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Drug cos at odds with FDA over acetaminophen risk

admin » 30 June 2009 » In Uncategorized » No Comments

Drug cos at odds with FDA over acetaminophen risk

Johnson & Johnson, Procter & Gamble and other manufacturers on Monday said cough and cold drugs with the pain reliever acetaminophen should stay on the market despite concerns from U.S. regulators.

While the Food and Drug Administration is weighing a ban on such combination products — often marketed to consumers with colds or other mild illnesses, the industry instead urged a widespread effort to warn buyers about the risks of liver damage linked to the ingredient.

“We believe there is a clear public health benefit with OTC (over-the-counter) products containing acetaminophen,” Consumer Healthcare Products Association (CHPA) President Linda Suydam, whose group represents the two companies along with others, told an FDA advisory panel meeting to discuss the risks.

Too much acetaminophen has been known to cause liver injury for decades, but FDA officials are worried that the rise of products that combine it with other medications can lead consumers unknowingly to overdose by taking too much of a medication or taking too many different products at once.

The agency called for stronger liver warnings earlier this year but is seeking advice from outside experts at a two-day meeting on whether such over-the-counter and prescription combination drugs can safely remain on the U.S. market.

A total ban on combination products could dent sales of acetaminophen-containing products, which were $2.6 billion in 2008, the FDA said, citing IMS Health. Nearly 80 percent of that stems from combination products sold directly to consumers, it said.

Impact could be especially significant for Johnson & Johnson’s McNeil Consumer Healthcare division, which CHPA said makes up 27 percent of the sector with its Tylenol brand as well as its Sudafed and Benadryl products.

Some of Procter & Gamble’s NyQuil, Vicks Formula 44 and other nonprescription medications contain acetaminophen. Other companies that make related products include Bayer AG, GlaxoSmithKline, Novartis, Perrigo Co, Schering Plough and Wyeth.

Some prescription medications also contain the ingredient, including Abbott Laboratories’ Vicodin and Endo Pharmaceuticals’ Percocet. Cadence Pharmaceuticals Inc is also seeking to sell injectable acetaminophen.

Other possible FDA actions include reducing the amount of medicine sold in packages, lowering the available strengths for over-the-counter products, and adding a strong, black-box warning on prescription medications.

Industry representatives said most overdoses result from people trying to commit suicide and that more deaths were seen with prescription versions than over-the-counter ones.

In April, the FDA ordered bolder warnings about the liver damage risk with acetaminophen products to highlight them better for consumers, and companies agreed to comply.

But a further ban on certain products would be “overly drastic,” said Paul Desjardins, a vice president for Wyeth Consumer Healthcare.

Instead, the FDA should require approval of nonprescription acetaminophen products before they could be sold, Desjardins told the panel. Wyeth, known for its widely-used ibuprofen pain medication Advil, also sells Robitussin Cough Cold & Flu and Dristan Cold over-the-counter products with acetaminophen.

FDA officials consider the ingredient safe when taken as directed but worry that the number of liver failure cases that continue to be reported despite various interventions since the 1990s show “overdose remains a serious public health problem,” the agency said in a memo released before the meeting.

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Matrixx recalls Zicam nasal cold products

admin » 24 June 2009 » In Uncategorized » No Comments

Matrixx recalls Zicam nasal cold products

Matrixx Initiatives Inc. said Wednesday it started a previously announced recall of Zicam nasal cold remedies following last week’s Food and Drug Administration warning that the products were unsafe.

Meanwhile, the company is being investigated by the Securities and Exchange Commission over the FDA warning letter.

The Scottsdale, Ariz., company said the recall was voluntary. Still, it occurred as the FDA warned consumers to not use the nasal cold remedies due to hundreds of reports of patients losing their sense of smell. Matrixx said it disagrees with the FDA’s safety warning, but “voluntarily” recalled the product to cooperate with the regulatory agency.

