FDA has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels. Information about the potential for generally non-serious and reversible cognitive side effects and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels.
The lovastatin label has been extensively updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury.
Read the FDA Drug Safety Communication for more information.
BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). Marketed as single-ingredient products, including Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Also marketed as combination products, including Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release),and Vytorin (simvastatin/ezetimibe).
RECOMMENDATION: Healthcare professionals should perform liver enzyme tests before initiating statin therapy in patients and as clinically indicated thereafter. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted. If an alternate etiology is not found, the statin should not be restarted.
Healthcare professionals should follow the recommendations in the lovastatin label regarding drugs that may increase the risk of myopathy/rhabdomyolysis when used with lovastatin.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
If ever there was a class of drugs that was all about making money for pharmaceutical companies and their prescribing monkeys then statins would be it. The faked research to support approval will hopefully one day take center stage. We already know that the drugs are very widely prescribed for groups of patients for whom there is no scientific basis to justify the use, not even faked research, such as older women for example.
How many people endure considerable pain and functional limitation due to polymyalgia or simply painful muscles and joints because they are taking statins? The answer is far, far too many. This is a class of drugs that should simply be dumped. Alas, there is too much money at stake. Between the completely unjustified (and ultimately dangerous) demonising of cholesterol and the absurd research justification for using statins it seems that a great deal more unnecessary suffering will be inflicted by ignorant, uncritical, non-thinking and downright stupid doctors who will continue to prescribe this rubbish like sheep following the lead of drug companies and equally inept health authorities.
The March 2012 edition of The Health Gazette Ezine will be published as scheduled on March 1st.
The March edition continues a brief series on aging. This month’s installment considers a simple definition of aging and briefly explores two theories of aging, one bio-physical and one psych-social.
Subscribers will find the ezine in their mailbox on publication. It will be posted in the subscribers’ archive around the same time.
Tags: Aging, Health Gazette Ezine
The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine’s active ingredient, bevacizumab, which my have resulted in patients not receiving needed therapy. 19 medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products.
BACKGROUND: Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. Roche is the company that manufactures Avastin approved for marketing outside of the United States. Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:
- are labeled with Roche as the manufacturer
- display batch numbers that start with B6010, B6011 or B86017
The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials. FDA approved versions of these medicines are available in adequate supply to meet demand.
RECOMMENDATION: Medical practices that have obtained products from Volunteer Distribution and QSP should stop using them and contact the FDA. These products should be retained and securely stored. To report suspect counterfeit products and other suspect products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions:
- Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989,
- Visit OCI’s Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
- Email – DrugSupplyChainIntegrity@fda.hhs.gov
Healthcare professionals and patients are encouraged to report adverse events related to the use of suspect injectable cancer medications to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
The Health Gazette is no friend of “big pharma” and does not support the use of any drug unless absolutely essential. What is worse than bad drugs (ie, toxic chemicals, inadequately tested, unwanted side effects riddled, etc) is fake drugs. When the drugs that are prescribed do not contain what they purport to contain then very serious consequences can arise from their use. It does not matter whether the drug is a cytotoic anti-cancer drug or a simple over-the-counter analgesic, the risks posed are just as bad. Knowing what is in a bad drug is one thing, not knowing what is in any drug is even scarier.
