Entries in Johnson & Johnson (9)


FDA Approves Johnson & Johnson Drug for Tuberculosis

Cristina Arias/Getty Images(WASHINGTON) -- The U.S. Food and Drug Administration gave its stamp of approval to Johnson & Johnson's drug, called Sirturo, that will treat a drug-resistant form of tuberculosis.

This form of tuberculosis (MDR-TB) is a bacterial infection, resistant to multiple drugs, and can be fatal. It affects as many as 630,000 people globally, although it is not as common in the U.S., according to Dr. Paul Stoffels, chief scientific officer and worldwide chairman at Johnson & Johnson.  

Though less than 100 cases of MDR-TB have been reported in the U.S., Stoffels says the FDA's approval of Sirturo, also called bedaquiline, "is a significant step" in fighting the global disease.  In fact, the company does not expect the drug to be a large driver of revenue.  Johnson & Johnson spokesperson Pamela Van Houten said that "commercial opportunity is very limited," according to a Wall Street Journal report.

"This is part of our commitment to advance innovative medicines that help address serious public-health issues," Van Houten said.

The Wall Street Journal reports that Johnson & Johnson expects to begin selling Sirturo in the second quarter of 2013. The company will hold off on announcing the drug's sales price until that time.

Copyright 2012 ABC News Radio


FDA Slaps J&J for Tampon, KY Trouble

Cristina Arias/Getty Images(SKILLMAN, N.J.) -- The beleaguered consumer product giant Johnson & Johnson has had its hand slapped again by the FDA, this time for problems with tampons and other popular personal care products.

In a warning letter released Wednesday, the FDA admonished J&J’s McNeil unit for failing to adequately follow up on a range of consumer complaints. The most serious of the complaints includes a report of a woman who suffered from toxic shock syndrome after using an O.B. tampon.

McNeil’s plant in Skillman, N.J., manufactures a variety of personal care products, including O.B. tampons, Carefree and Stayfree menstrual napkins, KY brand lubricant and moisturizing products, as well as Reach dental floss.

In the reported case of toxic shock syndrome, J&J waited more than a month before alerting the FDA. And in a separate incident, J&J failed to tell the FDA that a consumer had lost a tooth while using Reach floss.

But the latest and most extensive list of offenses involved KY Liquibeads Vaginal Moisturizer. J&J markets Liquibeads as an “ovule insert”  that contains a “premium quality silicone formula” that “dissolves within minutes, locking in your body’s natural moisture and keeping intimate skin hydrated while enhancing comfort.”

For 227 consumers, who complained to J&J between June 2010 and December 2011, the Liquibeads did not live up to those promises of “enhanced comfort” or “more enjoyable” intimacy. Yet the company filed away such complaints -- under headings like “does not dissolve,” “uncharacteristic consistency/texture and “does not perform as expected.” The complaints were not, the FDA said, “adequately evaluated or investigated.”

The agency’s warning letter also raised questions about whether Liquibeads should be on the market at all, given the manufacturer’s failure to prove that the moisturizer is compatible for use with latex condoms.

J&J has until early June to outline a plan to correct the problems.

“We take the issues raised by the FDA seriously,” McNeill PPC, Inc. said in a statement to ABC News. “We will respond fully to their concerns and take whatever steps are needed to resolve these issues.”

This chiding from the FDA is only the latest in a string of problems that has plagued J&J in recent years. In 2010, metal and wood particles were found in 13 million packages of Rolaids. In 2011, J&J’s Ethicon was sued by more than 100 women citing negligence and defective product design of the vaginal mesh, Gynecare Prolift. And in March, J&J recalled, yet again, thousands of bottles of Tylenol 8 Hour Extended Release Caplets.

Copyright 2012 ABC News Radio


Company Started Phasing Out Faulty Hip Implant Year Before Recall

File photo/ Photodisc/Thinkstock(NEW YORK) -- The makers of a faulty hip implant recalled in 2010 started phasing out the device in 2009, weeks after the U.S. Food and Drug Administration asked for safety data, the New York Times reported.

