A kidney medication taken by millions of Americans has been pulled from 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 come into contact with potentially harmful levels of nitrosamine.
The Food and Drug Administration (FDA) reports that some levels of nitrosamine are okay and common in foods and beverages consumed every day, but consistent use of medications with levels of potent carcinogens can be dangerous.
FDA experts recommend that patients immediately stop taking the compromised cinacalcet tablets and talk to health care professionals about “concerns and other treatment options.”
The risk level of the recall has been classified as “Class II,” meaning it “may cause temporary or medically reversible adverse health consequences.”
The affected drugs have labels indicating that they come from Dr. Reddy Laboratories in Princeton, New Jersey, but that they are “made in India.”
In total, 331,590 bottles of Cinacalcet tablets manufactured by Dr. Reddy’s Laboratories, Inc. in India have been recalled.
According to the FDA, there are multiple reasons why nitrosamines may be present in medications.
Medicines can become contaminated at any stage of the production process, and even the conditions in which they are stored can have an impact.
Dr. Reddy’s Cinacalcet tablets are available in 30 mg, 60 mg and 90 mg tablets in a bottle size of 30.
Dr. Reddy’s Laboratories was established in Hyderabad, India, in 1984 by Dr. Anji Reddy and today has more than 20 manufacturing facilities worldwide, producing more than 190 medicines.
The company, which went public in 2001, launched Dr. Reddy’s Cinacalcet tablets in the United States in 2000.
It is estimated that about 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 occurs when the parathyroid glands located in the neck produce too much parathyroid hormone (PTH).
This hormone helps 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 lead to complications such as kidney stones and bone loss.
Cinacalcet reduces the amount of PTH, which reduces calcium and phosphorus concentrations.
Cinacalcet is also used to lower blood calcium in patients with parathyroid cancer and primary hyperparathyroidism.
According to the American Kidney FundKidney disease is growing at an alarming rate and 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, and people of color are at higher risk for kidney failure.
Faced with this trend, Dr. Reddy’s launched its own brand of cinacalcet tablets.
It noted in a news release that the Sensipar brand of cinacalcet, manufactured by Amgen Inc., was generating $312 million in sales annually in the United States at the time.
Now the FDA has remembered 285,126 bottles of Dr. Reddy’s Cinacalcet tablets containing 30 mg pills, 35,880 bottles of 60 mg pills and 10,584 bottles of 90 mg pills.
DailyMail.com has contacted Dr. Reddy’s Laboratories for comment.