Alabama Personal Injury Blog - prescription drugs

Medical reform

Pete Burns — Mon, 22 Jun 2009 18:04:55 GMT

We must be alert that the insurance and pharmaceutical industries do not further limit the rights of victims of medical errors to recover fair compensation. No one knows who will be the victim of medical malpractice but the insurance companies know they will be paying the verdicts. Consequently, the insurance and pharmaceutical industries will be organized in their efforts to shift the burden of medical errors to the victims. We all need to make sure that future victims of medical errors are not twice victimized.

Originally posted at InjuryBoard by Pete Burns

FDA shows caution in evaluating new heart drug, delays report

Wendi Lewis — Mon, 29 Sep 2008 17:31:16 GMT

Could the U.S. Food & Drug Administration (FDA) finally be showing caution in its evaluation of potential new medications? After being thrashed by the media and the public in recent months for its apparent inability to protect us from insufficiently tested drugs that turn out to be ineffective or, worse, downright dangerous, the FDA seems to be putting on the brakes in its consideration of a new drug offered by manufacturer Eli Lilly and Daiichi Sankyo.

On Sept. 24, Forbes.com was anticipating a decision on Lilly and Sankyo’s new blood thinner, prasugrel, which would be used to treat heart disease. Forbes reported that the FDA had decided in June after an initial review of the drug to delay its decision until Sept. 26.

However, today the FDA delayed approval of the drug for a second time. According to an Associated Press report, the agency says it still has not completed its review of the drug, which was submitted in January. The AP quotes Lilly spokesperson Jennifer Stotka as saying the evidence from prasugrel trials and studies is a “very large, complex submission,” and that she is not surprised at the FDA request for more time.

Prasugrel would be a direct competitor with Plavix, the leading drug for treatment of cardiovascular disease, manufactured by Sanofi-Aventis and Bristol-Myers Squibb.

According to a second Forbes report released today upon news of the second delay, prasugrel is designed to treat patients with acute heart conditions who are at risk of developing blood clots. The news agency says prasugrel’s manufacturers paid for a study of 14,000 patients to test the medication, which it says prevented more heart attacks than Plavix. However, the report says, the drug also caused more dangerous bleeding, with deaths as a result almost canceling out the gain in cardiovascular benefit.

Results of this study, the TRITON-TIMI 38 trial, were apparently enough cause for concern that the FDA is taking its time to weigh its decision.

Forbes says cardiologists expect the drug to ultimately gain approval, although with “significant warnings” for those at higher risk for bleeding. The report says the drug also has hopes for wide use in angioplasty procedures, where drug-coated stents are used to open a clogged artery.

For now, however, the wait is on.Originally posted at InjuryBoard by Wendi Lewis

FDA begins posting list of drugs with potential safety issues on its web site

Wendi Lewis — Mon, 08 Sep 2008 16:42:11 GMT

A list of prescription drugs currently under investigation by the FDA for safety issues is now available online.

The U.S. Food and Drug Administration began posting the list on its web site in September. The new policy is required as a result of a drug safety bill passed by Congress last year. Drugs included on the list are under investigation because of complaints reported to the FDA by drug companies, doctors and patients.

The FDA collects reports of possible side effects through its Adverse Event Reporting System. Only drugs submitted through this system will be included on the list. According to a story in the Washington Post, last year the FDA received more than 480,000 reports of potential reactions to drugs.

The FDA will update the list every three months. The first list included 20 medications and the potential problems associated with each. But, just because a drug is included on the list does not mean the drug is not safe, only that the FDA is investigating it.

According to a report on National Public Radio, FDA officials said they are trying to walk a fine line between being more open with the public and avoiding needless scares.

Some consumer groups worry that patients will stop taking necessary medication if they see it listed on the FDA web site.

The FDA’s Dr. Janet Woodcock told NPR, “My message to patients is this: Don’t stop taking your medicine. You should continue taking it unless your doctor advises you differently.”

The FDA hopes that by posting the list of drugs under investigation, they will be able to improve communication with the public and with doctors. They hope this will lead to overall improvement in drug side-effect reporting and verification.

Consumer advocates told NPR the list is a good start, but should include more information to be truly effective.

Also, it is not clear at this time how the FDA will inform the public if a drug originally included on the list is cleared of suspected safety risks.

The list is available on the FDA web site.

Originally posted at InjuryBoard by Wendi Lewis