May 12, 2009: Medication Recall Alert
“A-S Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco
brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within
the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are
being recalled because they may differ in size and therefore could have more or less of the active
ingredient, digoxin. Caraco Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. This
recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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May 11, 2009: Medication Safety Alert
“OSI, Genentech and (the) FDA notified healthcare professionals of new safety information added to the
WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva®. Gastrointestinal
perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases
suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular
disorders, including corneal perforation or ulceration have been reported during use of Tarceva®.
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May 1, 2009: Medication Safety Alert
“(The) FDA notified healthcare professionals that, after an ongoing safety review initiated in February
2008, the manufacturers of licensed botulinum toxin products will be required by (the) FDA to strengthen
warnings in product labeling and add a boxed warning regarding the risk of adverse events when the
effects of the toxin spread beyond the site where it was injected.
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April 21, 2009: Medication Recall Alert
“Neilgen Pharma Inc. of Westminster, MD and Advent Pharmaceutical of East Windsor, NJ are recalling all prescription cough and cold drug products sold on or after March 5, 2008. Neilgen Pharma and Advent Pharmaceutical are contract manufacturers for these products and are recalling the listed products below due to their unapproved drug product category.
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April 9, 2009: Medication Withdrawal Alert
“Genentech and (the) FDA notified healthcare professionals of the voluntary, phased withdrawal of Raptiva®, a medication for treatment of psoriasis, from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML). By June 8, 2009, Raptiva® will no longer be available in the United States.
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March 31, 2009: Medication Recall Alert
“Caraco Pharmaceutical Laboratories, Ltd…announced today that all tablets of Caraco brand Digoxin,
USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired
and are within the expiration date of September, 2011, are being voluntarily recalled to the consumer
level. The tablets are being recalled because they may differ in size and therefore could have more or
less of the active ingredient, digoxin.
[more...]
March 24, 2009: Medication Recall Alert
“Watson Pharmaceuticals, Inc…announced today that one lot of Propafenone HCL 225 mg Tablets sold
in 100 count bottles in the United States is being voluntarily recalled to the consumer level as a
precautionary measure. The lot is being recalled because some tablets may contain slightly higher levels
of the active ingredient than specified.
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March 23, 2009: Medication Recall Alert
“Shire…announced today a voluntary market withdrawal/recall of thirty-nine (39) lots of the ADHD patch
DAYTRANA® (the lots of DAYTRANA® patches affected by this action are listed below). Shire is taking
this action because some DAYTRANA® patches no longer meet their release liner removal specification,
and as a result, patients and caregivers could have difficulties removing the liners.
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March 20, 2009: Medication Safety Alert
“The FDA notified healthcare providers and patients that insulin pens and insulin cartridges are never to be shared among patients. Sharing of insulin pens may result in transmission of hepatitis viruses, HIV, or
other blood-borne pathogens. Insulin pens are not designed, and are not safe, for multiple patient use.
Even if needles are changed between patients, any blood contamination of the pen reservoir could result
in transmission of already existing blood-borne pathogens from the previous user.
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March 5, 2009: FDA Public Health Advisory
“FDA notified healthcare professionals and patients that certain transdermal patches (medicated patches
applied to the skin), containing aluminum or other metals in the backing of the patches, can overheat
during an MRI scan and cause skin burns in the immediate area of the patch.
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February 27, 2009: Medication Safety Alert
“The FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat
gastrointestinal disorders, must add a Boxed Warning to their drug labels about the risk of its long-term or
high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include
involuntary and repetitive movements of the body, even after the drugs are no longer taken.
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February 26, 2009: FDA Drug Information Update
“The U.S. Food and Drug Administration announced today that a facility owned by India-based Ranbaxy
Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta
Sahib, has been under an FDA Import Alert since September 2008.
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February 23, 2009: Medication Safety Alert
“The FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. Patients with predisposing conditions or therapies may be at greater risk for developing metabolic acidosis and the risk of zonisamide-induced metabolic acidosis appears to be more frequent and severe in younger patients.
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February 19, 2009: Medication Safety Alert
“The FDA issued a Public Health Advisory to notify healthcare professionals of three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva®. In October 2008, the labeling for Raptiva® was changed to highlight, in a boxed warning, the risks of life-threatening infections, including PML.
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February 13, 2009: Medication Safety Alert
“The FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept® Medication Guide to provide important safety information in language that patients can easily
comprehend. The FDA regulations require a pharmacist to distribute a copy of the Medication Guide to
every patient who fills a CellCept® prescription from this point forward.
