Latelines for April 16, 2001
The FDA has confirmed reports of a temporary nationwide shortage of the narcotic antagonist naloxone HCl. Lack of inventory buildup and facility renovations appear to have caused this shortage. An alternate supplier, Sabex Inc., Boucherville, Quebec, has been granted permission by the FDA to temporarily supply naloxone HCl to the United States in 0.4-mg/ml vials (1-ml and 10-ml vials) as well as 1-mg/ml vials (2 ml). The program will not cover the pediatric strength of the product (0.02 mg/ml). Sabex, operating under a drug-allocation program, will have only limited supplies of naloxone HCl available via overnight delivery by telephone or fax orders sent to its headquarters in Canada.
Serono is voluntarily recalling a number of batches of Crinone 4% and 8% (progesterone gel) because of problems with some applicators. The decision was based on the recommendation of the manufacturer, Columbia Laboratories. For additional information contact Serono at www.serono.com.
Novo Nordisk Pharmaceuticals has received clearance from the FDA to market the company's NordiPenMate, a durable autoinsertion device developed for users of NordiPen who "desire added comfort and convenience" with their premixed Norditropin (somatropin) injections. According to the company, autoinsertion reduces pain perception compared with manual injection. Both NordiPen and NordiPenMate are used with NovoFine 30 disposable needles. Norditropin is indicated for treatment of growth failure due to growth hormone deficiency in children.
Meridian Medical Technologies will soon introduce the EpiPen 2-Pak, a new option for patients at risk for severe allergic reactions to insect stings or bites, foods, drugs, and other allergens as well as idiopathic or exercise-induced anaphylaxis. The EpiPen 2-Pak contains either two of the standard (0.3-mg dose) or two junior-sized (0.15-mg dose) epinephrine-filled auto-injectors and one EpiPen trainer. The product was designed for certain patients who may require more than one injection or who may benefit from the convenience of having more than one unit.
The labeling for Merck's Pepcid (famotidine) has been updated to include the need for dosage adjustments for patients with moderate renal insufficiency (creatinine clearance < 50 ml/min). Previously, the labeling recommended adjustments for severe insufficiency only (creatinine clearance < 10 ml/min), but CNS adverse effects have been reported in patients with moderate and severe renal insufficiency. To avoid excess accumulation of famotidine in these patients, the dose may be reduced by half, or the dosing interval may be prolonged to 36-48 hours as dictated by the patient's clinical response.
Pharmacia Corp.'s Consumer Healthcare division has received the FDA nod for NasalCrom nasal spray (cromolyn sodium) for use in children two to five years old. Initially introduced in 1983 as a prescription medication, NasalCrom became available over the counter in 1997 for adults and children age six and older. NasalCrom is intended to relieve nasal allergy symptoms and prevent allergic reactions before they begin.
Massachusetts has become the first state to extend Medicaid benefits to some HIV-positive residents. Those under age 65 and earning less than about $17,100 became eligible for direct aid or insurance premium assistance on April 1. Other states base eligibility on a diagnosis of AIDS.
A Louisiana-based on-line Rx business has agreed to stop selling in Pennsylvania. It will also pay $8,000 in civil penalties and investigative costs to settle charges that it practiced pharmacy and medicine in Pennsylvania without appropriate licenses. At-Cost Drugs and 4 Health Drugs, both of Sterlington, La., also agreed to return the $50 "consultation fee" it charged Pennsylvania consumers between December 1999 and May 2000, said Pennsylvania's attorney general Mike Fisher.
Organon Inc. is withdrawing its anesthesia drug, Raplon (rapacuronium bromide), from the market after reports of five deaths in patients given the product. The FDA approved Raplon, an injectable drug, in August 1999 as a muscle relaxant to facilitate tracheal intubation and for use during surgical procedures. A small percentage of patients in the clinical trials had experienced bronchospasms, which was noted in the labeling. After the drug became available, the FDA said reports "indicate that the risk of injury from bronchospasm may be greater than suggested."
