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Pharmaceuticals
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Some veterinarians wary of Novartis’ enticements to carry Sentinel
5/9/2013
Interceptor gone forever, company says
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Vetsulin back with label changes
5/3/2013
Surprising new instructions: ‘shake’ drug to mix
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Panel airs FDA restrictions on livestock antibiotics use
4/25/2013
Achieving greater veterinary oversight not simple
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Changing insulin brands may disrupt diabetics
2/5/2013
Problems in veterinary patients highlight heedless switching
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Veterinary prescription problems aired with regulators
1/12/2013
Pharmacy boards urge veterinarians to file complaints
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Company pursues first lymphoma drug for dogs
1/2/2013
$1.5 million raised to fund effort
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Insiders lift veil off veterinary drug distribution practices
9/25/2012
Upcoming FTC meeting prompts disclosures
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Novartis pleads with veterinarians: ‘Save us a spot’
8/29/2012
Interceptor, Sentinel found online but not in veterinary practices
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Future of Novartis anti-parasitics unfolding
8/23/2012
FDA approves new versions of Interceptor, Sentinel
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Accreditation body questions pharmacies on veterinary drug suppliers
6/28/2012
Vet-VIPPS applications said to be suspended during investigation
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Veterinarians say pharmacists change prescriptions without asking
6/18/2012
Retailers' foray into pet drugs causes rising tensions
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More legal turns in push to restrict antibiotics in livestock
6/12/2012
Disease prevention uses in dispute
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Franck's recall triggered by rash of fungal eye infections
5/29/2012
Pharmacy's ophthalmic drops, parenteral medications included
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Veterinarian opens up about going undercover
5/22/2012
Flea-product diversion adventure twisted, turned
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Merial: PureVax for ferrets coming back this week
4/30/2012
Backorder of distemper vaccine stirred worries
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Judge orders FDA to assess antibiotic safety in livestock
4/2/2012
AVMA responds with support for the judicious use of antimicrobials
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Veterinarians frustrated by Novartis backorders
3/26/2012
Practitioners face supply problems tied to generics-maker Sandoz
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Novartis warns veterinarians of possible Clomicalm tablet mixups
2/1/2012
FDA chastises company, prompts plant shutdown
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Veterinarians confront Internet pharmacy PetMed Express
1/16/2012
Company acknowledges: ‘Some mistakes were made’
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FDA limits cephalosporin use in livestock to curb drug resistance
1/6/2012
AVMA calls new restrictions reasonable
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Novartis temporarily suspends production of Interceptor, Sentinel
12/29/2011
Supply of other, unnamed drugs also impacted by plant improvements
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PetMed Express stumbles
12/8/2011
Competitive pressure up in veterinary-drug sales
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DOJ challenges ruling in veterinary compounding case
11/16/2011
Appeal sought of decision that restricted FDA's authority
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Veterinary compounding out of FDA’s jurisdiction, judge rules
9/13/2011
Franck's wins legal battle against federal regulators
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Immiticide supplies run dry
8/9/2011
New guidance from the American Heartworm Society expected
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Pfizer seeks to unload animal health division
7/8/2011
Sale or spin-off expected
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Gilded Lilly? Bayer challenges Elanco claims
6/24/2011
Bayer challenges Elanco claims about diversion, loyalty to veterinarians
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Researcher promotes awareness of accidental hormone exposure in pets
6/8/2011
VIN tallies more than 100 case reports since 2003
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Scientist fired by Merial alleges Heartgard Plus coverup
6/7/2011
Dr. Kari Blaho-Owens seeks damages, whistleblower protections
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Antibiotics: spinning the data from Denmark
5/27/2011
Antibiotics do little to enhance growth, yet producers still use them
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Antibiotics: precaution vs. proof
5/26/2011
Weighing risk to public health from antibiotics used in livestock
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FDA: Food-animal antibiotic consumption dwarfs human medical use
5/25/2011
New data reveal flaws in figures presented by AVMA, industry
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Scrutiny of livestock antibiotic use pressures veterinary profession
5/24/2011
AVMA negotiates shifting regulatory landscape
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Online veterinary pharmacies exploit cross-border regulatory gaps
4/25/2011
Canine heartworm prevention drugs sold without required prescription
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'Party time’s over’ for flea and tick killer ProMeris
4/21/2011
Pfizer plans to discontinue product in September
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Animal health companies move toward consolidation
4/12/2011
Trend promises to impact veterinary medicine
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Silver lining for veterinary medicine in failed union of pharmaceutical giants
4/11/2011
Competition between drug makers a positive for the profession, experts say
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Shar-Pei owners given affordable access to human drug
4/8/2011
Extreme price hike on colchicine caused stir
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Phenobarbital labeling mix-up results in recall, adverse events
