FDA’s Rush to Approve Pharmaceutical Drugs Raises Safety Concerns

Pills%20and%20more.jpgA new review of safety issues involving 3 medications that were recently approved by the Food and Drug Administration finds that the agency likely jumped the gun in approving these medications. That has Indiana product liability attorneys and consumer safety groups asking whether the Food and Drug Administration is speeding up the approval of new medications at the cost of patient safety.

The review has been published in the Journal of the American Medical Association, and focuses on the Food and Drug Administration’s approval of 3 drugs that were approved recently. The drugs in question are Boehringer Iingelheim’s Pradaxa, AstraZeneca’s Caprelsa, and Novartis’ Gilenya.

Pradaxa is a popular blood thinner which was launched in 2010, Gilenya was approved for the treatment of multiple sclerosis, while Caprelsa was approved for the treatment of cancer.

Since Pradaxa was launched in 2010, it has been linked to thousands of adverse incidents reported to the Food and Drug Administration. Most of these adverse incidents involved patients who suffered heavy bleeding after taking Pradaxa. The Food and Drug Administration is currently reviewing these incidents.

Clinical trials on its use have found a 65% drop in the risk of progression of the disease, but Caprelsa has also been linked to severe toxicity issues. Gilenya was approved for the treatment of multiple sclerosis, and has since been linked to heart rate problems. In their analysis, the researchers found that Gilenya had at least 7 safety issues, including a cardiac heart rate acceleration risk.

According to the Journal of American Medical Association research, when the drug was approved, the Food and Drug Administration had required the company to provide post-marketing studies, which were not forthcoming.

These 3 drugs were approved as part of an expedited approval process at the Food And Drug Administration. These accelerated approval processes have come in for plenty of scrutiny by Indiana personal injury lawyers, because very often, the approval comes at the cost of a stringent and detailed evaluation of the drug.

The Food and Drug Administration claims that it is helpless. There is tremendous public pressure from patients who suffer from these illnesses, as well as patient safety groups who want the agency to hurry up and approve new pharmaceutical drugs developed for the treatment of these illnesses. In fact, the Food and Drug Administration claims that the public would like the agency to speed up and move more proactively to approve new drugs, rather than be cautious about approvals. Cancer patient groups in particular, are keen to see the Food and Drug Administration move quicker on approval of key drugs for the treatment of cancer.

Regardless of the public support for such speedy approvals, the agency – which is arguably more informed about the deadly consequence of defective drugs – should be more cautious about expedited approvals.

The Indiana product liability attorneys at Montross Miller Muller Mendelson and Kennedy represent persons who have been injured as a result of the use of defective pharmaceutical drugs across Indiana.