Rimadyl: Friend or Foe
Steve’s entire award winning four-part series on Rimadyl. In 2000, Steve felt coverage of the Rimadyl story was superficial, so he embarked on this four-part series. To this day, he continues to receive requests…so, we’ve archived the articles here for you.
There are 52.9 million dogs in America; about half might one day be a candidate for Rimadyl. The acceptance of this non-steroidal anti-inflammatory drug has been staggering; four million dogs have popped this pill since its January, 1997 introduction. Rimadyl is used to relieve pain short term as a post surgical analgesic and longer term for osteoarthritis (and associated joint problems), which afflicts more than eight million dogs. However, it turns out this well received drug has several side-effects which can lead to death.
The Rimadyl drama has been played out on the Internet and in the media, inaccurate reporting has left pet owners confused. This four-part series intends to answer tough questions fairly, and depicts how Rimadyl’s story may forever alter how drugs will be dispensed to pet owners. Here’s part one of the series.
By Steve Dale
It may have been the busiest morning ever at Blum Animal Hospital in Chicago. The phone rang off the hook, people were clamoring for Rimadyl, a new non-steroidal anti-inflammatory drug which can help arthritic dogs.
The marketing campaign for Rimadyl hadn’t yet begun. Still, Internet buzz alone prompted an immediate onslaught the very day the drug was introduced to the U.S. market in January
1997, following approval from the Food and Drug Administration (FDA).
“In my 32 years of practice, I’ve never seen anything like it,” says Blum Chief of Staff Dr. Sheldon Rubin. “We didn’t even have the drug (at the clinic) yet. We took names on a waiting list, like we were offering tickets to a rock concert or Cubs game.”
Within months after Rimadyl first came out, Peter and Cindy Schramm happened to have an appointment with Rubin. Their 8-year old Pembroke Welsh corgi, named Bernie, had osteoarthritis so bad he could no longer climb stairs. “Bernie’s personality changed – he didn’t even want to be petted; he was in constant pain,” says Cindy. “We were desperate, poor Bernie was only just past middle-aged.”
Around the same time in John’s Island, SC Jean Townsend didn’t know what to do for George, whose osteoarthritis was worsening. It looked like George was a chocolate Labrador retriever, and about 11 or 12-years old. But she didn’t know for sure, since George was a stray who literally found Jean.
She’s the kind of pet lover who wears her heart on her sleeve. At the time, she had ten dogs, most of them were strays. “It’s as if dogs in need are attracted to me,” she says. Now, her heart was breaking for her crippled dog.
For both dogs, the answer seemed like a no-brainer – Rimadyl (generically called carprofen), the drug is particularly suited to treat osteoarthritis.
Within days, Bernie was his old self, bounding up and down stairs – at least as much as any corgi can bound – and again he loved to be petted. Today, he’s still on the twice daily pill that his owners say brought Bernie back to life.
George’s results were less dramatic, but Townsend noted at least some improvement, so she continued to use Rimadyl for about a month. Then, one morning George suddenly got very sick. He could barely move, he couldn’t keep food down. George’s condition worsened and within days he was being cared for by vets around the clock; he was no longer able to stand and could barely keep his head up.
Townsend fails in her attempt to hold back tears as she recalls, “I looked into his eyes and George told me ‘enough.’ We ended his suffering on October 13, 1997.”
A necropsy (an autopsy for animals) revealed acute hemorrhaging, essentially his insides blew up. Veterinarians agreed Rimadyl contributed significantly to George’s death. In fact, Townsend was so convinced of this fact, she leveled a class action law suit again Pfizer Animal Health, the Exton, PA manufacturer of Rimadyl.
Townsend isn’t alone. The FDA Center for Veterinary Medicine (CVM) reports 4,596 Adverse Drug Experiences (ADE) filed by users of Rimadyl, and 651 suspected deaths with Rimadyl being an alleged contributing factor. This is a record number of ADE reports for a drug for pets. In fact, of all the ADE’s filed in 1998 with the FDA/CVM, 43 percent targeted Rimadyl.