The FDA said some patients who got the metal ball-and-socket joint made by DePuy Orthopaedics, a division of Johnson & Johnson, showed a “high concentration of metal ions” in their blood, according to a confidential letter to the company obtained by the Times. But it was a year before the company issued a recall for the device, which had been surgically implanted inside some 93,000 patients. It’s unclear how many patients received the hip that year.

Calls to DePuy were not immediately returned, but a spokeswoman told the Times the decision to phase out the device and sell off remaining stocks was based on product sales, not safety. The company maintains the implant was working as well as those of competitors prior to the August 2010 recall. But 2009 data showed the device was failing just a few years after implantation, a far cry from its touted lifespan of 15 years, according to the Times.

Katie Korgaokar is one of thousands of patients to sue DePuy over the implant. The 43-year-old said she was shocked when she received a letter informing her that her hip had been recalled.

“I thought, ‘That’s what happens to cars,’” said Korgaokar, who lives in Denver. “It just really seemed like a joke. You don’t recall parts you put in a person.”

Five years after the painful procedure to implant the metal hip, Korgaokar underwent a second surgery to take it out. A spokeswoman for DePuy said the company “is committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary.”

When asked whether the 2009 letter from the FDA should have been released to doctors and patients, DePuy’s chief executive officer, Andrew Ekdahl, said any suggestion that the implant had safety issues was “simply untrue,” according to the Times.

The company claims the letter was asking for more safety and efficacy data, not raising safety concerns.

Copyright 2012 ABC News Radio


Johnson & Johnson Recalls Infants' Tylenol

Cristina Arias/Getty Images(NEW YORK) -- Johnson & Johnson is voluntarily recalling infants' Tylenol after parents reported trouble with the redesigned bottle.

There's nothing wrong with the medicine but some parents complained about the new syringe and flow restrictor that help measure the right dose.  Johnson & Johnson says there have been "no adverse events" but it’s voluntarily recalling more than a half-million bottles of grape-flavored infants' Tylenol and offering a refund to customers.

This is the 25th product recall from Johnson & Johnson's McNeil Consumer Healthcare unit since September 2009.

Copyright 2012 ABC News Radio


FDA, DOJ Take Action Against Johnson & Johnson-McNeil

Cristina Arias/Getty Images(WASHINGTON) -- The U.S. Food and Drug Administration and the Department of Justice announced Thursday afternoon that McNeil Consumer Healthcare (a unit of Johnson & Johnson) and two of its executives have been accused of violations of federal law for failing to comply with good manufacturing practices in connection with a series of product recalls and poor inspection reports at its manufacturing facilities.
Without admitting or denying the allegations, McNeil has entered into a consent decree with the government that places three of the company’s plants under supervision of the FDA. The decree also prevents them from reopening their Fort Washington, Pa. plant until it has been found by the FDA to be in compliance with the law.
McNeil can continue operating two of its other plants, one in Puerto Rico and the other in Lancaster, Pa., but the company must submit to independent inspections and adhere to a strict timetable to bring those facilities into compliance.

Copyright 2011 ABC News Radio 


Typo Prompts Johnson & Johnson Recall

Photo Courtesy - Getty Images(NEW BRUNSWICK, N.J.) -- Johnson & Johnson is recalling certain packages of Sudafed because of a typo.

The recall involves Sudafed’s extended-release 24 Hour tablets. The product is fine – consumers can still use it – but the problem is a misprint on the product’s box. There's a double negative that reads "do not not divide, crush, chew or dissolve the tablet."

The internal packaging has the proper instructions but Johnson & Johnson and the Food and Drug Administration were concerned enough about the typo to recall 600,000 packages.

Copyright 2011 ABC News Radio


Simple Blood Test to Detect Cancer?