The FDA also alleges the products were unlawfully marketed. Matrixx also disagrees with that allegation.

“The company is also in the process of preparing a submission to the FDA and, as previously reported, will soon ask to meet with the agency to present comprehensive scientific and medical data and analyses demonstrating that these products are safe,” Matrixx said, in a statement.

On June 16, the FDA issued the recall notice for Zicam products, which accounted for 40 percent of Matrixx’s sales last year. The regulatory agency said the products contain zinc, which could damage nerves in the nose needed for smell.

Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, though it maintains the nasal spray does not harm users’ sense of smell.

Shares of Matrixx rose 3 cents to $4.86 in morning trading. The stock has lost three-quarters of its value since the FDA issued its warning last week.

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Zicam may damage sense of smell – FDA

admin » 20 June 2009 » In Uncategorized » No Comments

Zicam may damage sense of smell – FDA

Consumers should discontinue use of Zicam Cold Remedy nasal gel and related products because they can can permanently damage users’ sense of smell, the government said Tuesday.

In a press release, the U.S. Food and Drug Administration advised consumers to stop use of three over-the-counter Zicam Cold Remedy products: nasal gel, nasal swabs and the discontinued “kids size” swabs.

The FDA warned the three products could cause anosmia, the loss of sense of smell, which “may be long-lasting or permanent.”

After that news was released, shares of Scottsdale, Ariz.-based Zicam manufacturer Matrixx Initiatives Inc. (MTXX) plummeted 55.5% to $8.56 before trading was halted.

About 130 consumers since 1999 have reported a loss of smell after using Zicam products. Many said the condition occurred after their first dose, the FDA said. The agency advised anyone who has experienced problems after using Zicam products to contact a doctor.
Matrixx responds

The products named comprised about 40% of the company’s net sales in 2009, according to a press release from Matrixx, which added that the company believes the Zicam products are safe and do not cause loss of smell.

Matrixx said the FDA’s actions are “unwarranted” — but the company is reviewing its options, which may include removing these products from the market.

A separate note on Matrixx’s Web site zicamlawsuits.com, titled “Response to Those Who Are Concerned About Zicam’s Purported Connection to Anosmia,” says the products are safe and that “allegations to the contrary are scientifically unfounded and misleading.”

However, the Matrixx note does acknowledge lawsuits that have been brought against the company, saying, “Although plaintiffs and their attorneys hoping for financial gain have sued Matrixx, no plaintiff has ever won a court case, because there is no known causal link.”
Homeopathic drug regulations

Zicam is considered a “homeopathic remedy” rather than a drug. These types of products can be marketed without the government oversight required of “conventional” foods and drugs.

Manufacturers are not required to register their products with FDA, nor must they receive the FDA’s approval before producing or selling these products.

The manufacturer is responsible for ensuring that the products are safe, and the FDA is responsible for taking action against any “unsafe” product after it reaches the market — as it did with Zicam.

In its warning letter, the FDA said Matrixx was in violation of its regulations by failing to file a new drug application for the nasal gel and gel swabs, and that the products did not adequately warn of risks.

The agency sent Matrixx a warning letter saying these products can no longer be marketed without FDA approval, according to its press release. Matrixx has 15 business days to notify the FDA of specific steps taken to correct violations.

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Hydroxycut Recall

admin » 10 June 2009 » In Uncategorized » No Comments

Hydroxycut Recall

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F.D.A. Recalls Of All “Hydroxycut” Weight Loss Products

admin » 10 June 2009 » In Uncategorized » No Comments

F.D.A. Recalls Of All “Hydroxycut” Weight Loss Products

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Hydroxycut Recall

admin » 10 June 2009 » In Uncategorized » No Comments

Hydroxycut Recall

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Hydroxycut Video

admin » 10 June 2009 » In Uncategorized » No Comments

Hydroxycut Video

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Chinese Drywall Highlights Hurdles to Holding Foreign Producers Responsible for their Products

admin » 10 June 2009 » In Uncategorized » No Comments

Chinese Drywall Highlights Hurdles to Holding Foreign Producers Responsible for their Products

