PHARMACY

FDA takes first step to stop the marketing of unapproved gout injections

BY Drew Buono

WASHINGTON The Food and Drug Administration is taking action to stop companies from marketing unapproved injectable colchicines, a drug used to treat gout. This follows the compliation of 50 reports of adverse events associated with the intravenous version of the drug, which includes 23 deaths. Other side effects include low blood cell counts, cardiac events and organ failure.

“Today’s action supports our ongoing efforts to end the marketing of unapproved drugs with serious health risks,” said Janet Woodcock, FDA deputy commissioner for scientific and medical programs, chief medical officer and acting director of the Center for Drug Evaluation and Research. “Such products put consumers’ health and sometimes their very lives at grave risk. It is a priority that these products be removed from the market.”

In addition to being manufactured by pharmaceutical companies, injectable colchicine products are sometimes formulated by compounding pharmacies, often for use in the treatment of back pain. Three of the deaths from intravenous colchicine occurred in March and April of 2007 and were associated with the use of compounded colchicine that, due to an error in preparation, was eight times more potent than the amount stated on the label. The FDA has not approved colchicine in any dosage for the treatment of back pain.

Individuals and companies must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action which could include seizure, injunction or other legal action deemed appropriate by the agency. After these dates, all injectable colchicine drug products must have FDA approval to be manufactured or shipped interstate.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

GSK, Amira ink deal worth potential $425 million

BY Drew Buono

PHILADELPHIA GlaxoSmithKline and Amira Pharmaceuticals have signed a deal worth as much as $425 million that gives GlaxoSmithKline worldwide rights to develop, make and sell experimental compounds from Amira for respiratory and cardiovascular disease, according to published reports.

One of those compounds, an experimental asthma treatment known as AM103, already has shown promise in early human trials.

Amira could receive as much as $425 million in payments if it meets all of its development and regulatory milestones. It also will receive royalty payments on sales of any of its drugs.

“This is a momentous day in the young life of Amira,” chief executive officer Bob Baltera said in a written statement. “This deal validates the abilities and expertise in Amira to expedite the delivery of novel medicines. We are particularly pleased to have partnered with GSK, one of the leading pharmaceutical companies in the world, and a company that has a strong heritage in the treatment of respiratory diseases.”

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

Studies explore intra-nasal mode of combatting Alzheimer’s

BY Drew Buono

ST. PAUL, Minn. Studies have been taken place for decades to find ways to combat Alzheimer’s disease, but recently news has been spreading that the way to fight it is with intranasal treatments, according to published reports.

Several studies are using the nose-to-brain method of delivering drugs that was invented in the late 1980s and patented by William Frey II, director of an Alzheimer’s research center at Regions Hospital in St. Paul. Last month, researchers in Washington State reported using intranasal insulin to improve memory and attention for patients with early-stage Alzheimer’s.

Most nasal sprays are directed to the lower part of the nose so medication can quickly enter the bloodstream. Drugs to treat neurological conditions don’t work through this route, though, because of the protective blood-brain barrier.

While this blockade of cells and blood vessels protects the brain and spinal chord from harmful organisms, it also keeps out most drugs and has blocked otherwise promising therapies.

Avoiding this barrier is what makes intranasal delivery “a potentially powerful therapeutic tool,” according to the Washington research group. Its study was small, with 24 patients receiving daily insulin or a placebo, but the results, published in the journal Neurology, were persuasive.

Patients taking intranasal insulin were mentally sharper, and their blood sugar levels remained healthy.

The goal now is to see if pharmaceutical manufacturers will take this information and try to develop something for the market and the 5.1 million Americans who suffer from this disease.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?