FDA stresses safety information for fentanyl patch
WASHINGTON The Food and Drug Administration has issued its second safety warning about all fentanyl transdermal patches. In July 2005, the agency issued a similar warning stating that the directions on the label and on the package insert should be followed exactly in order to avoid an overdose.
The FDA, though, is still receiving reports of deaths and life-threatening side effects from doctors after hearing that the medication has been inappropriately prescribed or patients have incorrectly used them, for example, patients replacing the patch more frequently than directed in the instructions. The patch contains the opioid fentanyl, which is a powerful narcotic. The patch is approved for the treatment of persistent, moderate-to-severe pain in patients who have become opioid tolerant. The drug is usually prescribed for cancer patients.
In its Public Health Advisory and Health Care Professional Sheet published today, the FDA stressed the following safety information:
- Fentanyl patches are only for patients who are opioid-tolerant and have chronic pain that is not well controlled with other pain medicines. The patches are not to be used to treat sudden, occasional or mild pain, or pain after surgery.
- Health care professionals who prescribe the fentanyl patch, and patients who use it, should be aware of the signs of fentanyl overdose: trouble breathing or slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, patients should get medical attention right away.
- Patients prescribed the fentanyl patch should tell their doctor, pharmacist and other health care professionals about all the medicines that they take. Some medicines may interact with fentanyl, causing dangerously high fentanyl levels in the blood and life-threatening breathing problems.
- Patients and their caregivers should be told how to use fentanyl patches. This important information, including instructions on how often to apply the patch, reapplying a patch that has fallen off, replacing a patch, and disposing of the patch, is provided in the patient information that comes with the fentanyl patch.
- Heat may increase the amount of fentanyl that reaches the blood and can cause life-threatening breathing problems and death. Patients should not use heat sources such as heating pads, electric blankets, saunas, or heated waterbeds or take hot baths or sunbathe while wearing a patch. A patient or caregiver should call the patient’s doctor right away if the patient has a temperature higher than 102 degrees while wearing a patch.
BioSante makes milestone payment of $875,000 to Antrares for Elestrin
EWING, N.J. Antares Pharma has received an additional payment of $875,000 from BioSante Pharmaceuticals in relation to a marketing agreement with Bradley Pharmaceuticals for the drug Elestrin.
Elestrin is a low dose transdermal estradiol therapy that is used for the treatment of hot flashes in menopausal women. Antares allowed BioSante to use its advanced transdermal delivery gel system for the drug. Additional sales based milestone payments could bring the deals total value to more than $13 million, not including royalties based on third party sales.
“We look forward to continued marketing progress with Elestrin in 2008. The December 2006 FDA approval of this product has validated our ATD gel system and that has been a significant milestone for Antares and our potential pipeline products including Anturol—our proprietary ATD gel based overactive bladder product—currently in pivotal trials,” said Jack Stover, president and chief executive officer of Antares Pharma.
GSK, Santaris ink deal worth a potential $700 million
LONDON GlaxoSmithKline has signed a deal with the biotech company Santaris Pharma to develop new antiviral medicine, in a deal that could be worth more than $700 million, according to Reuters. The deal involves drug candidates discovered and developed under the agreement in up to four different viral disease programs.
As part of the deal, Santaris will receive an upfront payment of $3 million for the first antiviral program and an equity investment of $5 million. The deal could be worth more than $700 million based on upfront payments and development and regulatory milestone payments, depending on the success on early-stage research in RNA antagonist compounds.
Santaris will also get high single- to double-digit percentage royalties on worldwide sales of marketed products. GSK will have the option to develop drug candidates in up to four different viral disease programs. It also has an option to include as an additional program Santaris’ pre-clinical hepatitis C compound SPC3649.