Personal Injury and Social Security Disability Blog

FDA Requires Suicide Warnings for Chantix and Zyban

NBC Nightly News (7/1, story 6, 0:30, Williams) reported, "The FDA says patients taking Chantix [varenicline] and Zyban [bupropion] should be watched closely for any signs of mental illness. There have been a growing number of reports of suicide, among patients who take the drugs." Regulators stressed, however, that the agency "is not trying to scare people away from the medicines because, as they put it, quitting is the most important thing."

The New York Times reports that Dr. Curtis J. Rosebraugh, director of a drug evaluation office at the Food and Drug Administration, said, "Stopping smoking is a goal we should all be working towards," adding that patients "should just be careful." Chantix-maker Pfizer "will add a so-called black box warning" to the drug's "packaging information." GlaxoSmithKline, Zyban's maker, will also "expand its existing black box warning on Wellbutrin [bupropion], citing suicidal thoughts by patients who use it for depression, to include Zyban."

The Wall Street Journal reports that both Pfizer and Glaxo claim "there is no evidence that their drugs actually cause suicides or mood swings."

From the American Association for Justice news release.

CDC Releases New E. Coli Figures

CNN International reports, "The toll of the nationwide E. coli outbreak linked to tainted cookie dough has continued to mount, federal health authorities said Tuesday." So far, the CDC said, "Seventy-two people infected with a strain of E. coli O157:H7 with a particular DNA fingerprint have been reported from 30 states," and 51 "have been confirmed as having the outbreak strain; confirmation was pending on the others."

In the Wall Street Journal Health Blog, Shirley Wang writes, "This is the same plant that refused to give FDA inspectors access to certain records in the past." Also it is "still a mystery" how the E. coli "ended up in the product." Normally, "the concern with eating raw cookie dough usually is...salmonella since it can be found in raw eggs."

From the American Association for Justice news release.

FDA Panel Recommends Smaller Acetaminophen Doses, Painkiller Bans

The CBS Evening News (4/30, lead story, 3:05, Couric) reported, "An FDA panel recommended today that prescription Vicodin [hydrocodone bitartrate and acetaminophen] and Percocet [oxycodone and acetaminophen] be banned, and that over-the-counter Tylenol, Excedrin, Nyquil, and Theraflu contain stronger warning labels...The problem, according to FDA advisors, is that they all contain acetaminophen, which can cause liver damage."

The FDA "panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect," the New York Times reports in a front-page story. "The two drugs combine a narcotic with acetaminophen," and the panel's vote to "recommend a ban on the combination drugs was one of 11 it took" at the meeting. The experts also recommended "that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills...to 325 milligrams, from 500," and "to reduce the maximum daily dosage to less than 4,000 milligrams."

The Wall Street Journal notes that the panel "of 37 doctors, pharmacists, and researchers voted on the recommendations Tuesday after spending two days discussing steps the FDA should take to reduce the number of acetaminophen overdoses." Gerald Dal Pan, director of the FDA's office of drug surveillance, said, "Whatever we do on any of these options, it will really affect the whole healthcare system." The agency also noted that the recommendation to pull "from the market a number of prescription products" may "affect 240 pending drug applications."

"But some on the panel opposed a sweeping withdraw of" prescription acetaminophen combination drugs "that are widely used to control severe, chronic pain," the AP reports. The panel decided that "if the drugs stay on the market, they should carry a black box warning, the most serious safety label available." Notably, "drug companies avoided the most damaging potential outcome with the defeat of [a] proposal to pull NyQuil and other over-the-counter cold and cough medicines that combine acetaminophen with other drugs."

From the American Association for Justice news release.

FDA Warns Against Use of Zicam Nasal Spray and Swabs

ABC World News (6/16, story 5, 2:05, Stephanopoulos) reported, "The Food and Drug Administration today told the makers of one of the country's most popular cold medications, Zicam, to stop selling its nasal spray and swabs. In the last ten years, about 130 consumers have filed complaints, saying they permanently lost their sense of smell after using Zicam."

The CBS Evening News (6/16, story 6, 1:30, Ashton) reported that "the FDA is not responsible to regulate" the safety of products like Zicam, "an over-the-counter remedy containing some natural ingredients" before it "comes to market," but the agency is "responsible to regulate its safety after it's been on the shelf." NBC Nightly News (12/6, story 4, 0:25, Williams) added that Zicam manufacturer Matrixx "has suspended shipments of the products, but says the warning is not supported by scientific evidence and is asking the FDA for a review."

Wall Street Journal reports that William Hemelt, Matrixx's acting president and chief operating officer, said, "This isn't a new issue for us. We've certainly studied it for many years, and we think our products are safe." The agency warned against the use of "nasal zinc-containing products, which are sold as Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs." Regulators "also warned against Zicam Cold Remedy Swabs, Kids Size." But, "the FDA's action doesn't affect other Zicam products."

Commenting on the products, Dr. Margaret Hamburg, FDA commissioner, "said the incidence of anosmia associated with Zicam 'strikes us as a fairly large problem,'" the New York Times reports. The company "paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell" in 2006, and "hundreds more such suits have since been filed."

