Remicade

One in four biologics gets safety warning

Tracy Staton — Fri, 24 Oct 2008 11:24:26 -0400

New generation biologics are raising some red flags on the safety side. According to a new study, nearly one in four new biological drugs end up bearing serious safety warnings. Serious side effects typically raise their heads within five years after these drugs hit the market, the researchers found. The survey might confound some doctors who consider biologics to be safer than traditional meds.

One reason these biotech drugs result in side effects is that many of them work by suppressing the body's immune system. That way, brain and fungal infections can sneak in. The report specifically mentions Abbott Laboratories' Humira and Schering-Plough and Centocor's Remicade--both of which treat rheumatoid arthritis and other autoimmune diseases. Both also bear safety warnings, including a "black box" infection warning added to the labels last month.

Also mentioned are Genentech's Rituxan and Erbitux, from Bristol-Myers Squibb and ImClone. (Generally thought of as cancer meds, they are also used for other conditions, too.) Genentech just revised Rituxan's label after a man died of the rare but potentially fatal brain infection PML.

That's not to say that traditional meds don't get dinged with safety warnings, too. But the Associated Press couldn't find any similar studies for comparison.

- read the story in the Boston Globe

FDA orders tougher warnings on TNF drugs

Tracy Staton — Fri, 05 Sep 2008 11:06:40 -0400

Forty-five deaths have prompted the FDA to demand new warnings on TNF inhibitors. The agency received reports of 241 cases of the fungal infection histoplasmosis in patients taking the drugs, which are used to treat rheumatoid arthritis and other autoimmune disorders. Among them were 45 patients who died. In at least 21 cases, doctors didn't diagnose the problem and treatment was delayed; 12 of those cases were fatal.

The drugs--Remicade from Johnson & Johnson; Humira from Abbott Laboratories; Cimzia from UCB; and Enbrel, co-marketed by Amgen and Wyeth--already carry warnings of infection risk, including a specific warning about tuberculosis.

But the FDA wants specific language about histoplasmosis and other fungal infections, particularly because doctors appear to have overlooked them in those 21 patients. Twenty percent of the patients who developed the infections died, but more than half of those treated late didn't make it.

- check out Amgen and Wyeth's statement
- see the WSJ Health Blog post
- read the story in the New York Times

NICE wants to limit anti-TNF use

Tracy Staton — Mon, 21 Jul 2008 10:42:48 -0400

Hear those cries of protest? They're coming from the U.K., whose National Institute for Health and Clinical Excellence (NICE) issued guidelines today that would limit patients' access to high-tech arthritis meds. Under the guidelines, each patient could use only one of the anti-TNF drugs--Centocor's Remicade (infliximab), Abbott Laboratories' Humira (adalimumab), and Amgen's Enbrel (etanercept)--and couldn't try another if the first stopped working or didn't help in the first place.

NICE said that giving patients more than one of these meds is not cost-effective, and that if one of them doesn't work, then docs should use Roche's Rituxan--known as Mab Thera in the U.K. and Rituxan in the U.S. Rheumatoid arthritis activists rose to the anti-TNF drugs' defense, saying that a limit of one would amount to "one roll of the dice" and "rationing without rationality."

The guidelines aren't in force yet; a final version is due in September. Activists are hoping that the outcry convinces NICE to change its mind. It worked before; NICE proposed anti-TNF limits in 2006, but recanted after protest.

- see the BBC story
- check out the coverage in the Telegraph

FDA checks arthritis meds for child-cancer link

Tracy Staton — Thu, 05 Jun 2008 09:30:02 -0400

In a development sure to spawn headlines across the country, the FDA is looking into a possible link between autoimmune drugs such as Remicade and Humira--known as TNF blockers for their action against tumor necrosis factor--and childhood cancers. The meds are already labeled with potential cancer risks for adults, but this is the first time the FDA has analyzed the risk in patients up to 18 years old. Why now? We're not sure, given that 30 reports of cancer in children and adolescents trickled into the FDA over the 10 years since the first TNF blocker was approved.

It's not a huge cognitive leap: TNF blockers do their job by suppressing the TNF protein, an immune-system component that causes inflammation. It also is potentially helpful against tumor cells. But these meds aren't for lightweight diseases, either. Thousands of kids take Amgen and Wyeth's Enbrel and Abbott Laboratories' Humira for rheumatoid arthritis, a serious and painful disorder that erodes joints. Johnson & Johnson and Schering-Plough's Remicade is approved for kids with Crohn's disease, which, left untreated, can destroy the intestines' ability to absorb nutrients. The FDA said in a statement that it believes the benefits of the drugs outweigh the risks--but also recommended that doctors consider the potential cancer link when prescribing.

FDA says the review will take about six months. Analysts are already hand-wringing over a possible black-box warning; Humira was Abbott's best-seller last year, with $3 billion in sales, and Remicade delivered $1.65 million to Schering-Plough. (The number of adults using these meds far outweighs the juvenile use, though.) Expect to hear more discussion of the possible cancer link June 18, when an agency advisory panel hashes over Amgen's application to market Enbrel for kids with psoriasis.

- see the FDA release
- read the story in the New York Times
- check out the Washington Post article
- get the Chicago Tribune's focus on Abbott
- find Amgen and Wyeth's response