3/10/2011
Veterinarians warned of mislabled Qualitest Pharmaceuticals tablets
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Future of veterinary compounding hangs in balance
2/25/2011
Judge hits federal government with tough questions
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Glycopyrrolate shortage hits human, veterinary medicine
2/24/2011
Atropine suggested as a replacement
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Campaign to defend veterinary compounding may be misdirected
2/18/2011
Lack of specifics from FDA begets confusion
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Vetsulin’s removal from market could be temporary
2/8/2011
Intervet ceases production due to bacterial contamination concerns
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Price soars on popular antibiotic metronidazole
1/13/2011
Limited competition among manufacturers behind increase
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AVMA cautions DEA on plans to raise propofol to controlled status
12/22/2010
Comment period closes Dec. 27
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Target tests market for pet medications
12/22/2010
Trend in retail sales of veterinary drugs accelerating
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Veterinarians scramble for mainstay chemotherapy drug
12/20/2010
Doxorubicin hydrochloride in short supply
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FDA releases government data on antibiotic use in food animals
12/9/2010
Non-therapeutic quantities not specified, leaving key questions unanswered
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Veterinarian struggles to protect her online reputation
12/8/2010
Practitioner suspects Internet extortion is at play
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DEA wants propofol elevated to scheduled status
11/10/2010
Change likely to impact veterinary practices
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PetMed Express reports slip in sales
10/19/2010
Ad costs rise as consumer spending falls with the online pharmacy
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Comments sought on EPA unused-drug disposal recommendations
10/15/2010
Agency skips medical facilities survey, directly drafts guidelines
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Lawsuit raises questions about sale of drugs to non-veterinarian
10/13/2010
Case brought by Bayer against shelter rescheduled for Dec. 2 hearing
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Accidental hormone exposures prompt proposed drug label changes
10/11/2010
Seller of topical hormone Evamist awaiting FDA review
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VIN unveils recall center for veterinarians, consumers
9/27/2010
Site intended to act as information resource
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Scrutiny of secondary topical hormone exposures deepens
9/9/2010
Veterinarians to be surveyed; FDA fields reports involving pets and children
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Supplies of injectable butorphanol tartrate to normalize, veterinary insiders report
9/3/2010
Pfizer Animal Health assures commitment to manufacture Torbugesic
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CEVA buys Summit VetPharm
9/2/2010
Plans to market Vectra parasiticides globally
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Propofol shortage hits veterinary medicine
8/26/2010
Clinics turn to alternatives with production of PropoFlo, Rapinovet stopped
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IV furosemide vanishing from veterinary market
8/12/2010
Medication on back order for months, distributors say
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FDA investigating accidental hormone exposure problem
7/29/2010
Issues safety alert on topical estrogen spray product Evamist
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Hormone replacement skin products affect users’ pets, confound veterinarians
6/10/2010
Symptoms include swollen vulvas, enlarged mammaries, fur loss
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Franck’s Pharmacy negotiates with FDA in Washington on veterinary compounding
5/20/2010
Outcome could have broad effects on industry, some contend
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Bayer wins some, loses some
4/28/2010
New sales policy continues to reverberate
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FDA calls veterinary compounding at Franck’s illegal
4/19/2010
In unprecedented action, agency seeks court injunction against pharmacy
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Heartworm treatment drug remains in short supply
4/15/2010
FDA must approve manufacturing facility, Merial reports
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Brand-name buprenorphine production up
4/14/2010
Extended shortage has had veterinarians scrambling
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Mexiletine hydrochloride is back in 150-mg capsules
4/9/2010
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U.S. EPA confirms problems exist with spot-on flea, tick treatments
3/18/2010
Agency proposes changes in labeling, safety monitoring
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Merial details company stance on product diversion
2/26/2010
Executives speak out after veterinarians question company loyalty
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New feline thyroid drug raises safe-handling questions
2/1/2010
Experts say warnings apply to all forms of methimazole
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Seven labels tied to Teva ketamine recall, FDA says
12/31/2009
Details from FDA could alleviate confusion for practitioners
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Expanded ketamine recall leaves veterinarians with unanswered questions
12/29/2009
Action culminates rocky year for Teva Animal Health
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2009 brought huge consolidations in animal health industry
12/21/2009
Butler and Schein merger latest in a series
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Drug maker sues compounding pharmacy
12/17/2009
Bayer says Wedgewood infringing on patent
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Merial reports Immiticide, Heartgard shortages
12/5/2009
Rationing of Immiticide leaves some veterinarians in a lurch
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Confounding Compounding
11/24/2009
Growth of pharmacy practice fuels worries about quality, future