The Los Angeles Times reports that the company will be required to "receive FDA approval" if it "wants to market the products in the future," Deborah Autor, director of compliance for the FDA's Center for Drug Evaluation and Research, explained. The company may have received 800 reports "of anosmia...associated with the use of the products from doctors and consumers," but has failed to "forward such reports to the FDA." Autor said that the agency has "asked Matrixx to provide" regulators with the reports.

The AP reports that the company said "it will consider withdrawing the products." Meanwhile, "government scientists say they are unaware of any data supporting Zicam's labeling, which claims the drug reduces cold symptoms, including 'sore throat, stuffy nose, sneezing, coughing and congestion.'"

From the American Association for Justice news release.

Wolfgang Puck Toaster Ovens Recalled Over Fire Hazard

From the Web site of the U.S. Consumer Product Safety Commission:

The following product safety recall was voluntarily conducted by the firm in cooperation with the CPSC. Consumers should stop using the product immediately unless otherwise instructed.

Name of Product: Wolfgang Puck Toaster Oven/Toasters

Units: About 1,500

Importer: Frontgate of West Chester, Ohio

Manufacturer: Kingpower Electrical Appliances of China

Hazard: The toaster oven can remain “on” after the toast pops up, posing a fire hazard.

Incidents/Injuries: The firm has received three reports of the toaster remaining on after the toast popped up. No injuries have been reported.

Description: The recalled toasters have model number WPTOT010 and date code 3608 or 3908 on an Underwriters Laboratories (UL) label, which is affixed to the back of the unit. The black and silver toasters have “Wolfgang Puck” stamped on the lower front right corner. They feature a silver handle on the oven door, three black knobs for controlling cooking, and a black push-down lever for toasting. Two slots for toasting bread and similar products are located on the top of the toaster. Toasters with model number BTOT0010 or WPTOT010 and date codes 0207, 0407, 0607, 0807, 4508, or 0309 are not included in this recall.

Sold by: Frontgate catalogs nationwide from November 2008 through March 2009 for about $100.

Manufactured in: China

Remedy: Consumers should stop using the recalled toaster/toaster ovens immediately and contact W.P. Appliances for instructions on returning the toaster/toaster ovens for a free replacement. All known purchasers have been notified directly by mail.

Consumer Contact: For additional information, contact W.P. Appliances toll-free at (800) 275-8273 between 8:30 a.m. and 8 p.m. Monday through Friday, and Saturday 9 a.m. to 5:30 p.m., or e-mail the firm at ovenrec@wphousewares.com.

AMA to Consider Whether to Adopt "Bare Below the Elbows" Dress Code

Oh great, one more thing to worry about when you go to the hospital - germs on the sleeves of your doctor. The Wall Street Journal Health Blog reports that the American Medical Association is going to consider recommending a new dress code for hospitals, and it will be "bare below the elbows." Here are excerpts:

One of the policy questions that AMA delegates will consider at their annual conference next week is whether doctors should forgo their iconic white coats for something a little more casual — and a little less dangerous for patients. The measure would urge hospitals to adopt dress codes of “bare below the elbows,” to avoid carrying bacteria between patients via coat sleeves.

According to the CDC, nearly 100,000 U.S. patients died in 2002 from infections contracted in hospitals. There has been no conclusive evidence linking infected cuffs to any of these deaths — studies have been done showing that bacteria like MRSA and C. difficile exist on sleeves, but there’s no proof that those germs actually get passed around that way. But backers of the change in dress code argue that as long as there’s the slightest potential of transmission, everything possible should be done to avoid it.

The British National Health System has already adopted a policy, banning ties, long sleeves, jewelry and white coats, as the BBC reported. Scotland went so far as to establish a uniform dress code that includes a short-sleeve requirement.

One irony, notes the BBC, is that the spanking white coat was borrowed from lab scientists and introduced in hospitals in the 19th century in part to help prevent the spread of contamination.

Government Announces Recall of Flammable Robes for Women

Consumers Urged to Check for Flammable Robes

Six Reported Deaths Prompt Urgent Re-announcement of Blair Recall of Women’s Chenille Robes

The U.S. Consumer Product Safety Commission (CPSC) and Blair LLC, of Warren, Pa., are re-announcing the voluntary recall by Blair of 162,000 women’s full length Chenille Robes. Since the recall was originally announced in April 2009, Blair has received reports of six deaths due to the robes catching on fire. Five of the six victims were female, and all five were cooking at the time of the incidents. Three of the victims were in their 80s.

CPSC and Blair announced the recall for the robes after Blair learned of three robes catching on fire, including one report of second-degree burns. Blair was subsequently made aware of the fatalities after the recall was announced and after Blair had sent letters of the recall to consumers who purchased the robes.

The Women’s Chenille Robes have the following item numbers: 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. The item number is identified on a label in the garment’s neckline. The robe is a one-piece garment made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robe has a full-button front with seven matching button closures, long sleeves with self cuffs, a straight bottom with self hem, and two sideseam pockets. The robe’s sewn in label states: “100% Cotton, RN 81700, Made in Pakistan”.

