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Thalidomide

Thalidomide

Definition

Thalidomide, which is also known as Thalomid, is a drug used to fight aggressive cancers, particularly those that have metastasized, or spread.

Purpose

There are many studies, either in progress or recently completed, that suggest thalidomide can slow or stop the spread of cancer of the brain, breast, colon and prostate, as well as multiple myeloma (a cancer of the marrow of the bone). Research studies that consider the benefit of thalidomide in treating other cancers are multiplying rapidly. The use of the drug in cancer therapy is likely to increase.

Description

Thalidomide was first introduced in 1957 primarily as a tranquilizer, a medication prescribed particularly for imparting drowsiness and sleep. Then, it was given to pregnant women to provide them with relief from morning sickness. Soon after being prescribed to pregnant women, thalidomide was linked to death or severe disabilities in newborns. Some children who had been exposed to thalidomide while in the womb (in utero) failed to develop limbs or had very short limbs. Others were born blind or deaf or with other physical problems.

The same action of thalidomide that harms babies, may make it useful as a powerful cancer fighter. Thalidomide interferes with the formation of blood vessels. It is called an antiangiogenic drug because angiogenesis refers to the formation of blood vessels.

Cancers that spread have a lot of blood vessels (are highly vascularized). Thus, when cancer cells are not nourished by a blood supply, they die. One way to stop the spread of cancer is to stop the formation of the blood vessels that carry nourishment to the cancer cells, and that is what thalidomide is thought to do. (Researchers are also interested in other activities of thalidomide, particularly the ones that make it capable of eliminating skin eruptions, such as sores, or ulcers, in the mouths of patients with AIDS and leprosy.)

Recommended dosage

Dosages being used depend on the type of cancer being attacked. For example, in one study, to treat multiple myeloma, a starting dose of 200 milligrams per day was increased to 800 milligrams per day over a two-week period.

In a colon cancer study, 400 milligrams per day of thalidomide were given in combination with the anti-cancer drug irinotecan . The dose of irinotecan was between 300 and 350 milligrams per day. Used in combination with irinotecan, thalidomide contributed its own cancer-fighting properties and it also seemed to reduce the side effects of irinotecan.

In a trial using thalidomide to treat prostate cancer , both low doses (as low as 200 milligrams per day) and high doses (as high as 1200 milligrams per day) were tried. The patients taking high doses fared somewhat better.

Precautions

The serious threat thalidomide poses to fetuses cannot be overstated. No pregnant woman and no woman who has any chance of becoming pregnant should take thalidomide. (Only women who have had a hysterectomy or who are at the age of menopause and have been in a menopausal state, which is no menses, or periods, for 24 consecutive months, can be considered as having no chance of becoming pregnant.)

Patients taking thalidomide must meet strict criteria for use. Pharmacies that dispense thalidomide must have special registration.

Side effects

Besides the extreme risk thalidomide poses to fetuses, it also produces side effects in the person taking the drug. The side effects of thalidomide are much milder than many other anticancer drugs, and because the drug poses less discomfort than other cancer-fighting drugs, it is particularly attractive to oncologists, or physicians who treat cancer patients.

Among the side effects are erratic heartbeat, swelling (edema), digestive upsets of all sorts, including both constipation and diarrhea , pain in muscles in the back and neck, and skin problems.

Interactions

Both barbiturates, salts and esters used to encourage sleep, and alcohol increase the effect of thalidomide's power of sedation. They should not be taken with the drug. Food interferes with the absorption of thalidomide, and it should be taken when the stomach is empty.

Diane M. Calabrese

KEY TERMS

Angiogenesis

The process by which tumors gain access to a blood supply, allowing tumor growth.

Fetus

Human embryo.

Kilogram

Metric measure that equals 2.2 pounds.

Milligram

One-thousandth of a gram, and there are one thousand grams in a kilogram. A gram is the metric measure that equals about 0.035 ounces.

Sedation

Process of reducing a particularly excited or agitated state.

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"Thalidomide." Gale Encyclopedia of Cancer. . Encyclopedia.com. 23 Jun. 2017 <http://www.encyclopedia.com>.

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"Thalidomide." Gale Encyclopedia of Cancer. . Retrieved June 23, 2017 from Encyclopedia.com: http://www.encyclopedia.com/medicine/encyclopedias-almanacs-transcripts-and-maps/thalidomide

thalidomide

thalidomide and the thalidomide disaster are firmly riveted together in the minds of the population, and it is worth considering how such a tragedy could occur and whether a similar occurence might be repeated with another new and promising drug. Thalidomide was introduced around 1957 as a safe hypnotic and sedative. In an immediate sense it was safe, massive doses producing no acute toxicity in animals. It was considered that the drug was far safer than the barbiturates, which were at that time the commonly used hypnotic, and often used by people committing suicide. It was impossible to commit suicide using thalidomide.

The drug became popular in Germany and because of the lack of acute toxicity it became available over the counter without prescription. Around 1960 a number of cases of phocomelia (meaning ‘seal-like limbs’), in which long limb bones failed to develop, appeared in new-born babies both in Germany and Australia. It took a long time before the connection was made between thalidomide and birth defects. The reasons for this are clear in retrospect. First, only a small proportion of the population taking the drug were pregnant, and even women who were pregnant needed to take the drug between the thirty-seventh and fifty-fourth day following the last menstruation for the teratogenic effects (drug-induced fetal abnormalities) to be manifest. Finally, not all women who took the drug during the crucial period produced babies with teratogenic abnormalities. Other candidates considered to be responsible were radioactive fallout from atomic testing, X-rays, hormones, food additives, and contraceptive pills. The correlation between those taking thalidomide in the crucial period and the incidence of phocomelia became more evident, and the drug was withdrawn in 1961. It must be noted that correlation and causation are not the same, although there can now be no doubt that thalidomide was the cause.

