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Bloomberg Businessweek: Colgate Total ingredient raises questions on FDA process

BY Antoinette Alexander

NEW YORK — The recent release of Colgate Total’s application submitted to the Food and Drug Administration, which included 35 pages summarizing toxicology studies on triclosan, is raising some eyebrows as some are wondering if the FDA did its due diligence in approving Total 17 years ago, according to a report from Bloomberg Businessweek.

Triclosan is an antibacterial chemical that has been linked to cancer-cell growth and malformations in animals. Colgate uses the chemical in its Total toothpaste to ward off gum disease, the report states.

Colgate insists that Total is safe, citing a rigorous FDA application process that led to its approval as an OTC drug in 1997. However, after the papers became public just this year, a closer look at the findings is raising some concerns. According to the article, the FDA released the pages earlier this year in response to a lawsuit over a Freedom of Information Act request. Later, following inquiries from Bloomberg News, the FDA put the pages on its website.

In response, Colgate spokesman Thomas DiPiazza reportedly said that Total’s effectiveness and safety are supported by more than 80 clinical studies involving 19,000 people, and that it gave the FDA 98 volumes, numbering hundreds of pages each, in support of Total. Colgate submits annual reports to the FDA reviewing new science and safety findings.

“In the nearly 18 years that Colgate Total has been on the market in the U.S., there has been no signal of a safety issue from adverse-event reports,” DiPiazza was quoted as saying in the article. Colgate also reportedly pointed to an independent 2013 review by the Cochrane Oral Health Group, a network of doctors, researchers and health advocates, which found no evidence of harmful effects associated with using Colgate Total.

In May, Minnesota Gov. Mark Dayton signed a bill that will prohibit the use of the antibacterial ingredient triclosan in consumer hygiene products beginning Jan. 1, 2017.

Meanwhile, the FDA is seeking stronger regulations on antibacterial soaps and body washes as nearly all soaps labeled "antibacterial" or "antimicrobial" and marketed to consumers contain ingredients such as triclosan and triclocarban.

In 2013, Procter & Gamble announced that it had decided to eliminate triclosan from its products by 2014.

In separate news, scientists are now reporting that many pregnant women and their fetuses are being exposed to antibacterial compounds. They presented their work at the 248th National Meeting & Exposition of the American Chemical Society on Sunday.

“We looked at the exposure of pregnant women and their fetuses to triclosan and triclocarban, two of the most commonly used germ-killers in soaps and other everyday products,” stated Benny Pycke, a research scientist at Arizona State University. “We found triclosan in all of the urine samples from the pregnant women that we screened. We also detected it in about half of the umbilical cord blood samples we took, which means it transfers to fetuses. Triclocarban was also in many of the samples.”

The problem with this, explained Pycke, is that there is a growing body of evidence showing that the compounds can lead to developmental and reproductive problems in animals and potentially in humans. Also, some research suggests that the additives could contribute to antibiotic resistance, a growing public health problem.

Although the human body is efficient at flushing out triclosan and triclocarban, a person’s exposure to them can potentially be constant. The compounds are used in more than 2,000 everyday products marketed as antimicrobial, including toothpastes, soaps, detergents, carpets, paints, school supplies and toys, according to researchers.

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FDA approves Invokamet from Janssen Pharmaceuticals

BY Ryan Chavis

RARITAN, N.J. — Janssen Pharmaceuticals received approval from the Food and Drug Administration for Invokamet, a fixed-dose therapy that combines canagliflozin and metformin hydrochloride in a single tablet. The drug is used for the treatment of adults with Type 2 diabetes.

“Invokamet combines, in one tablet, two complementary therapeutic approaches proven effective for managing Type 2 diabetes,” said Richard Aguilar, M.D. and medical director of Diabetes Nation. “Canagliflozin works with the kidney to promote the loss of glucose in the urine, whereas metformin decreases the production of glucose in the liver and improves the body's response to insulin.”

Invokamet will be available in tablets containing canagliflozin 50 mg or 150 mg, and metformin 500 mg or 1000 mg, the company stated. The recommended dosing is twice daily.

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FDA releases draft guidance on determining exclusivity period for biologics

BY Michael Johnsen

NEW YORK — The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported
 
According to the report, the agency is reviewing options for making information publicly available regarding reference product exclusivity and dates of first licensure. 
 
Approval of a 351(k) application may not take effect until 12 years after the date of first licensure of the reference product. A 351(k) application for a biosimilar or interchangeable biological product cannot be submitted for review until four years after the date on which the reference product was first licensed.

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