MedWatch - Boca Medical Products, Inc
(6 months posted on site)
May 4, 2007
FDA Advises Manufacturers to Test Glycerin for Possible Contamination
The Food and Drug Administration has issued an advisory statement to manufacturers that they test their glycerin for possible contamination. This advisory follows reports of deaths in other countries attributed to Chinese drug counterfeiters’ substituting diethylene glycol for glycerin. FDA has stated that it has “no reason to believe that the U.S. supply of glycerin is contaminated with DEG.” Nonetheless, it recommends testing of glycerin “due to the serious nature of this potentially fatal problem.” The Board of Pharmacy recommends that compounding pharmacies and other pharmacies that use glycerin heed FDA’s advisory statement and take any action they deem appropriate.
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
May 2, 2007
Re: Recall Of Compounded Injectable Colchicine- All Strengths, Sizes and Lots
ApothéCure and FDA notified all healthcare professionals of recent deaths associated with the use of compounded injectable Colchicine .5mg/ml, 4ml vials, lot number 20070122@26. The company issued an immediate drug recall for all strengths, sizes and lots of compounded Injectable Colchicine sold within the last year. Customers are asked to examine their stock for ApothéCure compounded Colchicine on hand and to discontinue use immediately and prepare the product to return to the company.
Read the complete 2007 MedWatch 2007 Safety summary, including a link to the Manufacturer's Recall Notice and Return Fax Cover Sheet regarding this issue at:
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
May 1, 2007
Re: Warning About Counterfeit Drugs From Multiple Internet Sellers
FDA informed consumers and healthcare professionals regarding the dangers associated with buying prescription drugs over the internet. FDA received information showing that 24 apparently related websites may be involved in the distribution of counterfeit prescription drugs. The website appear to be operated from outside the United States.
On three occasions during recent months, consumers obtained counterfeit versions of Xenical 120 mg Capsules, a drug used to help obese individuals who meet certain weight and height requirements to lose and maintain weight loss, from two different websites. Instead of receiving Xenical, a product manufactured by Hoffmann-LaRoche Inc, consumers received sibutramine, the active ingredient in Meridia. Although Meridia is also used to lose and maintain weight loss, the drug should not be used in certain patient populations and is not a substitute for other weight loss products. Consumers should be wary if there is no way to contact the website pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from their doctor is required. Additionally, consumers are urged to review the FDA web page at buyonline for additional information prior to making purchases of prescription drugs over the internet. See FDA press release for the list of the 24 web site that may be involved in the distribution of counterfeit prescription drugs.
Read the complete 2007 MedWatch 2007 Safety summary, including a link to the FDA Press Release regarding this issue at:
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
April 24, 2007
Re: Worldwide recall of approximately 300,000 S8 flow generators (Continuous Positive Air Pressure or CPAP) - Recall due to potential for a short circuit in the power supply connector
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:
April 10, 2007
Urgent Recall Notice
Griseofulvin Oral Suspension (microsize) 125mg/5ml
NDC #10147-0810-4
Distributor - Patriot Pharmaceuticals
Manufacturer - Ortho-McNeil Pharmaceutical
Reason for recall - amber glass bottles enclosed in a plastic film from top of the cap to the base. The over-wrap could potentially mask structural damage to the bottles and potential glass fragments might be in the suspension.
For questions and lot numbers call 1-800-510-0383
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
April 6, 2007
Re: Tigan (trimethobenzamide hydrochloride) - Product Market Withdrawal Due to Lack of Evidence of Effectiveness
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:
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
March 28, 2007
Re: Dangers involved with buying Accutane (isotretinoin) online
FDA notified consumers and healthcare professionals of a special webpage launched to warn about the dangers of buying isotretinoin online.
Isotretinoin is a drug approved for the treatment of severe acne that does not respond to other forms of treatment. If the drug is improperly used, it can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.
The new webpage, , will appear in online search results for Accutane (isotretinoin) or one of the generic versions, Amnesteem, Claravis, and Sotret. The webpage warns that the drug should only be taken under the close supervision of a physician or a pharmacist, and provides links to helpful information. The new webpage is in addition to special safeguards put in place by FDA and manufacturers of isotretinoin to reduce the risks of the drug, including a risk management program called iPLEDGE. The aim of iPLEDGE is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin.
Read the complete MedWatch 2007 Safety summary, including a link to the FDA Accutane Product Information Page regarding this issue at:
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
March 19, 2007
Re: V.MAX supplement product recalled
Barodon SF and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name V.MAX. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED).
