More than 300,000 kidney drugs have been recalled in the US over fears of cancer ingredients
A kidney drug taken by millions of Americans has been pulled from shelves after it was found to be contaminated with a cancer-causing ingredient.
A total of 331,590 bottles of cinacalcet tablets manufactured by Dr. Reddy’s Laboratories, recalled after they were found to have 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 drinks consumed daily, but consistent use of medications with levels of potent carcinogens can be dangerous.
FDA experts recommend that patients should immediately stop taking the affected cinacalcet tablets and talk to healthcare professionals about “concerns and other treatment options.”
The risk level of the recall is classified as ‘Class II’, meaning that ‘it may cause temporary or medically reversible adverse health effects.’
The drugs involved have labels that say they come from Dr. Reddy’s Laboratories in Princeton, New Jersey, but ‘made in India’.
A total of 331,590 bottles of Cinacalcet tablets manufactured by Dr. Reddy’s Laboratories, Inc. in India, recalled
According to the FDA, there are several 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 founded in 1984 in Hyderabad, India, 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. in 2000. Reddy’s Cinacalcet Tablets in USA
It is estimated that in the US, approximately 23 percent of patients with kidney disease are prescribed cinacalcet.
Cinacalcet is used to treat hyperparathyroidism in patients with chronic kidney disease who are on dialysis.
Hyperparathyroidism is a condition caused when the parathyroid glands in the neck produce too much parathyroid hormone (PTH).
This hormone helps control the levels 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 reduces the amount of PTH, which reduces calcium and phosphorus concentrations.
Cinacalcet is also used to lower the blood calcium levels of 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.
Currently, it affects more than 1 in 7 (or 14%) American adults, with people of color at greater risk for kidney failure.
In light of this trend, Dr. Reddy’s own brand of cinacalcet tablets.
It noted in a news release that the Sensipar brand of cinacalcet, made by Amgen Inc., had annual U.S. sales of $312 million at the time.
Now the FDA has remembered 285,126 bottles of Dr. Reddy’s Cinacalcet Tablets of 30mg Pills, 35,880 Bottles of 60mg Pills and 10,584 Bottles of 90mg Pills.
DailyMail.com contacted Dr. Reddy’s Laboratories for comments.
