Latelines for May 21, 2001



Supreme Court rules against medicinal marijuana exception

There is no "medical necessity" exception to federal drug laws that would permit use of marijuana, a unanimous Supreme Court has ruled. The decision came as a result of a 1996 California ballot initiative that allowed possession and distribution of marijuana to seriously ill patients for pain relief.

Lawyers likely to determine status of antihistamines

Don't expect three prescription antihistamines to go OTC anytime soon. This month's votes by two FDA advisory committees attested to the potential safety of consumer who use Claritin (loratadine, Schering-Plough), Allegra (fexofenadine, Aventis), and Zyrtec (cetirizine, Pfizer) "without a learned intermediary." Next, the FDA's own scientists must agree with the panels' judgments. That usually happens, but the agency isn't bound to follow the recommendations. In addition, the manufacturers don't want to make the switch yet; Blue Cross of California petitioned the FDA to make the change so it wouldn't have to cover the drugs. FDA lawyers will have to decide whether they have the legal authority to force a changeover. The manufacturers have given every indication they would go to court to fight it.  

NCPA urges examination of RxHub-PBM ties

NCPA is urging Congress and the FTC to investigate the impact on competition of RxHub, the $60 million electronic link among prescribers, PBMs, and pharmacies proposed by AdvancePCS, Express Scripts, and Merck-Medco Managed Care. At NCPA's 33rd annual legislative conference earlier this month, FTC official Molly Boast indicated that the joint venture by the three rivals "is the sort of structure that we would likely take a look at, despite their arguments about efficiencies." She did not promise a probe. NCPA also is trying to interest Congress in holding hearings on the general practices and cost-effectiveness of PBMs, which many lawmakers expect will play a prominent role in any Medicare Rx benefit. Pharmacy associations have expressed serious reservations about PBMs providing patient care or cost management functions.

USP, ISMP error reports protected in Oklahoma

Oklahoma has become the first state to give legal protection to Rx errors reported to USP. The state's board of health granted the privilege to USP's MedMARx database and the Medication Errors Reporting Program, which USP and the Institute for Safe Medication Practices run.

Generics under Congress and FTC microscopes

The FDA is developing an education campaign to tell consumers and prescribers about the scientific reasons generic drugs are pharmaceutically equivalent to brand-name products. The action comes at a time when Congress is considering whether the legal aspects of generic drug approval should be reexamined and the FTC is probing arrangements between generic and innovator firms that delay generic entry.

Plan to reduce Rx errors introduced in Senate

Bipartisan legislation to establish a $1 billion grant program for hospitals and skilled nursing facilities (SNFs) to pay for clinical information systems aimed at cutting medication mistakes is now before Congress. Sens. Bob Graham (D, Fla.) and Olympia Snowe (R, Maine) said the goal of their proposal is to have 25% of the Medicare hospitals and SNFs adopt medication error reduction systems within a decade.

FTC taking more time on wholesaler deal

The FTC has asked for additional data from AmeriSource and Bergen Brunswig on their proposed $2.4 billion merger. Three years ago, the FTC blocked McKessonHBOC's proposed purchase of AmeriSource and Cardinal Health's planned takeover of Bergen on the grounds the new entities would have too much marketplace clout. In April, the commission approved Cardinal's acquisition of Bindley Western Industries.

Axert joins family of triptans

The FDA has approved the fifth orally administered triptan, Pharmacia Corp.'s Axert (almotriptan maleate), for the acute treatment of migraine with or without aura in adults. The recommended dose of almotriptan is one 12.5-mg or 6.25-mg tablet. The most common side effects reported with almotriptan 12.5 mg were nausea, dry mouth, and paresthesia. The company asserts that, in clinical trials, almotriptan was shown to have a low percentage of side effects typically associated with the triptans, such as chest discomfort and chest pain. Almotriptan should not be given to patients with documented ischemic or vasospastic coronary artery disease because of the potential for this class of compounds to cause coronary vasospasm.

More Medicare money for SNFs

Beginning Oct. 1, HCFA will increase Medicare payments to skilled nursing facilities by 2.1%. That date also marks the end of the three-year phase-in of the prospective payment system. All SNFs will be paid at a federal rate instead of a blended federal and facility-specific rate, HCFA said.