FDA advised that this poses a threat to consumers because Aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Consumers who have V.MAX in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.
Read the complete MedWatch 2007 Safety summary, including a link to the firm press release, at:
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
March 16, 2007
Re: Rhino Max supplement product recalled
Cosmos Trading, Inc. and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name Rhino Max (Rhino V Max) in 5-tablet boxes or 15-tablet boxes. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED).
FDA advised that this poses a threat to consumers because Aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have Rhino Max (Rhino V Max) in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.
Read the complete MedWatch 2007 Safety summary, including a link to the firm's press release, at:
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
February 21, 2007
Re: Xolair (omalizumab) - new reports of serious and life-threatening allergic reactions (anaphylaxis)
FDA notified asthmatic patients and healthcare professionals of new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair. Usually these reactions occur within two hours of receiving a Xolair subcutaneous injection. However, these new reports include patients who had delayed anaphylaxis-with onset two to 24 hours or even longer-after receiving Xolair treatment.
Anaphylaxis may occur after any dose of Xolair (including the first dose), even if the patient had no allergic reaction to the first dose.
Health care professionals who administer Xolair should be prepared to manage life-threatening anaphylaxis and should observe their Xolair-treated patients for at least two hours after Xolair is given. Patients under treatment with Xolair should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following Xolair treatment, and how to treat it when it occurs. FDA has requested Genentech add a boxed warning to the product label and to revise the label and provide a Medication Guide for patients.
Read the complete MedWatch 2007 Safety summary, including links to the Healthcare Professional information sheet and FDA press statement, at:
February 15, 2007 Health Alert - FDA Issues Notice on RotaTeq Rotavirus Vaccine
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
February 7, 2007
Re: Heparin Sodium Injection 10,000 units/mL and HEP-LOCK U/P 10 units/mL associated with fatal medication errors
Baxter and FDA notified healthcare professionals of the potential for life threatening medication errors involving two Heparin products, Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL.
Baxter is aware of fatal medication errors that have occurred when two Heparin products with shades of blue labeling were mistaken for each other. Three infant deaths resulted when the higher dosage Heparin Sodium Injection 10,000 units/mL was inadvertently administered instead of the lower dosage of HEP-LOCK U/P 10 units/mL. The currently marketed 1 mL vials of both Heparin products use blue as the prominent background color on their labels.
Read the complete MedWatch 2007 Safety summary, including a link to the Baxter Dear Healthcare Provider letter, at:
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
February 6, 2007
Re: Use of Skin Products Containing Numbing Ingredients (Topical Anesthetic Drugs) for Cosmetic Procedures and Potential Life-Threatening Side Effects
FDA informed consumers and healthcare professionals of the potential hazards of using skin numbing products containing topical anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. Numbing products are widely used to numb the skin for medical and cosmetic procedures, and to relieve pain, burning and itching due to a variety of medical conditions. FDA has approved many of these products for these uses. Some of these products must be prescribed by a doctor, others may be purchased without a prescription.
FDA is aware that use of these products before a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, a patient may apply large amounts of the numbing product to their skin, which can cause life-threatening side effects and death. If a skin numbing product is prescribed or recommended for a procedure, consumers should do the following:
- use a topical anesthetic approved by the FDA.
- use a topical anesthetic that contains the lowest amount of anesthetic drugs possible that will relieve pain.
- ask for instructions from your doctor on how to safely use the topical anesthetic.
Read the complete MedWatch 2007 Safety summary, including the link to the FDA's Public Health Advisory regarding this issue at:
Paxil CR® Recall Notice - January 23, 2007 - Read the recall notice here (includes lot numbers and additional information.)
MedWatch - Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product
May 19, 2006
Boca Medical Products and FDA notified consumers and healthcare professionals of an extension of an earlier recall of Ultilet insulin syringes and the additional recall of Closercare insulin syringes because of bacterial contamination with Paenibacillus. This presents a risk of local infection due to soft tissue injection with a contaminated syringe as well a risk of introduction of contaminating organisms into a previously sterile vial. The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. The recall includes Closercare Insulin Syringe 29g 1cc product lot number 5JCZ1 as displayed on the inner case and Ultilet Insulin Syringe 30g 1/2cc, product lot number 5KEO1 as displayed on the inner case. The earlier recall of Ultilet syringes included lot number 5GEXI. This product has been distributed to the following states: FL, NY, MA, AL, SC, NC, CO, TX, MI, AR.
