Stoughton / Canton Area Personal Injury Lawyer - prescription drugs

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

Americans Foregoing Necessary Prescriptions to Save Money

Carrie Strasser — Sun, 25 Jan 2009 17:43:07 GMT

A recent study, reported by the New York Times, indicated that one in seven Americans under 65 did not take prescription medicines in 2007 because of the rising cost of such drugs. The Center for Studying Health System Change in Washington, D.C. said that figure has increased since 2003 when it was reported that one in 10 people under 65 went without prescription drugs.

Laurie E. Felland, a senior health researcher at the Center, explained that the current number may be even higher because of the most recent economic troubles.

The people who were least able to afford medicine were often those who needed it most, Ms. Felland said: uninsured, working-age adults suffering from at least one chronic medical condition. Almost two-thirds of them in the survey said they had gone without filling a prescription.

Those Americans in the most serious financial straits had the most difficulty obtaining proper prescription drugs because of such high costs. However, Ms. Felland explained that the rising drug prices are not the only thing causing people to skip necessary medications. This is also due to doctors becoming more reliant on such medications and prescribing them more frequently, new speciality medications and less expansive drug coverage.

Even 10% of those Americans with private health insurance provided by their employers went without such prescriptions drugs in 2007, up from the 8.7% reported in 2003.

Whether you are rich, poor, or middle class, getting necessary health care should not be a struggle. This applies to prescriptions drugs as well as receiving the necessary attention from a health care professional. Perhaps, with a new administration, solutions to these problems are on the not-so-distant horizon.

Originally posted at InjuryBoard by Carrie Strasser

FDA Asked to Overhaul its Medical Device Testing System

Carrie Strasser — Fri, 16 Jan 2009 09:28:09 GMT

Finally, reform may be coming to the Food and Drug Administration's medical device testing system. On Thursday, the Government Accountability Office released a report requiring the FDA to take "immediate steps" to fix this system.

The New York Times reported that the FDA has been promising this change for decades, but has failed time and time again to act on those promises. Congress's Accountability Office has been criticizing the FDA, in recent years, for failing to protect our food supply, failing to adequately inspect foreign drug plants that provide our medicines and failing to detect certain drug dangers.

While the FDA has mostly agreed with Congress's criticisms, this time, nine scientists within the FDA's medical device branch are also sounding the alarm on the faulty review process. These scientists have written letters to both Congress and President-elect Obama seeking the changes needed to improve this system.

The current medical device approval system allows medical devices that are similar in operation to older devices already on the market to be approved more quickly with minimal testing requirements.

"So on the one hand, the manufacturer wheels in their new Ferrari to the F.D.A. and says, 'Look, it's a car just like the Model T,'" said Dr. Peter B. Bach, a pulmonary physician at Memorial Sloan-Kettering Cancer Center in New York and a former senior adviser to Medicare and Medicaid. "Then they go out in the marketplace and say to doctors, 'Why would you drive anything but a Ferrari?' This drives up the cost of care without any necessary actual improvement in outcomes."

This system was created by the FDA in 1976 and divides products into three classes. Class I devices, like forceps, are mostly exempt from the review process. Class II devices, for example, a Mercury thermometer, get quick reviews. Class III devices, including pacemakers and heart valves, are able to receive expedited review if they are found to be similar enough to devices already on the market.

In 1990, the FDA was instructed to write rules that would provide for more rigorous testing for these Class III devices, but the agency never followed through. The Accountability Office told the FDA that they still needed to write those new rules.

Dr. Susan Alpert of Medtronic explained that many of the devices currently designated as Class III would, once the system is fixed, be reclassified as Class II, or less risky, devices.

If you or someone you know is dependent on a medical device, here is some information. For information on the FDA and prescription drugs, click here.

Originally posted at InjuryBoard by Carrie Strasser

FDA Sends Warning Letters To Stop Selling Fake Cancer 'Cures'

Chrissie Cole — Tue, 17 Jun 2008 15:22:00 GMT

The U.S. Food and Drug Administration (FDA) have sent warning letters to 23 U.S. companies and two foreign companies marketing products that fraudulently claim to prevent and cure cancer.

The FDA advises consumers against purchasing or consuming products which include: teas, tonics, tablets and creams and that are sold under various different names on the Internet.

A complete list of fake cancer cure products and manufacturers along with a consumer safety article can be found on the FDA’s website.

"Although promotions of bogus cancer 'cures' have always been a problem, the Internet has provided a mechanism for them to flourish," said Margaret O'K. Glavin, the FDA's associate commissioner for regulatory affairs. "These warning letters are an important step to ensure that consumers do not become the victim of false 'cures' that may cause greater harm to their health."

Consumers are urged to consult their doctor before discontinuing use of the products and to seek medical attention if they experience any adverse health effects associated with use.

Because the products claim to cure, treat and prevent disease, these products have not been shown to be safe and effective for their labeled use and they are unapproved drugs marketed in violation of the Federal Food, Drug and Cosmetics Act.

Originally posted at InjuryBoard by Chrissie Cole