FDA wants some teething medicines taken off shelves

HEALTH
               FDA says stop using over-the-counter benzocaine products on teething infants

Consumer-health companies must stop selling products such as Baby Orajel to parents with teething infants, US health regulators said, given the risk of developing a potentially deadly condition that reduces oxygen levels in the blood.

Over-the-counter products containing the anesthetic substance benzocaine are marketed to ease the pain of gums made sore by teething. Benzocaine can cause rare but deadly side effects in children, especially those two-years-old and younger.

More than 400 cases of benzocaine-associated methemoglobinemia have been reported to the FDA or in medical literature since 1971, according to a drug-safety communication the agency posted. The products are meant to temporarily alleviate pain in teething babies and children with sore gums. Rapid heart rate, headache, lightheadedness, difficulty in breathing, sleepiness, pale skin, and blue or gray eyes are some of the symptoms of methemoglobinemia.

The U.S. Food and Drug Administration (FDA) is warning consumers that some over-the-counter oral drug products should not be used to treat children under the age of 2. Educate families on the importance of reading the drug facts label to ensure products do not contain benzocaine. The FDA now says: stop right there. Manufacturers of prescription local anesthetics containing benzocaine must also include warning information regarding the risk of methemoglobinemia, and must respond to the FDA's letter within 30 days.

The FDA has asserted that if these product-manufacturing companies do not stop selling them, FDA will take strict actions against the companies to ban these products out of stores.

IPL 2018: Calm Dhoni says it's more about 'dressing room atmosphere'
Catches win matches: Dwayne Bravo is a human highlight reel and the Mumbai crowd saw no different against Hyderabad. The two-time World Cup winning captain added, "And you can't do that without the players and the support staff.

They also warn against using homeopathic alternatives.

Examples of products include Baby Orajel, Little Teether's Oral Pain Relief Gel, and Anbesol Gels, along with their adult versions.

These new directives may have parents wondering - what are they supposed to do with a teething baby?

Dr. Lisa Thebner, a New York-based pediatrician, said parents still ask about the products with some frequency. "Rubbing their gum or giving them something hard, like a teething ring, it will be a much bigger help".

The FDA issued warnings about the teething products in 2006, 2011 and 2014, but it did not call for their removal from the market. Additionally, the agency is requesting that companies add new warnings to all other oral health products containing benzocaine to describe "certain serious risks". Signs and symptoms may occur after using benzocaine for the first time, or after prior uses and may appear within minutes to 1 to 2 hours after using benzocaine.

Related News:



Most liked

Harvey Weinstein arrested on sexual assault charges
Rose McGowan on Friday gave her first TV interview to Megyn Kelly following the arrest of sexual predator Harvey Weinstein . We believe that they are constitutionally flawed. "He has entered a plea of not guilty and fully expects to be exonerated".

Michael Cohen Reportedly Advised Potential Clients Not to Deal with Corey Lewandowski
Mr Cohen is facing a probe by the United States attorney's office in Manhattan, which is examining his business practices. Cohen tweeted Wednesday that he was "one of the thousands" of licensed taxi operators who turned to management companies.

Trump supports NFL's decision on national anthem policy
The president's words inflamed the protest controversy last season , and this time around, they're likely to have the same effect. Also, how the fans will react, how the media will react. "Our league continues to fall short on the issue".

Battlefield 5 ditches Premium season pass for live services component
The company explains that Battlefield 5 will be set in the lesser known regions during the second World War, including Rotterdam. Interestingly, there was no mention of the heavily rumored battle royale mode that DICE has reportedly been working on.

Comcast prepares to top Disney's $50 billion offer for Fox
The largest US cable operator said it was in advanced stages of readying a bid that would be superior to Disney's all-stock offer. Comcast this morning announced plans to launch its own bid from the movie studio, offering a vague outline for a planned bid.

Jared Kushner receives full security clearance
Kushner's clearance has been contested over the last few months after he was stripped of his credentials in February. Kushner's lawyer said Wednesday that Kushner completed the background check process that began past year .

Trump willing to walk away from North Korea summit: Mike Pence
The definition and sequencing of "denuclearization" is going to be the crux of the Trump-Kim summit. The word is that recently the Border has become much more porous and more has been filtering in.

Crowd remembers victims of Manchester attack during 1 year anniversary
Over €2.7 million was raised from the gig and Grande was "moved" after being named an honorary citizen of Manchester . Julie, from Eccles, who came with her son Louis, said they wanted "to pay our respects as it just touched everybody".

M&S profits dive 62% for full year
At M&S's clothing business, which has failed to keep up with trends for many years, revenue fell 1.4% to £3.74bn. In total, the closures will see the amount of floor space devoted to clothing and homeware slashed by 25%.

The FDA approved a prophylactic for migraines
The two companies , Novartis and Amgen , are also collaborating on associated "The Aimovig Ally Product Support Program". FDA approves Aimovig (erenumab-aooe), a novel treatment developed specifically for migraine prevention [press release ].

Suspect Named in Leak of 'Vault 7' and Top-Secret CIA Hacking Tools
Prosecutors, the Times also reports , plan to file a new indictment against Schulte that pertains to the leak , within 45 days. Schulte is being held without bail on child pornography charges brought against him in Manhattan federal court.

Woman arrested after defecating on floor, throwing feces at coffee shop cashier
As the minute-long movie reveals, the woman entered the Tim Hortons restaurant and asked the employee to use the restroom. Last week, a Langley woman was arrested and charged after she threw a nasty fit inside a Tim Hortons restaurant.

Leonardo DiCaprio and Steven Spielberg eyeing Ulysses S. Grant biopic
Steven Spielberg could be set to make a second biopic movie about a former United States president. Grant led the Union Army to victory over the Confederacy under the supervision of Lincoln .

Supreme Court orders Karnataka Assembly floor test at 4 pm on Saturday
The bench had adjourned the matter asking the BJP counsel to produce the two letters written by Yeddyurappa to the governor. The court also junked Attorney General KK Venugopal's suggestion that the floor test be conducted through secret ballot.

E-commerce Sales A Big Driver In Walmart Inc's (WMT) Earnings Beat
The retailer reported $1.33 earnings per share (EPS) for the quarter, missing the Zacks' consensus estimate of $1.37 by ($0.04). The earnings statement also emphasised steps taken by the company during the quarter to reposition its portfolio of businesses.