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Drugs & Medical Safety

November 20, 2009

P&G recalls tainted Vicks Sinex nasal spray

Ucm191443(2) Procter & Gamble is recalling three lots—120,000 bottles—of its Vicks Sinex nasal spray in the U.S., Germany and the United Kingdom. P&G said it is taking this step after finding the bacteria B. cepacia in a small amount of the spray made at its plant in Gross Gerau, Germany.  There have been no reports of illness.

Readers may remember that Tylenol recalled 21 types of infants' and children's liquid Tylenol in September because it may have been contaminated with the same bacteria. According to the Centers for Disease Control, "people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia."

P&G is removing the Vicks Sinex from store shelves and has informed regulatory authorities in the affected countries.  The company said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing from lots sold in the U.K. (9224028832) and Germany (9224028833) that were produced from the same batch of raw material mixture. The lot number is listed on both the outer carton and the bottle. (Fun fact: In Germany the mist is called Wick Sinex Schnupfenspray Dosiersystem.)

Consumers should discard any affected spray and can call P&G for a replacement coupon or refund. The contact number in the U.S. is  877-876-7881.

September 25, 2009

Tylenol recalls 21 types of children's liquid medication

Tylenol_Recall

The maker of Tylenol is recalling 21 types of infants' and children's liquid Tylenol because it may be contaminated with bacteria. The affected lots were manufactured more than a year ago between April and June 2008. The full list of types and lots can be found on the Tylenol's Web site.

Included in the recall are a variety of flavors and remedies including Tylenol Suspension, Tylenol Cold, Tylenol Plus Cough, Tylenol Plus Flu and Tylenol Plus Cold/Allergy in cherry, grape, strawberry and bubble gum flavors.

In a letter to healthcare professionals, McNeil Consumer Healthcare wrote, "an unused portion of one inactive ingredient did not meet all quality standards." Specifically, the bacteria B. cepacia (Burkholderia cepacia) was detected. According to the Centers for Disease Control, "people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia."

McNeil said that the bacteria did not make it into the finished product adding that "the likelihood of a serious medical event is remote." Still, it directed that the products be removed from stores and warehouses.

Consumers are advised to check their medicine cabinets for the affected products. The lot numbers can be found on the bottom of the box and also on the sticker surrounding the bottle. Parents who think they have given the medicine to their child, should check with their pediatrician. The list of products follows:
  • Children’s Tylenol Plus Cold MS Suspension 4 oz. Grape
  • Children’s Tylenol Suspension 4 oz. Grape
  • Children’s Tylenol Suspension 4 oz. Strawberry
  • Children’s Tylenol Suspension 4 oz. Bubble Gum
  • Infants’ Tylenol Suspension 1/2 oz. Cherry
  • Infants’ Tylenol Grape Suspension Drops 1/4 oz.
  • Children’s Tylenol Dye Free Suspension 4 oz. Cherry
  • Children’s Tylenol Suspension 4 oz. Cherry
  • Children’s Tylenol Plus Cough & Runny Nose 4 oz. Cherry
  • Infants’ Tylenol Suspension Drops 1/2 oz. Grape
  • Children’s Tylenol Plus Flu 4 oz. Bubble Gum
  • Children’s Tylenol Plus Cold Suspension 4 oz. Grape
  • Children’s Tylenol Plus Cough/ST Suspension 4 oz. Cherry
  • Infants’ Tylenol Suspension Drops 1 oz. Grape
  • Infants’ Tylenol Dye Free Suspension 1 oz. Cherry
  • Children’s Tylenol Pediatric Suspension 1 oz. Cherry
  • Infants’ Tylenol Suspension Drops 1 oz. Cherry
  • Children’s Tylenol Plus Cold/Allergy 4 oz. Bubble Gum
  • Infants’ Tylenol Grape Suspension Drops H/G 1/2 oz.
  • Infants’ Tylenol Drops 1 oz. Grape
  • Children’s Tylenol Suspension 4 oz. Cherry, Hospital Govt.

September 11, 2009

This week in safety: Home hazardous home

Falling Each year more than 18,000 Americans die accidental deaths at home. In fact, the home is the second most common place for such mishaps, following the car, according to the Home Safety Council. To get the word out, Meri-K Appy, the council's president, talked to U.S. News recently about the five leading causes of unintentional home injury deaths and how to prevent them.

According to Appy, these are the five leading home injuries and the number of lives they claim each year.
  1. Falls: 6,000
  2. Poisoning: 5,000
  3. Fires and burns: 3,000
  4. Airway obstruction: 1,000
  5. Drowning: 800
Headlines
Lead-tainted toys linger on shelves despite law
NPR. org
At many discount toy stores in this country, products that test at dangerously high levels for lead are still on the shelves — despite a new federal law to protect children. Read more ...

Legal life: Watching out for the consumer
The New York Times.com
Earlier this summer I bought a new gas barbecue grill at Lowe’s. I had used it only a handful of times when one morning as I blankly stared at the Star-Ledger, I noticed a line of print announcing a recall of Blue Ember barbecue grills. Read more ...