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Company short on Vetsulin details, veterinarians long on frustration
11/9/2009
Practitioners confused, asking questions about stability concerns following FDA's warning
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BI reportedly stops U.S. sales of Mexitil, sparking concern from veterinarians
10/8/2009
Teva Pharmaceuticals USA might be nation’s only maker of mexiletine hydrochloride
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Dog stuck in crate highlights rare risk of spot-on flea treatment
10/7/2009
Benzyl alcohol acted like glue, sticking pet to plastic
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Virbac recalls Iverhart Plus
8/20/2009
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Propofol recall expanded
8/4/2009
Three additional lots affected
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Teva Animal Health closes shop
8/3/2009
FDA shuts down plant, sparks product availability concerns
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Sanofi makes $4-billion deal with Merck for Merial
7/31/2009
Ultimate plan could create world's largest animal-health company
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Tainted lots of propofol prompt recall
7/15/2009
CDC, FDA urge clinicians to check inventory
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FDA denies Nutro investigation despite reports indicating otherwise
4/27/2009
News outlets retract stories that link pet food to adverse reactions, including death
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Makers of spot-on products summoned for EPA meeting
4/24/2009
Oregon State University is taking adverse reaction reports from veterinarians
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EPA investigates reactions from flea, tick killers
4/17/2009
Agency is scrutinizing products' safety
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HSUS to take Prop 2-like action to Ohio
4/6/2009
Veterinarians gear up for talks to thwart high-stakes conflict with activists
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The flea market
4/6/2009
Exploring the diversion of parasiticides from manufacturers, veterinary offices to Web sites, store shelves
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Economic downturn hits veterinary practices
3/11/2009
New VIN survey results anticipated
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Merck buys Schering-Plough
3/11/2009
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Blockbuster Pfizer-Wyeth deal stirs veterinary medicine
2/9/2009
Merger muddies outlook for Fort Dodge Animal Health
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About-face by Florida regulators eases permit policy for DVMs
1/14/2009
Refunds are on the agenda, FVMA says
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Treatment for Cushing's syndrome to hit market
12/17/2008
FDA approves trilostane for canine patients
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VetCentric Executive Admits Accounts Irk Many
11/23/2008
VetCentric gives veterinarians a hard pill to swallow while altering business model in response to authorities ruling their original business model a kick back for writing prescription.
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Glycopyrrolate shortage?
10/17/2008
It's still in stock, distributors say
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FDA alerts veterinarians to new ivermectin directions
9/10/2008
Merial changes instructions for Eqvalan Liquid for Horses
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EPA survey: How do you dispose of unused pharmaceuticals?
8/29/2008
Agency wants to know why some still dump drugs down the drain
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Theophylline production held up by FDA, manufacturer says
8/11/2008
Drug remains available in 100mg, 200mg tablets
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Veterinarians face atropine shortage?
8/1/2008
Penn Veterinary Supply says it has the drug in stock despite backorder claims
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15 drugs received approval in 2007, FDA reports
7/23/2008
Slentrol, Vetmedin, Cerenia rank among what agency officials characterize as "new therapeutic advances"
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Drug makers agree to ethical code for doctor-company relationships
7/15/2008
Veterinary medicine might be next, insiders say
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FDA approves antimicrobial for aquaculture uses
7/11/2008
Supplemental OK involves Terramycin 200
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UPDATE: FDA bans cephalosporin drugs in food animals
7/3/2008
Federal regulators issue change amid concerns about antimicrobial resistance
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Expanded ketamine recall leaves veterinarians with unanswered questions
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December 29, 2009
By: Jennifer Fiala
For The VIN News Service
The reported death of five cats prompted Teva Animal Health to widen its recall to include all vials of ketamine hydrochloride injection last week, yet the company’s technical services department insists that the action was caused merely by “increased medical events that were kind of unfounded.”
That statement, offered by a Teva technical services representative who did not give her name, has confused some veterinarians. On Dec. 22, the U.S. Food and Drug Administration (FDA) issued a recall alert, instructing practitioners to stop using all 27 lots of Teva’s ketamine hydrochloride injection, USP CIII 100 mg/ml in 10 ml vials due to “serious adverse events.”
The expiration dates of the lots range from September 2009 to February 2012, the FDA says. Additionally, the American Veterinary Medical Association (AVMA) warns practitioners not to rely on the Teva brand name to determine whether their ketamine falls under the recall. Rather, the following signs offer a better indication:
* If the lot number is six numeric digits, the product is not part of the recall.
* If the lot number is seven numeric digits, the product should be returned.
* If the lot number starts with 5401, regardless of the number of digits or the presence of letters in the lot code, the product should be returned.
According to the FDA, reported problems with Teva’s ketamine include lack of effect, prolonged effect and death.
In response, practitioners have contacted the VIN News Service (VNS) looking for insight into the recall, which originated last summer and, at the time, took effect only at the wholesale level.
