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Posts Tagged ‘FDA’

FDA reports life-threatening complications with cervical spinal fusion

Posted by Marietta chiropractor on July 4, 2008

Every surgery has risks. I thought it very important to get this information from the FDA out as soon as possible. Many surgeries can be prevented with gentle, specific chiropractic adjustments. Check with your chiropractor before taking this risk. There should be absolutely NO problem consulting BOTH a chiropractor and MD for the same problem. A good chiropractor will tell you when the problem is beyond his/her scope.

If you need a referral to a good chiropractor in your area, e-mail me.

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. There have been at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure established by your facility. Reporting adverse events is everyone’s responsibility, even if the event involves off-label use of medical devices.

Read the entire 2008 MedWatch Safety Summary, including the FDA’s Public Health Notification regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Protein

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So, you REALLY want Government sponsored health care?

Posted by Marietta chiropractor on April 10, 2008

A new report from the FDA suggests that recent problems with heparin have proven to be even worse than originally thought.  The report concludes that deaths linked to all versions of heparin–including a tainted version of the drug sold by Baxter–have tripled. There now are 62 reports of patients dying who were infused with heparin from January 1, 2007 through the end of this past March who had a one or more allergic reactions. A prior FDA report had only listed 19 deaths. At present, the FDA isn’t sure what caused the spike in adverse reactions. Right now, they’re suggesting that this is more of matter of delays in reports from companies and a growth in reports from consumers reading about Baxter’s problems.

The FDA’s job is to PROTECT consumers from this kind of travesty!  Yet, it appears that the Government’s real job is to get drugs to the market as soon as possible and then cover its backside when things go wrong.  Unfortunately, the consumer loses!  If you can’t trust the FDA to prevent stuff like this from happening, how can you be confident of ANY FDA approved drug for whatever ailment for which you might be treated?

Stay healthy!  Avoid drugs when you can.

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Avandia: Another case of betrayed trust

Posted by Marietta chiropractor on April 10, 2008

According to the US Food & Drug Administration, GlaxoSmithKline didn’t turn over post-marketing data about Avandia to the agency, a lack of disclosure that looks pretty sinister given subsequent reports linking Avandia to increased risk of heart attack.  Many drug companies fail to report post-approval data to the FDA once they begin selling a drug, since the rules for such reporting are at best somewhat loose.  But in Glaxo’s case, the failure to report arguably could have harmed consumers, given the risks exposed by last year’s article in the New England Journal of Medicine. The agency now is demanding that the company turn over all data on Avandia, pronto, or risk regulatory action.

Why do I even mention drugs?  As a chiropractor, I don’t put people on drugs and I don’t take them off drugs.  So, why bother?  Because, the whole concept of “better living through chemistry” is killing Americans in droves.  There’s a better way!  Staying healthy and relying on the design of the body to BE healthy is a much better way to live.  The “science” so many Americans have come to rely upon to keep them healthy has become little more than a shell game to deceive the public, create false demand and extract as much money from consumers and their insurance companies in as little time as possible.  That’s why this chiropractor talks about drugs.

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Singulair-suicide link?

Posted by Marietta chiropractor on March 30, 2008

When will this madness stop?!  Now the FDA is investigating a possible link between Merck’s asthma drug Singular and suicidal tendencies.

Do we really know what causes asthma?  If we don’t, how can we possibly approve a drug BEFORE the potential side efects can be known?    And, why do we (our Government) keep putting drugs on the market that can be more dangerous than the problem they’re supposed to treat?  Too many questions.  Too few answers.

For years people have had great success reducing their asthma symptoms with chiropractic care.  If you need a referral to a good family chiropractor, please let me know.

Here’s the link to the story.

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FDA Warning! Tussionex life-threatening adverse events

Posted by Marietta chiropractor on March 11, 2008

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramFDA informed healthcare professionals of life-threatening adverse events and death in patients, including children, who have received Tussionex Pennkinetic Extended-Release Suspension (Tussionex). The reports indicate that healthcare professionals have prescribed Tussionex for patients younger than the approved age group of 6 years old and older, and more frequently than the labeled dosing interval of every 12 hours. Tussionex is contraindicated for use in patients less than 6 years of age because of their susceptibility to life-threatening and fatal respiratory depression.