However, the story isn’t that simple. For one thing, just because it’s alleged that Rimadyl may be contributed to a dog’s ill health, or death – it doesn’t necessarily mean it’s true in every instance.
The FDA/CVM does concur Rimadyl has arguably enjoyed the most successful introduction of any drug in the history of veterinary medicine. That’s saying something since veterinarians, generally a conservative bunch, are tentative about jumping on the bandwagon for any new drug.
Osteoarthritis and related joint problems have increased in recent years – and continue to increase – because dogs are living longer than ever, because far too many dogs are obese, as well as genetic factors. In severe cases – of which there may be millions – dogs can barely walk; the pain is agonizing and surgery is not an option.
Before Rimadyl hit the market vets once said, “Take two aspirin and call me in the morning” or they’d prescribe steroids.
Long-term usage of steroids can create severe side-effects. “Aspirin is cheap, but otherwise doesn’t cut it for dogs, their systems can’t tolerate aspirin,” says Dr. Jon Dee, Board certified veterinary surgeon in Hollywood, FL..
Rimadyl, it seemed, was a better option, it promised to be far more tolerant to canine gastro intestinal systems than aspirin and with fewer side effects than steroids or aspirin.
With so many dogs so desperate for pain relief, it’s no wonder word spread via the Internet faster than a greyhound can sprint. At dog parks across the country, everyone was talking about a great new hope called Rimadyl.
Actually, Rimadyl was first expected to be marketed for use in people. In 1988 it received FDA approval, but developer Roche Laboratories decided the market for such drugs was overcrowded, and they dropped it. With a desperate need for an effective and safe drug for pain relief for dogs, Pfizer saw a niche. After all, pet drugs are a big business, a howling $3 billion plus are spent annually on drugs for companion animals.
Pfizer wasn’t about to depend on word of mouth to promote their new product. – they spent millions on marketing, which on the surface seems okay because that’s what pharmaceutical companies do these days. However, this is where some say things began to go wrong.
Next week: Why Pfizer ultimately pulled their TV ads, and whether one “side effect” from using Rimadyl really is death. Also, human physicians offer surprising evidence that a similar drug to Rimadyl – aspirin – may actually cause death in people.
“Watching those TV ads made Rimadyl seem like the fountain of youth,” Robert Sinclair of West Bloomfield, MI says.
Officials at Pfizer Animal Health, Exton, PA , won’t say exactly how much money they’ve spent on marketing Rimadyl, but it certainly sets a record for dollars spent to launch a drug for dogs. Most importantly, the campaign reached consumers in record numbers. Today, those Rimadyl TV spots are gone.
The television commercials featured elderly dogs, once hobbled by osteoarthritis, now running and jumping pain free. In print ads, the headline read, “Give your dog relief from arthritis pain, and give your children back their favorite companion.”
“Those ads are absolutely true,” says Louise Clements of Meridian, ID. Brass, her 14-year old Pembroke Welsh corgi, couldn’t walk down two steps to do her business outside because of osteoarthritis. Within 48 hours of taking Rimadyl the pooch was acting like pretty much like a puppy again. “It was our own little miracle,” Clements says.
Misty, Sinclair’s 17 year old toy poodle, was put on Rimadyl in October of 1997. Misty’s arthritis improved, but by her third week on the drug she was having other serious medical problems. At first Robert and his wife Jayne thought their dog might be experiencing congestive heart failure. “The vets never said anything about (Rimadyl) side effects,” Jayne says.
As poor Misty languished, the Sinclair’s went online frantically trying to figure out what was going wrong with their beloved pet. They became convinced the use of Rimadyl was playing a role in their dog’s decline. By now, the U.S. Food And Drug Administration Center for Veterinary Medicine (FDA/CVM) website (www.fda.gov/cvm/) and the Senior Dog site (www.srdogs.com) had online lists of potential adverse reactions due to Rimadyl. The side-effects listed matched the symptoms Misty was now having. But the Sinclair’s efforts proved too late. Misty went downhill, suffering far more than the pain she was put on the Rimadyl for in the first place. Finally, the little pooch was put out of her misery.
