May 26, 2010 / 6:20 PM / 8 years ago

UPDATE 1-FDA probes hundreds of J&J children drug complaints

* FDA probing hundreds of reports

* House lawmakers to hold J&J hearing on Thursday

* Republicans voice concern about J&J’s corporate culture

* Shares down less than one percent (Adds details from J&J memo, share price, byline)

By Susan Heavey

WASHINGTON, May 26 (Reuters) - More than 700 complaints about health problems in infants and children given Johnson & Johnson (JNJ.N) medications, including 30 reports of deaths, have been lodged with the U.S. Food and Drug Administration but no direct link has yet been found, according to a congressional memo.

J&J took more than 40 nonprescription products off store shelves in late April, including Children’s Tylenol, in what the congressional staff called the largest recall of such children’s medications. The FDA received 775 complaints related to use of the medications between January 2008 and April 2010.

Since the recall, several hundred more complaints, including seven deaths, have been reported, the memo said.

Democratic staff on the House Oversight and Government Reform Committee released details of the FDA investigation on Tuesday. A U.S. House of Representatives hearing to examine manufacturing lapses at J&J plants that led to the recall is scheduled for Thursday.

The FDA has not disclosed how many reports its has processed.

According to the memo, the FDA does not consider the number of health problems reported to be above normal, and it has said there is no “clear pattern” indicating they were caused by the recalled products.

“It is the largest recall of children’s medicine in the history of the FDA,” congressional staff wrote in the memo, dated May 24, to committee lawmakers.

“At this time, FDA is not aware of any child being harmed by taking one of the recalled products,” the memo said. “FDA is still investigating some of these adverse events to determine if the events were related to a child taking one of the recalled medicines.”

FDA officials have repeatedly said the chance of getting sick from the products was “remote.”

J&J’s Chief Executive William Weldon, recovering from back surgery, is not expected to attend the House hearing, but Colleen Goggins, worldwide chairman of the consumer group, is expected to testify.

FDA Commissioner Margaret Hamburg is expected to be in Moscow on Thursday, so her deputy, Josh Sharfstein, is due to testify.


The recall included infant and children’s versions of pain medicine Motrin and allergy drugs Benadryl and Zyrtec. About “70 percent of the market for over-the-counter pediatric liquid medicines were involved,” the staff wrote in the memo.

    All of the recalled drugs are made by J&J’s McNeil Consumer Healthcare unit.

    J&J has stopped manufacturing at its Fort Washington, Pennsylvania, plant, as it works to rectify problems there. The plant must be cleared by the FDA.

    In late April, FDA inspectors found multiple problems, including bacterial contamination of ingredients and filthy equipment at the plant. They also found that some medications made at the plant were overly concentrated and “had the potential to be superpotent,” the congressional staff wrote in the memo.

    J&J is a diversified healthcare company that prides itself on first serving patients and healthcare providers. But in a separate document from committee Republicans, staff questioned J&J’s corporate culture and the autonomy it gives its subsidiaries.

    “Minority staff believes that there have been ongoing, systemic failures at McNeil facilities, which have put children’s health at risk,” the Republican staff wrote.

    In a memo to McNeil employees, J&J said that last Friday it gave the FDA its plan to correct the manufacturing problems and that it was “taking steps to bring its operation back to a level of quality that Johnson & Johnson demands of its companies.”

    J&J said it has called on a third-party consultant to help assess its plan, is improving employee training and quality procedures, and that it has “made significant organizational changes” to its management team at all McNeil facilities. It will share the consultant’s report with the FDA by July 15.

    The head of the U.S. Senate health committee is also investigating the recall, but so far no hearing is planned, a spokeswoman for chairman Senator Tom Harkin has said.

    Shares of J&J were down 5 cents at $60.30 in afternoon trading on the New York Stock Exchange. (Reporting by Susan Heavey; editing by Michele Gershberg and John Wallace)

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