelia due to thalidomide; only 50% of the 10,000 survived. 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 deafness.

Today, thalidomide is being marketed by Celgene.  Celgene Corporation is an American biotechnology company

A description of the experience

Drug Saf. 2001;24(2):87-117.

Thalomid (Thalidomide) capsules: a review of the first 18 months of spontaneous postmarketing adverse event surveillance, including off-label prescribing.

Clark TE1, Edom N, Larson J, Lindsey LJ.

Abstract

The sedative/hypnotic thalidomide was withdrawn from the worldwide market nearly 40 years ago, because of its teratogenic and neurotoxic effects.

Thalidomide was later found to very effectively suppress [not cure] erythema nodosum leprosum (ENL). The US Food and Drug Administration (FDA) has approved Thalomid (thalidomide) capsules for the acute treatment of the cutaneous manifestations of moderate to severe ENL.

Thalidomide is currently under investigation for the treatment of a wide variety of diseases, including conditions thought to have an inflammatory or immune basis, malignancies and complications of infection with HIV. Interest in the potential anti-inflammatory, immunomodulatory and anti- angiogenic effects of thalidomide has resulted in off-label use of prescription thalidomide.

During the first 18 months of spontaneous postmarketing adverse event surveillance for Thalomid, 1210 spontaneous postmarketing adverse event reports were received for patients treated with prescription thalidomide for all therapeutic indications, including off-label use.

The most common adverse events spontaneously reported would have been expected on the basis of the current Thalomid labelling/product information.

The current labelling/product information reflects what was known about the risks associated with thalidomide therapy in limited patient populations at the time of the approval of Thalomid. With the postmarketing use of thalidomide in populations other than patients with ENL, it becomes increasingly important to identify patient groups that may be particularly susceptible to specific adverse drug effects and to identify conditions under which specific adverse events may be more likely to occur.

Oncology patients may represent a patient population with increased susceptibility to thalidomide-associated adverse effects, including thromboembolic events.

Consideration of the spontaneous postmarketing safety surveillance data may help to identify and characterise factors associated with increased risk in this and other patient groups.

Serious unexpected adverse events reported with sufficient frequency to signal previously undetected product-event associations for which there may potentially be plausible evidence to suggest a causal relationship have included seizures and Stevens-Johnson syndrome.

The potential effects of thalidomide on wound healing are also being closely monitored.

Premarketing human clinical trials of drug products are inherently limited in their ability to detect adverse events.

Broader postmarketing experience with thalidomide in more varied patient populations and more experience in the setting of long term thalidomide use will increase our ability to detect rare adverse events and to identify signals that may need to be evaluated in more controlled settings.

PMID: 11235821

The source of the experience

PubMed

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