The Sinclairs are certain Rimadyl caused their dog’s demise. “Old age is not a disease,” Bob says. “I was horrified.”
“Many of the dogs on Rimadyl are old, and may have had pre-existing liver or renal disease or weren’t carefully pre-screened,” says Board certified orthopedic veterinarian Dr. Steve Budsberg, professor of surgery at the University of Georgia College Of Veterinary Medicine – Athens. “Being older, they may have underlying problems (that are) not easily detected, even with appropriate and thorough testing. Also, it may be difficult to predict idiosyncratic (individually unique) medical problems that seem to potentially occur with Rimadyl; that’s the nature of NSAID’s.” (NSAID’s are nonsteroidal antiinflammatory drugs. NSAID’s also include aspirin and Ibuprofen.) It’s also the nature of dealing with older dogs.
While being old is not a disease, the systems of these animals aren’t what they once were. Similarly, sometimes elderly people who might not have adversely responded to a drug 15 years early suddenly had an unexplained reaction.
According to Pfizer, fewer than one percent of all Rimadyl users reported cases of Adverse Drug Experiences (ADE’s) or side-effects to the Food and Drug Administration Center for Veterinary Medicine (FDA/CVM). In 1998 the suspected death rate where Rimadyl is implied (not necessarily proven) as a factor is 1.3 dogs per 10,000. (When you actually do the arithmetic, considering four million dogs have been given Rimadyl, less than 200 hundredths of one per cent of dogs have been harmed by Rimadyl.)
“That’s pretty darn good,” says Dr. Eli Ehrenpreis, assistant professor of clinical medicine at the University of Chicago. “The truth is that most human drugs are capable of a wide range adverse reactions, just read the fine print when you pick up a prescription. For example, aspirin (in the same drug class family as Rimadyl) can kill people.”
According to a report entitled “Gastrointestinal Toxicity of Nonsteroidal Antiinflammatory Drugs,” (by Dr. Michael Wolfe, Dr. David R. Lichtenstein and Dr. Gurkirpal Singh) published in the New England Journal of Medicine, June 1999, indicating potential side-effects of NSAID’s (on people), 7.3 of every 1,000 patients who take an NSAID for osteoarthritis suffer gastrointestinal complications with103,000 known hospitalization visits annually, costing $52 billion. According to this study, at least 16,500 deaths a year are attributed to the use of an NSAID (in people).
Ehrenpreis is an expert on the potential serious adverse affects of NSAID’s and is Board Certified in gastroenterology and Board eligible in clinical pharmacology. “Making a decision about prescribing any drug is weighing risks compared to benefits,” he adds. Ehrenpreis himself takes a buffered aspirin every other day, as do millions of Americans.
Still, listen to Bayer aspirin radio commercials, and you’ll hear the disclaimer: “Aspirin is not appropriate for everyone. Consult your doctor.”
Pfizer concedes, “Rimadyl is in a serious class of potent drugs and should carefully be considered,” according to director of special services Dr. Edward Kanara.
As the FDA/CVM began to document side-effects, they requested Pfizer change the Rimadyl package insert to list adverse drug reactions; Pfizer complied in May of 1997, only five months after the drug was first introduced. Pfizer also mailed a ‘Dear Doctor’ letter to vets which outlined the latest information available, and subsequently made several additional changes to the Rimadyl package insert.
As of April of 1999, 49 side effects were documented by the FDA/CVM in eight categories. Adverse reaction range from mild gastrointestinal upset (diarrhea and/or vomiting) to changes in behavior to serious liver or renal dysfunction. The package insert was also changed to read, “In rare situations, death has been associated with some of the adverse reactions…”
Dr. Bill Keller, director of the Division of Surveillance at the FDA/CVM says Pfizer has been due diligent, very responsible about making appropriate label changes.”
