VALSARTAN
Drugs in Pregnancy and Lactation.
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Name: VALSARTAN
Class: Antihypertensive
Risk Factor: CM*
Fetal Risk Summary
Valsartan is a selective angiotensin II receptor antagonist that is used, either alone or in combination with other antihypertensive agents, for the treatment of hypertension. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by preventing angiotensin II from binding to AT1 receptors.
Reproduction studies have been conducted in pregnant mice, rats, and rabbits (1). No teratogenic effects were observed in these species at oral doses up to 9, 18, and 0.5 times the maximum recommended human dose of 320 mg/day based on body surface area (MRHD), respectively. The highest dose caused rat maternal toxicity (reduction in body weight gain and food consumption). At this dose, administration during organogenesis or late gestation and lactation resulted in significant decreases in fetal weight, pup birth weight, pup survival rate, and slight delays in developmental milestones (1). In rabbits, maternal toxic doses (0.25 and 0.5 times the MRHD) resulted in fetal resorptions, litter loss, abortions, and low fetal body weight as well as maternal mortality. The no-observed-adverse-effect doses in mice, rats, and rabbits were 9, 6, and 0.1 times the MRHD, respectively (1). No adverse effects on reproductive performance of male and female rats were noted at oral doses up to 6 times the MRHD (1).
It is not known if valsartan crosses the human placenta to the fetus. The molecular weight (about 436) is low enough that passage to the fetus should be expected.
A 2001 case report described the pregnancy outcome of a 40-year-old woman with well-controlled chronic hypertension and diet-controlled type 2 diabetes mellitus who was treated with valsartan (80 mg/day) and atenolol (75 mg/day) until presentation at 24 weeks' gestation (2). Anhydramnios (amniotic fluid index zero), most likely due to valsartan, was diagnosed by ultrasound, but fetal growth was appropriate for gestational age. Valsartan was stopped and atenolol was continued at the same dose. The amniotic fluid volume normalized within 2 weeks. The blood pressure, without evidence of toxemia, and the diabetes remained under adequate control. Intrauterine fetal death was diagnosed at 31 weeks' gestation. At autopsy, very small, hypoplastic lungs were found (weight 18 g/expected 44 g), as were heavy kidneys (31 g/expected 18 g). The placenta was below the 10th percentile for gestational age (148 g/expected weight for gestational age at the 10th percentile 311 g). No other anomalies were detected. The very small placenta was thought to be primarily due to atenolol, but valsartan may have contributed to the condition. Death of the female fetus probably resulted from chronic placental insufficiency induced by the combination of valsartan and atenolol (2).
The antihypertensive mechanisms of action of valsartan and angiotensin-converting enzyme (ACE) inhibitors are very close. That is, the former selectively blocks the binding of angiotensin II to AT1 receptors, whereas the latter prevents the formation of angiotensin II itself. Therefore, use of this drug during the 2nd and 3rd trimesters may cause teratogenicity and severe fetal and neonatal toxicity identical to that seen with ACE inhibitors (e.g., see Captopril or Enalapril). Fetal toxic effects may include anuria, oligohydramnios, fetal hypocalvaria, intrauterine growth retardation, prematurity, and patent ductus arteriosus. Anuria-associated oligohydramnios may produce fetal limb contractures, craniofacial deformation, and pulmonary hypoplasia. Severe anuria and hypotension, resistant to both pressor agents and volume expansion, may occur in the newborn following in utero exposure to valsartan. Newborn renal function and blood pressure should be closely monitored.
[*Risk factor DM if used in 2nd or 3rd trimesters.]
Breast Feeding Summary
No reports describing the use of valsartan during human lactation have been located. The drug is excreted into the milk of lactating rats (1). Because the molecular weight (about 436) is low enough, excretion into human breast milk should also be expected. The effects of this exposure on a nursing infant are unknown. The American Academy of Pediatrics, however, considers ACE inhibitors, a closely related group of antihypertensive agents, to be compatible with breast feeding (see Captopril or Enalapril).