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February 12, 2009: Medication Shortage Alert
Mallinckrodt continues to work diligently to meet the market need during this temporary period of limited supply. Xanodyne has additional releases starting February 20th, 2009. Vintage Pharmaceuticals will be releasing additional product starting February 11th, 2009.
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February 12, 2009: Medication Shortage Alert
“Pfizer has immediately accelerated and increased production of all strengths of Nitrostat® (nitroglycerin) in order to make sublingual nitroglycerin tablets available for patients requiring
this therapy. Pfizer anticipates that they will be able to supply the full Nitrostat® demand within 2 months.
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February 4, 2009: Medication Recall Alert
“Ther-Rx Corporation, a subsidiary of KV Pharmaceutical Company is issuing a voluntary nationwide
recall of prescription prenatal and iron supplement nutritionals as identified below (all lots within their
expiration dates) at a wholesale level.
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February 4, 2009: Medication Recall Alert
“ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa/KVb), is issuing a
voluntary nationwide recall of the products identified below (all lots within their expiration dates) at a
wholesale level. The Company is taking this action as a precautionary measure, because the products
may have been manufactured under conditions that did not sufficiently comply with current Good
Manufacturing Practice (cGMP).
[more...]
January 30, 2009: Medication Shortage Alert
On December 23, 2008 Ethex Corporation informed the FDA that they would
voluntarily suspend all shipments of isosorbide mononitrate extended-release
(ER) tablets (30 mg, 60 mg, and 120 mg).
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January 28, 2009: Medication Recall Alert
“ETHEX Corporation, a subsidiary of KV Pharmaceutical (NYSE: KVa/KVb), is issuing, as previously
disclosed by KV Pharmaceutical Company on January 26, 2009, a nationwide voluntary recall of the
products identified below (all lots within their expiration dates) at a wholesale or a retail level as a
precautionary measure because they may have been manufactured under conditions that did not
sufficiently comply with current Good Manufacturing Practices (cGMPs).
[more...]
January 26, 2009: Medication Safety Review
“The FDA notified healthcare professionals that the makers of Plavix® have agreed to work with the FDA
to conduct studies to obtain additional information that will allow a better understanding and
characterization of the effects of genetic factors and other drugs (especially the proton pump inhibitors
(PPIs)) on the effectiveness of clopidogrel.
[more...]
January 19, 2009: Medication Event Alert
“The FDA issued a public health advisory to remind patients, healthcare professionals, and caregivers about
potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain
from mammography and other medical tests and conditions. The FDA is concerned about the potential for
these products to cause serious, life-threatening adverse effects, such as irregular heartbeat, seizures,
breathing difficulties, coma and even death, when applied to a large area of skin or when the area of
application is covered. The FDA is working with healthcare professional organizations and other media that
distribute healthcare information to spread the message about the potential hazards and safe use of topical
anesthetics. The Advisory and the Dear Colleague letter provide recommendations to both doctors and patients
on safe use of these products.
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January 15, 2009: Medication Shortage Alert
On December 23, 2008 Ethex Corporation informed the FDA that they would
voluntarily suspend all shipments of Metoprolol Succinate Extended-Release
(ER) tablets (25 mg, 50 mg, 100 mg, and 200 mg). Ethex explained its action to
be a precautionary measure that would allow review and enhancement of its
manufacturing, quality, and efficiency systems.
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January 13, 2009: Medication Safety Review Update
“The FDA has provided updated information to its March 2008 Early Communication (see below). The FDA is continuing to review clinical trial data to assess other neuropsychiatric events, (mood and behavioral adverse events) related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As a result, the FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton.
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January 9, 2009:Safety Review UpdateM
“On January 25, 2008, the FDA announced that it would be reviewing data from the ENHANCE trial (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia).
(http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm).
Preliminary results from this trial had indicated that there was no significant difference between Vytorin and simvastatin-treated patients in the thickness of the carotid (neck) arteries despite greater lowering of LDL (bad) cholesterol with Vytorin compared to simvastatin
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January 6, 2009: Medication Recall Alert
“PriCara,® Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., said today that one lot of 50 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and one lot of 50 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recall is being
conducted in cooperation with the U.S. Food and Drug Administration (FDA).
[more...]
January 2, 2009: Medication Event Update
“Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study
suggesting that Innohep® may increase the risk for death, compared to unfractionated heparin when
used to treat elderly patients with renal insufficiency. It recommended consideration of alternatives to
Innohep® when treating these patients for deep vein thrombosis with or without pulmonary embolism.
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