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Beware, genetically engineered and newer biological drugs

There is a rather well publicized issue surrounding multiple myeloma and the possibility of symptomatic treatment from a drug in this class that is approved for MS and Crohn's Disease. One of the serious side effects of the drug is that it can cause multiple myeloma and a very severe bacterial invasion of brain tissue that can be fatal. The drug is listed on the FDA's drug advisory information pages. These are reasons why the drug is so tightly controlled. Another may be that the effects of the drug really isn't known because no long term studies are completed before FDA approval and marketing.

Humira and other arthritis drugs have been worrisome for years, the risk of cancer has been raised, yet they are still plentifully prescribed.

Some forms of arthritis are well known to be associated with food allergy but this concept is absent or fleeting over (knee-jerk) consideration for promoting the drug.

Some cases of Chrohn's may be helped with more nutritional and natural approaches to revitlize the gut lining and function. Now this is a novel idea in MSM but its one I've seen work time and time again.

MS and multiply myeloma can be helped with more natural approaches too.

There just needs to be a better approach to health care.
Safety a problem for new generation drugs, tooBy LINDSEY TANNER, AP Medical Writer
He said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.

CHICAGO – Nearly a fourth of widely used new-generation biological drugs for several common diseases produce serious side effects that lead to safety warnings soon after they go on the market, the first major study of its kind found.

Included in the report released Tuesday were the arthritis drugs Humira and Remicade, cancer drugs Rituxan and Erbitux, and the heart failure drug Natrecor. All wound up being flagged for safety.

That might surprise some doctors who may have thought that these new treatments might be safer than traditional chemical-based medicines.

Researchers found that most of the warnings came within five years after these biologicals won government approval in the United States and Europe between 1995 and 2007.

Many traditional medicines wind up with safety warnings too after they go on the market. But experts said there were no similar studies of older medicines that made it possible to compare safety issues between the two groups of drugs.

The new study, by Dutch researchers, is the first comprehensive examination of these newer medicines, a driving part of the biotech revolution.

The drugs are known as biologicals because they're made from living material and they typically affect the body's disease-fighting immune system. Many relieve severe symptoms by suppressing that system.
It's that same mechanism that can result in side effects often not seen with traditional chemical-based medicines, said Dr. Charles Bennett, a Northwestern University drug safety expert. These can include brain and fungal infections and cancer.

Many are genetically engineered and Bennett said that because they typically resemble naturally occurring proteins, many doctors have assumed they were safer than traditional chemical-based medicines. But he said the study shows that's not necessarily true.

"They have an important role," Bennett said. "They're really the next generation of pharmaceuticals."

He said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.

Among the drugs under examination are Genentech Inc.'s psoriasis drug Raptiva, which just last week the Food and Drug Administration warned may contribute to a life-threatening brain illness and infections; and Exubera, an inhaled insulin product, linked with lung cancer risks. Exubera was approved by the FDA in 2006 but Pfizer Inc. stopped selling it last year.

The study appears in Wednesday's Journal of the American Medical Association.

It involved 136 biologics approved in the United States and 105 in the European Union between January 1995 and June 2007. A total of 41, or nearly 24 percent, got safety warnings issued through June 2008.

The results are a concern, and they underscore the need for closer scrutiny of drugs after their approval, said lead author Thijs Giezen of the University of Utrecht.

But he said the study also is reassuring because most problems showed up relatively soon after the drugs became available, which minimized the potential for widespread harm.

"If most issues are discovered within the first few years, then the system is working," Giezen said.

Bennett says it's unreasonable to think that the studied drugs' safety issues should have been discovered before they were marketed. That's because drug approval is based on relatively small studies with patients who generally are healthier than those in the general population. It often takes real-world experience for side effects to appear, he said.

Many biological drugs have advantages over conventional medicine, but the study shows their risks need to also be considered, said Thomas Moore of the Institute for Safe Medication Practices.

For example, non-steroid arthritis medicines including ibuprofen can reduce pain by decreasing inflammation, but they can cause stomach bleeding.

