Warning on Medications, Drugs, Etc.

[Harrison]

Thanks for sharing that tidbit of information! That's why I used a slightly sarcastic headline for the article: Retraction - of Sorts.

Tell us more about the doc's story when/if you can...

[annapurna]

There wasn't much to pass along. She had osteoporosis, took bi-phosphonates, and developed bone necrosis within her jaw. It was an extended nasty fight. As she still had to deal with the osteoporosis and was a doctor herself who treated joint and bone maladies, she's been following the situation for the past few years. It just happened that she mentioned the headline you posted yesterday while we were working on an unrelated concern. I've not done any research myself into it but I did want to pass along that at least one knowledgeable and personally concerned doc didn't believe the data.

[Harrison]

SPINE SAFETY CAUTIONARY NOTICE:
Information for Healthcare Professionals:
Drug Safety Labeling Changes -
Proton Pump Inhibitors (PPI)

According to MedWatch, FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the "Drug Facts" label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication.

Read the complete MedWatch safety summary, including links to the FDA Drug Safety Communication and Consumer Health Update pages, at:
http://www.fda.gov/Safety/MedWatch/S.../ucm213321.htm

SPINE SAFETY CAUTIONARY NOTICE:
Information for Healthcare Professionals:
Drug Safety Labeling Changes -
Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen)

According to MedWatch, Ortho-McNeil-Janssen and FDA notified healthcare professionals of changes to the Warnings section of the prescribing information for tramadol, a centrally acting synthetic opioid analgesic indicated for the management of moderate to moderately severe chronic pain. The strengthened Warnings information emphasizes the risk of suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs and also warns of the risk of overdosage. Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids or illicit drugs that cause central nervous system depression. Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression and death. Tramadol has mu-opioid agonist activity, can be abused and may be subject to criminal diversion.

Read the complete MedWatch 2010 safety summary, including links to the "Dear Healthcare Professional" letters, at:
http://www.fda.gov/Safety/MedWatch/S.../ucm213264.htm

SPINE SAFETY CAUTIONARY NOTICE:
Information for Healthcare Professionals:
Drug Safety Labeling Changes -
Tisseel (fibrin sealant)

According to MedWatch, FDA notified healthcare professionals that the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS text for Tisseel (fibrin sealant) has been updated. The following sentences have been added to the labeling:
WARNINGS and PRECAUTIONS
Application Precautions
Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. This event appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the tissue surface.

When applying Tisseel using a spray device, be sure to use the pressure within the pressure range recommended by the spray device manufacturer. In the absence of a specific recommendation avoid using pressure above 20-25 psi. Do not spray closer than the distance recommended by the spray device manufacturer. In the absence of a specific recommendation avoid spraying closer than 10-15 cm from the surface of the tissue. When spraying Tisseel, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism.

ADVERSE REACTIONS
Post Marketing

Air embolism associated with misapplication of fibrin sealant using the spray device, Class Effect: A post marketing fatality was reported in association with the use of another fibrin sealant when applied using a spray device. The case involved an attempt to stop active bleeding by applying the fibrin sealant using a spray device attached to a wall unit at a higher than recommended pressure for the spray device. In addition, the spray head was placed at a distance from the bleeding site that was closer than the recommended distance guidelines for the application of the sealant. The patient suffered a fatal air embolism.
Read the complete summary of MedWatch safety labeling changes at: http://www.fda.gov/Safety/MedWatch/S.../ucm212129.htm

SPINE SAFETY CAUTIONARY NOTICE:
Information for Healthcare Professionals:
Drug Safety Labeling Changes -
Zonegran (zonisamide) capsules

According to MedWatch, FDA notified healthcare professionals that the WARNINGS and PRECAUTIONS text for Zonegran (zonisamide) has been updated. The following sentences have been added to the labeling:

WARNINGS
Metabolic Acidosis
added safety-related language regarding metabolic acidosis
PRECAUTIONS
Kidney Stones
Although the clinical significance of the sonographic findings may not be certain, the development of nephrolithiasis may be related to metabolic acidosis.

Information for patients
Patients should contact their physician immediately if they develop fast breathing, fatigue/tiredness loss of appetite, or irregular heart beat or palpitations (possible manifestations of metabolic acidosis).