After snowmobilers killed, parents push for greater safety
The Journal Times (Racine, WI)
For six months after Nathan and Jennifer Kender went out for a morning snowmobile ride in northern Wisconsin and never made it home, their parents have wanted to know why the crash happened. Read more ...

Infant car seats can restrict babies oxygen levels
CNN.com
Infant car safety seats can—and do—save newborns' lives in traffic accidents. However, these seats, which require infants to be placed in an upright position, can also cause breathing problems when babies sleep in them. Read more ...

When food safety fails: E. coli victim fights to survive
The Los Angeles Times
Linda Rivera's mute state, punctuated only by groans, is the latest downturn in the swift collapse of her health that began in May when she curled up on her living room couch and nonchalantly ate several spoonfuls of Nestle Toll House cookie dough. Read more ...

Mask_Recall Don't miss these recalls
Safety news from the CR blogs

August 11, 2009

Poisoning overtakes firearms as second cause of accidental death

MMWR_ChartSm In recent years, poisoning has overtaken firearms as the second leading cause of death from injuries, trending right behind motor vehicle accidents, according to new data from the Centers for Disease Control and Prevention.

The report says that death rates for motor-vehicle traffic-related accidents and deaths from firearms decreased from 1979 to 2006, whereas the rate for poisoning more than doubled during the same period. And from 2005 to 2006, the  poisoning death rate increased 13 percent, whereas motor-vehicle traffic and firearm death rates remained unchanged.

The CDC defines a poison as "any substance that is harmful to your body when ingested (eaten), inhaled (breathed), injected, or absorbed through the skin.  This definition does not include adverse reactions to medications taken correctly." Most deaths from poison are unintentional.

In a second report on poisoning that focused on children, the CDC said that prescription and over-the-counter medications account for almost 7 out of 10 emergency room visits for childhood poisonings. Each year more than 71,000 children ages 18 and younger visit hospital emergency rooms for unintentional medication overdoses. Most of the ingestions are among toddlers.

"Unsupervised medication ingestions caused over 80 percent of the emergency department visits. These emergency department visits for unsupervised ingestions are ten times more common than overdoses from medication errors by a parent or caregiver," said Daniel Budnitz, M.D., the senior study author.

The medications children most often consumed included acetaminophen (such as Tylenol) opioids (such as Percodan) or benzodiazepines (such as Valium and Xanax), cough and cold medicines, nonsteroidal anti-inflammatory drugs (such as aspirin and ibuprofen), and antidepressants.

One explanation for the increase, according to the report, is that more adults and children are taking medications at home and more are taking multiple medications. "The high frequency of medication usage and the rising number of medications stored in American homes increases the potential for medication overdoses ... especially among children," the report states.

The CDC is working with drug manufacturers to encourage the implementation of passive safety innovations, such as individual dose packets. In the meantime, parents can take some common sense measures to make sure their children don't have access to medications. Put your medications in a locked medicine cabinet or box and be sure to always replace child-resistant caps. When parents of small children visit other people's homes, they should make sure the homeowner's medications are also out of reach. The CDC has more good advice including what to do if a poisoning occurs.

June 24, 2009

Don't play it again, Sam's

Here's a really bad idea, as reported by our colleagues over at our sister blog, the Consumerist. Sam's Club in Salisbury, Maryland is enticing kids to their pharmacy (hmmm  ... why?) with pill bottles filled with candy. Never mind that parents have spent years teaching their little ones never to touch medicine. Now, in one turn of the "child-safe" top all that is for naught, because your kids think that what's inside is really, really yummy.

One commenter to the Consumerist post remembered this Public Service Announcement from the 1980s, now available on YouTube.

This is just the latest example of lousy marketing to kids. Remember edible Legos?

May 20, 2009

Report questions safety of some children’s bath products

BabyBathProducts Recently, the Campaign for Safe Cosmetics (CSC) released a report showing the nonprofit advocacy group’s findings that several leading children’s bath and body-care products contain formaldehyde and 1,4-dioxane, which are considered probable carcinogens by the U.S. Environmental Protection Agency. Since both chemicals were present as byproducts, not ingredients, they weren’t listed on the product labels.

While the CSC’s study sample was small, out of the 48 products tested (28 for formaldehyde) more than half contained one or both chemicals. Formaldehyde, a chemical present in many other consumer products, may also cause allergic reactions in some people. The list of products found to contain the chemicals includes Baby Magic “Soft Baby Scent” lotion, Johnson’s Baby Shampoo, and Sesame Street Bubble Bath ("Orange Mango Tango").

Detected formaldehyde levels ranged from 54 to 610 parts per million (ppm) and levels of 1,4-dioxane ranged from 0.27 to 35 ppm. The health risks of using these products is unclear. In the case of formaldehyde, carcinogenicity has been demonstrated from inhalation exposure. It also isn’t clear how much formaldehyde in a particular cosmetic formulation would release into the air and contribute to inhalation exposure. In the case of 1,4-dioxane, carcinogenicity has been linked to inhalation and also to dermal exposure in animal studies. 

