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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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U.S. EPA confirms problems exist with spot-on flea, tick treatments
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March 18, 2010
By: Edie Lau
For The VIN News Service
The U.S. Environmental Protection Agency (EPA) is calling for an array of changes in the way spot-on pet flea and tick prevention products are tested, labeled and monitored, following a 10-month evaluation of health problems, including deaths, associated with use of the products.
In a 90-minute Webcast Wednesday that was open to the public, agency officials acknowledged that the numbers and types of “adverse incidents” reported by pet owners in recent years warrant action by the government. The EPA published its proposals in today's Federal Register and will take public comment for 60 days. Officials could not predict when labeling and other product changes might take effect.
“The bottom line is that the (EPA’s) Office of Pesticide Programs believes it is necessary to make significant changes in how we regulate pet spot-on products,” said Lois Rossi, director of EPA’s pesticide registration division.
The flea and tick killers are known as “spot-on” products because they come as liquids that are dabbed onto the skin of a pet’s back, usually between the shoulders. The products typically are applied once a month during flea and tick season to prevent infestations.
Most spot-ons, which as a class were introduced more than a decade ago, are considered highly effective in controlling parasites that can transmit disease as well as cause discomfort to pets.
However, the EPA, which regards the products as pesticides, became concerned about safety when the number of “adverse incidents” reported shot up 53 percent between 2007 and 2008.
In 2008, 44,000 incidents were reported. That equaled one incident for every 6,136 doses sold (a total of 270 million doses were sold that year).
The majority of incidents were classified as minor — along the lines of skin irritations that resolved quickly — but all products were associated with deaths and other major incidents, as well, said Dr. Kit Farwell, a veterinarian and toxicologist in the EPA’s Health Effects Division.
The organ systems affected were dermal, gastrointestinal, neurological, ocular and respiratory — the last two only rarely, Farwell said.
The EPA’s analysis, conducted with input from the U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM) and Canada’s Pest Management Regulatory Authority, looked at 21 different products registered by Bayer, Fort Dodge (now Pfizer), Hartz, Merial, Pet Logic, Sargeants, Summit VetPharm and Wellmark. Reports on each are posted on the EPA's Web site.
The evaluation did not identify particular ingredients nor specific product lines as the problem. “I don’t believe there’s necessarily one group of products that’s safer than another,” said Farwell, who led the scientific review.
Rather, problems apparently were shared among the whole class of spot-ons. Among the issues the agency identified:
Products designed for cats and products designed for dogs need to be better differentiated from one another. In particular, cats being exposed to dog products is “a big problem, and label warnings are not effective,” Farwell said.
The problem is twofold, he said: “Not only are cats getting a larger dose (due to their typically smaller size), but cats are more sensitive to a lot more chemicals.”
In some cases, cats were treated directly with products made for dogs; in other cases, cats were exposed to dogs that had been treated. Officials advised keeping cats away from dogs for a period immediately following treatment.
For the future, the EPA is proposing a prohibition on using the same brand names on cat and dog products. That would apply even to formulations that are safe to use on cats and dogs alike, said Kimberly Nesci, an EPA Registration Division official.
"What we want to do is put out to the public a message that dog products should never be used on cats,” Nesci said. “We want that message to be universal.”
Dosages may be assigned to too broad a range of weights, the EPA stated. Consumers typically choose a spot-on treatment based on the species and weight of their pet. As an example, the product Frontline Plus for Dogs comes in four dosage sizes: for dogs 22 pounds and less; dogs between 23 and 44 pounds; dogs between 45 and 88 pounds; and dogs between 89 and 132 pounds.
Farwell said that in some cases, animals at the low or high end of their weight range may be receiving too much or not enough of a dose. Nesci said the agency is considering labeling and/or packaging changes that would result in narrower weight ranges.
Spot-on treatments are not monitored by the government once their registration has been approved. Unlike drugs approved by the FDA, the officials said, flea and tick treatments do not undergo post-market surveillance. The EPA said it would like to grant conditional registrations for new products, which would give the agency an opportunity to monitor the safety of products after they go to market.
Safety testing required before products are registered may be inadequate. Specifically, Farwell said the beagle is the standard laboratory animal used for companion-animal safety studies, but that breed is not sensitive to spot-on products. “The beagle is not the appropriate animal,” he said. He did not say what changes, if any, the agency would propose on testing protocol.
The EPA said it also will pursue whether inert ingredients may be contributing to adverse reactions.
Meanwhile, pet owners are advised to continue using flea and tick treatments as needed and to follow existing label instructions.
Information and updates on the EPA’s ongoing evaluation of spot-on products is posted at http://www.epa.gov/pesticides/health/petproductseval.html.
EPA officials involved with the evaluation can be reached by e-mail at pets@epa.gov
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