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Drug Safety Experts Say FDA Allowing Dangerous Drugs on the Market

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Drug safety experts report that the U.S. Food & Drug Administration (FDA) is allowing dangerous drugs to find their way to market. The article was published, today, in the Journal of the American Medical Association.

The article blames the agency’s work to speed approval of new drugs to be what has allowed stroke prevention, cancer, and multiple sclerosis medications to be released without proper safety reviews, said The Wall Street Journal. The article, written by drug safety experts Thomas J. Moore and Curt D. Furberg, states that, in the agency’s zeal to approve medications, they might have mitigated prescription-drug safety. The pair pointed to a multiple sclerosis (MS) drug that has some significant cardiac side effects as well as numerous other risks, as well as Pradaxa, an anticoagulant linked to dangerous bleeding that can be “difficult to treat,” said The Journal.

“These examples raise the question of whether it was good policy to approve three innovative

new drugs with significant safety questions unanswered,” Mr. Moore and Dr. Furberg wrote. Moore is the author of two drug safety books and director of drug-safety publication, QuarterWatch, which provides independent evaluations of drug side effect data to the FDA. Co-author, Dr. Furberg, is emeritus professor of medicine at Wake Forest University and a clinical studies researcher, said The Journal.

The Journal pointed out that FDA Commissioner, Dr. Margaret A. Hamburg, has stressed the agency’s work to quicken approvals for innovative drugs, noting that the FDA approved 35 of these drugs in fiscal year 2011, alone. Only one time in the prior 10 years has the agency exceeded this number. And, noted The Journal, of the 35 drugs approved, 16 received some an expedited or shortened review or approval. The agency told The Journal that it could not provide comparable numbers for prior years’ accelerated approvals.

Janet Woodcock, director of the FDA’s center for drug evaluation and review, told The Journal that both the public and medical groups have sought quicker, not more cautious, approvals, saying, “I’d like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks.” She added, “The cancer community in particular says we haven’t used accelerated approvals enough.”

The three drugs on which the authors concentrated are Caprelsa (vandetanib), an advanced thyroid cancer treatment; Gilenya (fingolimod), which is used to treat MS; and stroke prevention drug, Pradaxa (dabigatran etexilate), said The Journal. According to the authors, Caprelsa “was sufficiently toxic that overall survival” was “not different from that achieved with placebo,” citing company research. Caprelsa has been linked to serious abnormal heart rhythm and AstraZeneca Canada and Health Canada have advised Canadian healthcare providers about its safety, said NewsInferno. Patients have also reported rash, other skin reactions, diarrhea, increased blood pressure, and vision abnormalities.

The team also said company research on Gilenya, “disclosed seven major safety issues” including adverse cardiac effects. The drug received agency approval, but said that the drug will continue to be evaluated on 10 post-marketing studies. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, told The Journal that the agency could find a better safety-innovation balance by urging drug makers to provide safety and efficacy data soon after drug approval and calling for drug withdrawal if data is not provided. “Once a drug is approved, it is often very difficult to put the genie back in the bottle,” he said. NewsInferno noted that U.K. regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), issued a warning against Gilenya use in heart patients, calling for extended early monitoring for patients diagnosed with significant bradycardia or heart block after the first dose. The announcement followed new FDA restrictions that followed reports of patient deaths.

Pradaxa, while offering some usage benefits over its predecessor, warfarin, can lead to dangerous bleeding that “may be more difficult to treat than warfarin-related bleeding,” said the team, noting that “no antidote is available for use in bleeding emergencies” linked to Pradaxa. Manufacturer Boehringer Ingelheim did not immediately respond to The Journal’s questions. Meanwhile, NewsInferno wrote that Pradaxa patients, involved in about one dozen lawsuits, are waiting to hear about a multidistrict litigation (MDL) concerning injuries they allege they suffered in association with the controversial blood thinner. The 12 lawsuits represent about half of what Boehringer and some other foreign corporations in the U.S., are facing. Pradaxa has been associated with about 260 fatal bleeds, worldwide, from March 2008 through October 2011, noted NewsInferno.

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