At the time questions were asked why tests for teratogenic potential of the drug had not been made before it was released. First, the effects produced by thalidomide in pregnant women had not occurred before with other drugs and secondly, it was not easy to replicate the effects seen in humans in animal species. Altogether there were some 10 000 cases of babies with phocomelia, mostly in Europe, with some in Australia and a few in the US, of whom about 50% survived with deformed limbs, eyes, hearts, alimentary, and urinary tracts. All of these have required long term care and treatment, only partially ameliorated by the settlement made by the manufacturer. Another question asked was why there were so many cases before the cause of the teratogenic effects was identified. It was unlikely that any medical practitioner would have seen more than one case, and while the incidence of fetal abnormalities of the thalidomide type in normal pregnancy are very rare, the incidence is not zero. It was a German paediatrician who had encountered more than one case, and noted that thalidomide had been taken in all instances, who suggested the connection which was eventually verified.

While the human misery that resulted from the introduction of this seemingly harmless drug is incalculable, an important new development was introduced. To make it less likely that other, yet unknown, bizarre effects from the introduction of new drugs can ever occur on the same scale, most countries have introduced a monitoring system. In the UK, practitioners record any effect a patient reports, or signs which become obvious upon examination, together with the drugs prescribed. This data is entered immediately onto a national database. Of course, most of the reported effects will be nothing at all to do with drug treatment, but as the data will come from an entire country, or group of countries, correlations of effects with drug usage will be quickly spotted and sound the alarm before thousands of people are affected. The thalidomide story also illustrates another problem in regard to the introduction of new drugs: the public demand the unattainable — that all drugs should be perfectly safe under all conditions — but ultimate answers can be provided only by the consequences of general release.

Alan W. Cuthbert


See also congenital abnormalities; drug.

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thalidomide

thalidomide (thəlĬd´əmĬd´), sleep-inducing drug found to produce skeletal defects in developing fetuses. The drug was marketed in Europe, especially in West Germany and Britain, from 1957 to 1961, and was thought to be so safe that it was sold without prescription. In 1961 an extremely high incidence of European babies born with malformed, shortened limbs was correlated with use of thalidomide by women in their first trimester of pregnancy. Before it was recalled from use the drug had caused the malformation of about 8,000 children throughout the world.

Thalidomide never entirely disappeared from use, however, and it was later found to benefit some leprosy patients. In 1998, after a complex safety monitoring system had been established to prevent further birth defects, thalidomide was approved for use in the United States for a complication of leprosy. The drug is also used to treat multiple myeloma, a cancer that affects the bone marrow.

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thalidomide

thalidomide (thă-lid-ŏ-myd) n. a drug that was formerly used as a sedative but withdrawn because it was found to cause fetal abnormalities involving limb malformation if taken during the first three months of pregnancy. Recently it has been found to be effective in treating myeloma and severe reactions in leprosy and is being investigated for treating certain other disorders (including Behçet's syndrome).

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thalidomide

tha·lid·o·mide / [unvoicedth]əˈlidəˌmīd/ • n. a drug formerly used as a sedative, but withdrawn in the early 1960s after it was found to cause congenital malformation or absence of limbs in children whose mothers took the drug during early pregnancy.

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thalidomide

thalidomide Drug originally developed as a mild hypnotic, but whose use by women in early pregnancy until the early 1960s came to be associated with serious birth deformities. It is still manufactured for occasional use in the treatment of leprosy and acquired immune deficiency syndrome (AIDS).

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"thalidomide." World Encyclopedia. . Retrieved June 23, 2017 from Encyclopedia.com: http://www.encyclopedia.com/environment/encyclopedias-almanacs-transcripts-and-maps/thalidomide

thalidomide

thalidomide a drug formerly used as a sedative, but withdrawn in the UK in the early 1960s after it was found to cause congenital malformation or absence of limbs in children whose mothers took the drug during early pregnancy.

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thalidomide

thalidomideabide, applied, aside, astride, backslide, beside, bestride, betide, bide, bride, chide, Clyde, cockeyed, coincide, collide, confide, cried, decide, divide, dried, elide, five-a-side, glide, guide, hide, hollow-eyed, I'd, implied, lied, misguide, nationwide, nide, offside, onside, outride, outside, pan-fried, pied, pie-eyed, popeyed, pride, provide, ride, Said, shied, side, slide, sloe-eyed, snide, square-eyed, starry-eyed, statewide, Strathclyde, stride, subdivide, subside, tide, tried, undyed, wall-eyed, wide, worldwide •carbide • unmodified •overqualified, unqualified •dignified, signified •unverified • countrified •unpurified • unclassified •unspecified • sissified • unsanctified •self-satisfied, unsatisfied •unidentified • unquantified •unfortified • unjustified • uncertified •formaldehyde • oxhide • rawhide •cowhide • allied • landslide • bolide •paraglide • polyamide • bromide •thalidomide • selenide • cyanide •unoccupied

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