PHARMACY

FDA issues alert over safety of epilepsy drugs

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration said Monday that it was investigating preliminary data that indicated an increase in serious skin reactions among Asian patients using the epilepsy drugs phenytoin and fosphenytoin sodium.

The FDA has received reports of the drug causing reactions such as toxic epidermal necrolysis and Stevens Johnson syndrome among Asian patients who test positive for the human leukocyte antigen allele, HLA-B*1502. The allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Filipinos, Malaysians, South Asians, Thais and Han Chinese.

The FDA said healthcare providers should consider avoiding phenytoin and fosphenytoin sodium as alternatives for carbamazepine in patients who have the allele.

Phenytoin is marketed as Pfizer’s Dilantin, Mylan’s Phenytek and as a generic drug. Fosphenytoin sodium is marketed in generic versions and as Parke Davis’ Cerebyx.

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Kirby Lester completes sale of pill-counting machines to supplier in Iraq

BY Alaric DeArment

LAKE FOREST , Ill. Kirby Lester announced Thursday that it had sold several of its KL 15df pill-counting machines to Najmat Burgan, a medical and hospital goods supplier based in Kuwait City.

The company said the recent sale was part of its growing international presence. In the past three months, it has sold its devices to clients in Saudi Arabia, Botswana, Greece, Honduras and others, bringing its total number of customers to more than 30,000.

“When you consider all of the different medications, dispensing methods and manufacturing practices across the globe, only Kirby Lester can address the needs of all customers as well as deliver absolute counting accuracy,” Kirby Lester vice president for business development Christopher Thomsen said in a statement. “No other pharmacy technology has such broad appeal, bridges all of these differences and provides a universal solution.”

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Waxman voted House chairman of the Committee on Energy and Commerce

BY Michael Johnsen

WASHINGTON Rep. Henry Waxman, D-Calif., on Thursday was voted in as chairman of the Committee on Energy and Commerce for the House of Representatives, which oversees all legislation surrounding health and health services, including food and drug.

“I am honored by the vote of the Democratic Caucus,” Waxman stated. “We are at a unique moment and have an opportunity that comes only once in a generation.  I will work with all parts of our Caucus and across the aisle to deliver the change that the American public expects us to deliver.”

“Some of the most important challenges we face—energy, climate change and health—are under the jurisdiction of the Commerce Committee,” Waxman wrote earlier this month in a statement explaining his pursuit of the Commerce Committee Chair. “In large measure, our success as Congress will depend on how the Commerce Committee performs. Enacting comprehensive energy, climate and health care reform will not be easy. But my record shows that I have the skill and ability to build consensus and deliver legislation that improves the lives of all Americans.”

Waxman helped engineer the generics industry as co-author of the Hatch-Waxman Act, which promotes generics while leaving in tact a financial incentive the research and development of branded pharmaceuticals. And while Waxman may be a fan of the generics industry, he has not in the past supported dietary supplements. Waxman has repeatedly called for greater regulation of dietary supplements and has proposed revisiting the Dietary Supplement Health and Education Act, which governs how supplements are regulated.

However, outgoing chairman Rep. John Dingell, D-Mich., was also critical of the dietary supplement industry, having in the past partnered with Waxman on several pieces of legislation regarding regulation of dietary supplements.

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