Patients have administered the incorrect dose due to misinterpretation of the dosing directions, and have used inappropriate devices to measure the suspension. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory depression. Prescribers should be familiar with the dosing recommendations of Tussionex before prescribing. In addition, patients and caregivers should use a properly marked measuring device to measure Tussionex to prevent overdose.

Read the complete 2008 MedWatch Safety Summary, including links to the Public Health Advisory, Information for Healthcare Professionals, and the Prescribing Information at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tussionex

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FDA lists drug safety warning changes

Posted by Marietta chiropractor on February 29, 2008

The Food and Drug Administration has issued a list of drugs which required changes in the safety warnings and precautions in NOVEMBER. Remember, the best way to avoid (or reduce) the dangers of drug use is to build health naturally. Here’s the list followed by a link to the specific warnings:

In November 2007, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Abilify (aripiprazole) Tablets, Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets, Abilify (aripiprazole) Oral Solution, Abilify (aripiprazole) Injection For Intramuscular Use Only

Aranesp (darbepoetin alfa) For Injection

Avandia (rosiglitazone maleate) Tablets

Epogen (epoetin alfa) For Injection

Myfortic (mycophenolic acid) Delayed-Release Tablets

Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Sarafem (fluoxetine hydrochloride tablets)

Crestor (rosuvastatin calcium) Tablets

Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules

Kaletra (Iopinavir/ritonavir) Tablets and Solution

Lac-Hydrin (ammonium lactate) Lotion, 12%

Zometa (zoledronic acid) Injection – Concentrate for Intravenous Infusion

Arava (leflunomide) Tablets

Avalide (irbesartan-hydrochlorothiazide) Tablets

Celebrex (celecoxib capsules)

Eligard (leuprolide acetate for injectable suspension)

Invanz (ertapenem for injection)

Motrin IB (200 mg ibuprofen) Tablets

Nexavar (sorafenib) Tablets

Sprycel (dasatinib) Tablet For Oral Use

Toradol (ketorolac tromethamine tablets)

Vectibix (panitumumab) For Intravenous Use Only

The Detailed View Page identifies safety labeling sections and subsections revised along with a bref summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

http://www.fda.gov/medwatch/safety/2007/nov07.htm

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Botox, Cerebral Palsy and Chiropractic

Posted by Marietta chiropractor on February 9, 2008

The FDA has just released the following notice on adverse reactions to Botox injections for approved and not approved uses of the drug, specifically spastic contracture of muscles in children. The media is reporting this dangerous off-label use of Botox as a treatment for conditions relating to cerebral palsy.

As you’ll read in the text of the FDA release, the problems occur away from the injection site, causing difficulty in swallowing, weakness and breathing problems. All are neurological symptoms of botulism poisoning.

Most chiropractors know that specific adjustments of the upper cervical spine may improve parasympathetic nervous system function. While the damage resulting from cerebral palsy may not be reversible, its effects can be reduced without subject children to off-label experimentation with dangerous drugs.

I know parents will go to any means to reduce their child’s suffering. But, medical quackery should not be allowed at the risk of a child already damaged at birth. If you or someone you know needs a referral to chiropractor in your area or if I can answer any specific questions, e-mail me today.   Read “Rockie’s Story” on this blog or “Why I am a chiropractor” on my web site.

The full text and the link to the FDA’s notice follows:

Adverse Reactions Linked to Botox

Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.

In an early communication based on FDA’s ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.

The adverse effects were found in FDA-approved and non approved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults.

The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.

FDA is not advising health care professionals to discontinue prescribing these products. The agency is reviewing safety data from clinical studies submitted by the drugs’ manufacturers, as well as post-marketing adverse event reports and medical literature. After completing a review of the data, FDA will inform the public of its conclusions, resulting recommendations, and any regulatory actions.

http://www.fda.gov/consumer/updates/botox020808.html

Posted in Alternative health care, Chiropractic, Health care, health insurance, Health Issues, Insurance, Life, Other Advocacy Blogs, self help, vaccination, wellness | Tagged: , , , , , , , , , , , | 7 Comments »

FDA – Anti-epileptic drugs double risk of suicide

Posted by Marietta chiropractor on February 1, 2008

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.

NOTE:  I’m posting this because of its relevance to my practice.  See “Rockie’sStory: Why I am a chiropractor”.

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