The robes were sold in Blair catalogs and Web site, and Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009 from about $20 to $40.

CPSC and Blair once again urge consumers to stop wearing the garments immediately and contact Blair LLC for information on returning the robe and to receive a refund or a $50 gift card for Blair merchandise. Contact Blair toll-free at (877) 392-7095 between 9 a.m. and 9 p.m. ET Monday through Saturday, visit the firm’s Web site at www.blair.com/recall, or contact the firm by e-mail at blairproductrecall@blair.com
“CPSC urges all consumers to report any incidents or injuries involving consumer products, even after a recall has been announced,” said Acting CPSC Chairman Thomas Moore. “Contact the CPSC so that we may help prevent tragic deaths or injuries like those that might be related to the Blair robes.”

FAA Faces Criticism Over Commuter Plane Safety

The Wall Street Journal reports, "Facing escalating congressional criticism, the Federal Aviation Administration said Tuesday it ordered immediate inspections of pilot-training programs at smaller carriers." Now, "as part of stepped-up oversight efforts, the agency and the Department of Transportation...set a safety meeting of major carriers, regional airlines, labor and aviation-industry groups for Monday." Also, "commuter airlines plan to launch their own call for wide-ranging new safety measures." After the plane crash near Buffalo, New York, "the government and the regional industry, which transports one in four U.S. passengers, have come under fire." As a result, "Randy Babbitt, the FAA administrator, said, his goal 'is to make sure that the entire industry-from large commercial carriers to smaller, regional operators-is meeting our safety standard.'"

ABC World News (6/9, story 10, 0:20, Gibson) reported, "Federal safety officials today announced they're immediately stepping up inspections of pilot training programs at the nation's regional airlines. The FAA is doing it because of February's Colgan Air crash near Buffalo that killed 50 people. The investigation has revealed critical pilot errors and inexperience."

The New York Times reports that J. Randolph Babbitt, administrator of the Federal Aviation Administration, said, "The reality is, when you're hiring a pilot at a major carrier, you're probably going to get somebody who walks through the door with 5,000 hours." He added, "When you're hiring a pilot at a regional, you're going to get somebody with considerably less time."

Pilot in Flight 1549 had more experience than pilots in Buffalo crash. The CBS Evening News (6/9, lead story, 3:10, Couric) reported that the veteran pilot in the crash of US Airways Flight 1549 said that he believed his experience had helped him remain calm and avoid fatalities. In contrast, "the pilots in this deadly Colgan Air crash in Buffalo in February had significantly less experience, and the captain had failed five flight tests, leading the FAA today to order its inspectors to immediately focus on training programs at regional airlines like Colgan."

Airlines to replace Pitot tubes, NTSB to look into growing bird threats. NBC Nightly News (6/9, story 3, 3:20, Williams) reported, "Air France today insisted no plane will fly until at least two of its air speed Pitot tubes are replaced. US Airways and Delta say they are also replacing the tubes." In addition, "developments in the investigation into the bird strike that forced US Airways Flight 1549 to make a water landing on the Hudson River last January in New York." Now the "NTSB is looking at the best way to reduce the growing bird threat."

ABC World News (6/9, story 2, 2:25, Gibson) reported, "Here in the US, Delta, US Airways, and United are rushing to replace their sensors, and reminding pilots how to safely compensate if the sensors fail. Maintain speed, keep the plane level, figure out what's wrong."

From the American Association for Justice news release.

Businesses Struggle to Comply with Lead Law

The National Law Journal reports, "At first, a far-reaching law implementing a lead ban and other toy safety standards sent companies and industry groups into a panic. Then, it sent them running to their lawyers." The attorneys "representing industry say they're trying to help clients comply with the law, but that a big part of the job is strategizing about which rules require immediate attention and which ones -- at least for now -- can be set aside." According to attorney, so far, "the most effective enforcers so far have been retailers, many of whom now insist that manufacturers and suppliers provide proof their products are in compliance with the new rules."

From the American Association for Justice news release.

25,000 Bugaboo Baby Strollers Recalled for Brake Failure

As reported in the Milwaukee Journal Sentinel, 25,000 Bugaboo Bee baby strollers have been recalled due to potentially faulty brakes.

The Bugaboo Bee strollers have brakes that can fail on one or both sides causing them to roll away on an incline. The company has received 121 total complaints with no injuries reported. In a statement on the company’s Web site, Bugaboo said they have developed a bracket that attaches to the strollers to fix the problem.

The strollers have the item code 580210 on a label on the back of the seat and item code 50100 on a label on the plastic support under the seat according to the U.S. Consumer Product Safety Commission.

Consumers who have registered their warranty’s automatically receive the new piece in the mail but can also visit this site to register for the bracket.

For additional information, contact Bugaboo at (800) 460-2922 between 9 a.m. and 5 p.m. PT Monday through Friday, or visit the firm’s Web site.