Photo Courtesy - Getty Images(BOSTON) -- Researchers from Massachusetts General Hospital and health giant Johnson & Johnson are combining efforts to streamline a simple blood test that may be able to identify cancer cells in the blood stream of patients already diagnosed with a specific type of cancer.

But many experts question what place, if any, this test will have in the world of cancer prevention, early detection or even treatment.

The partnership is part of a nearly $30 million endeavor funded by Johnson & Johnson company Veridex and the advocacy group Stand Up to Cancer to develop and refine technology that will be able to accurately and quickly detect and analyze circulating tumor cells, the company said Monday.

Circulating tumor cells are a rare form of free-flowing cancer cells detached from the smallest of tumors and can be found at extremely low levels in the blood stream.

"For every one tumor cell in the blood there's over a billion normal blood cells in the circulation. So that's the big challenge for developing a test that can pull out one in a billion cells," said Dr. Daniel Haber, director of the cancer center at Massachusetts General Hospital in Boston.

CTC technology, approved by the Food and Drug Administration in 2004, is widely used in cancer centers to monitor a patient's response to treatment. But researchers now hope to expand its use to create a faster automated version that will analyze genetic components of a tumor and ultimately guide oncologists to personalize cancer treatments for patients.

"Harnessing the information contained in these cells in an in vitro clinical setting could enable tools to help select treatment and monitor how patients are responding," said Robert McCormack, head of technology innovation and strategy at Veridex.

Some cancer experts agreed the technology may be able to track some patients' cancer progression.

"It can help oncologists determine how well the drugs are working to kill cancer cells and it potentially could tell if the tumor returns at a later time," said Dr. Sarah Blair, associate professor of surgery in the division of surgical oncology at University of California San Diego.

Copyright 2011 ABC News Radio


13 Million Packages of Rolaids Recalled

Photo Courtesy -- McNeil Consumer Healthcare(FORT WASHINGTON, Penn.) -- Johnson & Johnson recalled over 13 million packages of Rolaids antacids Thursday after reports that metal and wood particles were found in the products.

The voluntary recall of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews and Rolaids Multi-Symptom Plus Anti-Gas Softchews follows "a small number of adverse reports associated with the product being recalled," according to information posted on the Rolaid's website.

Vomiting, gum and tooth injury, and abnormal taste were among the adverse reactions reported. J&J's McNeil Consumer Healthcare business, which sells the products, stated that "risk of serious adverse health consequences [in connection with the recalled products] is remote," but have nonetheless advised consumers to discontinue use at this time.

The company says the materials were potentially introduced into the products during the manufacturing process at an outside plant, but McNeil spokeswoman Bonnie Jacobs declined to provide ABC News with the identity of this third-party manufacturer.

While McNeil investigates the cause of the recall, the company has suspended production of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews and Rolaids Multi-Symptom plus Anti-Gas Softchews.

Copyright 2010 ABC News Radio


Johnson & Johnson CEO: 'Sorry' About 'Phantom Recall'

Image Courtesy - Johnson & Johnson Services, Inc.(WASHINGTON) -- The House Oversight and Government Reform Committee held a hearing Thursday on the extent of "phantom recalls" by Johnson and Johnson which resulted in the largest recall of children's medicine in history.

Documents show Johnson and Johnson hired contractors to go into stores and buy Children's Tylenol products that the company wanted to recall, an effort apparently conducted to avoid publicizing the recall. The company originally told Congress in May that it didn't know what the contractors were doing, but the House committee obtained documents showing Johnson and Johnson ordered the phantom recall.

Johnson and Johnson Chairman and Chief Executive Officer William Weldon said he knows the company has let the public down and admitted the company made a mistake in not notifying the FDA. 

"We did not maintain our high quality standards and as a result, children do not have access to our important medicines. I accept full accountability for the problems," Weldon said, adding that the company's children's liquid products will be back on shelves next week.

Copyright 2010 ABC News Radio

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