A kidney drug taken by millions of Americans has been pulled from the shelves after it was found to be contaminated with a cancer-causing ingredient.
In total, 331,590 bottles of cinacalcet tablets manufactured by Dr. Reddy’s Laboratories have been recalled after they were found to contact potentially harmful levels of nitrosamine.
The Food and Drug Administration (FDA) reports that some levels of nitrosamine are ok, and frequent in food and drink consumed everyday, but consistent use of drugs with levels of potent carcinogens can prove dangerous.
Experts from the FDA recommend that patients should stop taking the compromised cinacalcet tablets immediately and talk to health care professionals about ‘concerns and other treatment options.’
The risk level of the recall has been classified as a ‘Class II’, meaning ‘it may cause temporary or medically reversible adverse health consequences.’
The affected drugs have labels stating that they are from Dr. Reddy’s Laboratories in Princeton, New Jersey but ‘made in India.’
In total, 331,590 bottles of Cinacalcet tablets manufactured by Dr. Reddy’s Laboratories, Inc. in India have been recalled
There are multiple reasons why nitrosamines can be present in drugs, according to the FDA.
Medications can become contaminated at any stage of the production process, and even the conditions in which they are stored in can have an impact.
Dr. Reddy’s Cinacalcet Tablets are available in 30 mg, 60 mg, and 90 mg tablets in a bottle count size of 30.
Dr. Reddy’s Laboratories was established in Hyderabad, India, in 1984 by Dr. Anji Reddy and today it has more than 20 manufacturing facilities worldwide, producing over 190 medications.
The company, which went public in 2001, launched Dr. Reddy’s Cinacalcet Tablets in the US in 2000.
It is estimated that around 23 percent of patients with kidney disease are prescribed cinacalcet in the US.
Cinacalcet is used to treat hyperparathyroidism in patients with chronic kidney disease who are on dialysis.
Hyperparathyroidism is a condition that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH).
This hormone helps to control the concentrations of calcium and phosphorus in the blood.
Dr. Reddy’s launched its own brand of cinacalcet tablets in the US in 2000
Higher calcium levels can potentially lead to complications such as kidney stones, and bone loss.
Cinacalcet lowers the amount of PTH which lowers the calcium and phosphorus concentrations.
Cinacalcet is also used to lower calcium in the blood of patients with parathyroid cancer and primary hyperparathyroidism.
According to the American Kidney Fund, kidney disease is growing at an alarming rate and it is one of the top 10 causes of death in the US.
It currently affects more than 1 in 7 (or 14%) of American adults, with people of color at greater risk for kidney failure.
In light of this trend, Dr. Reddy’s launched its own brand of cinacalcet tablets.
It noted in a press release that the Sensipar brand of cinacalcet, made by Amgen Inc., made $312 million in sales per year in the US at the time.
Now the FDA has recalled 285,126 bottles of Dr. Reddy’s Cinacalcet Tablets containing 30mg pills, 35,880 bottles of 60mg pills, and 10,584 bottles of 90mg pills.
DailyMail.com has contacted Dr. Reddy’s Laboratories for comment.
