Dentistry has been grappling with shortages of the antibiotics doxycycline and tetracycline, but both have become available again. Tetracycline capsules went back on the market in October after generic drugs manufacturer Heritage Pharmaceuticals began production; the firm is also selling two forms of doxycycline: monohydrate and delayed release.
"We were the first back after a two-year shortage," Jeff Glazer, president and CEO of Heritage, said during an interview with DrBicuspid.com. "It was on shortage due to a discontinuance of an ingredient. It's fair to say that these are typical reasons for shortages."
The U.S. Food and Drug Administration (FDA) updated the status of tetracycline on November 13 with Heritage Pharmaceuticals' production, but the antibiotic remains on the FDA's Current Drug Shortages list.
Heritage had not previously manufactured either drug. "We acquired the residual Lederle Laboratories assets and had to qualify as a new manufacturer," Glazer explained. "Lederle was a well-known, reputable generics manufacturer in the 1980s and 1990s."
For now, Heritage is the only source of the drug in the U.S. Teva Pharmaceuticals has no timeline for when it will begin producing the drug again, while Watson Pharmaceuticals estimated a fourth-quarter 2013 release, according to the FDA's website. Production by Teva and Watson was stymied by a lack of availability of active pharmaceutical ingredient.
The ingredient is now sourced by a third party in Europe before production in the U.S., after the previous Chinese manufacturer of the raw material exited the market. "I understand that there was a compliance issue at the site," Glazer said. "The FDA no longer allowed them to sell it."
Doxycycline producer Mutual Pharmaceutical cited the same issue as the reason -- "raw material shortage" -- for its halt in production, according to a report by the American Society of Health-System Pharmacists.
Glazer noted that his company and other drugmakers don't simply exit the market. "We could cry about some margins, but we don't exit either," he explained. "Some of those large manufacturers are the first to enter and the last to leave."
While the doxycycline shortage has affected dentistry overall, it has affected periodontology in particular, noted Edmond Truelove, DDS, vice chair of the ADA Council on Scientific Affairs, in an ADA article. Alternatives to the drug are limited, so practitioners have had one less tool to keep gingiva stable and less inflamed in certain cases, he explained.
Drug shortages and dentistry
Dentistry is no stranger to drug shortages. Endemic issues have plagued drugs like propofol as domestic production ended amidst slim profit margins and legal battles. A single supplier makes a drug highly vulnerable to disasters or other issues.
"FDA inspections sometimes shut down factories for violations. All of a sudden, if there are no other manufacturers, then the drug is unavailable," Joel M. Weaver, DDS, PhD, explained in a previous interview with DrBicuspid.com. Dr. Weaver is a dentist anesthesiologist who has practiced in the Ohio State University dental clinic and hospital operating rooms for more than 30 years; he is also a past president of the American Society of Dentist Anesthesiologists.
In the same interview, Dr. Weaver discussed the hazards that legal battles present to drug manufacturers.
"With propofol, there have been several misuses of that drug by physicians who are using it under unsanitary conditions, resulting in the spread of hepatitis B and C and perhaps other diseases as well," he explained. "That should have nothing to do with the drug, yet lawyers go after the deep pockets, the drug company."
In Tulsa, OK, where a high profile case of a dental practice's lapse in infection control is unfolding, attorneys for the victims are suing drug manufacturers for their alleged role. Oral surgeon W. Scott Harrington, DMD, allegedly exposed some 7,000 patients to blood-borne viruses at his practice, infecting at least 100 of them with HIV or hepatitis.
Attorneys for Stephanie Capraro, one of Dr. Harrington's patients, filed a lawsuit against propofol manufacturers and distributors last month, claiming that the pharmaceutical firms should have produced smaller vials of the anesthetic. Multiple uses and the resulting risk of spreading infection could have been prevented by producing smaller single-use doses, according to the suit.
Currently, there is no propofol shortage, but the last one was due, in part, to a drug manufacturer being sued.
"A huge, multimillion dollar judgment was levied against a company due to a dirty needle, and the company threw in the towel," Dr. Weaver explained. "They no longer make propofol, and a shortage resulted."
