Bayer pulls clotting drug from worldwide market
FRANKFURT, Germany Bayer has stopped worldwide sales of its anti-bleeding drug after a clinical study revealed the drug poses a higher risk of death.
Trasylol (aprotinin), designed to stem blood loss and enable patients receiving heart bypass surgery to avoid the use of transfusions, was tested in a Canadian clinical study last month. Preliminary results from that trial also suggested Trasylol increased the risk of death when compared with the other drugs.
Additional tests, which would have compared the safety and effectiveness of Trasylol with two others was halted after the initial results surfaced.
Leverkusen-based Bayer said Monday that it made the decision after discussions with the Food and Drug Administration, the German Federal Institute for Drugs and Medicine Products along with Health Canada.
Last week, the FDA said that evidence suggests Trasylol increased the risk of death compared with other drugs, and that the drug was blocking enzymes which dissolve blood clots, instead of aiding them. The agency began reevaluating the drug’s safety after the January 2006 publication of two studies that linked the drug’s use to serious side effects, including kidney problems, heart attacks and strokes.
The FDA approved the drug in 1993 to prevent the loss of blood and thwart the need for blood transfusions in surgeries to bypass clogged coronary arteries.
More recent studies have suggested the drug also raises the risk of death. One of those studies previously was withheld by Bayer from the FDA due to what a company investigation later characterized as a “regrettable human error.”
Bayer said it wanted to review the results from the Canadian trials before moving forward.
“Once the complete … dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol,” the company said in a statement. “At that time the temporary marketing suspension will be reevaluated.”
Shares of Bayer gained nearly 1.6 percent to €57.57 ($83.36) in Frankfurt.
AVI gets fast-track status from FDA for DMD drug candidate
WASHINGTON The Food and Drug Administration has granted fast-track status to drug developer AVI Biopharma’s product candidate for Duchenne muscular dystrophy, a fatal genetic disorder in children, the Associated Press reported.
Duchenne muscular dystrophy is an incurable muscle-wasting disease, caused by a mutation in a person’s dystrophin gene. The result is membrane leakage and fiber damage, leading to degeneration and death of the muscle fiber. About one in 3,500 boys is born with it, and roughly 15,000 to 20,000 children have DMD in the U.S., according to AVI.
The status means a company can submit data to the FDA as it becomes available and receive agency feedback, rather than having to wait and turn it in all at once. AVI plans to initiate a clinical trial with its drug candidate by mid-2008 to evaluate the safety and effectiveness of the drug in DMD patients who can still walk on their own.
FDA investigation suggests online drug sales driven by lax prescription rules
WASHINGTON A yearlong Food and Drug Administration investigation has found that consumers may be purchasing drugs online to avoid the need for a prescription from their physician.
Although several drugs are mailed to the United States from foreign countries more often than not, the FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet.
The investigation found 88 percent of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. Among the remaining products were dietary supplements, foreign products with “incomprehensible labeling”, and some were medications not available in the United States.
The FDA stressed the risk of purchasing drugs online, as they may be a front for an illegal operation. Unregulated Internet drug sellers, they said, might have products which might not contain the correct ingredients and could contain toxic substances.
“The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor since these Web sites typically do not require the purchaser to have a prescription,” said Randall Lutter, FDA’s deputy commissioner for policy. “In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice.”
Meanwhile, more than half (53 percent) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the United States to be generally cheaper than a comparable drug in Canada or Western Europe. Approved generic versions of nearly half (47 percent) of the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online.
These data are based on surveys conducted from September 2006 to August 2007 in international mail facilities and courier facilities across the country. At each city, all parcels suspected by customs and border patrol of containing pharmaceuticals were stopped for a period of 24 hours. The FDA then recorded data on the contents of these packages, before handling them in accordance with its usual procedures.