Read the complete summary of MedWatch safety labeling changes at: http://www.fda.gov/Safety/MedWatch/S.../ucm212116.htm
The North American Spine Society is committed to quality patient care through promotion of patient safety and prevention of medical errors. NASS monitors a variety of government and other resources for patient safety related notices that may be useful to our members. Information from these notices is also archived on the NASS website at http://www.spine.org/Pages/PracticeP...s/Default.aspx. This information is provided as a service for information and education only.

[Harrison]

Osteoporosis drugs linked to cancer
Published: September 05, 2010

Long-term users of bone strengthening medications called oral bisphosphonates have nearly double the risk of developing esophageal cancer, a study from Oxford Universityclaims.

The study involved some 80,000 patients and took place over the course of seven years. According to the findings, those patients who were diagnosed with esophageal cancer were 1.93 times as likely to have received at least 10 prescriptions for oral bisphosphonates compared with controls not having cancer, ABC News reports.

While research findings so far suggests these osteoporosis drugs can have an influence on the development of cancer, more studies need to be conducted to in order to find the exact links and causes.

“But the risk, if it does exist, is small in absolute terms and is not something people taking these drugs should worry too much about,” Oxford University epidemiologist Dr. Jane Green told WebMD.

For the moment it is unknown why these drugs could increase the risk of cancer, it however a fact that the medication irritates the throat and esophagus.

Dr. Green, however, maintains the chances of developing cancer when taking the drugs is very small.

“Our findings are part of a wider picture, the BBC quotes her as saying.

“Bisphosphonates are being increasingly prescribed to prevent fracture and what is lacking is reliable information on the benefits and risks of their use in the long term.”

Find out more about esophageal cancer, otherwise known as throat cancer. Celebrities who have battled throat cancer include Michael Douglas and George Harrison.

Source: Click here.

[Harrison]

FDA warns of deadly side effect with imaging drugs

By MATTHEW PERRONE, AP Business Writer
Thu Sep 9, 4:24 pm ET

WASHINGTON – Federal health regulators are warning doctors that a class of injectable drugs used in MRI medical imaging scans can cause a rare and sometimes fatal condition in patients with kidney disease.

The Food and Drug Administration said Thursday it is adding its strongest warning label to imaging agents that contain the chemical gadolinium, highlighting the risks when used in patients with kidney problems.

"These label changes are intended to help ensure these drugs are used appropriately," the FDA said in a posting to its website. The warning language will appear in a bolded box at the top of the drugs' labels.

The agency said in a statement that use of the drugs can lead to a rare syndrome that causes hardening of the skin and tissue growth along joints, eyes and internal organs. The ailment, which is sometimes fatal, is called nephrogenic fibrosing dermopathy and has been reported in patients with weakened kidney function.

There is no known treatment for the condition, though kidney transplant appears to slow disease and even reverse it in some cases.

Known as contrast agents, the products are used to improve clarity in medical scans of the heart and other internal organs. The FDA has approved seven such agents since 1988.

While the nephrogenic syndrome has been reported with all seven drugs, the FDA said three have greater risks than the others: Bayer Healthcare's Magnevist, General Electric Healthcare's Omniscan and Covidien's Optimark. The FDA label stresses that these drugs should not be used in patients with kidney disease.

An agency spokeswoman said those three drugs are "chemically more unstable" than the others in the class and "thus more likely to release gadolinium."

Gadolinium is a metal with distinctive magnetic properties that increase its visibility during MRI scans. It is known to be toxic to the liver.

The four other drugs are Prohance and Multihance from Brocco Diagnostics Inc., Bayer's Eovist and Ablavar from Lantheus Medical Imaging.

The new FDA labels for all seven drugs instruct physicians to screen patients for kidney disease before administering the agents. Doctors should also order lab tests for patients who may be at increased risk of reduced kidney function. The FDA said there haven't been any reports of the syndrome in patients with normal kidney function.

There are two non-gadolinium-based imaging agents on the market, though the FDA has approved them only for liver scans.

GE Healthcare said in a statement that the FDA's labeling reinforces physician guidelines that already stress the importance of screening for patients with kidney problems.

The company said MRI contrast agents "continue to be a valuable diagnostic tool with a proven safety record for the overwhelming majority of patients to whom they are prescribed."

Bayer said it will cooperate with regulators and "will make periodic safety reports to the FDA and other regulators."

[Harrison]

FDA Delays May Have Cost Lives
Edward F. Blizzard
Posted: November 23, 2010 12:14 PM

When the FDA pulled from the market the sometimes-deadly prescription painkiller propoxyphene (sold under the brand names Darvon and Darvocet in the U.S.), the agency was acting finally -- if belatedly -- in the public interest.