See the Full Article

May 19, 2009

Senate confirms Margaret Hamburg to lead FDA

In a voice vote, the Senate confirmed Margaret Hamburg, a bioterrorism expert, as the 21st commissioner of the Food and Drug Administration. She is the second woman to hold the post in 100 years of agency history, according to the Associated Press.

Hamburg told senators at her confirmation hearing that she wants to restore public confidence in the agency by putting science first and by running an open and accountable operation, AP reported.

"Her expertise and judgment will serve FDA well," Kathleen Sebelius, Health and Human Services Secretary, said after the Senate confirmed Hamburg's nominati, Reuters reported.

May 15, 2009

Obama picks New York City's health commissioner to run the CDC

President Obama has tapped another New York City official for his administration, choosing Dr. Thomas R. Frieden, the New York City health commissioner, as the next director of the Centers for Disease Control and Prevention. The appointment does not require Senate confirmation.

In March, Obama nominated Dr. Margaret A. Hamburg, who was New York's health commissioner in the 1990s, as commissioner of the Food and Drug Administration. Her confirmation is seen as likely. Frieden and Hamburg worked together in New York City fighting a tuberculosis epidemic.

In New York, Frieden led the crusade to ban smoking in restaurants and bars, pushed to make H.I.V. testing a routine part of medical exams, and defended a program that passes out more than 35 million condoms a year, the New York Times reports.

Earlier in his career, Frieden worked at the CDC. In an e-mail sent today to the CDC staff, he wrote, “I love CDC; I am honored and humbled by the challenge and privilege of working with the greatest public health agency in the world.”  He begins in June.

Obama also announced that Dr. Rich Besser, the acting CDC director who has been prominent during the recent H1N1 flu outbreak, will continue in the job he's held for the past four years as head of the agency's coordinating office for terrorism preparedness and emergency response.

May 8, 2009

Nominee to lead FDA well received at confirmation hearing

FDANominee9Dr. Margaret Hamburg , President Obama's nominee to lead the Food and Drug Administration, made it through her Senate confirmation hearing Thursday unscathed. Her confirmation seems likely and may come as early as next week.

“I want you to know that I support you,” said Senator Orrin G. Hatch, Republican of Utah, “and I intend to help you not only to get through this process but to do your job out there.” (The New York Times.)

"The American people place a huge amount of trust in the FDA. It is critical that we take steps to boost their confidence, particularly when it comes to the safety of drugs and foods," Hamburg told the Senate health committee. (The Washington Post)

Prior to the hearing, the Obama administration released its proposed budget for next year, which included increasing the FDA's budget by $500 million, $215 of which would come from registration and user fees not yet enacted by Congress. Of the $500 million, $259 million would go to food safety.

If confirmed, food safety will be one of Hamburg's biggest challenges but the first thing on her plate will be overseeing development of a vaccine for the swine flu.

May 1, 2009

FDA recalls Hydroxycut supplements after reports of liver damage

Hydroxycut After reports of one death and several of serious liver damage, the popular supplement Hydroxycut has been recalled by the Food and Drug Administration. Popular with dieters and body builders, the supplement is sold in grocery stores and pharmacies. A reported nine million packages were sold last year, according to the FDA. Consumers should stop taking the supplements.

Dr. Linda Katz of the FDA's food and nutrition division said the agency has received 23 reports of liver problems, including the death of a 19-year-old boy living in the Southwest. The teenager died in 2007, and the death was reported to the FDA this March, according to the Associated Press.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.  The list of products being recalled by Iovate currently includes:

  • Hydroxycut Regular Rapid Release Caplets
  • Hydroxycut Caffeine-Free Rapid Release Caplets
  • Hydroxycut Hardcore Liquid Caplets
  • Hydroxycut Max Liquid Caplets
  • Hydroxycut Regular Drink Packets
  • Hydroxycut Caffeine-Free Drink Packets
  • Hydroxycut Hardcore Drink Packets (Ignition Stix)
  • Hydroxycut Max Drink Packets
  • Hydroxycut Liquid Shots
  • Hydroxycut Hardcore RTDs (Ready-to-Drink)
  • Hydroxycut Max Aqua Shed
  • Hydroxycut 24
  • Hydroxycut Carb Control
  • Hydroxycut Natural

The products contain a variety of ingredients and herbal extracts. The FDA has not determined which ingredients, dosages, or other factors are toxic and causing the health problems.

Katz said it has taken time to assess the Hydroxycut problem because the FDA has no authority to review supplements before they're marketed. "Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow," she told the AP.

Public health researcher Ano Lobb, who has studied Hydroxycut and other dietary supplements for Consumer Reports, said the problem may be an ingredient called hydroxycitric acid. Derived from a tropical fruit, it's been linked to liver problems in at least one medical journal study. Lobb said it's likely that other supplements containing the same ingredient remain on the market.

"You really have to be careful about dietary supplements, especially weight-loss pills," Lobb told the AP. "People believe that the FDA has verified that these products are at least safe and effective, and that's really not the case. When you see fantastic claims—that's generally what they are."

More information is available on the FDA's Web site.