Go and sin no more is the admonition the FTC has given Hoechst Marion Roussel (now Aventis Pharmaceuticals), Andrx, and Carderm Capital to resolve charges the commission lodged last year over an agreement the three companies struck affecting the $750-million-a-year market for Cardizem CD (diltiazem). In 1997, in the midst of a patent lawsuit, Hoechst offered to pay Andrx $10 million a quarter to keep generic Cardizem CD off the market when it won FDA approval and at least $60 million if Andrx eventually won the patent case, the FTC complaint alleged. (Carderm holds some of the patents.) The FTC said the agreement delayed generic competition. Andrx called it a prudent hedge because it could lose the patent case. Earlier this month, the companies agreed not to make deals like that again with anyone.
Concerned about news reports of diversion and abuse of opioid medications, the American Pain Society is urging policy makers to avoid erecting barriers that would keep such analgesics from patients who need them. Noting reports that some pharmacies refuse to stock the drugs for fear of theft and that some physicians are reluctant to prescribe them, the society of pain-management specialists called for a balance between curbing abuse and maintaining appropriate access.
House and Senate Democrats have introduced legislation that would require Rx makers to offer Medicare beneficiaries prices similar to those they charge overseas. The U.S. prices would be pegged to an average of those in six industrial nations: Britain, Canada, France, Germany, Italy, and Japan. PhRMA expressed opposition to the plan.
The FTC has charged Schering-Plough, American Home Products, and Upsher-Smith with entering into an anticompetitive agreement involving $75 million in payments to keep generic versions of Schering's K-Dur 20 (potassium chloride) off the market. The three companies denied the allegations and vowed to fight them.
A long-pending class action lawsuit pitting nearly 2,000 N.Y. pharmacies against Aetna U.S. Healthcare was scheduled to go to trial April 23. The original 1997 suit sought a full accounting of contributions pharmacies made as part of capitation payments into the HMO's pooled catastrophic fund. The suit was amended last year to include charges of fraud and negligent mismanagement. Aetna has sought to have the case dismissed. The New York City Pharmacists Society created a legal fund to pursue the case and earlier this month issued an appeal for contributions.
Medicaid lost $81 million in rebates because seven manufacturers excluded sales to HMO repackagers in their best-price calculations in fiscal year 1999. That was the finding of an audit by the HHS Office of Inspector General. Neither the companies nor the HMOs were named. An earlier-released audit determined $29 million was lost in fiscal year 1998. HCFA will collect the monies owed and clarify its policy guidance concerning sales to HMOs.
A coalition of consumer groups operating as the Prescription Access Litigation project has sued Bristol-Myers Squibb in federal and state courts over BuSpar (buspirone). The groups allege that BMS filed a false secondary patent to keep generic competition off the market. In March, a federal judge ruled against BMS in a BuSpar patent case brought by Mylan Laboratories, which is now on appeal. BMS has consistently defended the validity of the patent it filed in November for a metabolite formed in patients who take the anti-anxiety medication.
"Don't wait, rehydrate," is the focus of an educational campaign aimed at preventing dehydration in children experiencing diarrhea. The campaign was launched by the National Association of Child Care Professionals (NACCP) and the Ross Products division of Abbott Laboratories, maker of Pedialyte. The campaign urges parents and caregivers not to wait until a child exhibits signs of complications before beginning measures to prevent dehydration. The warning signs of diarrheal dehydration include the following: diarrhea (frequent loose, watery stools) that lasts more than 24 hours or worsens, decreased urination or blood in the stool, extreme thirst, unusual drowsiness, sunken eyes and lack of tears, and unusual changes in the child's behavior.
The FDA has approved Celltech Pharmaceuticals' Metadate CD (methylphenidate HCl) extended-release capsules, 20 mg, for the treatment of attention deficit hyperactivity disorder (ADHD) in patients six years of age and older. The once-daily formulation of methylphenidate utilizes Eurand's novel Diffucaps technology; it provides an initial rapid release of the drug, followed by a second, continuous-release phase. According to the company, the biphasic-release profile provides school-day-long control of ADHD symptoms.
Marina Marketos. Latelines. Drug Topics 2001;8:9.