The medical community has expressed serious concerns over the drug for most of the 50 years it has been on the market. Not only is propoxyphene not very effective as a painkiller, but the drug is highly addictive and, most importantly, it can be toxic even at low levels.

This toxicity and the risk of causing abnormal heart rhythms have caused thousands of deaths in patients who took these medications.

So risky and dangerous is propoxyphene that the United Kingdom banned the drug in 2005 and the entire European Union followed suit in January of 2009.

But in this country, it was not until last week that the FDA finally pulled the plug on the brand-name propoxyphene drugs, Darvon and Darvocet, as well as their generic surrogates.

For thousands of Americans, the FDA's action comes decades too late. Back in 1978 the consumer group Public Citizen first petitioned U.S. regulators to remove the drug from the market. Public Citizen recognized that propoxyphene can cause a toxic metabolite to accumulate in the body. The organization further maintains that thousands of Americans may have died from the cardiac toxicity of the drug, which interrupts the electrical conduction to the heart.

Given the body of evidence, the 30-year old questions about propoxyphene, and the U.K.'s and European Union's decisions to ban the drug outright, we have to ask: what took the FDA so long to do right the right thing for American consumers?

Officially, the FDA said it needed more time to conduct a study about the drug's efficacy and safety. Their study found that even the recommended dose caused "significant changes to the electrical activity of the heart" which can "increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death."

That is a shocking admission.

Fifty-three years after approving the drug, the FDA and the multiple companies who have manufactured and sold it have only now discovered that using propoxyphene under normal conditions can cause sudden death.

The FDA eventually took the right action, but U.S. regulators continue to lag behind our European and British cousins when it comes to patient safety.

While there are many differences between the two drugs, there are striking similarities between propoxyphene and Vioxx. Both were used to treat pain conditions. Both caused severe cardiovascular complications. And both were subject to belated warnings from the FDA.

The FDA eventually estimated that Vioxx caused as many as 139,000 heart attacks during the five years the drug was on the market. We should hope that the estimates for propoxyphene, which the FDA approved back in 1957, will be far fewer.

Source: Huffington Post

_______________________________________________

Hospital urges caution on Darvocet disposal

BLOOMINGTON -- If you're disposing of unused Darvocet after Friday's withdrawal of the opiod pain reliever by its manufacturer, do so in an environmentally sound manner by bringing unused medicine to area drop-off boxes, OSF St. Joseph Medical Center urged Monday.

U.S. Food and Drug Administration notified health care providers Friday that Xanodyne Pharmaceuticals agreed to withdraw propoxyphene -- which is sold as Darvocet or Darvon -- from the U.S. market at FDA's request after new data showed that the drug can cause serious toxicity to the heart. The FDA requested that generic manufacturers of propoxyphene-containing products remove their medicine as well.

Doctors should stop prescribing the medicine and patients should stop taking it and dispose of unused medicine as other pain management strategies are discussed, the FDA said.

Drop-off boxes are at the Bloomington Police Department, 305 S. East St., Bloomington; Normal Police Department, 100 E. Phoenix Ave., Normal; and Illinois State University pharmacy, 293 Student Services Building, Normal, St. Joseph's Christy McFarland said.

Meanwhile, collection sites for unused, non-controlled substances, prescriptions, over-the-counter and veterinary medicines, inhalers and mercury-filled thermometers are in Eastland Pharmacy on St. Joseph's campus, 1505 Eastland Drive, Bloomington; Atrium Pharmacy in Advocate BroMenn Medical Center, 1304 Franklin Ave., Normal; Merle Pharmacy, 203 E. Locust St., Bloomington; Ryan Pharmacy, 1118 E. Oakland Ave., Bloomington; Chenoa Pharmacy, 209 S. Green St., Chenoa; and Doc's Drugs, 304 Sunset Drive, LeRoy.

[Harrison]

This message below was forwarded to me by a patient. It seems unusual, but important; so please read and check out the FDA links too.
________________________________________________

Hi Everyone,

I am passing this email forwarded to me this morning. It's about a medication that is familiar to many of us. Note also the FDA’s comments at the end of the message. I received this information from a friend whose mother recently passed away.

Apparently, this was caused by a medication that is deadly. Here are the details and I suggest you pass it on to your loved ones and others.