Tags: Avastin counterfeit, MedWatch
The MedWatch January 2012 Safety Labeling Changes posting includes 63 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
The “Summary Page” accessible via the following link provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm289859.htm
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:
- Accupril (quinapril hydrochloride)
- Accuretic (quinapril HCl/ hydrochlorothiazide)
- Altace (ramipril)
- Avalide (irbesartan/hydrochlorothiazide)
- Avapro (irbesartan)
- Azor (amlodipine/olmesartan)
- Benicar HCT (olmesartan medoxomil/hydrochlorothiazide)
- Diovan (valsartan)
- Diovan HCT (valsartan/hydrochlorothiazide)
- Exforge (amlodipine/valsartan)
- Exforge HCT (amlodipine/valsartan/hydrochlorothiazide)
- Lotensin (benazapril)
- Lotensin HCT (benazapril/hydrochlorothiazide)
- Lotrel (amlodipine besylate and benazepril hydrochloride)
- Mavik (trandolapril)
- Micardis (telmisartan)
- Micardis HCT (telmisartan/hydrochlorothiazide)
- Tarka (trandolapril/verapamil hydrochloride)
- Teveten (eprosartan mesylate)
- Teveten HCT (eprosartan mesylate/hydrochlorothiazide)
- Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide)
- Univasc (moexipril hydrochloride)
- Uniretic (moexipril hydrochloride/hydrochlorothiazide)
- Ceftriaxone for Injection and Dextrose Injection in Duplex Container
- Evoclin (clindamycin phosphate)
- Mavik (trandolapril)
- Micardis (telmisartan)
- Micardis HCT (telmisartan/hydrochlorothiazide)
- Micardis HCT (telmisartan/hydrochlorothiazide)
- Twynsta (telmisartan/amlodipine)
- Xenical (orlistat)
- Chantix (varenicline)
- Erbitux (cetuximab)
- Fanapt (iloperidone)
- Fazaclo (clozapine)
- Gralise (gabapentin)
- Morphine Sulfate Oral Solution,
- Morphine Sulfate Tablets
- Nexium (esomeprazole sodium)
- Nexium (esomeprazole magnesium)
- Performist (formoterol fumarate)
- Pradaxa (dabigatran etexilate mesylate)
- Vimovo (naproxen/esomeprazole magnesium)
- Vytorin (ezetimibe/simvastatin)
Remember to exercise great care with drugs, whether prescribing or consuming. All drugs are dangerous. Only consume drugs that are truly essential. Unless persuaded to your satisfaction as to the essential nature of any prescribed drug, seek a second opinion. Ensure that you know exactly what a prescribed drug is intended to do and what side effects it may have and what alternatives exist to taking the drug.
Tags: MedWatch
The US FDA notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve. The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.
FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers. H2 receptor blockers are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and heartburn.
Drugs of concern include:
- AcipHex (rabeprazole sodium)
- Dexilant (dexlansoprazole)
- Nexium (esomeprazole magnesium)
- Omeprazole (omeprazole) Over-the-Counter (OTC)
- Prevacid (lansoprazole) and OTC Prevacid 24hr
- Prilosec (omeprazole) and OTC
- Protonix (pantoprazole sodium)
- Vimovo (esomeprazole magnesium and naproxen)
- Zegerid (omeprazole and Sodium bicarbonate) and OTC
BACKGROUND: Proton pump inhibitors (PPIs) are marketed under various brand and generic drug names as prescription and over-the-counter (OTC) products. They work by reducing the amount of acid in the stomach. Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter PPIs are used to treat frequent heartburn.
Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea that does not improve. Symptoms include watery stool, abdominal pain, and fever, and patients may go on to develop more serious intestinal conditions. The disease can also be spread in hospitals.
RECOMMENDATION: Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve. Information for Healthcare Professionals:
- A diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve.
- Advise patients to seek immediate care from a healthcare professional if they experience watery stool that does not go away, abdominal pain, and fever while taking PPIs.
- Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
It is good that the FDA MedWatch system is in operation as it can respond to situations such as this one. How much better would it be however, if we were not always shutting the gate after the horse had bolted? Remember that this system is nothing more than an elaborate drug trial where unsuspecting consumers are effectively used as “lab rats.” This recent finding of a link between manipulated gastric acid levels and a bacterial infection is just one of the several problems associated with this line of treatment. These drugs are seriously over used anyway so let us hope some people will be motivated to seek more appropriate treatment.
Tags: Clostridium Difficile-Associated Diarrhea (CDAD), gastroenterology, MedWatch Alert, Proton Pump Inhibitors (PPIs)