Limited published data on atorvastatin calcium from observational studies, meta-analyses and case reports have not shown an increased risk of major congenital malformations or miscarriage. Rare reports of congenital anomalies have been received following intrauterine exposure to other HMG-CoA reductase inhibitors. In a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. The number of cases is adequate to exclude a ≥3 to 4-fold increase in congenital anomalies over the background incidence. In 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified.
Statins interfere with cholesterol synthesis and theoretically might blunt adrenal and/or gonadal steroid production. Clinical studies have shown that LIPITOR does not reduce basal plasma cortisol concentration or impair adrenal reserve. The effects of statins on male fertility have not been studied in adequate numbers of patients. The effects, if any, on the pituitary -gonadal axis in premenopausal women are unknown. Caution should be exercised if a statin is administered concomitantly with drugs that may decrease the levels or activity of endogenous steroidhormones, such as ketoconazole , spironolactone, and cimetidine .
Experts aren’t convinced Acushnet has a case. “The lawsuit is probably doomed because nobody would think that Titleist made these products. It’s a parody, and most people would get the joke,” explained intellectual property attorney David Erikson, principal of Erikson Law Group in Los Angeles. “Trademark law doesn’t prevent all uses of a competitor’s name—it only forbids uses that are likely to confuse consumers about the source of goods. Because he’s not passing off his golf products as coming from Titleist, [I Made Bogey operator Benjamin] Russell would probably prevail.”