Amlodipine Besylate, a calcium channel blocker (per the Wikipedia website) that restricts blood flow to treat hypertension and angina, was the subject of an FDA recall in February of 2011, an expansion of a previous recall, which included medications such as Amantadine, Baclofen, Bethanechol and Androxy.
The recall, while alarming, was nonetheless prompted by the parent company that manufactures the drug, Upsher-Smith Laboratories, working collaboratively with the FDA to obviate the most severe of the Amlodipine side effects and bring more “generic” medications into the market to alleviate similar patient problems.
What are the Amlodipine Side Effects?
The difficulty in the Amlodipine side effects was that the calcium channel blocker operates more selectively for arteries than for the heart muscle wall for which it is intended, and these arteries, affected with reduced blood flow, created multiple problems for patients, among them peripheral edema (the swelling of tissues, particularly in the lower limbs) and frequent dizziness, palpitations, dyspepsia, nausea and similar stomach problems.
Where the FDA is content to label most such medications with warnings for patients and health professionals (where the side effect incidence is perhaps 1 in 500), the recall was based on the alarming frequency of the Amlodipine side effects (1 in 100 patients). (see also Topamax recall)
Slightly less frequent and less severe Amlodipine side effects included transient cases of hepatitis and jaundice, as well as a few observable instances of erratic behavior, hyperglycemia and tremors; the latter were glimpsed in only one out of every one hundred thousand users.
Amlodipine is contraindicated for pregnant and nursing mothers (previous experiences with similar drugs indicated that the milk of a mother nursing an infant may become contaminated with the chemical compounds).
The drug is the direct cause of vasodilation (shrinking of the arteries), which is its primary function; unfortunately, because it thus narrows the passages of the cardiovascular system, it creates an effect which, although beneficial in hypertensive management, is quite deleterious to the heart in general. (read about maxalt side effects)
The drug reduces cardiac output, a truly problematic condition in patients with aortic valve stenosis (which narrows the opening the aortic valve, thus reducing the entire output of blood to the body).
No immediate actions, legal or otherwise, have been taken against Upsher-Smith, who continue to manufacture the product internationally under some 25 different names, including Amlovasc and Istin in the UK and Norvasc (under the aegis of Pfizer) in North America. The reader is referred to http://en.wikipedia.org/wiki/Amlodipine for a complete listing of product names.
If you want more information about Amlodipine and its effects, or you have been a patient under treatment with Amlodipine-based pharmaceuticals, you are urged to contact your health professional as soon as possible.