However, not everyone sees it that way. Robert Sinclair says, “A dog is no more a statistic than a child. Pfizer spent millions on their TV ads, but they sure didn’t spend millions informing us of the possible dangers (of Rimadyl).”
The FDA also asked Pfizer to include ‘death’ as a possible side effect in the TV campaign. Pfizer didn’t want theirs heartening 30 second TV ads with a bounding, leaping tail-wagging dog to culminate with that warning, so they chose to cease their TV commercials all together.
Pfizer has made offers to reimburse veterinary costs related to treatments for at least some pet owners with apparently valid claims of severe reactions, including death. However, many say Pfizer will only reimburse vet bills if various conditions – such as releasing Pfizer from all blame in writing – are met. Kanara says there may have been some miscommunication early on, but denies Pfizer is now demanding any “conditions.”
Nancy Friedman, a retired Chicago nurse says she spend $2,500 on Bravo, her 8-year old Rottweiler that an FDA/CVM investigation concurred “crashed” as an adverse response to Rimadyl. “My initial reaction is that no amount of money can replace Bravo – period,” says Friedman. “This should never have happened. I was duped by their ad campaign.”
Next week: Some vets didn’t warn their clients about the potential side-effects. Can vets be swayed by incentives offered by drug companies? And what all dog owners need to know about Rimadyl. You’ll also learn how you can get a free videotape about Rimadyl
Poochie was 9-years old, not exactly a spring chicken for a 107-lb. German shepherd dog/Alaskan Malamute mix. Still, Poochie was in generally good health.
“I never expected him to die like this,” says Sandy Salzinger, a violinist with the Atlanta Symphony Orchestra.
Poochie was having hip problems, difficulty walking, not unusual considering his girth and age. In September, 1999, the veterinarian prescribed Rimadyl, an obvious choice.
“I’m absolutely sure I was not told about any fatal side-effects,” says Salzinger. Although, he does admit he may have been given printed information with warnings, but adds, “I suppose I tossed it without reading.”
For several months, Poochie had no apparent problems. “Rimadyl worked marvelously, his pain disappeared,” Salzinger says.
On February 1, Poochie didn’t want to eat and appeared listless. Poochie was first diagnosed with an enlarged liver and ultimately with autoimmune hemolytic anemia. Four days later, Poochie was dead.
Sazlinger never thought about an adverse drug reaction, until he read a story about Rimadyl in the Wall Street Journal.
According to Salzinger, Poochie’s liver and renal function were not thoroughly checked prior prescribing Rimadyl, which is recommended. Also, periodic assessments of liver values are typically suggested during the course of taking Rimadyl, but not considered in this case.
Atlanta, GA veterinarian Dr. Andrea Dunnings confirmed later that Rimadyl may have indeed contributed to her client’s dog’s death. “I don’t know absolutely what happened (to Poochie). But I’m hesitant to place the blame on Rimadyl for certain.” There was no necropsy (an animal autopsy), so no one will ever know.
Dunnings is confident she did warn her client of some common side-effects, particularly gastrointestinal upset. She concedes she didn’t rattle off each and every potential adverse reaction, and she didn’t mention potential death. “I’ve never seen a serious side effect (due to Rimadyl),” she said.
Robert Sinclair of West Bloomfield, MI is one of the more outspoken voices in a loose-knit group called B.A.R.K.S., (Be Aware of Rimadyl’s Known Side Effects). He lost his own toy poodle, Misty, as a result of an adverse reaction to Rimadyl. Sinclair says some vets are motivated to push Rimadyl because its manufacturer, Pfizer Animal Health of Exton, PA, offers incentives for selling big volume. “To push this dangerous drug is a game of Rimadyl roulette,” he says.