Read the complete MedWatch 2006 Safety summary, including links to the current and past firm recall notices, at:
Spectrum Laboratory Products, Inc. Issues Nationwide Recall of Tacrolimus Active Pharmaceutical Ingredient
May 11, 2006
FOR IMMEDIATE RELEASE -- Gardena, CA -- May 11, 2006 -- Spectrum Laboratory Products, Inc, (Spectrum), Gardena, California, is initiating a voluntary nationwide recall of the active pharmaceutical ingredient (API) tacrolimus after learning some lots are sub-potent. Tacrolimus is an immunosuppressive drug used to prevent rejection of transplanted solid organs such as heart or kidney. Blood levels of tacrolimus in some patients were significantly lower than would be expected based solely on the lower assay results. The use of sub-potent tacrolimus in compounded drugs for transplant recipients may lead to sub-therapeutic tacrolimus blood levels and an unacceptably increased risk of solid organ transplant rejection. At least one injury has been reported. FDA has been apprised of this action.
To read the press release in its entirety, visit:
FDA MedWatch - Oral Sodium Phosphate Products for Bowel Cleansing: Risk of acute phosphate nephropathy and renal failure
May 5, 2006
FDA notified healthcare professionals and consumers of reports of acute phosphate nephropathy, a type of acute renal failure, that is a rare, but serious adverse event associated with the use of oral sodium phosphates (OSP) for bowel cleansing. Documented cases of acute phosphate nephropathy include 21 patients who used an OSP solution (such as Fleet Phospho-soda or Fleet ACCU-PREP) and one patient who used OSP tablets (Visicol). Individuals at increased risk of acute phosphate nephropathy include: those of advanced age, those with kidney disease or decreased intravascular volume, and those using medicines that affect renal perfusion or function [diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and possibly nonsteroidal anti-inflammatory drugs (NSAIDs)]. Recommendations were offered for providers and patients when choosing and using a bowel cleanser.
To read more, visit:
FDA Alert
April 26, 2006
Promethazine Contraindicated in Young Children
Medications containing promethazine hydrochloride (HCl) should not be used for children less than two years of age because of the potential for fatal respiratory depression. This includes promethazine HCl in any form: syrups, suppositories, tablets, or injectables. Cases of respiratory depression including fatalities have been reported with use of promethazine HCl in children less than two years of age. Caution should also be exercised when administering promethazine HCl in any form to pediatric patients two years of age and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings. One manufacturer of suppositories and tablets has notified healthcare professionals of the changed label. The FDA is issuing this safety alert to make sure that healthcare professionals, other caregivers, and patients realize that the warnings apply to promethazine HCl syrups as well.
To read more, visit:
Hollister-Stier Laboratories, LLC
April 20, 2006
Device Recall Notification
A device Recall Notification has been issued to all consignees that have purchased the following product:
Sterile Empty Vial
10 mL size
Lot #6743
Item No's: 7515ZA; 7515ZC; 7515ZD
Click here for more information, including a Recall Response Form.
FDA Alert
April 2006
Diazepam Rectal Gel (marketed as Diastat AcuDial) Information
Cracks have been found in the applicator tips of the 10 and 20 mg Diastat AcuDial prefilled syringes. Medicine can leak through the cracks. If medicine leaks, there may not enough medicine to treat a seizure.
If you or someone in your care uses Diastat AcuDial, carefully check your pre-filled syringes for cracks. You should check the syringes WITHOUT REMOVING THE CAP. For instructions: visit and click on the “Alert” Box to see photos, or call Valeant Pharmaceuticals at 1-877-361-2719, about how to check for cracks.
If you see a crack, use a different syringe. Take all cracked syringes back to the pharmacist and exchange them for new syringes. Cracks can appear over time, so keep checking on your syringes to make sure you have good ones ready to use if needed.
If seizures continue after using Diastat, get emergency medical help right away by calling 911.
The company that makes Diastat AcuDial prefilled syringes is working to correct the problem, but new syringes will not be available until June or July. Meanwhile, the old prefilled syringes will still be dispensed because there is no other product available to treat sudden increased seizures.
(from FDA: )
From the Food and Drug Administration
April 14, 2006
Media Inquiries: Press Office, 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Statement Regarding Voluntary Market Withdrawal of Bausch & Lomb ReNu MoistureLoc® Contact Lens Solution
FDA is continuing to work closely with the Centers for Disease Control and Prevention (CDC) and Bausch & Lomb to investigate the source of Fusarium keratitis eye infections. The agency supports Bausch & Lomb's decision to voluntarily withdraw ReNu MoistureLoc® contact lens solution from the market until the agencies have had a chance to conclude their investigation.
