Latelines for Feb. 19, 2001



FDA restrictions on compounding ruled unconstitutional

A federal appeals court has struck down the compounding provisions of the 1997 FDA reform law as unconstitutional. "The government asserts that increased distribution of compounded drugs is dangerous because of the health risks associated with large numbers of patients taking such drugs," said a three-judge panel of the 9th Circuit on Feb. 6. "The government neither explains nor supports this contention. In fact, most of the evidence runs to the contrary." NCPA called the decision "an astounding victory for independent pharmacy practitioners" and said it would urge the Bush Administration not to challenge it. The appeals court upheld a district court ruling in a Nevada case. A number of R.Ph.s argued that a provision in the 1997 law that barred them from advertising or promoting that they compound a particular Rx or class of Rxs violated their First Amendment free speech protections.

Women more at risk for adverse events than men?

Eight of the 10 prescription drugs withdrawn from pharmacies for safety reasons since 1997 posed greater health risks for women than for men, according to a GAO report. Four of the eight Rxs may have had more adverse events in women because they were prescribed more often to women, GAO suggested. Those Rxs were Lotronex (alosetron HCl, GlaxoSmithKline), Pondimin (fenfluramine HCl, Wyeth-Ayerst), Redux (dexfenfluramine HCl, Wyeth-Ayerst), and Rezulin (troglitazone, Parke-Davis). The other four Rxs "posed greater health risks for women even though they were widely prescribed" to both sexes, GAO continued. Those Rxs were Hismanal (astemizole, Janssen), Posicor (mibefradil dihydrochloride, Hoffmann-La Roche), Propulsid (cisapride monohydrate, Johnson & Johnson), and Seldane (terfenadine, Aventis). The two remaining Rxs, Duract (bromfenac sodium, Wyeth-Ayerst) and Raxar (grepafloxacin HCl, GlaxoSmithKline), have not demonstrated a greater risk for women. Four lawmakers who requested the report expressed concerns about Rx manufacturers not including enough women in clinical trials and about whether enough analysis of sex-related variations was being performed. The GAO is continuing to study the issue.


FDA weighs labeling changes for Vioxx, Celebrex

An FDA advisory panel has suggested the labeling for Vioxx (rofecoxib, Merck) be amended to include study results that found the osteoarthritis medication was safer on the stomach than naproxen. The same study also indicated that Vioxx did not protect users against heart attack the way aspirin does. The panel also found that Celebrex (celecoxib, Pharmacia) was not easier on the stomach than ibuprofen and diclofenac, as Pharmacia and copromoter Pfizer had hoped to prove. The FDA will make the final labeling decisions.

Bill would give FDA power over tobacco

Three Senators are sponsoring legislation to give the FDA authority to regulate tobacco as a drug and cigarettes as nicotine-delivery devices. The agency was moving in that direction until a 5-4 Supreme Court ruling last March said Congress had never given the FDA that authority. The sponsors are Sens. Lincoln Chafee (R, R.I.), Tom Harkin (D, Iowa), and Bob Graham (D, Fla.).

Bush outlines patients' bill of rights protections

President George W. Bush has spelled out his principles for a patients' bill of rights that he could support, including access to needed Rxs and clinical trials, consumer choice, and continuity of care. The President also wants a cap on damages awarded by courts against managed care organizations well below that of the $5 million proposed by Sen. John McCain (R, Ariz.).

Dosing, labeling changes approved for Ferrlecit

The FDA has approved Watson Pharmaceuticals' supplemental NDA for its injectable iron therapy product, Ferrlecit (sodium ferric gluconate complex in sucrose), indicated as a first-line treatment of iron deficiency in chronic hemodialysis patients receiving supplemental erythropoietin therapy. The new labeling allows for undiluted intravenous injection of the therapeutic dose (125 mg), without the need for a test dose, over a period of 10 minutes. Prior labeling had required that a test dose confirm lack of hypersensitivity and allergic reactions and that both the first dose and subsequent doses be diluted and administered as infusions over extended periods. Additionally, the bold type in the label's warning section has been eliminated. Approval was based on the results of a 1,097-patient postmarketing safety study.

Program targets generic compliance

Health Resource has introduced its Generic Compliance Plus program for retail pharmacies to boost patient compliance and sales of generic drugs for chronic conditions. Therapeutically targeted motivational messages are part of the Health Resource Newsletter given to patients with their Rx. Health Resource is a subsidiary of Catalina Marketing, St. Petersburg, Fla.

Are vendors shortchanging small chains?

Regional drug chains need more personal service from OTC product vendors, May's Drug CEO Gerald Heller said at a panel dis-cussion during NACDS' Regional Chain Conference, this month in Orlando, Fla. One supplier has switched from periodic sales visits to telephone reorders, a practice Heller believes puts smaller chains aside and hampers business growth. "We talk to people on the telephone who aren't knowledgeable about how to grow our business," he said. NACDS president Craig Fuller responded that the organization's should help vendors better communicate with both regional and larger chains.

New indication for Toprol-XL approved

The indication for AstraZeneca's Toprol-XL (metoprolol extended release) has been extended to include the treatment of chronic and congestive heart failure. The FDA approval was based on data showing that Toprol-XL reduced the mortality rates in these patients by 34%. The drug was previously approved for the treatment of hypertension and angina. According to the company, Toprol-XL is only the second beta-blocker to win approval for the heart failure indication, after GlaxoSmithKline's Coreg (carvedilol).

Expanded access available for HIV drug

Via a limited expanded-access program, Gilead Sciences' 300-mg once-daily HIV drug tenofovir disoproxil fumarate (tenofovir DF) will be available to patients with advanced infection. To receive top priority, seriously infected patients must meet strict criteria regarding viral load, white cell count, and failure with previous HIV therapies as well as be at least 18 years of age. Expanded-access programs make drugs in late-stage clinical trials available to patients before approval, which is particularly critical for HIV patients.

New system helps R.Ph.s calculate drug dosages

Micromedex, a division of Thomson Healthcare, has announced the availability of the KINETIDEX 2.0 System, designed to help pharmacists calculate dosages for the most difficult drugs to dose. It is a stand-alone or network CD-ROM program that takes into account specific patient variables, including interacting drugs and disease states, while suggesting initial and maintenance dosages and projecting serum concentrations. The drugs included in this release are: aminoglycoside antibiotics (gentamicin, tobramycin, and amikacin), vancomycin, digoxin, theophylline, and valproic acid.

Agatha Christie saluted in Poison Prevention Month

The 110th Agatha Christie celebration is slated for March 16-25, during Poison Prevention Month. Poisons frequently figured in the mystery novels of this English pharmacist-turned-author. Sponsored by Pharmacists Planning Service Inc., San Rafael, Calif., observances will include an Agatha Christie film festival, high tea, a murder cruise, and a seminar during the American Pharmaceutical Association annual meeting in San Francisco.

Study backs antidote for methanol poisoning

Based on a study of 11 patients, the alcohol dehydrogenase inhibitor fomepizole could become the treatment of choice for methanol poisoning. Of the 11 methanol-poisoned patients studied, nine recovered and two—whose brains had been damaged by lack of oxygen—died when they arrived at the hospital. Prior to FDA's late-December approval for this indication, the only treatment available was intravenous ethanol until the blood could be cleansed by dialysis; fomepizole can be given once every 12 hours, rather than continuously. The drug is marketed by Orphan Medical of Minnetonka, Minn., under the name Antizol.


Marina Marketos. Latelines. Drug Topics 2001;4:5.