Veterinarians and Pfizer have confirmed these incentives do exist, rewards for points earned for sales include palm pilots, ZIP drives for computers, veterinary books and tuition for continuing education.
Dr. Sheldon Rubin has been a private practitioner in Chicago for 32 years. He says other pharmaceutical companies (in addition to Pfizer) offer similar programs tied to sales. “I can’t imagine a veterinary professional making a decision about a drug based on receiving a book or a palm pilot,” he says.
Dr. Leonard Seda, president of the Schaumburg, IL based American Veterinary Medical Association points out his counterparts in human medicine are also offered incentives, and of far greater overall value. “As far as I know Pfizer has done nothing that hints at being unethical,” he says. “There clearly has never been so much press or hoopla, or so much emotion surrounding concerns about a veterinary drug.”
However, this isn’t the first time a drug for pets has entered the market followed by a near immediate wave of side effects or adverse reactions.
A drug called Heartgard appeared with a big time introduction in 1988 (originally a product Merck AgVet, now manufactured by Merial, Duluth, GA) to pervent mosquito-transmitted heartworm disease. It turns out Heartgard and another similar drug (Interceptor) have an active ingredient called ivermectin that in some cases created several serious adverse reactions that no one suspected, most dramatically death in collies.
Dr. Bill Keller, director of surveillance with the Food and Drug Administration Center for Veterinary Medicine (FDA/CVM) explains that clinical trials for animal drugs are done differently than tests for human drugs. Typically, one twentieth of the number of dogs are used as test subjects when doing trials for animal drugs, than the number of people who partake in trials for human medications. There were approximately 500 dogs involved in the Rimadyl trials.
“The reality is cost,” says Keller. “If clinical trials for animals had the same requirements as trials for people, we wouldn’t have (any) drugs for pets coming to market.”
Some argue, the biggest difference between the response to Heartgard’s adverse reactions in1988 and Rimadyls reactions is the Internet. Adverse Drug Experiences can now be filed directly to the FDA/CVM with a click of a mouse, instead of weaving through government bureaucratic paperwork. Also, those who have experienced problems – such as members of B.A.R.K.S., correspond with one another via Email, and reach out to pet owners through “list serves.”. There are many “list serves” with users discussing Rimadyl over the Internet, including local breed clubs and pet chats that discuss the issue on a nightly basis. Some of these postings have deteriorated to gossip and scare tactics. Still, much of what’s available is legit, including a ten-minute video produced by B.A.R.K.S. called “Rimadyl Update.” The video is now available for $4. (Send to Cheryl Walton, c/o B.A.R.K.S., Advance Multimedia, 26600 Telegraph Road, Suite 181, Southfield, MI 48034).
This fervor has launched a unique media onslaught in the popular press about a drug for dogs. Rimadyl happened to be the first non-steroidal anti Inflammatory drug of its kind. A similar drug to Rimadyl, called EtoGesic (Fort Dodge Animal Health), was released about year later, but with less fanfare, and it hasn’t reached anywhere near the popularity of Rimadyl. Sure enough, about a year after the reported Adverse Drug Reactions began to pile in for Rimadyl, they began to trickle in for EtoGesic.
Dr. Jon Dee, a Board certified surgeon from Hollywood, FL has arguably prescribed more Rimadyl than any other vet in the U.S. He used Rimadyl off label two years before FDA approval. As far as he knows none of his canine clients have suffered an adverse reaction more serious than minor gastrointestinal upset. In fact, he used Rimadyl for two years on his own yellow Labrador, who suffered from degenerative joint disease, from ages 12 to 14.
“If it wasn’t for Rimadyl, Nolan would now be dead,” says Sheree Parks of San Diego, CA. Nolan is the family’s 12-year old golden retriever who began taking the twice daily pill in March of 1999 and hasn’t missed one since. “His pain was enormous; he could barely move,” adds Parks. “Friends were telling us to euthanize Nolan. We tried Cosequin (Glucosamine/Chondroitin Sulfate, a nutritional supplement). It worked for a while but ultimately provided no relief. Even acupuncture was no longer helping. It’s not only the extra time we have with Nolan that matters, it’s that Nolan is now enjoying quality life without pain.”
