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April 2007 |
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4/25 PharmaFab Inc., agrees to stop illegal manufacturing practices 4/24 ResMed S8 Flow Generators (Continuous Positive Air Pressure or CPAP) - Recall 4/18 FDA seizes all medical products from Shelhigh, Inc for manufacturing violations 4/11 Zanaflex (tizanidine hydrochloride) Tablets and Capsules - Changes to the CONTRAINDICATIONS and WARNINGS 4/10 Grifulvin V (griseofulvin) Oral Suspension & Griseofulvin Oral Suspension - Nationwide recall 4/3 April 2007 FDA Patient Safety News 4/3 March 2007 Monthly Safety Labeling Changes Posted Subject: FDA MedWatch: PharmaFab Inc., agrees to stop illegal manufacturing practices of unapproved and adulterated prescription and over-the-counter drugs Date: Wednesday, April 25, 2007 7:36 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, to stop the illegal manufacture and distribution of prescription and over-the-counter drug products. The products are illegal because they are not produced according to the required current good manufacturing practice (CGMP) and many also lack required FDA approval. Compliance with CGMP is necessary to ensure that drugs have the requisite safety, identity, strength, quality, and purity. PharmaFab is a major contract manufacturer and distributor of more than 100 different prescription and over-the-counter drug products, including cough and cold products, ulcer treatments, and postpartum hemorrhage products. Consumers who have products manufactured by PharmaFab should consult with their physician. Read the complete MedWatch 2007 safety summary, including a link to the FDA Press Release, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#PharmaFab _________________________________________________________________ Subject: FDA MedWatch: ResMed S8 Flow Generators (Continuous Positive Air Pressure or CPAP) - Recall due to potential for a short circuit in the power supply connector Date: Tuesday, April 24, 2007 3:49 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program ResMed and FDA notified consumers and healthcare professionals of a worldwide recall of approximately 300,000 S8 flow generators (Continuous Positive Air Pressure or CPAP) used for the treatment of obstructive sleep apnea. In Model S8 devices manufactured between July 2004 and May 15, 2006, there is a potential for a short circuit in the power supply connector. ResMed plans to work with its distribution partners globally to provide a replacement device to patients who have an affected S8 flow generator. See recall notice for serial numbers for affected S8 models. Patients may continue to use their S8 flow generators until they receive a replacement device. As with any electrical device, patients should make sure that it is placed on a hard clean surface and that the area around the device is clear during use. Patients should discontinue use of the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or charred smell. Patients should not use supplemental oxygen with an affected device; patients using supplemental oxygen should immediately contact their home healthcare provider for a replacement. Read the complete MedWatch 2007 safety summary, including a link to the manufacturer's Recall Notice, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#ResMed _________________________________________________________________ Subject: FDA MedWatch: ResMed S8 Flow Generators (Continuous Positive Air Pressure or CPAP) - Recall due to potential for a short circuit in the power supply connector Date: Tuesday, April 24, 2007 3:49 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program ResMed and FDA notified consumers and healthcare professionals of a worldwide recall of approximately 300,000 S8 flow generators (Continuous Positive Air Pressure or CPAP) used for the treatment of obstructive sleep apnea. In Model S8 devices manufactured between July 2004 and May 15, 2006, there is a potential for a short circuit in the power supply connector. ResMed plans to work with its distribution partners globally to provide a replacement device to patients who have an affected S8 flow generator. See recall notice for serial numbers for affected S8 models. Patients may continue to use their S8 flow generators until they receive a replacement device. As with any electrical device, patients should make sure that it is placed on a hard clean surface and that the area around the device is clear during use. Patients should discontinue use of the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or charred smell. Patients should not use supplemental oxygen with an affected device; patients using supplemental oxygen should immediately contact their home healthcare provider for a replacement. Read the complete MedWatch 2007 safety summary, including a link to the manufacturer's Recall Notice, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#ResMed _________________________________________________________________ Subject: FDA MedWatch: Avastin (bevacizumab) and formation of tracheoesophageal fistula in a recent clinical study in patients with limited-stage small cell lung cancer Date: Saturday, April 21, 2007 11:20 AM MedWatch - The FDA Safety Information and Adverse Event Reporting Program Genentech and FDA notified healthcare professionals of important new safety information regarding tracheoesophageal (TE) fistula formation in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC). This multicenter, non-randomized, single-arm phase II clinical trial study combined chemotherapy and radiation plus Avastin. There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in this study. A third, fatal event (upper aerodigestive tract hemorrhage and death of unknown cause), was also reported, in which TE fistula was suspected but not confirmed. All