News & Trends
April 2003
FDA Approvals
Two New Filler Substances Receive FDA Approval
T he FDA recently granted approval for the first time in more than 15 years for the first filler agents that contain human collagen. CosmoDerm and CosmoPlast contain human collagen purified from human dermal tissue. The fillers are approved for correction of facial wrinkles, acne scars and other soft tissue contour deficiencies. In addition, they’ve also been approved for restoration of the lip border. According to the company, the dermal fillers are the first commercially approved fillers in the United States that don’t require a skin test prior to use, so patients can be treated on their first visit. In addition, physicians don’t need to learn any new injection techniques.
Inamed Corp. will market and distribute CosmoDerm and CosmoPlast human collagen products.
New Anti-Fungal Shampoo
M edicis received FDA approval for ciclopirox 1% (Loprox Shampoo) in early March. The first prescription anti-fungal shampoo to get approval for treating seborrheic dermatitis of the scalp, Loprox will be available in a 120-ml size within several months. Medicis will have a 3-year patent-pending period of exclusivity with Loprox, and longer if the patent is granted.
First Drug in a New Class of HIV Treatments
I n mid-March, the FDA approved enfuvirtide (Fuzeon), a drug that received accelerated approval as a treatment for patients with advanced HIV-1 infection in adults and children age 6 and older. The drug will be used in combination with other anti-HIV medications. Fuzeon is the first drug in a new class called fusion inhibitors. These drugs inhibit the fusion of viral and cellular membranes and therefore hinder the entry of HIV-1 into cells. Administered via subcutaneous injection, this drug offers hope to HIV sufferers who have previously used other anti-HIV treatments and have developed resistance to their effectiveness.
Warning for Lindane
T he FDA issued a health advisory regarding Lindane Lotion and Lindane Shampoo to significantly update the products’ labeling to include additional warnings and a Medication Guide that will be directly distributed to patients. The boxed warning on the products will highlight the following points:
• Lindane should be used as a second-line therapy for patients who found first-line therapy intolerable or ineffective.
• Because of reports of neurologic toxicity (seizures and deaths) with repeated or prolonged use of Lindane, the product shouldn’t be used with caution in infants, children, the elderly, and patients who have other skin conditions such as psoriasis or eczema. Patients who weigh under 110 pounds may be at risk for serious neurotoxicity.
• Lindane Lotion is contraindicated in premature infants and people who have uncontrolled seizure disorders.
• In addition to these warnings, product package sizes will be limited to 1 to 2 ounces to help avoid misuse or overuse.
Skin Lotion for Military Personnel
U .S. military personnel will now have a liquid decontamination lotion at their disposal for removing and treating chemical warfare agents and T-2 fungal toxins from the skin. The FDA approved the lotion, which is manufactured by O’Dell Engineering, on March 28. Reactive Skin Decontamination Lotion, the brand name of the product, is indicated for application as soon as possible after exposure to chemical agents. A sponge pad is soaked with the lotion and packaged in a heat-sealed foil pouch. The product was studied in more than 300 people for skin irritation, sensitization and photo irritation before approval.
Research Shorts
Study Finds No Correlation to BCG Vaccination and Reduced Risk of Atopy
I n a study published in the February issue of the Journal of the American Medical Association (JAMA), researchers tested the theory that the BCG vaccination given to infants reduced the risk of atopy. Conducted on the northwest coast of Greenland (Greenland infants were routinely given the BCG vaccination until 1990 when it was withdrawn from the vaccination program), 1,686 children between the ages of 8 and 16 participated in the study. The children had a blood sample drawn with atopy being defined as a positive test result in an assay that tests for IgE specific against common inhalant allergens in serum. The results indicated that atopy’s risk in BCG vaccinated children versus unvaccinated children was the same. The age of vaccination did not affect the risk of atopy in BCG-vaccinated children. Researchers indicated a BCG vaccination administered to infants did not reduce the risk of developing atopy.
