Price soars on popular antibiotic metronidazole

Limited competition among manufacturers behind increase

January 13, 2011 (published)
By Edie Lau

The price of generic metronidazole, an antibiotic prescribed regularly by veterinarians for dogs and cats with certain infections, has skyrocketed some 700 percent overnight.

Charlie Mayr, a spokesman for Watson Pharmaceuticals — one of a limited number of manufacturers that makes oral tablets and capsules for sale in the United States —  acknowledged in an interview with the VIN News Service that the company raised its prices.

While declining to speak in detail about metronidazole, Mayr said the action follows a pattern common in the generic-drug market: When a drug first goes generic, a number of players enter the market, which tends to push down prices over time. “Then, it no longer becomes profitable, so they gradually depart the marketplace,” Mayr said. “When you get towards the latter stages ... the remaining competitors do tend to take price increases, because they can .... It becomes part of the business rationale for maintaining the product and supply.”

Mayr said Watson’s price hike was on the order of 250 to 300 percent of the "wholesale acquisition cost," which he likened to a list price on cars. He noted that the percentage increase seen by product distributors and their customers could vary from that, depending upon what prices distributors originally paid to the supplier for the drug.

The increase directly and immediately affected prices in the nation’s three largest veterinary product distributorships: Butler Schein, MWI and Webster Veterinary, which experienced and passed on price increases of 600 percent and up.

Veterinarians learning the news from their distributors reacted with dismay. They shared notes in an online discussion of the Veterinary Information Network (VIN), a professional membership organization.

Dr. Scott Vaughan, a practitioner in China Grove, N.C., and a representative and associate editor for VIN, reported that the price from Butler on a 500-count 250-mg bottle leapt from $9.73 to $138.

The VIN News Service was unable to independently confirm the price increase at Butler because a company spokeswoman did not respond to several telephone messages.

At Webster Veterinary, Dr. Scott R. Handler, director of marketing, communications and education, confirmed that his company saw six- to eight-fold price increases on the drug. Handler noted that such a steep rise is rare. He declined to identify from whom Webster obtains its supplies.

MWI, which purchases metronidazole directly from Watson, saw increases of between 600 and 850 percent on five different products, a source said.
The number of current manufacturers of generic metronidazole tablets and capsules approved by the U.S. Food and Drug Administration (FDA) to sell the drug in this country is unclear. Watson’s Mayr said his company, which has headquarters in California and New Jersey, is one of only two remaining. He said Watson supplies about 40 percent of the market. He identified the second active manufacturer as Teva Pharmaceutical Industries Ltd., which is based in Israel with operations worldwide.

An FDA database of approved drug products known as the Orange Book lists six active manufacturers. In addition to Teva and Watson, they are Alembic Ltd. of India; Mutual Pharmaceutical Co., owned by URL Pharma of Philadelphia; Par Pharmaceutical Companies of Woodcliff Lake, N.J., and Pliva, a company in Croatia that was acquired by Teva in 2008.

Teva spokeswoman Denise Bradley said her company has not raised the price of metronidazole since spring 2009. She declined to divulge the magnitude of that increase.

Teva initiated a recall of one lot of metronidazole last month, but Bradley said the recall is limited in scope, did not spur a product shortage and has no relation to the price increase.

She said the recall was caused by the discovery of undersized tablets, part of a lot (No. 312566) distributed in October 2009. She said that the company identified 75 bottles still on shelves, of which it had retrieved 55 as of last week.

Bradley added that for unrelated reasons, metronidazole is on backorder at Teva. She said the cause is “supply constraints” with the raw material.

Metronidazole manufactured by two other companies on the FDA list — Pliva and Par Pharmaceutical — is marketed by Teva. Pliva is owned by Teva. Par is a contract supplier to Teva, according to Par’s manager of sales and marketing, Lyn Pickford.

Mutual spokesman Matthew Scampoli said Mutual no longer manufacturers the drug. A notation on the website of Mutual’s parent, URL Pharma, states that the company has shifted from generic drugs to brand-name pharmaceuticals.

“With a 63-year history distributing and manufacturing generic drugs, peaking ... in 2005, we projected that the manufacturing of U.S. generic drugs would move to Asia, resulting in intense commodity price and profit deterioriation,” the site states. “Thus, in 2004, we formed our branded and technology division and have directed most of our R&D budget towards new branded product development since then.

