‘Can medical researchers prove that a drug is safe during pregnancy? Assuming they can, does an official green light mean all pregnant women can use the drug freely?

‘Years after the horrors of thalidomide, amid arguments over whether an expectant mother can drink a glass of wine, smoke one cigarette or take a single aspirin without endangering her baby’s health, these questions still have not been satisfactorily resolved.

‘The current debate surrounds the decision of Merrell Dow Pharmaceuticals just over a week ago to stop selling Bendectin, a prescription drug designed to combat so-called morning sickness. According to manufacturer estimates, in the 27 years during which Bendectin has been sold more than 33 million pregnant women throughout the world have used it to curb their nausea and vomiting. It is the only drug approved in the United States for treating this condition, and last year one in 10 pregnant women here used it.

‘In the last five years, however, Bendectin has become the imputed cause of a host of birth defects. More than 300 lawsuits are pending against the manufacturer claiming damages for deformed babies born to mothers who took the drug. The company withdrew it from the market 13 days after a Washington, D.C. jury awarded $750,000 to the family of one such child.

‘According to Merrell Dow, the decision was made not because the drug has been proved hazardous, but because the company’s insurance premiums have soared to $10 million a year, only $3 million less than income from the sale of the drug. ”We were forced for business reasons to take a safe and effective medication off the market,” said William Donaldson, the director of professional communications.

‘For most women, the symptoms of morning sickness are short-lived and of little or no medical significance. They usually diminish following simple changes of habit, such as eating dry crackers or drinking very cold or very hot water immediately after awakening. Occasionally, however, the nausea and vomiting are so severe or prolonged that the mother’s or baby’s well-being may be jeopardized. For such women – a small fraction of Bendectin‘s market – the American College of Obstetricians and Gynecologists said the drug’s withdrawal will leave ”a significant therapeutic gap.”

‘The case against Bendectin is unclear. The Food and Drug Administration admitted as much in 1980, after an intensive two-day review of available data. The review panel said no association between Bendectin and birth defects had been demonstrated. It added, however, that because there was no way to prove the absolute safety of any drug in all women under every circumstance, there must remain a ”residual uncertainty” about how this drug affects an unborn child.

‘The research on Bendectin has been inconclusive and contradictory. Questionable scientific methods have raised doubts about the validity of some findings. For example, several studies that linked Bendectin use to an increased risk of birth defects compared mothers of malformed babies with those who had normal children. Psychologists have shown, however, that people are more likely to recall factors associated with an abnormal event than with a normal one. Thus, mothers of defective babies may have been more likely than mothers of normal children to remember and report that they took Bendectin during pregnancy. Several studies that tried to counteract this bias found no increased risk of defects associated with Bendectin use.

‘Other doubts about Bendectin‘s risks stem from the range of defects attributed to it. While the largest number of complaints involve limb and other musculoskeletal deformities, the list also includes facial and brain damage; defects of the respiratory, gastrointestinal, cardiovascular and genital-urinary systems; blood disorders and cancer. Doctors know of no teratogen – an agent that causes birth defects – that produces anything resembling this variety of problems. Nearly all teratogens act at specific times during fetal development and affect the organs then forming.

‘There is another complication. About 5 percent of babies born in the United States each year have some type of birth defect, and about half of those have serious abnormalities. It is inevitable, then, that some Bendectin users would have given birth to defective children if they hadn’t taken the drug.

‘Still, there is that ”residual doubt” that while Bendectin is not a high-risk teratogen, such as thalidomide, it may affect some women under some circumstances. One study suggested that babies were at greater risk if their mothers also smoked cigarettes during pregnancy. Proceed With Caution

‘Dr. Hugh R.K. Barber, director of obstetrics and gynecology at Lenox Hill Hospital in New York, said ”If there is a lesson to be learned from the Bendectin story, it is that no drug or drug-like substance – even vitamins – can be assumed to be completely safe during pregnancy. In pregnant women with chronic illnesses that require medication, a drug’s benefits must be weighed against the possible risks.”

‘At least four factors suggest that pregnant women should proceed with extreme caution when it comes to medication. First, only 20 percent of drugs now marketed have been tested for prenatal effects, and some of those tests are far from scientifically sound. Second, it is difficult, if not impossible, to detect interactions between substances that alone may have no effect on a fetus. Third, it is equally difficult to determine whether metabolic or other peculiarities in some women can turn an otherwise harmless drug into a hazard. Finally, substances long thought safe, such as alcohol, have only recently been proved harmful to an unborn child.

‘Most birth-defect specialists now recommend that a pregnant woman take no drug that is not essential to her health and prescribed by a physician who knows she is pregnant. This does not guarantee a healthy baby, but it greatly reduces the chances of a drug-induced abnormality”.

Also read here . .

This study – rats and rabbits ARE NOT similar to humans – they both produce Vit C – guinea pigs (are too cute) do not and should only be used . .