Troubles within Teva Animal Health surfaced in late July, when the FDA shut down the company via a permanent injunction and filed a lawsuit, alleging that regulatory inspectors had uncovered adulterated animal drugs at Teva’s main facilities in St. Joseph, Mo. The generics manufacturer agreed to cease production of its drugs and its DVM Pharmaceuticals line of products following a much-publicized crackdown by the FDA on the company’s quality control practices.
At the time, Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs, stated: “The FDA will not tolerate the manufacture and distribution of adulterated animal drugs. Veterinarians and pet owners can be assured that the FDA will investigate and take regulatory actions against companies that produce animal drugs under conditions and controls that are inadequate to assure their safety and quality.”
But Laura Alvey, deputy director of communications with the FDA’s Center for Veterinary Medicine (CVM), notes in a recent interview with the VNS that, “FDA’s evaluation was that use or exposure to these products was not likely to cause adverse health consequences.”
To some, that assessment now appears flawed, considering veterinarians have been ordered to stop using Teva ketamine and to return it to their distributors because of the reported feline deaths.
Rumors also have surfaced that the recall affects ketamine manufactured by Teva but sold under private labels. Dr. Sue Kelly, a VIN member and acupuncturist in West Halifax, Vt., says that a Butler Animal Health representative warned that her bottle of Butler-labeled ketamine was included in the recall.
“Nowhere on the label does it say where it was manufactured,” Kelly says of her vial, now boxed and ready for shipment to Butler. “So I called Butler last week, and they told me that it is under the recall and to send it back for a refund. If, in fact, there is product out there that’s not labeled as Teva but is made by them and it’s hard for us to trace, that’s truly alarming.”
While CVM representatives did not immediately respond to a VNS request for clarification, AVMA notes in a Web alert that, "Teva Animal Health also manufactures ketamine products for other companies."
Kay Knox, manager of the Butler’s regulatory affairs, refutes the suggestion that the recall extends beyond Teva's label and says that she’s in the process of sending 14,000 letters to veterinary customers with more of an explanation.
“What I’m telling (veterinarians) right now is that it has to be manufactured by Teva within the dates on the recall notice,” Knox says. “Maybe if my phone stopped ringing I could get these letters out to answer these questions.”
Knox stated that the phone calls she alludes to have not come from veterinarians.
According to CVM spokeswoman Alvey, the events that led up to the ketamine recall expansion began on Nov. 19, when Teva Animal Heath received a report of two cat deaths linked to use of the drug four days earlier. On Dec. 4, the company received three more reports that cats had died following the use of ketamine; two on Oct. 2 and one on Dec. 2. All of the cats received Teva ketamine from the same lot.
Teva Animal Health forwarded reports of those incidents to the FDA on Dec. 7, and the agency received them on Dec. 11.
“The company is not out of compliance with ADE (adverse drug experience) reporting requirements,” writes Alvey in an e-mail to VNS.
She went on express some uncertainty that the adverse reactions were indisputably related to Teva’s ketamine or problems with the drug, by explaining that the anesthetic is typically used in combination with other agents. She also reinforced the fact that all anesthetic drugs “have some inherent risk with the use of them.”
“It is not uncommon to receive reports of one to five deaths per year that may or may not be related to the product,” she writes. “Determining the causality is difficult because of many potentially contributing factors, including other anesthetic agents used, product used during surgical procedures, etc.”
That’s not news to veterinarians, considering most administer anesthetic drugs to manage pain in patients on a regular basis.
But Dr. Meghan Richey, a VIN consultant and boarded anesthesiologist who practices in Oklahoma and regularly uses Fort Dodge’s Ketaset, notes that most pharmaceutical preparations of ketamine are racemic mixtures. Because of this, she wonders if the mixture of sterioisomers in Teva’s ketamine might be off kilter, explaining that the mixture is not always 50/50 in some generic brands due to improper screening.
Such chemical differences, Richey says, can work to lessen the anesthetic agent’s potency or, if there is more of the active S(+) isomer present, cause an exaggerated effect. Richey is careful to note that when it comes to the recall of Teva’s ketamine, she’s merely guessing. But a difference in the relative concentrations of the isomers could account for unusual reactions to the drug or other medical events.
“I don’t have a lot to go on,” she says. “Given the information I have, I am speculating at best.”
When posed with the idea that the drug’s concentration might be off, the Teva technical services representative contacted by VNS insisted: “It’s nothing with the drug. It’s not super-potent.”
Dr. Kristin Fuhrman, of Teva, did not return VNS phone calls seeking a more detailed explanation. Teva spokeswoman Denise Bradley could not be reached for comment.
Veterinarians with questions about the recall can contact Teva Animal Health at (800) 759-3664. Business hours are between 8 a.m. and 5 p.m. CST, weekdays.
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