three events occurred during the Avastin maintenance phase of the study in the context of persistent esophagitis. Additionally, six other cases of TE fistula have also been reported in other lung and esophageal cancer studies using Avastin and chemotherapy alone or with concurrent radiation treatment. Avastin is not approved for the treatment of SCLC. The current prescribing information includes a description of gastrointestinal tract fistula formation in patients with colorectal cancer and other types of cancer treated with Avastin. Genentech intends to revise the Avastin package insert to include more detailed information regarding the incidence of all cases of fistula in patients treated with Avastin. Read the complete MedWatch 2007 Safety Alert with links to the Genentech Dear Healthcare Professional Letter and the most recent Avastin labeling, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avastin _________________________________________________________________ Subject: FDA MedWatch: FDA seizes all medical products from N.J. device manufacturer (Shelhigh, Inc.) for significant manufacturing violations Date: Wednesday, April 18, 2007 1:49 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA seized all implantable medical devices from Shelhigh, Inc., after finding significant deficiencies in the company's manufacturing processes. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices. Physicians should use alternative devices. Physicians should also monitor patients with any Shelhigh implants for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information. Healthcare professionals and consumers are encouraged to review the attached FDA Press Release as well as the Preliminary Public Health Notification, and Advice for Patients, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Shelhigh _________________________________________________________________ Subject: FDA - MedWatch - Boston Scientific/Guidant Contak Renewal 3 & 4, Vitality, Vitality 2- Subset of Devices Recalled Because A Faulty Capacitor In The Devices Can Cause the Batteries to Deplete Date: Thursday, April 12, 2007 3:24 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program Boston Scientific/Guidant and FDA informed healthcare professionals and patients that a subset of devices within the CONTAK RENEWAL 3 & 4, VITALITY and VITALITY 2 families were recalled. The recall included approximately 73,000 implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because of faulty capacitors. The capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator and end of life to less than three months. Although the current recall is similar to the recall of May 2006, the failure modes and patient outcomes differ from those described in the May 2006 recall. Patients with one of the recalled devices should contact their healthcare provider regarding the next steps to take. Read the complete 2007 MedWatch 2007 Safety summary, including a link to the manufacturer's Dear Doctor Letter and the FDA's Q&A document regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#icd _________________________________________________________________ Subject: FDA - MedWatch - Zanaflex (tizanidine hydrochloride) Tablets and Capsules - Changes to the CONTRAINDICATIONS and WARNINGS Sections of the Approved Product Labeling Date: Wednesday, April 11, 2007 4:09 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program Acorda Therapeutics and FDA informed healthcare professionals of changes to the CONTRAINDICATIONS and WARNINGS Sections of the product labeling for Zanaflex, a drug used to treat spasticity, In pharmacokinetic studies where tizanidine was coadministered with either fluvoxamine or ciprofloxacin (CYP1A2 inhibitors), the serum concentration of tizanidine was significantly increased and potentiated its hypotensive and sedative effects. Although there are no clinical studies evaluating the effects of other CYP1A2 inhibitors on tizanidine, coadministration of tizanidine with other CYP1A2 inhibitors (zileuton, other fluroquinolones, antiarrythmics, cimetidine, famotidine, oral contraceptives, acyclovir and ticlopidine) should be avoided. Read the complete MedWatch 2007 Safety summary, including a link to the manufacturer's Dear Healthcare Provider Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zanaflex _________________________________________________________________ Subject: FDA MedWatch: Ziagen (abacavir sulfate) & Combivir (lamivudine and zidovudine) Tablets - Apparent tampering causing misbranding of Ziagen Tablets as Combivir Tablets Date: Tuesday, April 10, 2007 6:41 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program GlaxoSmithKline and FDA informed healthcare professionals of an apparent third-party tampering that resulted in the misbranding of Ziagen as Combivir and employed counterfeit labels for Combivir Tablets. Both medications are used as part of combination regimens to treat HIV+ infection. Two 60-count misbranded bottles of Combivir Tablets contained 300 mg tablets of Ziagen. The counterfeit labels identified are Lot No. 6ZP9760 with expiration dates of April 2010 and April 2009. The incident appears to be isolated and limited in scope to one pharmacy in California. Pharmacists should immediately examine the contents of each bottle of Combivir in their pharmacy to confirm that the bottles contain the correct medication. The Dear Pharmacy Professional Letter contains photos of actual Combivir and Ziagen Tablets. If a bottle contains anything other than Combivir Tablets, pharmacists should notify the manufacturer. Read the complete MedWatch 2007 Safety summary, including a link to the firm's "Dear Pharmacy Professional Letter" regarding this issue, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Ziagen _________________________________________________________________ Subject: