GSK Consumer Healthcare to update Alli label
PARSIPPANY, N.J. GlaxoSmithKline Consumer Healthcare last week announced it will update the Alli product label to alert consumers to certain symptoms that have been associated with rare instances of severe liver injury reported in people taking orlistat, the active ingredient in Alli. This update followed FDA’s completion of its safety review of orlistat and is being implemented in conjunction with Roche, the manufacturer of the prescription dose of orlistat (Xenical). The agency stated that a cause-and-effect relationship has not been established.
The updated Alli label will advise consumers to: “Stop use and ask a doctor if you develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat.”
“GSK is committed to ensuring that consumers and physicians understand the safety profile of orlistat and alli,” stated Howard March, chief medical officer for GSK Consumer Healthcare. “Although reports of serious liver injury in people taking orlistat are rare, GSK takes all adverse events reports seriously.”
Since Alli was made available over-the-counter in 2007, more than 10 million people worldwide have used the product. With more than 100 clinical studies involving 30,000 patients, orlistat is the most extensively studied weight loss drug in the world and continues to be a safe and effective product when used as directed to help people lose weight. More than 40 million people have used orlistat since it first became available in 1998.
AAFA releases ‘Allergy Capitals’ list
LANDOVER, Md. The Asthma and Allergy Foundation of America on Thursday released its new list of the 100 “Allergy Capitals” (www.AllergyCapitals.com), naming Knoxville, Tenn. as the most challenging place to live with spring allergies this year due to high pollen counts, high use of allergy medications by patients and too few allergists to treat the burgeoning allergy population.
This year, the foundation has teamed up with Lowe’s Home Improvement to educate Americans about the importance of indoor air quality and how a few simple steps can help you reduce your exposure to allergens and irritants at home.
“Outdoors in spring is tough so some patients think they can stay indoors to remain safe, but you should be just as concerned about indoor air quality,” stated Beth Corn, assistant professor of medicine at the Mount Sinai School of Medicine and past president of the New York Allergy and Asthma Society.
Experts said that reduction of allergens inside the home is an important part of asthma and allergy prevention, the AAFA stated, especially as Americans spend an estimated $10 billion annually on such household products as vacuum cleaners, air cleaners, bedding, toys and flooring.
FDA to keep a close eye on McNeil operations
WASHINGTON According to prepared testimony immediately posted online before members of the Committee on Oversight and Government Reform convened its “Johnson & Johnson Recall of Children’s Tylenol and other Children’s Medicines” hearing Thursday morning, J&J may be under scrutiny for more than the 40 varieties of over-the-counter infant’s and children’s liquid medicines recalled April 30.
“Just last night, the Committee obtained from the [Food and Drug Administration] even more disturbing information,” committee chairman Rep. Edolphus Towns, D-N.Y., stated as part of his opening remarks. “According to an FDA document, McNeil knew there was a potential problem with one of its Motrin products that was on the market in 2008, but rather than issue a public recall, McNeil allegedly sent contractors out to stores to buy the product back and told the stores ‘not to mention’ a recall,” Towns wrote. “After the FDA confronted McNeil about this, McNeil announced a recall of the affected products.”
Regarding the latest recall, Colleen Goggins, J&J worldwide chairman for consumer group, expressed the company’s disappointment in the factors leading up to the recall.
“Across our organization, we believe our first responsibility is to the doctors, nurses, and patients, to mothers and fathers, and all others who use our products and services,” Goggins noted has part of her prepared testimony. “In this instance, we have not lived up to that responsibility, and the recall is therefore a disappointment to our chairman Bill Weldon, to me personally, and to the thousands of employees in the Johnson & Johnson family of companies.
“Johnson & Johnson embraces the work of this Committee, and we hope that today’s hearing will be an important step in furthering public understanding of the recall,” she added, stating that the quality and process issues at McNeil that led to the recall “are unacceptable.”
Goggins also stressed before the committee that the health risks associated with the recalled products were remote. No serious adverse events associated with recalled products have been reported to date; no raw materials that tested positive for objectionable bacteria were ever used in the manufacture of McNeil’s pediatric products; and McNeil had rejected the products that it found had excess active ingredient before those products reached the supply chain.
Despite the public apologies issued by J&J, both legislative and regulatory officials have been taking a hard line against the company.
“Over the last several years, FDA has had growing concerns about the quality of [McNeil Consumer Healthcare’s] manufacturing process,” remarked Joshua Sharfstein, FDA principal deputy commissioner, as part of his prepared remarks. “These concerns have led to a number of unsatisfactory inspections and consumer recalls,” he continued. “FDA has inspected the company’s facilities with an increased frequency, and in February 2010, the agency took the extraordinary step of convening a meeting with the management of the parent company, Johnson & Johnson, to express concern about a pattern of noncompliance.”
The meeting took place Feb. 19, Sharfstein testified, and included the president of McNeil, J&J’s group chairman and “a number of quality assurance executives from both companies.”
Sharfstein testified that “FDA requested that senior officials from Johnson & Johnson attend the meeting so they would be on notice regarding FDA’s rising concerns about whether McNeil’s corporate culture supported a robust quality system to ensure the purity, potency and safety of its products.”
Sharfstein also testified that of all the good manufacturing practices violations the agency identified at McNeil’s Fort Washington, Pa., plant, that the “pubic health risk from these quality problems is low.” The FDA did not find evidence that McNeil used raw materials that tested positive for bacterial contamination. And while there was a potential for higher concentrations of Tylenol per dropper, “none of the final products released for sale tested with high levels [of active ingredient].”
Going forward, FDA plans to keep a close eye on McNeil operations, Sharfstein testified. What’s more, the FDA will take corporate culture into account in future reviews of any company. “One lesson to be drawn from the McNeil story is that it is important for the Agency to even more fully consider the corporate structure when investigating and enforcing the law,” Sharfstein testified. “[The] FDA will be developing new procedures to use what we learn at one facility in guiding our inspections of other facilities run by the same company.”