Duragesic pain patches getting recall
WASHINGTON Ortho-McNeil-Janssen, a unit of drug and consumer giant Johnson & Johnson on Tuesday said it was recalling certain strengths of its Duragesic pain patches, which have the potential to expose patients to a dangerous gel inside.
All lots of Ortho-McNeil’s 25 microgram-per-hour strength patch of Duragesic are being recalled, in coordination with the Food and Drug Administration.
The recalled patches may have an opening which could result in release of the gel—made of the drug fentanyl—inside, Reuters reported. Exposure to fentanyl directly can cause serious harm, including breathing problems and overdose, which can be fatal, the company said.
All the recalled patches have an expiration date on or before December 2009.
FDA gives Hi-Tech Pharmacal approval for generic Hycodan
AMITYVILLE, N.Y. Hi-Tech Pharmacal Co. announced that the Food and Drug Administration has granted an approval to the company’s application for hydrocodone bitartrate and homatropine methylbromide syrup, the generic equivalent of Endo Pharmaceuticals’ Hycodan. Hydrocodone bitartrate and homatropine methylbromide syrup is indicated for symptomatic cough relief.
Hi-Tech specializes in difficult-to-manufacture liquid and semi-solid dosage forms of generic medications and produces a range of sterile ophthalmic, otic and inhalation products.
Hydrocodone bitartrate and homatropine methylbromide syrup had sales of approximately $5 million for 2006, according to IMS Health data. Hi-Tech expects to start marketing the product immediately.
Study suggests epilepsy drug does not prevent migrains
NEW YORK New research has suggested that the anti-epilepsy drug oxcarbazepine does not appear to prevent migraine headaches.
According to a study published in the journal Neurology by Stephen Silberstein of the Jefferson Headache Center in Philadelphia, some anti-epilepsy drugs have shown success in the prevention of migraine, and reports have suggested that oxcarbazepine—marketed by Novartis as Trileptal—would be effective as well. However, results of a study lasting almost five months, showed no difference between the oxcarbazepine and placebo groups in the change in the number of migraine attacks from the beginning to the end of the study.
The severity of the attacks and the amount of acute rescue medication required also was not affected by treatment allocation. “The results of this trial do not support preliminary data that had suggested oxcarbazepine was effective in preventing migraine,” Silberstein noted in a written statement. “While several epilepsy drugs have been used for decades to prevent migraine, oxcarbazepine did not prevent migraine in this study despite it being shown to be safe and well-tolerated.”
Silberstein also noted that the three epilepsy drugs that most effectively prevent migraine headaches—topiramate, divalproex and gabapentin—have several mechanisms by which they treat migraines, including the ability to regulate a brain chemical known as GABA. In contrast, oxcarbazepine has no apparent activity on GABA. Silberstein says it’s possible that epilepsy drugs must be able to regulate this specific brain chemical in order to prevent migraine headaches.