“Rimadyl is a tool, the best one now available to ease pain of osteoarthritis,” says Dee. “Like any tool, it can be used wisely or unwisely.”
“I’m not anti-Rimadyl,” says Mary Gadbois of East Lyme, CN, whose 13-year old Siberian husky suffered what appeared to be a serious adverse reaction to Rimadyl. “It’s just that vets, the FDA and the pharmaceutical companies need to do a better job of informing consumers. We pay the bills, it’s our right to know about these drugs.”
(Next week: The giant leap Pfizer has made to communicate with pet owners, and whether other pharmaceutical companies will follow.
“If a member of my family gets a (prescription) drug, I receive all kinds of printed information about potential side-effects, it’s required by law,” says Robert Sinclair of West Bloomfield, MI., an outspoken voice in the loosely-knit group organized on the Internet known as B.A.R.K.S. (Be Aware of Rimadyl’s Known Side Effects). “We’re entitled to the same information concerning drugs for our four legged family members.”
Americans have more than 115 million pets, and spend in excess of $3 billion a year on drugs for their care. With spending on companion animals increasing at a rate of 20 per cent annually, this makes animal health one of the fastest growing segments of the entire pharmaceutical industry.
Even the typically standoffish Food and Drug Administration (FDA) barks out loud their association with the burgeoning pet market. The FDA proudly hurried to write their own press releases in an effort to tout two products they approved in 1999: CLOMICALM (Novartis Animal Health), a drug for dogs who suffer anxiety-related issues; and a drug called Anipryl (Pfizer Animal Health) which eases the effects of a disease much like Alzheimer’s in people called Canine Cognitive Syndrome.
Still, the majority of drugs used by vets are prescribed off label, meaning these medications haven’t specifically been tested for treating pets (but have been FDA tested and approved on people). Off label prescriptions have been a longstanding veterinary practice. Examples range from stalwarts such as Prednisolone – a steroid used for a variety of ailments from allergies to autoimmune disease – to fairly recent products, such as Prozac, used for several purposes including aggression in dogs.
“Because pet owners are uninformed there are pets suffering every day,” Sinclair says.
Veronica Stantson of Plymouth, MA dissolved her cat’s medication in milk for months, but Peaches condition worsened, and she was eventually hospitalized. Only when Stantson happened to mention told her vet about her technique for encouraging Peaches to lap up her medication did she learn that milk totally negated the pill’s effects.
A Rottweiler, named Leisel, had been on Prednisolone, and then was put on Eto Gesic (a non-steroidal anti-inflammatory drug from Fort Dodge Animal Heath that works much like Rimadyl) by a second veterinarian. That vet never asked the dog’s owner, Delores Mays of Anapolis, MD, what other medications Leisel might be on. As a result of taking two contraindicated drugs, Leisel nearly died. Just before a frustrated and desperate emergency veterinary team was about to euthanize Leisel, one vet inquired, “Is your dog by any chance on another drug?” With that last minute information, the vet managed to heroically save Leisel’s life.
Who do you blame? Are vets at fault for not communicating with clients? Are pharmaceutical companies at fault for not informing consumers of all known information about drugs for pets? Or can pet owners even be at fault?
“It’s not a matter of fault, it’s also human nature, now that pets have become members of our families, we’re desperate to get them well, ” explains Dr. Leonard Seda, president of the Schaumburg, IL-based American Veterinary Medical Association, and a vet in private practice for 41 years. “It’s human nature to minimize any risks in your own mind – you don’t hear what the veterinarian is really telling you. I have a spouse who’s been through cancer (treatments), I’ve been there; I understand how this can happen.”