Biologic rheumatoid arthritis medicines Remicade, Enbrel and Humira are designed to ease painful joints by keeping the body's immune system from attacking itself, the underlying problem in the disease. But they are much more expensive and have been linked with higher risks for potentially fatal infections. Also, the FDA is investigating possible cancer risks.

"My message to patients is that these biological products often can treat very difficult to treat diseases but may have very substantial risks and that you need to take extra care to educate yourself as to what those risks might be," Moore said.

And in another report on this timely topic -
Reports of serious drug reactions hit recordBy RICARDO ALONSO-ZALDIVAR, Associated Press Writer

WASHINGTON – The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday.

The Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including more than 4,800 deaths, said an analysis of federal data by the Institute for Safe Medication Practices.

Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. Most of the drug's problems were prompted by tainted heparin imported from China. The other was Chantix, a new kind of anti-smoking drug from Pfizer.

Chantix, which had the most reports of any medication, works directly in a smoker's brain to ease withdrawal symptoms. It also blocks the pleasurable effects of nicotine if the patient is tempted to light up again. Earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Pfizer said Wednesday it stands by Chantix, and that the volume of reports might be linked to publicity about the side effects.

"The FDA is aware of the increasing number of reports, and we take them seriously," said spokesman Christopher DiFrancesco. But officials are not sure whether reports are up because problems are getting worse, or simply due to greater awareness about drug safety issues.

The watchdog group that prepared the analysis has served hospitals and pharmacists for years as a clearinghouse for information on medication errors. Known as ISMP, the organization is now trying to reach consumers with regular reports on drug safety trends.

"We believe that one of the most important tools to promote is to monitor trends on a regular basis," said Thomas J. Moore, a senior scientist with ISMP. "Knowing which drugs are causing injuries and how many people are being hurt is the raw material we need to fashion sound measures to promote patient safety."

The FDA defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy. The agency's monitoring system relies on voluntary reports from doctors and is only believed to capture a fraction of overall problems.

The 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said.

The number of deaths, 4,824, was a nearly threefold increase from the last calendar quarter of 2007. The FDA said heparin was largely to blame.

Previous ISMP research has shown that reports of serious drug safety problems had increased markedly since the late 1990s.

The FDA case reports provide a signal of possible problems with a drug, but a cause-and-effect connection can only be established through painstaking investigation. If the FDA were a police agency, the reports would indicate "probable cause," but not necessarily "guilt beyond a reasonable doubt."

The ISMP study found that heparin accounted for 779 reports of serious problems, including 102 deaths. The FDA, using data that covers a longer time period, has reported 238 deaths possibly linked to heparin.

Heparin "illustrates an example of a significant drug safety problem that was promptly and effectively resolved by the drug manufacturers and the FDA once the issue was detected and understood," the report said.

Not so with Chantix, it concluded.

The FDA should forcefully warn patients taking Chantix that they may have blackouts that could lead to accidents, the report said. Current warnings say patients may be too impaired to drive or operate heavy machinery, but such language is standard for many medications. The government has banned the drug for pilots.

The report found 15 cases of Chantix patients who appeared to have been involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The FDA said it taking a second look at the Chantix warnings.

The agency received 1,001 reports of serious injuries linked to Chantix, more than for the 10 best-selling brand name drugs combined.

Chantix "continued to provide a striking signal of safety issues that require investigation and action," the report said. The authors acknowledged Pfizer's concern that publicity may be driving up the number of reports, but concluded there's enough evidence to warrant stronger FDA action.

Pfizer said the total sum of its Chantix data, including results from clinical trials, show the drug's benefits clearly outweigh its risks.

"We stand by the efficacy and safety profile of Chantix," the company said in a statement. "There are few things that provide greater health benefits than quitting smoking. Pfizer is committed to reducing the prevalence of smoking globally. As part of that mission, we want to increase peoples' understanding of the dangers of smoking and the benefits of quitting."

But then again we've mentioned Chantix in several other posts herein.
And if you've queries regarding more natural ways to approach stopping smoking, contact us.

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