FDA started its investigation of the Bausch & Lomb manufacturing plant on March 22, 2006, and will continue inspections of the Greenville, SC manufacturing plant and other facilities through next week. While the investigation continues, FDA will work with CDC to identify and confirm cases of Fusarium keratitis reported by state health departments and from FDA Medwatch reports.
FDA and CDC are advising consumers to take precautions to reduce their risk for Fusarium keratitis through preventive practices for contact lens wearers that include:
Wash hands with soap and water, and dry (lint-free method) before handling lenses.
Wear and replace lenses according to the schedule prescribed by the doctor.
Follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer.
Keep the contact lens case clean and replace every 3-6 months.
Remove the lenses and consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.
For more information, please visit FDA’s Contact Lens and Eye Infections page at:
From the Food and Drug Administration
FOR IMMEDIATE RELEASE
March 31, 2006
Media Inquiries: Rae Jones, (301) 827-6242
Consumer Inquiries: 888-INFO-FDA
Permanent Court Order Halts Illegal Importation of Prescription Drugs
On March 9, 2006, the United States District Court for the Southern District of New York entered a Consent Degree that permanently enjoins Canada Care Drugs, Inc. (Canada Care), Christine Ruggiero, and Claire Ruggiero (defendants) from causing the importation of drugs, receiving commissions from the importation of drugs, and advertising or promoting any drug importation service.
Additional FDA inspections, as directed by the court order, will be used to ensure that the defendants do not continue to violate the law. In addition, the court ordered the defendants to surrender to the U.S. Treasury $4,000 in profits from their illegal activities.
"This court order is another example of the FDA's efforts to stop illegal drug imports – a practice which can present a health hazard to patients," said Margaret O'K. Glavin, Associate Commissioner for Regulatory Affairs. "Our agency will continue to help protect Americans from potentially harmful consequences of this practice, while also working to help assure that Americans have access to quality, safe, and effective products."
The permanent injunction is the result of a legal process that started on November 9, 2004, when the federal government filed a civil complaint against these defendants based on an FDA investigation of Canada Care's illegal importation operations. This consent decree of permanent injunction follows one filed August 20, 2004 in the case of Rx Depot and Rx of Canada, where the defendants were also ordered to cease all operations involving the illegal importation of prescription drugs.
FDA's investigation, conducted in February and August, 2004, involved undercover purchases of prescription medications through Canada Care. Medications purchased outside the consumer safety protections built into the U.S. drug distribution system are a public health concern because patients cannot be sure of the quality or the safety and effectiveness of such drugs. In addition, as in the case of products purchased undercover by FDA from Canada Care, these kinds of products are often shipped with inadequate instructions for use or in inappropriate quantities that facilitate use of the product without the input of a physician that is needed to assure that the product is used in a manner to prevent serious, and even fatal, consequences.
In addition, previous FDA investigations found that drugs purchased under these conditions are more likely to be contaminated, counterfeit, inherently ineffective, or contain different amounts of the active ingredients from similar drugs that are FDA approved and are safeguarded by the consumer protections built into the U.S. drug distribution system.
For more information go to: bbs/topics/news/2004/NEW01142.html and bbs/topics/ANSWERS/2004/ANS01337.html.
From the Department of Health and Human Services - Centers for Disease Control and Prevention
CDC HEALTH ALERT
CDC Recommends against the Use of Amantadine and Rimantadine for the Treatment or Prophylaxis of Influenza in the United States during the 2005–06 Influenza Season
Recent evidence indicates that a high proportion of currently circulating Influenza A viruses in this country are resistant to these medications
Distributed via Health Alert Network
January 14, 2006, 3:25 PM EST
While the primary strategy for preventing complications of influenza infections is annual vaccination, antiviral medications with activity against influenza viruses can be effective for the prophylaxis and treatment of influenza. Two classes of antivirals are currently available—the M2 ion channel inhibitors (i.e., the two adamantanes amantadine and rimantadine) and the neuraminidase inhibitors (i.e., oseltamivir and zanamivir). The neuraminidase inhibitors are effective for the treatment and prophylaxis of influenza A and B, while the adamantanes are only active against influenza A viruses. This alert provides new information about the resistance of influenza viruses currently circulating in the United States to the adamantanes, and it makes an interim recommendation that these drugs not be used during the 2005–06 influenza season. Amantadine is also used to treat the symptoms of Parkinson’s disease, and should continue to be used for this indication.