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References
- Product information. Diovan. Novartis Pharmaceuticals, 2001.
- Briggs GG, Nageotte MP. Fatal fetal outcome with the combined use of valsartan and atenolol. Ann Pharmacother 2001;35:859–61.
Q&A about Valsartan
Valsartan is used alone or in combination with other medications to treat high blood pressure. It is also used to treat heart failure in people who cannot take angiotensin-converting enzyme (ACE) inhibitors. Valsartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain chemicals that tighten the blood vessels, so blood flows more smoothly.
I need someone who is well-versed in medications to answer this question. Thanks in advance.
Diovan is the trade name of Valsartan.
It should be Stamlo and not stamilo. Stamlo is amlodipine.
Both are medications for high blood pressure, though there are some other uses as well.
I'm keen to know please and would thank you kindly for your time.
I have to have regular blood tests and checks on my kidney and liver functions but so far all is ok.
Took Atenalol before this for a while then became asthmatic due to an allergy to it.
Im away from home at present so unable to ask my Doc. The above meds are a Angiotensin II receptor blocker, a calcium channel blocker and a thiazide diuretic taken for hypertension. Can i take St johns with them??
If not what is the most effective herbal/plant derived Anti Depressant.
As with other antidepressants, St John’s Wort may take two to four weeks to begin to take effect.
There are no listed contraindications for St John’s Wort (situations when it should not be used). It should be used with caution during pregnancy and while breast-feeding because there is no information on its safety in these conditions. Patients with a diagnosis of manic depression should use it with caution, since, as with all antidepressants, its use is associated with ‘switching’, or moving rapidly from a low to a high mood.
St John's wort has significant interactions with a large number of prescribed medicines which are in common use, in addition to those mentioned below. These are listed in the British National Formulary (BNF). People who are taking any other medicine should always seek professional advice from a doctor or a pharmacist before combining it with St John’s Wort. If you are away from your doctor then maybe phoning the surgery and asking the receptionist to have a word on your behalf and arrange a later time to find out whether it is suitable or not. Another suggestion is to call into a pharmacy and asking the pharmacist or phoning the NHS helpline or going on to their website.
You should not take St John’s Wort at the same time as SSRI or MAOI antidepressants. (It has been made a prescription-only drug in the Irish Republic because of anxieties about its possible similarity to MAOI antidepressants.)
St John’s Wort may prolong the effects of some sleeping pills and anaesthetics. If you are to receive an anaesthetic you should tell the anaesthetist if you are taking St John’s Wort.
It also reduces blood levels of oral contraceptives , increasing the risk of pregnancy and breakthrough bleeding.
The most commonly reported side effects include gastrointestinal symptoms (such as nausea, vomiting, diarrhoea), allergic reactions, fatigue, dizziness, confusion, and dry mouth in a small percentage of patients. Another rare side effect is photo-sensitisation – increased sensitivity to sunlight. This is associated with high doses, but people taking it should increase their sun protection and avoid strong sunlight.
Hope this helps.
There is no swelling, when pressed, the area sometimes hurts . I do not do any sports only gardening. I have some presumed rhumatism in my thumb joints. I am 65 and otherwise healthy. I am on Thyroxin and Valsartan. The condition occured about a year ago for a short time then disappeared. When accidentally knocked the pain was severe for a time.
See the links below for further information.
What is the best blood pressure medication with the least side effects ? I have tried Linsinopril, Diovan (valsartan),
Atenolol, Altace. They all bring my blood pressure down some, except for Diovan. It doesnt. The rest have similar side effects. Dizziness, incoherent, lack of energy.
Thank you for your response. I am at risk of a stroke each day.
From a previous answer, Vasotec is in the same family as Altace & lisinopril so it may have the same side effects. It is a good inexpensive choice. The others you have taken are all good 1st line choices. They actually have some of the better side effect profiles compared with other BP medicines.
Good luck.
Again, it isnt available without a prescription though, and you'd have to visit a doctor first.
RN
