Officials Warn of Risk of Suicide with Two Anti-Smoking Drugs

Carrie Strasser — Thu, 02 Jul 2009 09:58:23 GMT

The New York Times reported that federal drug regulators advised patients taking two anti-smoking drugs to watch for signs of mental illness because of an increased risk of suicide among the drugs' users.

However, officials stressed that patients should not stop taking these drugs all together, but just be aware of increased risk of mental illness.

The two drugs are Chantix, by Pfizer, and Zyban, by GlaxoSmithKline. Zyban is also sold under the name, Wellbutrin, which is used to treat people suffering from depression.

“Stopping smoking is a goal we should all be working towards,” said Dr. Curtis J. Rosebraugh, director of a drug evaluation office at the Food and Drug Administration. “We don’t want to scare people off from trying a medication that could help them achieve this goal. You should just be careful.”

Pfizer is going to add a black-box warning to Chantix packaging and Glaxo is going to expand its already existing black-box warning on Wellbutrin to include Zyban.

Both drug manufacturers are going to conduct clinical trials to determine the extent of the mental health risks associated with these drugs.

Officials for both companies explained that it was difficult to determine whether it was the drugs causing the increased depression and suicidal thoughts, or whether it was the nicotine withdrawal associated with patients trying to stop smoking.

Despite the fear that this latest FDA action would affect drug sales, analysts say that it probably won't have much of an effect because of the previous information related to these drugs and their side effects.

Among those using Chantix, FDA officials have received 98 reports of suicides and 188 reports of attempted suicides. With Zyban, officials discovered 14 reported cases of suicide and 17 reports of attempted suicide.

For more information about the FDA and prescription drugs, click here.

To read the FDA Press Release regarding these two drugs, click here.

Originally posted at InjuryBoard by Carrie Strasser

Botox Gets Black-Box Warnings

Carrie Strasser — Fri, 01 May 2009 09:38:46 GMT

The New York Times reported that on Thursday, the FDA ordered that Botox and similar anti-wrinkle drugs carry stringent warning labels explaining the potential for the toxic material to spread to other parts of the body. This can cause serious difficulties including problems with swallowing and breathing.

Requiring a drug to carry a box with bold-face risk information — a so-called black-box warning — is one of the strongest safety actions the F.D.A. can take. Black boxes are typically reserved for medications known to have serious or life-threatening risks. Antidepressants, for example, carry black boxes warning of the increased danger of suicidal thoughts and actions.

The day before issuing the order, the FDA approved Dysport, another injectable drug derived from botulinum toxin. Dysport will be the first competition to Botox in the United States. Dysport is manufactured by Ipsen, a Paris-based company, and has been approved for use in Europe for years.

Because Botox has faced no serious competition in the US, Botox manufacturer, Allergan, has been able to raise the price annually. Now, with Dysport entering the market at a lower price, this will likely change.

Botulinum toxins are purified forms of botulism and work to temporarily reduce or stop muscle activity. The FDA has approved Botox for use in treating crossed eyes, eyelid spasms, severe underarm sweating and cervical dystonia. Botox Cosmetic is also used to treat frown lines.

This new order for black-box warnings was spurred by a petition from Public Citizen, a public advocacy group that noted the serious health risks and 16 reported deaths connected with Botox injections.

For more information on the FDA and other dangerous drugs, click here.

Originally posted at InjuryBoard by Carrie Strasser

Stoughton / Canton Area Personal Injury Lawyer - black-box warnings

Officials Warn of Risk of Suicide with Two Anti-Smoking Drugs

Botox Gets Black-Box Warnings