Viral resistance to adamantanes can emerge rapidly during treatment because a single point mutation at amino acid positions 26, 27, 30, 31, or 34 of the M2 protein can confer cross-resistance to both amantadine and rimantadine. The transmissibility of adamantane-resistant viruses is not impaired by any of these amino acid changes. A recent report on the global prevalence of adamantane-resistant influenza viruses showed a significant increase (from 1.9% to 12.3%) in drug resistance over the past 3 years. In the United States, the frequency of drug resistance increased from 1.9% in 2004 to 14.5% during the first 6 months of the 2004–05 influenza season.
For the 2005–06 season, 120 influenza A (H3N2) viruses isolated from patients in 23 states have been tested at CDC through January 12, 2006; 109 of the isolates (91%) contain an amino acid change at position 31 of the M2 protein, which confers resistance to amantadine and rimantadine. Three influenza A(H1N1) viruses have been tested and demonstrated susceptibility to these drugs. All influenza viruses from the United States that have been screened for antiviral resistance at CDC have demonstrated susceptibility to the neuraminidase inhibitors.
On the basis of available antiviral testing results, CDC is providing an interim recommendation that neither amantadine nor rimantadine be used for the treatment or prophylaxis of influenza A in the United States for the remainder of the 2005–06 influenza season. During this period, oseltamivir or zanamivir should be selected if an antiviral medication is used for the treatment and prophylaxis of influenza. Testing of influenza isolates for resistance to antivirals will continue throughout the 2005–06 influenza season, and recommendations will be updated as needed. Annual influenza vaccination remains the primary means of preventing morbidity and mortality associated with influenza.
Additional information about the prevention and control of influenza is available at flu. Specific information regarding the use of the neuraminidase inhibitors is available at flu/protect/antiviral. These websites will be updated as new information becomes available.
To read more, visit: and
U.S. Food and Drug Administration
January 27, 2006
Media Inquiries:
Laura Alvey, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes
There is a new, potential alternative for many of the more than 5 million Americans who take insulin injections, with the Food and Drug Administration's approval today of the first ever inhaled insulin. Exubera, an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new insulin delivery option introduced since the discovery of insulin in the 1920s.
"Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition," said Dr. Steven Galson, Director, Center for Drug Evaluation and Research, FDA. "It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars."
Diabetes is a disease that affects the amount of insulin and sugar in your body. Exubera is a human form of insulin and as such, lowers blood sugar concentrations by allowing the blood sugar to be taken up by cells as a source of fuel. Exubera is a powdered form of insulin that is able to be inhaled into the lungs through the patient's mouth using a specially designed inhaler.
There are two major types of diabetes -- type 1 and type 2. People with type 1 diabetes produce virtually no insulin. In type 2, the most common form of the disease, the body does not produce enough insulin or effectively use insulin. If people with diabetes do not properly control their blood sugar levels, serious complications including heart disease, kidney failure, blindness, and nerve damage may develop.
The safety and efficacy of Exubera have been studied in approximately 2500 adult patients with type 1 and type 2 diabetes. In clinical studies, Exubera reached peak insulin concentration more quickly than some insulins, called regular insulin, administered by an injection. Peak insulin levels were achieved at 49 minutes (range 30 to 90 minutes) with Exubera inhaled insulin compared to 105 minutes (range 60 to 240 minutes) with regular insulin, respectively. In type 1 diabetes, inhaled insulin may be added to longer acting insulins as a replacement for short-acting insulin taken with meals. In type 2 diabetes, inhaled insulin may be used alone, along with oral (non-insulin) pills that control blood sugar, or with longer acting insulins.
Exubera prescriptions will be accompanied by a Medication Guide containing FDA-approved information written especially for patients. Pharmacists are required to distribute Medication Guides with products FDA has determined are important to health, and patient adherence to directions for use is crucial to the product's effectiveness. Patients are advised to read the entire Medication Guide and talk to their healthcare provider if they have further questions.
Like any insulin product, low blood sugar is a side effect of Exubera and patients should carefully monitor their blood sugars regularly. Other side effects associated with Exubera therapy seen in clinical trials included cough, shortness of breath, sore throat, and dry mouth.
Exubera is not to be used if you smoke or if you recently quit smoking (within the last 6 months). Exubera is not recommended in patients with asthma, bronchitis, or emphysema. Baseline tests for lung function are recommended after the first 6 months of treatment and every year thereafter, even if there are no pulmonary symptoms.