Still, it seems clear not all vets are telling clients about potential adverse reactions, they’re either rushed or they just don’t know the potential side-effects themselves. When Bravo became ill after taking Rimadyl in February of 1999, Nancy Friedman of Chicago never thought about an adverse drug reaction. She figured Bravo, a Rottweiler Champion show dog, just picked up ‘a bug’ at a dog show. However, her health care professional should have thought about the possibility of an adverse drug reaction before placing Bravo on Rimadyl a second time several months later. Bravo became very ill very quickly and soon died. According to Friedman, the FDA Center for Veterinary Medicine (CVM) later concurred Rimadyl was likely to have precipitated her dog’s death.
“Pfizer has been walking a pharmaceutical tightrope,” says Ross Becker, publisher of Good Dog Magazine (and www.gooddogmagazine.com), a sort of Consumer Reports for canines; he’s been following this story closely and reporting on it from the very beginning. “What bothers pet owners most is that they weren’t warned about side-effects. It’s clear, there are too many holes in the current system – there’s got to be a better way to inform consumers about the drugs their pets are taking.”
Perhaps, Pfizer created that better way. In February (2000), they released a page of Dog Owner Information about Rimadyl which is automatically included in pre-packaged seven and 30 day supplies of the drug.
Seda says the information on this page (printed on both sides) about potential adverse reactions, interactions with other drugs, and dosage and administration is far easier to understand than the complicated medical jargon consumers receive for their own drugs.
Pfizer is planning to create similar user friendly disclosures for their other animal drugs. “We answer tough questions that consumers should ask about any drug prescribed for their pet,” says Dr. Edward Kanara, director of technical services for Pfizer.
However, apparently, not all pharmaceutical companies are as willing. For example, Novartis, a major player in animal health, refused to comment on the issue.
No wonder, voluntary disclosures aren’t enough to please several pet owners who have taken action recently, including Jean Townsend of John’s Island, SC who leveled a class action lawsuit against Pfizer (after her dog died allegedly as a result of using Rimadyl), Townsend and Sinclair attended an FDA/CVM meeting in April (2000), and called for the FDA to create for federal legislation. Such regulations would mandate pharmaceutical companies and the veterinary industry provide consumers with all known information about the drugs prescribed for their pets.
Although Seda says he wants to find ways to better inform pet owners, he doesn’t want a government agency to oversee the veterinary industry. And he’s not alone. That government agency doesn’t want to do it either. Dr. Bill Keller, director of surveillance at the FDA/CVM says there are “resource limitations,” meaning budget restraints.
On recently approved FDA approved drugs for animals, pharmaceutical manufacturers do include at least most of the jargon we read on labels for human drugs. The problem is that many drugs are dispensed by vets in little plastic bottles without any such information, not to mention the vast array of medications that are prescribed off label or longtime animal drugs where current facts about side effects and contraindications are not documented.
“Still, vets have a responsibility to provide whatever information is known about a drug, everything from whether it should be refrigerated to whether there are any potential serious side effects,” Sinclair says.
“At the very least you’d think the FDA could mandate that vets and pharmaceutical companies find a way provide easy to understand owner information for all drugs approved over the past five years, or the past ten years,” adds Sinclair. “Drug companies could follow Pfizer’s lead with all pre-packaged products, and computer programs are now available – and with demand others will no doubt step up to the plate – so vets can print out information whenever they dispense in those little plastic vials.”
“Currently, the FDA takes nearly a year to provide summaries and information to the public about adverse drug reactions,” Sinclair adds.
Becker says, “The FDA managed to find a way to fully inform people about human drugs, you bet they ought to do the same for companion animals. Pets can’t read or ask questions, it’s our responsibility. I believe we all learned several lessons from the Rimadyl story. All drugs have potential side effects, and people need to ask questions about medications. If your vet doesn’t take the time to answer, consider another vet. If your vet doesn’t know the answer, wait for one. Potentially saving your pet’s life is worth it.”