HPV vaccine is linked to more adverse incidents
July 29, 2008
Judicial Watch, a public interest group that investigates and prosecutes government corruption, reported that it has obtained new Food & Drug Administration records about Merck’s vaccination for human papillomavirus (HPV) Gardasil. The records show that there have been 10 new deaths since September 2007 and 140 serious adverse events since January 2008. These new data come on top of thousands of adverse event reports that Judicial Watch had obtained previously from the agency. In light of these negative incidents, Judicial Watch urges FDA to refrain from mandating this vaccine for children and reevaluate its safety for minors.
By Judy Chi, DrugTopics.
Popular Antidepressants Linked to GI Bleeding
July 10, 2008
A new study found the commonly prescribed antidepressant class SSRIs may cause bleeding in the upper gastrointestinal tract, especially when combined with NSAIDs. The researchers said the numbers suggest one in 2,000 patients treated with an SSRI would have a case of upper GI tract bleeding, and one in 250 on SSRIs and NSAID drugs would have GI bleeding.
Complete Story at Yahoo! Haelth News
FDA orders ‘black box’ warning on certain antibiotics
July 8, 2008
The U.S. FDA Tuesday ordered the makers of certain antibiotics to add a “black box” label warning to alert patients of possible tendon ruptures and tendonitis.
The new language will strengthen the existing warnings,” said Dr. Edward Cox, director of the FDA’s Office of Antimicrobial Products.
The FDA is requiring the label warnings and a medication guide for fluoroquinolone drugs, which include Cipro, Levaquin, Avelox, Noroxin and Floxin. Read more
Generic Risperdal
July 2, 2008
The Food & Drug Administration has approved the first generic version for the Risperdal. Pharmacies can buy varying strengths of risperidone tablets from TEVA Pharmaceuticals or they can purchase an authorized generic version from Patriot Pharmaceuticals, a subsidiary of McNeil-PPC. Both Patriot and Janssen are part of Johnson & Johnson.
The Food & Drug Administration cautions that the labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity. Risperdal is used to treat schizophrenia, bipolar disorder, and other psychiatric conditions.
[drug topics]
Two lots of Daytrana patch recalled
June 13, 2008
Two lots of Daytrana (methylphenidate transdermal system, Shire) have failed to meet their release liner removal specification, leading to a voluntary recall by the manufacturer. Lot numbers 2750211 and 2764111 are affected and may cause difficulty removing the liners for both patients and caregivers, but do not pose any safety concerns, according to the company.
Shire said it will continue to perform quality assurance monitoring to ensure no new cases of liner failure occur and that current supply levels of the patch should be sufficient despite the recall. Pharmacists with questions should direct them to the Daytrana customer service line at 1-(888)-879-8218.
(Article by Heidi Belden, Pharm.D. via Drug Topics)
Digitek Recall
April 29, 2008
Actavis Totowa LLC is recalling all lots of the prescription drug Digitek, used to treat heart failure and abnormal heart rhythms, because some of the drug’s tablets might contain twice the approved level of the active ingredient.
Spokesman John LaRocca said 11 people have reported getting sick after taking the drug, but the Morristown, N.J., company is not aware of any deaths. The drug was distributed by Mylan Pharmaceuticals Inc. under a “Bertek” label and by UDL Laboratories Inc. under a “UDL” label.
Attorney General sued FDA over OxyContin
April 1, 2008
Attorney General Richard Blumenthal filed a lawsuit in federal court today against the U.S. Food and Drug Administration (FDA) to force the agency to act on his 4-year-old citizen petition seeking stronger warnings related to OxyContin.
Blumenthal said that continued inaction by the FDA on OxyContin
warnings and other matters could be devastating because, as the U.S. Department of Justice has confirmed, abuse of prescription drugs such as OxyContin has become the greatest drug threat in the Northeast region. Blumenthal filed the citizen petition in January 2004 as a result of his 2003 investigation into Purdue Pharma L.P., OxyContin’s manufacturer.
OxyContin is a controlled-release narcotic designed to deliver a consistent level of oxycodone over a 12-hour period. Despite information on the drug’s package insert that the FDA recommends only 12-hour dosing, Blumenthal’s investigation has revealed that Purdue Pharma had strong evidence showing that shorter dosing is rife with hazard and approximately 20 percent of all OxyContin prescriptions were written for dosing intervals of eight hours or less.
Although this powerful painkiller can benefit many patients if used properly, prescribers and patients cannot make sound treatment decisions without full knowledge of the risks and benefits of prescribing OxyContin, Blumenthal said.