FDA approves novel oral contraceptive

Berlex Laboratories has received FDA approval for its new, low-dose oral contraceptive Yasmin (drospirenone and ethinyl estradiol). Drospirenone is unlike other progestins currently available in oral contraceptives in that it is an analog of the diuretic spironolactone and exhibits antimineralocorticoid activity, which influences the regulation of water and electrolyte balance in the body. Due to this activity, patients taking drugs that may increase serum potassium should consult their health-care professional before taking drospirenone.

Gleevec wins fast approval

In what is being touted as the fastest time to market of any cancer treatment, Novartis' Gleevec (imatinib mesylate) has received FDA approval. It is a once-daily oral therapy for the treatment of patients with chronic myeloid leukemia (CML) in the blast-crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy. According to Novartis, imatinib is the first in a new class of drugs that specifically target the cancer cells—unlike other oncology products, which may also affect healthy cells. A study recently reported in the New England Journal of Medicine showed 51 of 53 CML patients remained in remission one year after treatment.

Effexor gains new indication

In addition to being used for the treatment of depression, Wyeth-Ayerst's Effexor (venlafaxine) can now be prescribed for patients with major depressive disorder. The FDA approval, which includes both the tablet and the extended-release capsule formulations, was based on new data that showed venlafaxine was superior to placebo in preventing relapse and also demonstrated a significant reduction in recurrent episodes. Effexor XR is also currently indicated for the treatment of generalized anxiety disorder.

Prevacid approved in new formulation

TAP Pharmaceutical has received FDA clearance to market a new delayed-release oral suspension form of its proton pump inhibitor, Prevacid (lansoprazole). The new formulation will be available in reconstitutable 15-mg and 30-mg unit-dose packets and was developed specifically for patients who have difficulty swallowing capsules, according to TAP. Prevacid capsules added a new indication in December: to treat NSAID-associated gastric ulcers in patients who continue NSAID use.

New cholesterol guidelines released

The National Cholesterol Education Program Expert Panel has issued its updated report on the detection, evaluation, and treatment of high blood cholesterol in adults. In addition to emphasizing primary prevention of coronary heart disease (CHD) in patients with multiple risk factors, the guidelines also focus on early, aggressive lipid-lowering therapy for those at highest risk. The guidelines recommend aggressive treatment for patients with an absolute 10-year risk of 20% for developing CHD, with a treatment goal of LDL levels less than 100 mg/dl. Those with LDL cholesterol of 130 mg/dl or higher are recommended for drug therapy.

Sporanox, Lamisil add stiffer warnings

The FDA has issued a public health advisory concerning Sporanox (itraconazole, Janssen) and Lamisil (terbinafine, Novartis). The systemic drug therapies, which are used to treat onychomycosis (nail fungal infections), have a possible association with cardiac and hepatic failure. The more serious health alert centered on itraconazole, which the FDA believes may lead to a real risk of developing congestive heart failure and, therefore, should not be given to patients at risk for CHF. Both itraconazole and terbinafine have been associated with serious hepatic problems resulting in hepatic failure and death. New labeling for both agents recommends that physicians obtain nail specimens for laboratory testing before prescribing these drugs to confirm the diagnosis. The new warnings do not apply to the OTC versions of terbinafine.

Distribution of 160-mg OxyContin suspended

Citing growing abuse problems, Purdue Pharma has voluntarily suspended the distribution of its 160-mg dosage form of OxyContin (oxycodone HCl controlled-release), approved in 1995 for relief of moderate to severe pain. Abusers have discovered the powerful morphine-like euphoria achieved by crushing or chewing the tablets, short-circuiting the drug's time-release feature. OxyContin has been linked to more than 100 fatal overdoses nationwide. Shop 'n Save supermarkets has pulled the drug from its Maine pharmacies, and the DEA has urged Purdue to reformulate the drug.

Snake bite antidote in short supply

Outdoor enthusiasts should be extra careful about avoiding snake bites for the next two months. That's because the antidote could be hard to find. Wyeth-Ayerst Laboratories, which makes Antivenin (Crotalide) Polyvalent, (equine origin) said the product is expected to be out of stock due to an increase in demand and manufacturing constraints. There is another antivenin on the market—CroFab—made by Protherics PLC and distributed by Savage Laboratories, but its supply also cannot be guaranteed, Wyeth-Ayerst noted.


Latelines. Drug Topics 2001;10:5.

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