Subject: Phenylpropanolamine (PPA)

I would like to thank those of you who expressed condolences on the recent passing of my mother. She suffered a hemorrhagic stroke while she was driving home from my house at 7:30 and passed away at 8:30. My mother's stroke and passing was an enormous shock to my family because she did not have any symptoms or risk factors for a stroke. Just the week before she had gone to her doctor for a check up and received a clean bill of health. She did, however, develop a cold while she was visiting me and had taken Alka Seltzer Cold Plus for 3 days. Since her passing, we have learned that Alka Seltzer is one of the many cold medicines that contains Phenylpropanolamine (PPA) which can cause hemorrhagic stokes or cerebral bleeding even with the first use. I am forwarding a list of other medications that currently use PPA. These medicines are supposedly being recalled but my mother just purchased this medication less than two weeks ago. Pharmaceutical companies have known about this danger for years; we unfortunately, did not.

I urge you to review the list of medicines with PPA and avoid these medications. All drugs containing PHENYLPROPANOLAMINE are dangerous. You may want to try calling the 800 number listed on most drug boxes and inquire about a REFUND. Please read this CAREFULLY. Also, please pass this on to everyone you know. STOP TAKING anything containing this ingredient. It has been linked to increased hemorrhagic stroke (bleeding in brain) among women ages 18-49 in the three days after starting use of medication. Problems were not found in men, but the FDA recommended that everyone (even children) seek alternative medicine.

The following medications contain Phenylpropanolamine:

Acutrim Diet Gum Appetite Suppressant
Acutrim Plus Dietary Supplements
Acutrim Maximum Strength Appetite Control
Alka-Seltzer Plus Children's Cold Medicine Effervescent
Alka-Seltzer Plus Cold medicine (cherry or orange)
Alka-Seltzer Plus Cold Medicine Original
Alka-Seltzer Plus Cold & Cough Medicine Effervescent
Alka-Seltzer Plus Cold & Flu Medicine
Alka-Seltzer Plus Cold & Sinus Effervescent
Alka Seltzer Plus Night-Time Cold Medicine
BC Allergy Sinus Cold Powder
BC Sinus Cold Powder
Comtrex Flu Therapy & Fever Relief
Day & Night Contac 12-Hour Cold Capsules
Contac 12 Hour Caplets
Coricidin D Cold, Flu & Sinus
Dexatrim Caffeine Free
Dexatrim Extended Duration
Dexatrim Gelcaps
Dexatrim Vitamin C/Caffeine Free
Dimetapp Cold & Allergy Chewable Tablets
Dimetapp Cold & Cough Liqui-Gels
Dimetapp DM Cold & Cough Elixir
Dimetapp Elixir
Dimetapp 4 Hour Liquid Gels
Dimetapp 4 Hour Tablets
Dimetapp 12 Hour Extentabs Tablets
Naldecon DX Pediatric Drops
Permathene Mega-16
Robitussin CF
Tavist-D 12 Hour Relief of Sinus & Nasal Congestion
Triaminic DM Cough Relief
Triaminic Expectorant Chest & Head
Triaminic Syrup ! ! Cold & amp;am p; Allergy
Triaminic Triaminicol Cold & Cough

I just found out and called the 800# on the container for Triaminic and they informed me that they are voluntarily recalling the following medicines because of a certain ingredient that is causing strokes and seizures in children:

Orange 3D Cold & Allergy Cherry (Pink)
3D Cold & Cough Berry
3D Cough Relief Yellow 3D Expectorant

They are asking you to call them at 800-548-3708 with the lot number on the box so they can send you postage for you to send it back to them, and they will also issue you a refund. If you know of anyone else with small children,

PLEASE PASS THIS ON. THIS IS SERIOUS STUFF! DO PASS ALONG TO ALL ON YOUR MAILING LIST so people are informed. They can then pass it along to their families. To confirm these findings please take time to check the following:

Phenylpropanolamine (PPA) Information Page

[jerlin09]

it was anger without the bodily sensation of it. No increased heart rate, muscle tightness, etc. Hard to explain but, hopefully, your reaction is the same in that you have no desire to act out your feelings.

[2 Young 2 Hurt Like This]

I've been on both sides of suicide. I know the hurt that comes with it and I can not put my family or friends through that. When my pain medications (morphine, lyrica, ultrum, soma) made me have dark thoughts I had no choice but to get off of them. I'm facing another back surgery and I'm scared to death to get mixed up with pain medications. No matter who you are, just know that there is always someone in your life that cares and loves you.