— JAMA, February 2003
Researchers Say Adverse Drug Events Can Be Prevented Among Ambulatory Care Patients
N ew research is suggesting adverse drug events are potentially preventable among older patients in an ambulatory clinical setting. A study published in the March issue of the Journal of the American Medical Association (JAMA), followed all Medicare enrollees cared for by a multispecialty group practice between July 1, 1999, and June 30, 2000. During this 12-month period, 1,523 adverse drug events were identified, and 27.6% were considered preventable. Common medication categories associated with preventable adverse drug events included cardiovascular medications (24.5%), diuretics (22.1%), non-opioid analgesics (15.4%), hypoglycemics (10.9%) and anticoagulants (10.2%). The most common types of preventable adverse drug events included electrolyte/renal (26.6%), gastrointestinal tract (21.1%), hemorrhagic (15.9%), metabolic/ endocrine (13.8%) and neuropsychiatric (8.6%) events.
— JAMA, March 2003
FDA Aims to Improve Patient Safety
New proposals were unveiled to reduce medical errors and to more quickly identify potential errors before they occur.
L ast month, Health and Human Services Secretary Tommy G. Thompson announced two new proposals from the FDA to improve patient safety during the National Patient Safety Foundation’s (NPSF) 2003 Patient Safety Congress, “Let’s Get Results: Improving the Safety of Patients.”
The two plans would require bar coding on medications and improved reporting requirements for safety problems involving medicines. The required bar code would contain the National Drug Code (NDC) number, which contains unique identifying information about the drug that is to be dispensed to the patient, in a linear bar code as part of the drug label. A design was proposed that would also allow manufacturers to include additional information about the drug. The hope for this program is that when the bar codes are used with scanner and computerized patient information systems, it will prevent many medication errors, including administering:
• the wrong drug
• a drug the patient has a known allergy to
• the wrong dose
• the drug at the wrong time
• the wrong route (such as injection instead of by mouth).
The second plan proposed revamping the safety reporting requirements, aimed at enhancing the FDA’s ability to effectively monitor and improve the safe use of medications, including drugs and biologics. The rule would:
• Improve the quality and usefulness of safety reports submitted to the agency, and facilitate the consistency of safety reporting worldwide.
• Require the submission of all suspected serious reactions for blood and blood products on the market.
• Require reports on important potential medication errors.
This plan would give the FDA more useful, timely and extensive information. It would also require all healthcare groups to submit to the FDA, within 15 days, all reports they receive of actual and potential medication errors in the United States.
The expected annual savings from preventing adverse events, due to medication errors, is $3.9 billion.
Cipro Ineffectiveness Against Gram-Negative Bacilli
Antibiotic overuse to blame.
R esults of a study published in the February 19 issue of the Journal of the American Medical Association (JAMA), showed an increasing incidence of ciprofloxacin (Cipro) resistance among Gram-negative bacilli in coincidence with increased use of fluoroquinolones.
Researchers studied data submitted by hospital institutions in Washington, D.C. and 43 other states showing antibiotic susceptibility results for 35,690 nonduplicate Gram-negative aerobic isolates recovered from intensive care unit (ICU) patients between 1994 and 2000. Susceptibility tests were performed and national fluoroquinolone consumption data were also studied. Researchers concluded that the susceptibility to ciprofloxacin decreased from 86% in 1994 to 76% in 2000, and that this decrease was significantly associated with increased national use of fluoroquinolones.
Bacteria that this study found to be increasingly resistant to ciprofloxacin included Escherechia coli, Pseudomonas aeruginosa and Klebsiella pneumoniae.
It was reported that the anthrax bacterium was not studied and that this study does not conclude that ciprofloxacin has become any less effective against anthrax.
In Brief…
Dermik Labs Acquires New-Fill…from Biotech Industry S.A. in Luxembourg. The non-animal, non-human source of New-Fill is poly-lactic acid, which as vicryl sutures, has been used in surgical procedures for more than 20 years and has a low allergenic potential, with no pre-test or waiting period required prior to treatment. It’s currently available in more than 25 countries and has been used in Europe, South America, Australia and other countries for more than 3 years to treat facial lines and wrinkles around the eyes, lips, and chin. A full development program is underway working towards an approval by the U.S. FDA.
