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COUMADIN can cause fetal harm when administered to a pregnant woman. While COUMADIN is contraindicated during pregnancy, the potential benefits of using COUMADIN may outweigh the risks for pregnant women with mechanical heart valves at high risk of thromboembolism . In those individual situations, the decision to initiate or continue COUMADIN should be reviewed with the patient, taking into consideration the specific risks and benefits pertaining to the individual patient’s medical situation, as well as the most current medical guidelines. COUMADIN exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage , and an increased risk of spontaneous abortion and fetal mortality. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use In Specific Populations ].

Not shortly after Roger Maris record was broken, another baseball player, Jason Giambi and various other athletes were either suspected of, or proven to have, taken anabolic steroids. Again, Congress convened a hearing, and just as they did the first time in 1990, they did not determine that steroids were a danger, but rather that the danger was more in protecting professional sports organizations. The updated statute has been updated to proscribe pro-hormones also The definition of an anabolic steroid as defined currently in the United States under (41)(A) is that "anabolic steroid" means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens , progestins, corticosteroids, and dehydroepiandrosterone (7).

Letrozole has been used for ovarian stimulation by fertility doctors since 2001 because it has fewer side-effects than clomiphene ( Clomid ) and less chance of multiple gestation. A study of 150 babies following treatment with letrozole or letrozole and gonadotropins presented at the American Society of Reproductive Medicine 2005 Conference found no difference in overall abnormalities but did find a significantly higher rate of locomotor and cardiac abnormalities among the group having taken letrozole compared to natural conception. [6] A larger, follow-up study with 911 babies compared those born following treatment with letrozole to those born following treatment with clomiphene. [7] That study also found no significant difference in the rate of overall abnormalities, but found that congenital cardiac anomalies was significantly higher in the clomiphene group compared to the letrozole group. Despite this, India banned the usage of letrozole in 2011, citing potential risks to infants. [8] In 2012, an Indian parliamentary committee said that the drug controller office colluded with letrozole's makers to approve the drug for infertility in India and also stated that letrozole's use for infertility was illegal worldwide; [9] however, such off-label uses are legal in many countries such as the US and UK. [10] [11]

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