Breaking News

July 25, 2005

FDA issues public health advisory on fentanyl patch The FDA has issued a public health advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. In addition, a patient information sheet and an alert to healthcare professionals were issued, identifying several important safety precautions for the use of fentanyl transdermal patches.

FDA issues public health advisory on fentanyl patch The FDA has issued a public health advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. In addition, a patient information sheet and an alert to healthcare professionals were issued, identifying several important safety precautions for the use of fentanyl transdermal patches. These safety precautions include, but are not limited to, patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal. For more information, go to http://www.fda.gov/cder/drug/infopage/fentanyl/default.htm.

Novartis to acquire OTCs from BMS Novartis announced that it has agreed to acquire the rights to a portfolio of OTC products from Bristol-Myers Squibb. The brands include Excedrin, Keri, 4-Way, Comtrex, NoDoz, Vagistat, Bufferin, and Mineral Ice.

FDA panel: Asthma drugs should stay on marketAn FDA advisory committee has unanimously voted that GlaxoSmithKline's Serevent (salmeterol xinafoate) and Advair (fluticasone propionate/salmeterol xinafoate), as well as Novartis' Foradil Aerolizer (formoterol fumarate) should remain on the market. The panel convened amid concerns that these long-acting beta-agonists raise the risk of severe asthma attacks in rare cases. Glaxo's drugs already carry a black box warning after a small, but significant, risk of life-threatening asthma episodes or asthma-related deaths was observed in patients taking these drugs. Since Foradil is a member of the same drug class, the panel ruled that it should carry a similar warning, though study data for Foradil "to date do not confirm or refute" the conclusion that the drug may have an effect similar to that of Serevent and Advair.

FDA asks Purdue Pharma to withdraw Palladone Purdue Pharma L.P. has been asked by the FDA to remove Palladone (hydromorphone HCl) extended-release capsules from the market after acquiring new information that serious and potentially fatal adverse reactions can occur when the drug is taken with alcohol. Hydromorphone HCl is a once-a-day pain management drug containing a potent narcotic. Patients currently taking the agent should consult with their physicians. For more information, visit http://www.fda.gov/cder/drug/infopage/palladone/default.htm.

VNU to acquire IMS Health VNU NV, a Netherlands-based media firm, announced that it would buy IMS Health in a deal worth $7 billion. IMS provides information and consulting solutions for the pharmaceutical and healthcare industries. The merger is expected to close in the first quarter of 2006. Meanwhile, IMS' competitor, NDCHealth, is still looking for a buyer.

Easy-to-use kit now available to treat hypoglycemia The GlucaGen HypoKit (glucagon [rDNA origin] for injection) is now available from Novo Nordisk to treat severe hypoglycemic reactions in patients with insulin-dependent diabetes. The emergency kit, which consists of a syringe prefilled with sterile water for mixing and a vial of GlucaGen powder, provides a user-friendly means of administering glucagon with no danger of overdose. The product is packaged in a hard-shell, bright orange case for product protection and ease of identification and does not require refrigeration.

Revised labels for ED drugs reflect vision loss risk The product labeling for the three marketed phosphodiesterase 5 inhibitors will be updated to reflect a small number of postmarketing reports of sudden vision loss, attributed to nonarter-itic ischemic optic neuropathy (NAION), a condition in which blood flow is blocked to the optic nerve. The three products affected are Lilly's Cialis (tadalafil), Bayer AG's Levitra (vardenafil HCl), and Pfizer's Viagra (sildenafil citrate). In a statement, the FDA advised patients to immediately discontinue taking any of these erectile dysfunction drugs should they experience any sudden decreased vision. Patients should also inform their healthcare professional if they ever had severe loss of vision, which may indicate a prior episode of NAION. The statement also reports that at this time it is not possible to determine whether these drugs were the cause of the vision loss or whether the loss is related to other factors, such as hypertension or diabetes.