FDA MedWatch: Grifulvin V (griseofulvin) Oral Suspension & Griseofulvin Oral Suspension - Nationwide recall due to reports of glass fragments found in bottles of the liquid formulation Date: Tuesday, April 10, 2007 6:04 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program Ortho-McNeil and FDA informed healthcare professionals and consumers of a nationwide recall of griseofulvin oral suspension, a prescription medication used to treat ringworm and other fungal infections. The recall was issued based on two reports of glass fragments found in bottles of the liquid formulation. The recall is limited to the liquid formulation of the medication and does not include any other dosage form. Consumers in possession of the medication should contact the pharmacy where they purchased the drug to determine if they have the product that has been recalled and direct medical questions to their healthcare professional. Read the complete MedWatch 2007 Safety summary, including a link to the Firm's Press Release regarding this issue, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Grifulvin _________________________________________________________________ Subject: FDA - MedWatch - Tigan (trimethobenzamide hydrochloride) - Product Market Withdrawal Due to Lack of Evidence of Effectiveness Date: Friday, April 06, 2007 2:40 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and consumers that companies must stop manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride. These products are used to treat nausea and vomiting in adults and children. The products have been marketed under various names, including Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz. Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness. This action does not affect oral capsules and injectable products containing trimethobenzamide that have been approved by FDA. FDA urges consumers currently using trimethobenzamide suppositories or who have questions or concerns to contact their healthcare professional. Alternative products approved to effectively treat nausea and vomiting are available in a variety of forms. Read the complete MedWatch 2007 Safety summary, including a link to the FDA Press Release regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#trimethobenzamide _________________________________________________________________ Subject: FDA MedWatch: March 2007 Monthly Safety Labeling Changes Posted on Website Date: Tuesday, April 03, 2007 2:37 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program Safety-related drug labeling changes for March 2007 were posted on the MedWatch website. The March 2007 posting includes 40 drug products with safety labeling changes to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The Summary page -- http://www.fda.gov/medwatch/SAFETY/2007/mar07_quickview.htm -- provides drug names and a listing of the sections changed. The Detailed view -- http://www.fda.gov/medwatch/SAFETY/2007/mar07.htm -- includes sections/subsections changed and a description of new or modified safety information in the Boxed Warning, Contraindications, or Warnings sections. The full labeling may be accessed by clicking on the prescribing information link below the drug's name. The following drugs had modifications to the CONTRAINDICATIONS, and/or WARNINGS sections: Cyclessa (desogestrel/ethinyl estradiol) Tablets Genotropin (somatropin [rDNA origin] for injection) Saizen (somatropin [rDNA origin] for injection) for Subcutaneous or Intramuscular Injection Ambien (zolpidem tartrate) Tablets Aristospan (triamcinolone hexacetonide injectable suspension, USP) 5 mg/mL Aristospan (triamcinolone hexacetonide injectable suspension, USP) 20 mg/mL Cordarone (amiodarone HCl) Tablets Keppra (levetiracetam) Tablets and Oral Solution Noroxin (norfloxacin) Tablets Prilosec OTC (omeprazole magnesium delayed-release tablet) Primaxin I.M. (imipenem and cilastatin injectable suspension) The following drugs had modification to patient information labeling [either Medication Guide or Patient Package Insert]: Cyclessa (desogestrel/ethinyl estradiol) Tablets Keppra (levetiracetam) Tablets and Oral Solution Aldara (imiquimod) Cream, 5% for Topical Use Only Orencia (abatacept) Reyataz (atazanavir sulfate) Capsules Avandaryl (rosiglitazone maleate and glimepiride) Tablets Baraclude (entecavir) Tablets and Oral Solution Dolobid (diflunisal) Tablets Fentora (fentanyl buccal tablet) Geodon (ziprasidone HCl) Capsules Kaletra (lopinavir/ritonavir) Tablets and Oral Solution Soliris (eculizumab) Zyban (bupropion hydrochloride) Sustained-Release Tablets _________________________________________________________________ Subject: FDA - MedWatch - April 2007 FDA Patient Safety News is Now Available Date: Tuesday, April 03, 2007 10:21 AM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions. Stories in the April 2007 edition include: New Breast Cancer Prognostic Test http://www.accessdata.fda.gov/psn/transcript.cfm?show=62#1 Narrower Indications and New Warnings for Ketek http://www.accessdata.fda.gov/psn/transcript.cfm?show=62#2 Higher Mortality when Treating Certain Anemias with Erythropoietic Agents http://www.accessdata.fda.gov/psn/transcript.cfm?show=62#3 Update on Avoiding Gadolinium-Containing Contrast Agents in Patients with Renal Failure http://www.accessdata.fda.gov/psn/transcript.cfm?show=62#4 Alert on Custom Ultrasonics Endoscope Washers and Disinfectors http://www.accessdata.fda.gov/psn/transcript.cfm?show=62#5 Warning on Using Cough and Cold Medicines in Young Children http://www.accessdata.fda.gov/psn/transcript.cfm?show=62#6 Safe Use of Pneumatic Tourniquet Cuffs http://www.accessdata.fda.gov/psn/transcript.cfm?show=62#7 Dangers of Patient-Applied Local Anesthetic Skin Products http://www.accessdata.fda.gov/psn/transcript.cfm?show=62#8 |
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