Importation Of Unapproved Versions Of Fertility Drugs example essay topic

Alcohol and drugs -- including marijuana, nicotine, and certain medications -- can temporarily reduce sperm quality. Also, environmental toxins, including pesticides and lead, may be to blame for some cases of infertility. Drugs and Surgery Depending on what the tests turn up, different treatments are recommended. Eighty to 90 percent of infertility cases are treated with drugs or surgery. Therapy with the fertility drug Clomid or with a more potent hormone stimulator -- Pergonal, Metrodin, Humegon, or Fertinex -- is often recommended for women with ovulation problems. The benefits of each drug and the side effects, which can be minor or serious but rare, should be discussed with the doctor.

Multiple births occur in 10 to 20 percent of births resulting from fertility drug use. Other drugs, used under very limited circumstances, include Parl odel (bromocriptine mesylate), for women with elevated levels of a hormone called prolactin, and a hormone pump that releases gonadotropins necessary for ovulation. If drugs aren't the answer, surgery may be. Because major surgery is involved, operations to repair damage to the woman's ovaries, fallopian tubes, or uterus are recommended only if there is a good chance of restoring fertility. In the man, one infertility problem often treated surgically is damage to the vas deferens, commonly caused by a sexually transmitted disease, other infection, or vasectomy (male sterilization).

Other important tools in the battle against infertility include artificial insemination and the so-called assisted reproductive technologies. (See "Science and Art". ) Fulfillment Regardless Lisa became pregnant without assisted reproductive technologies, after taking ovulation-promoting medication and undergoing surgery to repair her damaged fallopian tubes. Her daughter is now 4 years old. "It was definitely worth it.

I really appreciate having my daughter because of what I went through", she says. But Lisa and her husband won't try to have a second child just yet. "At some point you have to stop trying to have a baby, stop obsessing over what might be an unreachable goal", she says. When having a genetically related baby seems unachievable, a couple may decide to stop treatment and proceed with the rest of their lives. Some may choose to lead an enriched life without children. Others may choose to adopt.

And no, according to Resolve, you " re not more likely to get pregnant if you adopt a baby. Drug Supply Restored The availability of sufficient supplies of the FDA-approved fertility drugs Pergonal, Metrodin, and Humegon, and the recent FDA approval of the fertility drug Fertinex have ended a sh 0 rage of these types of drugs in the United States. Since the drugs are not in short supply anymore, FDA will no longer allow the importation of unapproved versions of fertility drugs, even for personal use. In February 1995, FDA became aware of a shortage of the approved fertility drugs Pergonal and Metrodin, both manufactured by Serono Laboratories Inc of Switzerland. Because of the shortage, FDA has allowed people to temporarily import unapproved foreign versions of fertility drugs for their own use. "FDA used its enforcement discretion to allow the importation of unapproved versions of fertility drugs on a personal use basis", says Thomas Gardine, director of the agency's division of import operations and policy.

FDA asked doctors to wait until the supply of approved drugs increased unless a patient was in the midst of therapy. "There's always a danger in taking unapproved drugs because they are of unknown quality and haven't been shown to FDA to be safe, effective, and adequately labeled", Gardine says. The Serono manufacturing plant in Switzerland is again supplying adequate amounts of Pergonal and Metrodin for U.S. patients. Also, other products are now available for the same use. "The drug shortage no longer exists to merit our allowing importation of the unapproved products", Gardine says. After a reason albe time to make the public aware of the change in FDA's position, the agency will no longer allow the unapproved versions of these drugs to enter the country.

The following fertility drugs are approved by FDA and can be obtained with a doctor's prescription: o Some of these drug products may be sold under other brand names by distributors who buy the products from the listed manufacturers. o Chorionic gonadotropin is not normally used alone as a fertility drug -- it is normally administered after administration of menotropins or urofollitropin As with all expectant mothers, folic acid is extremely important. Taking folic acid 1 month prior to and throughout the first 3 months of pregnancy will decrease the risk of neural tube defects (such as spina bifida). Although behavioral studies clearly indicate that exposure to drugs, alcohol and tobacco in utero is bad for a baby's developing brain, specific anatomic brain effects have been hard to tease out in humans. Often users don't limit themselves to one substance, and demographic factors like poverty can also influence brain development. Anew study using magnetic resonance imaging (MRI) brain scans, led by Children's Hospital Boston neurologist Michael Rivkin, MD, suggests that prenatal exposure to cocaine, alcohol, marijuana or tobacco (alone or in combination) may have effects on brain structure that persist into early adolescence.

The findings, published in Pediatrics, are of public health significance, the researchers say, since it's estimated that more than 1 million babies born annually in the United States have been exposed to at least one of these agents in utero. Researchers at Children's and Boston Medical Center employed volumetric MRI imaging to study the brain structure of 35 young adolescents prenatally exposed to cocaine, marijuana, alcohol or tobacco. The children, who averaged 12 years old at the time of imaging, were part of part of an historic cohort of children assembled by Deborah Frank, MD at Boston Medical Center and followed there since birth. Prenatal exposures were confirmed by a combination of maternal history, urine testing of the mother or urine or me conium (stool) testing of the infants at birth.

Notably, the effects were found to be additive -- the more substances a child was exposed to in utero, the greater the reduction in brain volume. Rivkin notes that the study is also the first to document joint long-term neuro anatomic effects on the brain of prenatal cocaine, cigarette and alcohol exposures. Moreover, while previous studies have documented brain effects of prenatal alcohol exposure, these studies were mostly limited to children with fetal alcohol syndrome, a diagnosis that was excluded in the current study. Although investigators initially set out to study cocaine exposure, they were struck by the finding of brain effects of prenatal tobacco exposure. "Approximately 20 percent of women who smoke continue to smoke during pregnancy", Rivkin says.

"From the vantage point of preventive health care, it is important to determine the consequences on brain structure of prenatal exposure to cigarettes, alone and in combination with other substances". Rivkin emphasizes that the number of children studied was too small to find statistically significant effects of single substances after controlling for exposure to other agents. The study was also too small to consider the effects of different levels of exposure. But the overall results are highly suggestive. "We " re hopeful to be able to study the whole sample of 150 children followed at Boston Medical Center, which will permit such determinations", Rivkin says. Both investigators concur that health care providers should offer pregnant women comprehensive care to help them reduce use of all psychoactive substances.

Public health campaigns should not ignore the risks of some substances while focusing on others, as it may well be that the greater the number of total prenatal exposures, the higher the chance there will be adverse and lasting consequences for the developing brain.