While Exubera has been extensively studied for safety, the sponsor has committed to performing long-term studies to confirm the continued safety of Exubera after it is marketed and to examine more thoroughly the issue of the efficacy and safety of Exubera in patients with underlying lung disease.
Exubera is manufactured by Pfizer Inc., NY, NY.
U.S. Food and Drug Administration
January 20, 2006
The Food and Drug Administration announced the approval of updated labeling for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus).
Elidel Cream (pimecrolimus)
Protopic Ointment (tacrolimus)
The Food and Drug Administration announced the approval of updated labeling for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The labeling will be updated with a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling) will be distributed to help ensure that patients using these prescription medicines are aware of this concern. The new labeling also clarifies that these drugs are recommended
for use as second-line treatments. This means that other prescription topical medicines should be tried first. Use of these drugs in children under 2 years of age is not recommended.
Read the complete MedWatch 2006 Safety Summary, including links to the FDA Public Health Advisory and the FDA Drug Information Page that includes links
to the Healthcare Professional and Patient Information Sheets, at:
U.S. Food and Drug Administration
January 18, 2006
Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Announces New Prescription Drug Information Format to Improve Patient Safety
The U.S. Food and Drug Administration (FDA) today unveiled a major revision to the format of prescription drug information, commonly called the package insert, to give healthcare professionals clear and concise prescribing information. In an effort to manage the risks of medication use and reduce medical errors, the newly designed package insert will provide the most up-to-date information in an easy-to-read format that draws physician and patient attention to the most important pieces of drug information before a product is prescribed. The new format will also make prescription information more accessible for use with electronic prescribing tools and other electronic information resources.
Revised for the first time in more than 25 years, the new format requires that the prescription information for new and recently approved products meet specific graphical requirements and includes the reorganization of critical information so physicians can find the information they need quickly. Some of the most significant changes include:
A new section called Highlights to provide immediate access to the most important prescribing information about benefits and risks.
A Table of Contents for easy reference to detailed safety and efficacy information.
The date of initial product approval, making it easier to determine how long a product has been on the market.
A toll-free number and Internet reporting information for suspected adverse events to encourage more widespread reporting of suspected side effects.
To continue reading, please visit:
U.S. Food and Drug Administration
January 11, 2006
FDA Cautions Consumers Against Filling U.S. Prescriptions Abroad
Drugs With Same or Similar Names May Contain Different Active Ingredients Than in U.S. and Pose Health Risks
The U.S. Food and Drug Administration (FDA) is warning healthcare professionals and consumers that filling their prescriptions abroad may have adverse health consequences because of confusion with drug brand names that could inadvertently lead consumers to take the wrong medication for their condition. An FDA investigation has found that many foreign medications, although marketed under the same or similar-sounding brand names as those in the United States, contain different active ingredients than in the United States. Taking a different active ingredient may not help, and may even harm, the user.
"Consumers who fill U.S. prescriptions abroad, either when traveling or when shopping at foreign internet pharmacies, need to be aware of this potential health hazard," said Dr. Murray Lumpkin, Deputy Commissioner for International and Special Programs. "The name of a drug bought from another country may be identical or similar to the name on the U.S. prescription, but the active ingredient in the medicine may be different and not provide the right treatment."
FDA's investigation illustrates this health risk inherent in filling U.S. prescriptions abroad and highlights the lack of standardization of drug trade names internationally. For example, in the United States, "Flomax" is a brand name for tamsulosin, a treatment for an enlarged prostate, while in Italy, the active ingredient in the product called "Flomax" is morniflumate, an anti-inflammatory drug. In the United States, "Norpramin" is the brand name for an anti-depression drug containing desipramine but, in Spain, the same brand name, "Norpramin," is used for a drug that contains omeprazole, a treatment for stomach ulcers. While some of the identical brand names have different active ingredients appropriate for the same health condition, even these products should not be substituted without the guidance of a healthcare professional because of the potential for different doses, side effects, allergies, and interactions with other drugs.
FDA also has found 105 U.S. brand names that have foreign counterparts that look or sound so similar that consumers who fill such prescriptions abroad may receive a drug with the wrong active ingredient. For example, in the United Kingdom, "Amyben," a brand name for a drug product containing amiodarone, used to treat abnormal heart rhythms, could be mistaken for "Ambien," a U.S. brand name for a sleeping pill. Using Amyben instead of Ambien could have a serious adverse outcome.
For more information, see FDA's Public Health Advisory at .
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