Britain to Allow Over-the-Counter Sales of Zocor
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The British government will soon allow over-the-counter (OTC) sales of Merck’s simvastatin (Zocor), marking the first time any country has allowed the OTC sale of a statin. The drug lost its patent protection in England last year, and Merck is eager to make up for some lost revenues by entering the lucrative OTC market. It is likely the drug will be available in an OTC dose of 10 mg. Pharmacists will be asked to carry out a simple screening questionnaire on the spot to screen for appropriateness and safety. Not everyone is happy about the OTC switch however. An editorial in the British journal Lancet stated that there is insufficient evidence to justify the OTC switch and implied that the British government is simply trying to save money by defraying prescription drugs costs. Currently over 1.8 million patients in England take statins at a cost of over $1.1 billion per year.
FDA Rejects Plan B Bid
FDA regulators have rejected a bid from Barr Pharmaceuticals to market their "morning after pill" as an OTC. The product, called Plan B, contains 0.75 mg of levonorgestrel, a progestin commonly used in birth control pills. Plan B is marketed as an emergency contraceptive that can be used up to 72 hours after unprotected intercourse or suspected contraceptive failure. The decision by the FDA was somewhat surprising as it went against the recommendation the agency’s own advisers who, last December, voted overwhelmingly in favor of the over-the-counter switch for Plan B. The decision prompted some groups to suggest that political pressure from the Bush administration was responsible for the denial. The FDA, however, stated in its rejection letter that they were concerned about the safety of the product for younger women, and kept the door open by suggesting that more data may prompt a reconsideration. In the meantime, Plan B is still available by prescription.
Recombinant Erythropoietin Products May Stimulate Tumor Growth
Two recent studies have raised the question of whether recombinant erythropoietin products may stimulate tumor growth in cancer patients. One study, published in the October 2003 Lancet, reviewed 351 adult patients with head neck cancer who were randomized to subcutaneous erythropoietin or placebo 3 times weekly prior to radiation therapy and continuing throughout radiation therapy. Patients treated with erythropoietin had improved hemoglobin concentrations, but otherwise had poor outcomes. Median locoregional progression-free survival was 745 days with placebo and 406 days with erythropoietin (relative risk, 1.62; [95% CI, 1.22-2.14]; P = .0008). Overall, over the 4 years of study, 52% of placebo-treated patients died, compared to 61% of erythropoietin treated patients (RR 1.39; [95% CI, 1.05-1.82]; P = .02). A second study in Europe of erythropoietin in breast cancer patients was terminated early because patients receiving the drug had lower 12 month survival rates than patients receiving placebo (70% vs 76%; P = .0117). An editorial in the December 17th Journal of the National Cancer Institute reviewed this issue and raised the plausibility of the findings. The authors noted that erythropoietin receptors have been found on head and neck cancer cells, prostate cancer cells, and ovarian cancer cells, as well as breast, renal, and uterine cancer cells. They also noted that the preliminary data suggest that some of these cancers may proliferate in the presence of erythropoietin.
The editorial concluded by calling for more research into the possible relationship between erythropoietin and poor outcomes in the treatment of cancer patients. The FDA’s Oncologic Drugs Advisory Committee recently met in May, and backed a proposal by Johnson & Johnson (makers of Procrit) and Amgen (makers of Aranesp) to study this issue. The exact design of these studies is still to be delineated, but both companies have pledged to collaborate on such research.
Rosuvastatin: Market’s Most Potent Statin
Rosuvastatin (Crestor-Astra Zeneca) appears to be the most potent statin currently marketed. In a study of 3140 patients with CAD, atherosclerosis, or type 2 diabetes, patients were randomized to rosuvastatin 10 mg, atorvastatin 10 or 20 mg, simvastatin 20 mg, or pravastatin 40 mg for 8 weeks. Patients either remained on these treatments or were switched from other statins to rosuvastatin. The primary pinpoint was a LDL cholesterol of < 116 mg/dL. Significant improvement in LDL cholesterol goal achievement was found for patients who were switched to rosuvastatin 10 mg compared with patients who remained on atorvastatin 10 mg (86% vs 80%; P < 0.5), simvastatin 20 mg (86% vs 72%, P <.001), and pravastatin 40 mg (88% vs 66%, P < .0001). For patients who were switched from atorvastatin 20 mg to rosuvastatin 20 mg, the rate at goal was 90% vs 84% (P < .01) (Am Heart J. 2004;147:705-712). But while rosuvastatin appears to be the most potent statin, it may carry a higher dose related risk of muscle toxicity including myositis and rhabdomyolysis. Astra Zeneca has recently acknowledged 4 cases of rhabdomyolysis in patients who were taking 40 mg of rosuvastatin, and has urged physicians in England to avoid initial high dose therapy with the drug, instead starting at 10 mg and titrating with appropriate follow-up.
FDA Actions
Immunex Corp.’s etanercept (Enbrel) has been approved for use in patients older than the age of 18 with moderate-to-severe plaque psoriasis. Enbrel is currently marketed for use in patients with ankylosing spondylitis, psoriatic arthritis, moderate to severe rheumatoid arthritis, and juvenile rheumatoid arthritis. The expansion of indications to treat psoriasis was expected after 2 phases.
All studies showed improvement with treatment up to 1 year. Etanercept, which is a tumor necrosis factor inhibitor, joins the biologics alefcept (Amevive) and efalizumab (Raptiva) in the suddenly rather crowded market for the treatment of psoriasis.
The FDA has approved Indevus Pharmaceutical’s trospium chloride (Sanctura), for the treatment of overactive bladder with symptoms of the urge urinary incontinence, urgency and frequency. The drug is a muscarinic receptor antagonist, and as such, has side effects that include dry mouth and constipation. It is, however, relatively well-tolerated with fewer drug-drug interactions than currently available medications.
Fondaparinux (Arixtra-Fonda BV), the synthetic selective factor Xa inhibitor, has been given the expanded indication for treatment of acute pulmonary embolism and acute deep venous thrombosis without PE when coadministered with warfarin. Previously, the drug had been approved for prevention of DVT in the setting of orthopedic surgery.
Salix Pharmaceuticals has received approval to market rifaximin (Xifaxan) for the treatment of travelers diarrhea caused by noninvasive strains of Escherichia coli. The drug is unique in that it is minimally absorbed (< 0.5%) after oral administration, and exerts its action only in the gut. It is not for use in patients with diarrhea associated with fever or bloody stools, or pathogens other than E. coli. The drug is approved for patients age 12 and older and appears to be well-tolerated.
This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. Telephone: (404) 262-5416. E-mail: [email protected]. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.
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