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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, May 07, 2013

Tanning Beds - more dangerous then previously though (CAUSES CANCER)

those who use tanning bads are 75% more likely to develop skin cancerWashington, May 6 (Reuters - By Toni Clarke) - Tanning beds and sunlamps will be required to carry stronger warning labels under new regulations proposed by the U.S. Food and Drug Administration, which is also recommending the machines not be used by people under the age of 18.

The FDA said on Monday that it plans to reclassify sunbeds from low-risk to moderate-risk products, meaning they will need to be cleared by the agency before being allowed onto the market.

Faulty equipment has led to patients being burned or exposed to too much radiation, Jeffrey Shuren, director of the FDA's center for devices and radiological health, said in an interview.

Skin cancer is the most common form of cancer in the United States, according to the Centers for Disease Control and Prevention. Basal cell and squamous cell cancer, the two most common forms, are generally curable; but melanoma, the third most common type, is deadly.

In 2009, the most recent year numbers are available, 61,646 people in the United States were diagnosed with melanoma and 9,199 people died, according to the CDC.

The FDA's proposed regulations stop short of recommendations made by the International Agency for Research on Cancer, part of the World Health Organization, which in 2009 concluded that commercial tanning devices were more dangerous that previously thought and recommended people under 18 be banned from using them.

The FDA's regulations also stop short of new rules being developed by some U.S. states.

More than 30 states regulate the use of tanning facilities to differing degrees. Delaware, New Hampshire and North Dakota, for example, ban the use of indoor tanning by anyone under age 14 unless medically necessary and they require parental consent for those between the ages of 14 and 18.

Some states, including Georgia, Illinois and Maine, ban tanning beds for children under the age of 14, and eighteen states require tanning bed operators to limit exposure time to a manufacturers' recommendations and provide eye protection.

In January 2012, California became the first state to ban tanning beds for all people under 18.

The Indoor Tanning Association argues vigorously that the decision on whether a teen is allowed to suntan is one for parents, not government, and it supports parental consent. But it is fighting the growing number of states issuing bans.

"Is the next step to ban teens from sun bathing at public beaches and pools?" the association asked in a statement last year in opposition to New Jersey's proposal to ban tanning bed use for those under 17.

"You also have to consider the health risks associated with banning teenagers from using tanning salons," it said. "They will just go outside with no adult supervision and no trained staff where they are much more likely to get sunburned."

The FDA's actions follow a 2010 meeting of a federal advisory panel which unanimously recommended that the agency reclassify tanning devices. Panelists had mixed views on whether to implement a ban on minors.

An estimated 5.6 percent of U.S. adults reported indoor tanning at least once in 2010, with the highest rates among white, female 18 to 25-year-olds, according to the CDC, which notes that frequent exposure to UV rays for people under the age of 35 increases the risk of developing melanoma by 75 percent.

"For right now our proposal tries to focus on providing better information for consumers," Shuren said, "including a warning on the tanning beds themselves that they shouldn't be used in people under 18," he said.

Depending on the feedback the agency receives to its proposal, it may make changes to the final order, he said.

Tuesday, December 04, 2012

generic Lipitor (atorvastatin) recalled after glass discovered...


Ranbaxy Laboratories (generic drug maker) will stop manufacturing its version of Pfizer Inc's cholesterol fighter, Lipitor, while it gets to the bottom of the cause of a recent recall.

Earlier this month, after the company discovered contamination with tiny glass particles, Ranbaxy recalled certain lots of the widely used cholesterol lowering medicine known generically as atorvastatin at doses of 10 milligrams, 20 mg and 40 mg.

During its first six months on the market, when it enjoyed marketing exclusivity, atorvastatin generated sales of nearly $600 million for Ranbaxy, according to Bhagwan Singh Chaudhary, a research associate at the brokerage IndiaNivesh

FDA said it will continue to oversee the recall process and work with the Ranbaxy to resolve pharmaceutical quality issues.

The recall is the latest in a series of manufacturing problems at Ranbaxy, which is operating under heightened scrutiny due to past problems that nearly derailed it ability to sell atorvastatin in the United States.

In 2008, the FDA banned the company from importing about 30 drugs after it found manufacturing deficiencies at two of the company's facilities in India, and Ranbaxy was later accused of falsifying data used in drug applications.

Under a proposed settlement earlier this year, Ranbaxy agreed to engage a third party to conduct a review of its facilities, implement procedures to ensure data integrity in its marketing applications, and ensure it meets good manufacturing practices.

If you or someone you know has suffered injury due to a defective drug/medication call the experienced defective product attorneys at Buttafuoco & Associates 1-800-669-4878

Thursday, April 14, 2011

Drug Recall - Avandia


Avandia, the type-2 diabetes medication, has had its use severely restricted in the United States, and the drug has been withdrawn from the market in Europe due to concerns over severe side effects. The U.S. Food and Drug Administration (FDA) concluded there is significant evidence that Avandia, also known as rosiglitazone, increases the risk of heart attack, stroke, and congestive heart failure in those taking it.