PID Diagnosis Predicts Future STI's in Teenagers

A study among Baltimore inner-city teenage girls treated for pelvic inflammatory disease shows they are highly vulnerable to subsequent sexually transmitted infections (STI) — sometimes within a few weeks or months of their treatment.

Results of the research by Johns Hopkins Children’s Center investigators, reported in the November issue of Archives of Pediatric and Adolescent Medicine, suggest that treating pelvic inflammatory disease (PID) “with a prescription and a brochure” is simply not enough to change behavior and prevent future infections, according to lead investigator Maria Trent, M.D., M.P.H., a pediatrician and adolescent medicine specialist at Hopkins Children’s.

Repeat infections can increase a teenager’s risk for chronic pelvic pain, ectopic pregnancies and infertility.

“Because our findings show that PID is not a single isolated incident, doctors should look for ways to change behaviors in these girls and not just treat the acute clinical episode,” said Trent. “We are talking counseling, we are talking strict follow-up and, most importantly, we need to develop new strategies that actually work.”

While cautioning that the study was limited to Baltimore City girls, the researchers say teenage girls across the country’s urban areas likely face similar problems linked to inner-city life and practice behaviors that put them at high risk for repeat STIs.

In the four-year study of 110 girls ages 15 to 21 and diagnosed with PID, 80 girls returned for follow-up during the 48-month study period. Under the Hopkins protocol, those with confirmed diagnosis of PID are given a course of free medication and asked to return within 72 hours and advised to follow up again at three and again in six months with a primary-care provider.

Of the 80, 27(34 percent) were diagnosed with at least one subsequent sexually transmitted infection over a six-month period. Of the 27, eight (30 percent) had two or more STIs in the six-month period.

Getting girls to come back is challenging, researchers say. An earlier study by the Hopkins Children’s group found that only 38 percent of girls diagnosed with PID could be reached, and of these only 43 percent returned for follow-up care.

The best — and narrow — window of opportunity to counsel girls, researchers say, may be at the time of diagnosis or when they return for the repeat screening in 72 hours. This counseling, moreover, must be more thorough, not just admonitions to practice safe sex or not to have sex at all.

“What we think we need is individually tailored counseling by a clinical provider that is done after an in-depth interview with each patient to determine what aspects of her behavior put her at risk and must change,” Trent says.

Researchers are currently testing a pilot program that involves showing an educational video to teenage girls coming to the ED with PID. The Hopkins team also plans to test the value of house calls to patients by a nurse within 72 hours of diagnosis.

Funding for this research came from the Thomas Wilson Sanitarium Foundation for the Children of Baltimore City, the Robert Wood Johnson Foundation and the Centers for Disease Control and Prevention.

Other investigators in the study: Jonathan Ellen, M.D.; Shang-en Chung, M.Sc.; Lynette Forrest, all of Hopkins.

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Federal Agents Seize more than $24 Million in Unapproved New Drugs

Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

"American consumers are entitled to have safe and effective drugs," said Hanaway.

The seizure followed an inspection of several of the company's plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

"The FDA is committed to taking enforcement action against firms that circumvent the drug approval process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER). "Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace."

In a routine inspection of KV Pharmaceutical's facilities in early 2008, the FDA found the company was violating its May 29, 2007, notice (72 FR 29517) requiring companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs. FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled. For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.

The FDA required companies to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before November 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs after the cessation dates.

The inspection also exposed the company's manufacturing and distribution of other unapproved drug products. Today's action addresses numerous unapproved drug products manufactured and distributed by the company.

The following drug products were seized and will be destroyed:

• PhenaVent Capsules
• PhenaVent LA Capsules
• PhenaVent PED Capsules
• Ethezyme Papain-Urea Ointment
• Ethezyme 650 Papain-Urea Ointment
• Ethezyme 830 Papain-Urea Ointment
• Hista-Vent DA Tablets
• Meperidine/Promethazine Capsules
• Pseudovent Capsules
• Pseudovent 400 Capsules
• Pseudovent PED Capsules
• Tri-Vent DM Syrup
• Tri-Vent DPC Syrup
• Hydro-Tussin DM Liquid
• Hydro-Tussin CBX Syrup
• Hydro-Tussin DHC Syrup
• Hydro- Tussin EXP Syrup
• Hydro-Tussin HD Syrup
• Hyoscyamine Sulfate Sublingual Tablets
• Hydroquinone 4% Cream
• Hydroquinone 4% Cream with Sunscreen
• Bromfenex Extended Release Capsules
• Bromfenex PD Extended Release Capsules

The seized drugs had been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.

"The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date," said Deborah M. Autor, director of the FDA's Office of Compliance within CDER. "When a company does not heed a cessation date relating to a specific product, the FDA will take enforcement action relating to the company's other unapproved drugs."

In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs—Compliance Policy Guide (CPG)." This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective.

The FDA encourages consumers who may have these products to contact their health care professional about FDA-approved treatments and discard these products.