'Black box' warnings

[scotty]

This is the Bill that Lisa and I have been working for here in N.J.


http://www.nj.com/search/index.ssf?/...l=1&thispage=1


Industry Insider: Thursday, October 26, 2006

'Black box' warnings

A bill was introduced in the state Assembly earlier this week to ensure doctors, nurses and other health professionals who prescribe drugs with so-called black box warnings to children must also inform parents or legal guardians of possible side effects.

Black box warnings are the most severe type of alert issued by the Food and Drug Administration in connection with serious side effects that may be caused by a prescription medicine. Among the medications that have black box warnings are antidepressants, which have been linked to suicide in youngsters.

The bill, which is sponsored by Patrick Diegnan Jr. (D-Middlesex) and Jim Whelan (D-Atlantic), was drafted after several New Jersey parents complained antidepressants were sometimes being dispensed without medication guides. The FDA last year required these guides, which contain detailed risk information, to be distributed with all antidepressants.

In recent weeks, U.S. Rep. Mike Ferguson (R-N.J.) contacted the FDA, pharmacy groups and drugmakers about parent complaints that medication guides aren't always dispensed with antidepressants.

-- Ed Silverman

FDA warning

The Food and Drug Administration reported overdoses had been seen in patients taking Wyeth's widely used anti-depressant Effexor, and urged that it be given in the smallest possible quantities.

The reports of overdoses were mainly in patients using Effexor, or venlafaxine HCI, in combination with alcohol or other drugs, the agency said in a statement.

"Health care professionals are advised to prescribe Effexor and Effexor XR in the smallest quantity of capsules consistent with good patient management to reduce the risk of overdose," the FDA said.

The reported overdoses of the world's most lucrative anti-depressant resulted in death or such symptoms as rapid heartbeat, coma, seizures, vomiting and vertigo, Wyeth said in a letter it sent to doctors and health care providers.

The warning letter from the Madison-based drugmaker did not disclose how many Effexor overdose cases had been reported. It urged doctors to report any adverse reactions to Effexor to the company or to the FDA.

Prudential analyst Tim Anderson said the Wyeth warning letter will "only have a marginal direct impact" on Effexor sales.

But Anderson said the letter is likely to "further cement" the current trend by doctors to prescribe SSRIs -- selective serotonin reuptake inhibitors -- first, and to opt for Effexor as a "second-line" alternative if patients fail to adequately benefit from the SSRIs.

Effexor and Eli Lilly's rival Cymbalta both work by maximizing the presence of two brain-messenger chemicals, serotonin and norepinephrine.

A competing class of anti-depressants known as SSRIs maximizes the presence only of serotonin. They include Lilly's older Prozac treatment, Pfizer's Zoloft and Forest Laboratories' Lexapro.

[BriOnH]

Go Laurie and Lisa!!!!!!!!!!!!!!!!!!

May I ask, after this is approved, will you be persuing that everyone sign such an agreement even when it is used on label? Seeing people that were prescribed SSRI's for stuff SSRI's shouldn't have been prescribed for is awful. But, baby steps.

That's wild that effexor is the "world's most lucrative anti-depressant".

[elisa]

AWSOME Laurie and Lisa!!

Let's hope that NJ will approve and that other States will follow!!

[mouse]

Goon on ya Laurie ...

[scotty]

Originally Posted by BriOnH

Go Laurie and Lisa!!!!!!!!!!!!!!!!!!

May I ask, after this is approved, will you be persuing that everyone sign such an agreement even when it is used on label? Seeing people that were prescribed SSRI's for stuff SSRI's shouldn't have been prescribed for is awful. But, baby steps.

That's wild that effexor is the "world's most lucrative anti-depressant".

It's the presence of the "black box warning" that makes this one possible. That would be the next step for adults. We have an FDA warning, but not a black box one.

[mouse]

Good on ya Laurie ...

[elisa]

Originally Posted by BriOnH

That's wild that effexor is the "world's most lucrative anti-depressant".

Marketing!!

[mouse]

Originally Posted by elisa

Marketing!!

Indeed...
Its all down to marketing...
GSK went mental with Paxil Ads on US televison after 9/11...
Just goes to show ...they have no HUMANITY...
Sick Fuks...

[rdjanis]

Good stuff Laurie.. this is huge!!

[BriOnH]

Originally Posted by rdjanis

Good stuff Laurie.. this is huge!!

Totally. You are actually making a difference. So often people talk the talk (especially in the businesses I work in) and when it comes time to walk the walk, nothing happens. Not an easy task, but you two are DOING IT!!

[scotty]

Thanks Bri0nh.. one step at a time.I have the actual bill in a pdf file. If anyone wants to see it, just pm me your email address.

[elisa]

Originally Posted by scotty

.. one step at a time. .....

These words remind me of Neil Armstrong when he took his first step on the moon!!!

[BriOnH]

Laurie, That bill is awesome. Did you and Lisa author it? When it comes time for signatures when used On-Label I am very willing to help you draft it if you would want my help. It's is an honor to say I know you! Even if it is virtually.

[scotty]

The Assemblyman drafted it with input. His first bill was a bit "stronger", but to strong to actually get it passed. This one is clear cut.