Today’s lawsuit, filed with the U.S. District Court, seeks a court finding that the FDA’s failure to act on the petition was unlawful, and an order compelling FDA action on the petition.
“The FDA has irresponsibly and illegally ignored the clear need for warnings about OxyContin prescription practices that promote abuse and addiction,” Blumenthal said. “Prescription narcotic abuse of drugs like OxyContin has become the biggest drug threat in the Northeast, causing countless cases of diversion and addiction tragedies. Twenty percent of OxyContin prescriptions are for doses at dangerous eight-hour time intervals or shorter, but the FDA remains oblivious and obtuse. These ongoing practices produce, in effect, an extra dose a day. After four years of proven dosing dangers and Purdue Pharma criminal convictions, the FDA seems in denial. The agency has failed to approve or even deny our 4-year-old petition seeking strengthened warnings. We now need to resort to a court order to force the FDA to take action to warn and protect patients.
“The FDA is disregarding dangers of adverse reactions and side effects, as well as abuse and addiction, by failing to require stronger black box warnings or issue a safety alert or public health advisory. The FDA has a legal and moral responsibility to ensure that providers and patients fully understand the potential dangers of improperly prescribing OxyContin. Inaction by the FDA is completely inexplicable and unacceptable when public health and safety are clearly at risk.”
Purdue Pharma’s internal documents confirm that many physicians,
particularly family practice and general practitioners, did not understand OxyContin’s controlled release delivery system and accordingly were prescribing the drug inappropriately.
As one company document cautioned sales representatives, “[l]ook
especially hard at FP/GP percentages [of off-label prescribing] they are the worst offenders, and therefore require the most education on Oxy’s dosing.”
On Jan. 23, 2004, Blumenthal petitioned the FDA to require that Purdue Pharma:
• Strengthen OxyContin’s black box warning to expressly reinforce the FDA approved dosing regimen and to add specific information regarding the potential dangers associated with an off-label dosing schedule;
• Issue a “Dear Healthcare Professional” letter to inform physicians of controlled substances about the potential risks of prescribing OxyContin at dosing intervals that are shorter than the FDA-approved 12-hour dosing schedule.
In addition, or as an alternative, Blumenthal requested that the FDA disseminate warnings concerning the OxyContin dosing issues through a Safety Alert, Public Health Advisory, Talk Paper or Urgent Notice.
Blumenthal thanked those in his office who worked on the investigation – Assistant Attorneys General Christopher Haddad, Robert Deichert, Karen Haabestad, Arnold Menchel and Michael Cole.
Via Attorney Generals Office/StamfordPlus.com
Early warning of Spiriva’s potential stroke risk
March 24, 2008
The long-term maintenance treatment of COPD with Spiriva HandiHaler, containing tiotropium bromide, may be associated with an increased risk of stroke. An Early Communication has been issued by the Food & Drug Administration that warns of a potential increased risk of stroke in patients using the inhaler. The manufacturer reported to the agency a preliminary estimate that the risk of stroke during clinical trials is eight patients per 1,000 patients treated for one year with tiotropium and six patients per 1,000 patients treated with placebo for the same amount of time. The resulting risk of any type of stroke due to the inhaler appears to be two patients for every 1,000 using the inhaler for a year. The FDA cautioned practitioners that the findings are only preliminary and no regulatory action is being taken at this time. The agency will further evaluate postmarketing adverse event reports and will review data from the company’s UPLIFT study, a large four-year study that will provide additional long-term safety data. The results are due out in June. At that time the FDA will analyze the new information and communicate its conclusions.Article Via: Drug Topics, by By: Heidi Belden, Pharm.D.
2007’s top drugs by units
February 20, 2008
Drug Topics and Verispan have released a list of the top prescribed brand and generic drugs, by unit.
Topping the generic list: Hydrocodone/APAP, Lisinopril, and Amoxicillin.
The top brand name drugs were Lipitor, Singulair, and Lexapro.
To view the full listing of generics, Click Here. And for Brands, Click Here.
Fentanyl patches recalled
February 17, 2008
PriCara is recalling certain pain patches with an expiration date on or before December 2009. The recall covers all lots of 25 mcg/hr Duragesic (fentanyl transdermal system) CII patches sold by PriCara and all 25 mcg/hr fentanyl patches sold by Sandoz. PriCara explained that the patches are being recalled as they may have a cut along one side of the drug reservoir within the patch. Exposed fentanyl is dangerous to those who touch it and should be washed off with water, but not soap. Anyone with the Duragesic patches being recalled should call (800) 547-6446; for the Sandoz patches, call (800) 901-7236.
