Product News and Recalls

FDA panel votes against Xarelto because information missing

A U.S. Food and Drug Administration advisory panel has voted against approving Johnson & Johnson’s blood thinner Xarelto for prevention of blood clots in people with acute coronary syndrome.

According to U.S. News and World Report, the 6-to-4 decision came as a surprise because an FDA briefing document filed Monday in advance of the ruling gave the drug a favorable assessment.

But panel members reportedly said company studies did not provide enough data to justify a favorable ruling.

This isn’t the first time that withholding information has worked to Johnson & Johnson’s detriment. The company is now facing thousands of lawsuits based on claims it sat on information indicating that its metal-on-metal hip replacements and transvaginal mesh implants were dangerous, causing catastrophic problems for patients who received them.

The FDA is expected to make a final decision about the new approved use for Xarelto on June 29. The agency is not required to follow the advice of its advisory panel, but it typically does.

Johnson & Johnson is promoting Xarelto, the brand name of rivaroxaban, as an alternative to the standard treatment, warfarin, which requires frequent blood testing.

According to the report, panel members on Wednesday expressed concerns about a lack of data on potential side effects.

It quotes FDA reviewer Dr. Karen Hicks as writing: “What is not reflected in the sponsor’s analysis are minor bleeding events. While it is true that these bleeding events typically do not lead to death or irreversible harm, these events may represent the biggest problem for both patients and health care providers if rivaroxaban is approved.”

Johnson & Johnson is currently trying to repair its reputation after instituting more than 30 recalls of medications and medical devices in recent years. And in some of those cases, evidence suggests that the company intentionally marketed products despite knowing that they were harmful.

And the U.S. Food and Drug Administration is investigating metal-on-metal hip implants manufactured by a subsidiary of Johnson & Johnson in response to thousands of reports that the devices fail prematurely and leave toxic metal debris in patients’ bodies.

The hip implants were recalled in 2010. But an investigation by British medical journal The Lancet found internal company documents indicating that Johnson & Johnson officials were aware as early as 2005 of the device’s high early failure rate, yet continued to market it.

The company is also facing legal difficulties over transvaginal mesh implants, used to treat urinary incontinence and pelvic organ prolapse. Up to 10 percent of patients who received the devices had the devices fail within a year.

The most common reported problem is the vaginal mesh eroding and sticking through the walls of the bladder and vagina, causing debilitating pain for patients. The company is still marketing the device, despite thousands of such cases.

If you’ve received either of these devices, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a lawyer familiar with the DePuy hip implant or transvaginal mesh case to discuss your legal rights.

See the report here:

http://health.usnews.com/health-news/news/articles/2012/05/24/fda-panel-votes-against-new-use-for-blood-thinner-xarelto