HEALTH

Dulcolax, CCA encourage consumers to get screened for colon cancer

BY Allison Cerra

RIDGEFIELD, Conn. — Dulcolax has teamed up with the Colon Cancer Alliance and American fashion designer Carmen Marc Valvo to encourage men and women to be proactive about their colon health by getting a colonoscopy.

According to a new survey conducted on behalf of Boehringer Ingelheim, the makers of Dulcolax, and the CCA, more than a quarter (27%) of respondents ages 50 years and older have not had a colonoscopy, a colon cancer screening test, with the most often-cited reason being that they do not have a family history of colon cancer. What’s more, 60% of those respondents said they would be more concerned about the preparation than the actual procedure. Valvo, who was diagnosed with colon cancer eight years ago, said the benefits of a colon cancer screening outweighed the discomfort.

"I certainly understand why people are hesitant to be examined, but the fact is, it’s not nearly as uncomfortable as you might imagine, and any discomfort from the screening is surely outweighed by the benefits of preventing cancer from developing or catching it in its early stages," Valvo said. Valvo now is cancer-free.

As part of its support of colon cancer screenings, Boehringer Ingelheim noted that a portion of proceeds from the purchase of Dulcolax supports free colon cancer screenings for those in need.

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FDA targets unapproved cough-cold, allergy drugs with Unapproved Drugs Initiative

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has taken action against makers of prescription drugs for cough-cold and allergies that don’t have regulatory approval, the agency said Wednesday.

The action is part of the agency’s Unapproved Drugs Initiative, which seeks to remove from the market drugs that have not received approval. In many cases, the drugs were marketed before the FDA adopted its current regulatory standards.

The products include a wide range of drugs with active ingredients ranging from guaifenesin to dextromethorphan to pseudoephedrine hydrochloride, which also appear in a number of FDA-approved prescription and over-the-counter products. The agency said that many healthcare providers didn’t know the drugs didn’t have FDA approval because they lacked any labels indicating they didn’t.

“Removing these unapproved products from the market will reduce potential risks to consumers,” FDA Office of Compliance director Deborah Autor said. “There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough-cold and allergy symptoms; so we expect little or no negative impact on consumers from the removal of these unapproved products.”

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Perrigo announces re-inspection of Allegan, Mich., plant

BY Allison Cerra

ALLEGAN, Mich. — Following the warning letter it received last April, Perrigo announced that the Food and Drug Administration has arrived at the company’s Allegan, Mich.-based facility for re-inspection.

The re-inspection of the plant follows an initial inspection that occurred between Nov. 17, 2009, and Jan. 14, 2010, in which the FDA "identified significant violations of current good manufacturing practice regulations for finished pharmaceuticals," the regulatory agency said in its letter last year, noting certain production problems, including an equipment failure that shredded metal shavings into bottles on a production line of 200-mg ibuprofen tablets.

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