Hurricane Katrina Victims among Families that Face Further Home Complications

Washington, DC–Chris Whitfield is just one of the families who lost his home to Hurricane Katrina in Louisiana’s St. Bernard Parish. Just a few years later, his family now faces another uncertain future upon finding Chinese drywall in their new Picayune, Mississippi home. The drywall is corroding his appliances, and causing an egg-like smell that he has no idea what effect it will have on his families’ health or home.

Chris is just one of hundreds, if not thousands of families who wonder where they can turn for justice when their unsafe home is made from defective materials manufactured in another country.

Today the U.S. Senate Judiciary’s Administrative Oversight and the Courts Subcommittee will explore the topic of holding foreign manufacturers responsible in a hearing titled, “Leveling the Playing Field and Protecting Americans: Holding Foreign Manufacturers Accountable.”

“Unfortunately, when the product comes from abroad an unfair and unnecessary battle over civil procedure becomes the focus of the litigation instead of focusing on the real issue at hand, the victim’s injuries,” said Tom Gowen, of Locks Law Firm in Philadelphia, Pennsylvania. “It makes no difference whether the product is drywall, tire valves, or toothpaste. Someone has been harmed and someone has to be held responsible for the defective products.” Gowen will be testifying before the subcommittee.

There are four primary hurdles when perusing legal action against a foreign entity: identifying the manufacturer, service of process, jurisdictional issues, and collection of judgment.

Some foreign products do not contain an adequate label with the manufacturer’s proper name and might be labeled, “Made in China,” or have a retailers name like Sears, Walmart or Target. This presents a problem identifying the manufacturer responsible residing within a foreign country.

Once a manufacturer can be identified, service of process, is simply actually servicing the legal papers to pursue further legal action. The process has been made easier by a Hague Convention treaty signed by about 70 countries, but still requires the complaint to be translated in to the company’s home language, transmitted to the authority in the foreign country, and delivered to the defendant according to rules of service in the country. India, for example, has not signed the Hague Convention, so servicing the legal documents requires going through the U.S. Department of State.

Also testifying before the subcommittee, Chuck Stefan is one of the owners of The Mitchell Company which builds homes in Alabama, Florida, and Mississippi that had unknowingly used the defective drywall in manufacturing about 45 homes. “Foreign manufacturers should not be allowed off the hook for harming U.S. consumers and businesses like ours, especially if they are conducting substantial business here in the U.S.,” said Stefan. “If American businesses can’t hold foreign manufacturers accountable, it hurts their bottom line in addition to harming U.S. consumers and homeowners. It also puts U.S. businesses like Mitchell Homes at a competitive disadvantage.”

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Microsoft’s Bing Ad Campaign Takes On Google’s Dominance

admin » 08 June 2009 » In Uncategorized » No Comments

Microsoft’s Bing Ad Campaign Takes On Google’s Dominance

A new Microsoft Corp. (MSFT) television campaign to promote its Bing search engine seeks to do with Google Inc. (GOOG) what an earlier set of commercials tried to do with Apple Inc. (AAPL): burst its bubble.

In a series of spots that will air beginning Wednesday, Microsoft tries to suggest that the Google search experience is cluttered, irrelevant and confusing. The Bing campaign doesn’t direcly mention Google, though the target is clear.

The campaign, produced by agency JWT at a reported cost of over $90 million, develops a theme similar to the one Microsoft used in earlier commercials that targeted Apple. In those, Microsoft challenged ordinary people to find attractively priced laptops. In every scenario, a laptop based on Microsoft’s Windows platform was shown to be the more cost-effective alternative to Apple.

The underlying theme of both campaigns is that while Google and Apple may have either a higher market share or sexier brand image, Microsoft’s products are the pragmatic, affordable solution for the regular consumer.

