.jpg)
Johnson & Johnson is yanking two lots, or about 57,000 bottles, of its Topamax epilepsy drug (100 mg tablets). These were distributed in the U.S. last fall and winter, but J&J’s Ortho-McNeil Neurologics unit believes only about 6,000 are still circulating. Topamax has recently been in the news because on March 4, 2011, the FDA informed OB/GYN doctors and neurologists about new data demonstrating that infants born to women treated with Topamax during pregnancy have an increased risk for developing cleft palate or cleft lip.
Interestingly, Topamax is also widely prescribed “off-label” for weight management, or night eating. The drug has an appetite suppressant effect.
Why are the lots being pulled? There were four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole), a chemical used in wooden pallets that transport and store packaging materials.
J&J maintains no adverse events have been reported. In any event, this latest recall adds to a long and impressive list of products that J&J has pulled over the past year due to assorted manufacturing gaffes - tens of millions of over-the-counter meds, including Tylenol, Motrin and Benadryl; contact lenses, syringes and hip replacement devices.
Makes you wonder who’s in charge of manufacturing these drugs and whether J&J is properly overseeing their manufacture? This could potentially become a big issue for J&J -- let’s not forget the recent whistleblower, Cheryl Eckard, who was the catalyst for an investigation into GlaxoSmithKline’s plant in Cidra that ultimately led to GSK receiving a $750 million fine for manufacturing adulterated medicines. The whistleblower received $96 million for reporting the misconduct. Watch out J&J ... you could be next!
Claudine Q. Homolash, Esq. is a partner at Sheller, P.C. who represents pharmaceutical whistleblowers, as well those injured by dangerous pharmaceutical products and medical devices. She can be contacted at (215) 790-7379 or at chomolash@sheller.com
Interestingly, Topamax is also widely prescribed “off-label” for weight management, or night eating. The drug has an appetite suppressant effect.
Why are the lots being pulled? There were four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole), a chemical used in wooden pallets that transport and store packaging materials.
J&J maintains no adverse events have been reported. In any event, this latest recall adds to a long and impressive list of products that J&J has pulled over the past year due to assorted manufacturing gaffes - tens of millions of over-the-counter meds, including Tylenol, Motrin and Benadryl; contact lenses, syringes and hip replacement devices.
Makes you wonder who’s in charge of manufacturing these drugs and whether J&J is properly overseeing their manufacture? This could potentially become a big issue for J&J -- let’s not forget the recent whistleblower, Cheryl Eckard, who was the catalyst for an investigation into GlaxoSmithKline’s plant in Cidra that ultimately led to GSK receiving a $750 million fine for manufacturing adulterated medicines. The whistleblower received $96 million for reporting the misconduct. Watch out J&J ... you could be next!
Claudine Q. Homolash, Esq. is a partner at Sheller, P.C. who represents pharmaceutical whistleblowers, as well those injured by dangerous pharmaceutical products and medical devices. She can be contacted at (215) 790-7379 or at chomolash@sheller.com
1 comment:
Johnson and Johnson's reputation has been at stake because of the recall of defective device just like
asr hip recall
Post a Comment