“...We have also retasked our manufacturing resources, including people and equipment, towards our branded product development.”

Another manufacturer on the FDA’s list, the Indian company Alembic, is listed as having received approval in 2009 from regulators to sell 250-mg and 500-mg tablets and 375-mg capsules of oral metronidazole. It was further cleared in 2010 to market 750-mg extended release tablets.

A company agent in Maryland declined to answer questions from the VIN News Service, saying his client’s business is confidential.

Robert West, deputy director of the FDA’s Office of Generic Drugs, said the Orange Book is updated daily and that most companies readily inform the agency when they discontinue products. However, he added, companies are obligated to notify the agency about changes in marketing status only once yearly.

West said the FDA is not involved in drug pricing and has no information about price increases. “We do not get involved in financial issues,” he said. “What you’re (describing with metronidazole) is simple supply and demand in the marketplace. The agency really has no position on that. It’s a business decision.”

Metronidazole, which also is available as the brand-name antibiotic Flagyl marketed by Pfizer, is approved for use in humans but long has been used off-label by veterinarians to treat dogs and cats for anaerobic bacterial infections — most frequently, for conditions that result in digestive and intestinal problems such as colitis, giardiasis, inflammatory bowel disease, enteritis and gastroenteritis.

In their online discussion, members of VIN lamented the pricing development and shared information on suppliers and possible substitute drugs.

“Sounds like these lovely pharmaceutical companies are really jacking up costs if they are the only game in town,” wrote Dr. Angela Anderson, a practitioner in Sioux Falls, S.D. “Seems like some competition should be in order. Soooooo frustrating.”

Dr. Joey Gaines, owner of two practices in Omaha, Neb., told the VIN News Service that metronidazole became a mainstay in small-animal practice because it was cheap and effective.

“It works almost all the time,” she said.

One alternative Gaines identified is the antibiotic tylosin. Unfortunately, tylosin is a bitter-tasting powder, which makes it more difficult to administer, she said. Metronidazole also is notoriously bitter, but as a pill, it can be easier to give.

However, the flavor of metronidazole can be a problem as well, especially for cats. Consequently, it is one of the most commonly compounded drugs placed in suspension, which masks the unpleasant taste, according to Dr. Brett Cordes, veterinary medical director of animal health at The Apothecary Shops, a pharmacy chain based in Phoenix.

Medication compounding — the custom preparation of drugs by pharmacists — is legal when serving the needs of patients for whom FDA-approved, commercially available drugs do not suffice. However, medications are not supposed to be compounded simply to enable a customer to avoid paying higher prices for commercially available drugs.

All the same, Cordes predicted that the drastic price change on metronidazole would prove a boon to compounders. “My guess is, we’ll see a lot more (orders for) suspensions being called in,” he said.

Another alternative to metronidazole suggested in the VIN discussion is the antibiotic sulfasalazine. In addition, Gaines, said, practitioners might be more apt to consider placing dogs prone to diarrhea while under stress — such as while being boarded — on prebiotics or probiotics in hopes of preventing stomach upset.

Yet another option is for practitioners to provide prescriptions to clients to have filled in human pharmacies. The price increase seems not to be reflected in those outlets, at least not yet. Searches of Walmart’s and Target’s online generics prescription databases, for example, show that a bottle of 28 250-mg tablets can still be had for $4; and 84 tablets for $10.

However, sending clients to outside pharmacies is not a popular notion among veterinarians.

“You lose an income stream,” said a practitioner who asked not to be named because of the sensitivity of the subject. “It’s more time-consuming for me to write a prescription, and then I don’t make any money on it.”

But Gaines said she would rather keep clients’ trust that she is working in their best interest than their pharmacy business. “I think in general, overall, we’re losing our (in-house) pharmacies, whether it be to Walmart or Walgreens or the Internet. I don’t want to be dependent on my pharmacy so I’m trying not to get worked up over something I have no control over,” she said.

“I’m more worried about chemotherapy drugs being backordered,” she added, noting that a recent shortage of a cancer-treatment medication had tragic consequences for one of her patients, who had to be euthanized.

Metronidazole — as useful and frequently called for as it is — is not on the same scale, Gaines said: “Looking at the big picture, it’s not a life or death thing in a majority of cases.”

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