The advertising push comes as the software maker seeks new drivers for its $60 billion in revenue. That’s an increasingly important effort as its core software franchises Windows and Office come under pressure from the slack economy and growing number of alternatives.

Apple’s rival operating system has staged a resurgence in recent years, and many companies, including Google, are offering alternatives to Microsoft’s software products. The growth of low-power computers used mainly to connect to the Internet also has the potential to affect Microsoft. Though Windows still runs on more than 90% of the world’s PCs, these newer computers, known as netbooks, rely less on the standard operating system.

Against this backdrop, Microsoft has spent hundreds of millions of dollars over the past six months on a broad brand overhaul aimed at shaking its stodgy image. The Bing campaign is the latest effort.

In the first spot, a voice-over discusses the “search overload” the information age has created, while visual and verbal references to the financial crisis imply that too much information of inadequate quality was a factor in the crisis. Later campaigns will feature a series of vignettes in which people seeking help with simple transactions from friends, family or customer-service representatives are bamboozled by bizarre, free-associating responses that mimic the random results search engines can generate.

In one situation, a woman goes into a clinic saying: “I’m having this back pain.” The receptionist says: “Back-packing? Back-to-school? Johann Sebastian Bach?”

Microsoft’s overall campaign began with a whimsical commercial last September, featuring a conversation between Microsoft’s founder, Bill Gates, and the comedian Jerry Seinfeld. A surreal conversation between the two men in a shoe store, which never referenced any of Microsoft’s products directly, sought to underscore the theme that Microsoft has lots of exciting ideas in the pipeline.

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Bing’s Search Page Could Be Better For Advertisers Than Google’s

admin » 08 June 2009 » In Uncategorized » No Comments

Bing’s Search Page Could Be Better For Advertisers Than Google’s

It’s been less than two weeks since Microsoft finally unveiled the new and improved Bing search, but there’s already a consensus that the changes were mostly cosmetic. Our Joe Tartakoff found that the quality of Bing’s search results still didn’t measure up to Google’s, and TechCrunch reports that Bing’s leapfrog over Yahoo Search to the number two spot was short-lived. But new eye-tracking data from user experience research firm User Centric finds that Bing’s cosmetic changes could ultimately evolve into a major advantage for search advertisers.

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But there are caveats. First is the small sample size. User Centric studied about two dozen searchers for this test; managing director Gavin Lew said the smaller size allowed for more qualitative analysis (through one-on-one interviews) that backed up the numbers. There’s also the question of whether Bing’s newness contributed to the searchers’ willingness to look at the ads on the right side of the page; Lew said it could be indicative of a more ad-friendly design. “Bing’s three column layout, with the related links on the left, and sponsored results on the right almost forms bookends around the center content,” he said. “Bookends compel users to look at both sides of the page, not just the center. That’s a direct contrast to the left-centered Google.com interface.” He added that Google had much more white space between its core results and the right side ads.

But the eye-tracking data and design theories can’t make up for the fact that Bing’s results currently aren’t as comprehensive as Google’s. If Microsoft (NSDQ: MSFT) can fix that?meaning indexing sites faster and increasing relevance?while maintaining the high level of user attention on the paid search ads, then Bing’s new interface could actually wind up being a game-changer in terms of search advertising. User Centric plans to repeat the study in a few months to see whether the trend has legs, so we’ll definitely be able to find out. Release.

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The company studied a small group of searchers, giving them four specific queries so that they’d get the same results on both Google and Bing?and found that Bing users were much more likely to look at the search ads on the right side of the page. On average, 42 percent of Bing searchers looked at those sponsored links, while just 25 percent did on Google (NSDQ: GOOG). The difference didn’t extend to ads that showed up above the organic results; it also didn’t show up in terms of clicks, as ad click-through rates were about the same on both engines. Find out about User Centric’s methodology and the implications for advertisers after the jump.

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