Novartis Pharmaceuticals’ popular blood pressure drug Tekamlo (aliskiren and amlodipine) has recently been linked to serious and potentially life-threatening side effects including strokes, kidney injuries, high potassium, and dangerously low blood pressure levels. A recent study conducted by the manufacturer found that type 2 diabetics treated with Tekamlo were at an increased risk of developing these conditions compared to patients being treated with other drugs. In response to the study’s findings, Novartis announced that it would halt the promotion of its aliskiren-containing medications, including Tekamlo, until health authorities evaluate the data.
Tekamlo Update 4/20/12: The FDA issued a warning today to healthcare professionals stating that blood pressure drugs containing aliskiren should not be prescribed to patients with diabetes or kidney impairment with other medications called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs). These drugs are contraindicated, and may result in serious side effects when taken simultaneously.
What’s the problem?
First approved by the U.S. Food & Drug Administration (FDA) in August 2010, Tekamlo is a combination blood pressure lowering medication that works by decreasing substances in the body that narrow blood vessels and raise blood pressure. Tekamlo belongs to a class of drugs known as calcium channel blockers that are designed to relax (widen) blood vessels and improve blood flow. These medications are FDA-approved to treat high blood pressure (hypertension).
In addition to Tekamlo, other aliskiren-containing calcium channel blockers include:
- Tekturna HCT (hydrochlorothiazide and aliskiren)
- Rasilamlo (aliskiren and amlodipine)
- Rasilez (aliskiren)
- Rasilez HCT (hydrochlorothiazide and aliskiren)
Tekamlo Side Effects
Though Tekamlo has been shown to be relatively effective at treating high blood pressure, it has also increasingly been linked to the following serious side effects:
- kidney problems
- non-fatal strokes
- hyperkalemia (high potassium)
- hypotension (low blood pressure)
- renal complications
Other, less severe side effects commonly reported by Tekamlo users include:
- slow, uneven heart rate
- weak pulse
- swelling around the eyes
- stomach pain or upset stomach
- itching skin
- skin rash
- back pain
- joint pain
- stuffy nose
- sore throat
Tekamlo Kidney Injuries
Tekamlo may force the heart to work harder than usual to perform its everyday tasks and, over time, can damage blood vessels throughout the body. If blood vessels in the kidneys are damaged, they may stop removing wastes and extra fluids from the body. The extra fluid in the blood vessels may then raise the blood pressure and cause a number of other serious side effects. Signs and symptoms of a Tekamlo-induced kidney injury may include:
- protein loss in the urine (macroalbuminuria, also known as overt nephropathy)
- high blood pressure
- high cholesterol and triglyceride levels
- swelling (edema), first in the feet and legs and later throughout the body
- poor appetite
- weight loss
- feeling tired or worn out
- nausea or vomiting
- trouble sleeping
New research shows that blood pressure medications like Tekamlo can increase the risk of stroke in certain users. Tekamlo has the potential to cause strokes by directly affecting blood vessels in the brain, or indirectly by affecting other organs in the body such as the heart or liver. Signs and symptoms of a Tekamlo-induced stroke may include:
- numbness on one side of the body
- loss of vision / problems with vision
- change in alertness
- sudden intense headache
Tekamlo ALTITUDE Clinical Trial
Novartis announced in December 2001 that it was halting its so-called ALTITUDE clinical trial because a high number of test subjects had developed strokes, heart damage and kidney injuries. An independent data monitoring committee recommended terminating the study after concluding that Tekamlo and other similar aliskiren-containing medications may increase the risk for these conditions in patients who take the drugs for an extended period of 18 months or more. Novartis subsequently announced that it would halt the promotion of its aliskiren-containing medications, including Tekamlo, until health authorities are able to fully evaluate the data.
Tekamlo and Pregnancy
The FDA currently classifies Tekamlo as a Pregnancy Category D medication, which means that the drug may cause injury or death to an unborn baby if taken by the mother during the second or third trimester. Women taking Tekamlo should always use an effective form of birth control. Additionally, it is not known whether Tekamlo has the ability to pass into breast milk, or if it has the potential to harm a nursing baby. You should not breast-feed while taking this medication.