Pregnancy monitoring requirements

Figure 11.2 User requirements for pregnancy monitoring systems.

Despite their clear benefits, ACE inhibitors are still underutilized in HF. One reason is undue concern or confusion regarding absolute versus relative contraindications for their use. Absolute contraindications include a history of angioedema, bilateral renal artery stenosis, and pregnancy. Relative contraindications include unilateral renal artery stenosis, renal insufficiency, hypotension, hyperkalemia, and cough. Relative contraindications provide a warning that close monitoring is required, but they do not necessarily preclude their use. 

The FDA allows women to enter carefully controlled and monitored trials in which adequate contraceptive measures and pregnancy testing are performed without requiring results from animal reproductive toxicity tests. In Japan and Europe, because of the high level of concern regarding imintentional exposure of the developing embryo or foetus, an assessment of fertility in a rodent, and embryo/foetal development in a rodent or non-rodent are required if women of childbearing potential are to be included in a Phase I trial. The FDA would expect such results to support Phase II and Phase III studies. 

Hepatic function impairment Exposure to anagrelide is increased 8-fold in patients with moderate hepatic impairment. Use of anagrelide in patients with severe hepatic impairment has not been studied. In patients with moderate hepatic impairment, dose reduction is required carefully monitor patients for cardiovascular effects. Pregnancy Category C. 

Special Precaution Gastrointestinal hemorrhage may occur Patients with renal impairment have shown higher MPA and MPAG AUCs than normal volunteers Should not be used in conjunction with azathioprine Repeated laboratory monitoring is required Pregnancy Category C... 

Hypothyroid women frequently have anovulatory cycles and are therefore relatively infertile until restoration of the euthyroid state. This has led to the widespread use of thyroid hormone for infertility, although there is no evidence for its usefulness in infertile euthyroid patients. In a pregnant hypothyroid patient receiving thyroxine, it is extremely important that the daily dose of thyroxine be adequate because early development of the fetal brain depends on maternal thyroxine. In many hypothyroid patients, a modest increase in the thyroxine dose (about 20-30%) is required to normalize the serum TSH level during pregnancy. Because of the elevated maternal TBG, the free thyroxine index (FT4I) or free thyroxine (FT4) and TSH (Table 38-2) must be used to monitor maternal thyroxine dosages. 

In pregnancy a hypothyroid patient should be carefully assessed and monitored monthly a 50-100% increase in dose of levothyroxine may be required breast feeding is not contraindicated though the baby s thyroid status should be watched. 

Neonates require close monitoring if their mothers received enzyme inducers such as phenytoin, pheno-barbital, carbamazepine, or rifampin during pregnancy... 

If lithium is necessary after first trimester, dosage adjustments are necessary due to pregnancy-induced kidney function changes. Frequent lab monitoring is also required. 

S.M.A.R.T. ) and the Accutane Pregnancy Prevention Protocol (PPP) to be used in conjunction with the prescription of Accutane. Management of toxic effects involves monitoring by the appropriate specialist and discontinuation of the exposure where indicated. Isotretinoin-related depression may require long-term monitoring. 

Neonates require close monitoring if their mothers received enzyme inducers such as phenytoin, phenobar-bital, carbamazepine, or rifampin during pregnancy or if they need one of these drugs themselves. Examples of drugs that inhibit the metabolism of other medications include cimetidine, erythromycin, and ketoconazole." ... 

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