Berlex Laboratories and Allergan Team Up…to promote Berlex’s new topical rosacea treatment, Finacea Gel 15% (azelaic acid). Berlex received marketing approval from the FDA in December 2002 for Finacea, making it the first new therapeutic class option to be approved for the treatment of rosacea in more than 10 years. The new drug was launched at last month’s American Academy of Dermatology meeting in San Francisco. Under the co-promotion agreement, both companies will call on dermatologists to provide information and product samples for Finacea.
SkinMedica Acquires NouriCel Product Line…The pharmacuetical company announced its purchase of this line of products and related assets from Advanced Tissue Sciences on March 21. NouriCel-MD, a part of the NouriCel product line, is the primary ingredient in the company’s TNS Recovery Complex, a topical skin care product only available through physicians.
New Wound Dressing Introduced that Absorbs into Skin…Researchers at the Virginia Commonwealth University in Richmond, VA, have introduced a new wound dressing that can be applied to the wound, gradually dissolving as new skin forms over the wound. The wound dressing, made from the blood protein fibrinogen, would be treated by the body as part of the normal healing process. The fibrinogen protein protects the wound from infection and stops bleeding. Researchers say the dressing should quicken healing.
AAD Honors Former Galderma President…Stephen W. Clark in a March 23 ceremony in San Francisco. The Academy recognized Mr. Clark as an honorary member — an honor bestowed only once before in the AAD’s history. The honorary membership recognizes Mr. Clark’s 32 years (16 as president) with Galderma and his help in advancing the practice of dermatology.
AIDS Vaccine Trial Found Ineffective…A large clinical trial to test an AIDS vaccine has failed, according to a report issued by the vaccine’s manufacturer, VaxGen. The trial, conducted in California, was the first trial to be tested on a large group of people. The vaccine, known as Aidsvax, demonstrated virtually no effectiveness in protecting people with HIV from infection. The researchers were encouraged that the vaccine seemed to significantly lower the infection rate among African Americans and other non-Hispanic minorities. More research was called for in this area because minorities were a small fraction of people in the trial.
Phase II Results Announced for Potential New Psoriasis Therapy…Recent Phase II trial results have been announced by Canadian-based biotech company, Isotechnika, for an immunosuppressive therapy, ISA247, to treat patients with moderate to severe psoriasis. The therapy demonstrated ISA247 to be well tolerated and efficacious. ISA247 met or exceeded all of the primary and secondary efficacy and safety endpoints of the study. The trial consisted of 201 patients in a 12-week, double-blind, placebo-controlled, randomized study. Patients were studied at 12 centers throughout Canada. At the study’s conclusion, patients were monitored for an additional 6 weeks.
Common Gene Found in Lupus Patients…Researchers at the University of Minnesota and the North Shore Long Island Jewish Research Institute have discovered a genetic signature found in some patients with systemic lupus erythematosus (SLE). Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other parts of the National Institute of Health (NIH), gene expression profiling was used to analyze thousands of genes in peripheral blood cells of 48 lupus patients and 42 healthy couples. Of the genes studied, 161 showed different expression patterns in patients with SLE versus healthy controls.
The researchers noted that 14 of the thousands of genes studied were linked to a subset of SLE patients with severe disease. Known collectively as the interferon expression signature, the 14 genes are activated with the activity of interferon that regulates immune responses. Patients with severe SLE presented with higher expression levels of the interferon expression signature. Researchers suggest this data will help in developing new therapies to block interferon expression signature pathways in patients with severe lupus. Gene expression profiling will also helpful in identifying patients that would benefit from the new therapies, researchers conclude.
FDA Approvals
Two New Filler Substances Receive FDA Approval
T he FDA recently granted approval for the first time in more than 15 years for the first filler agents that contain human collagen. CosmoDerm and CosmoPlast contain human collagen purified from human dermal tissue. The fillers are approved for correction of facial wrinkles, acne scars and other soft tissue contour deficiencies. In addition, they’ve also been approved for restoration of the lip border. According to the company, the dermal fillers are the first commercially approved fillers in the United States that don’t require a skin test prior to use, so patients can be treated on their first visit. In addition, physicians don’t need to learn any new injection techniques.
Inamed Corp. will market and distribute CosmoDerm and CosmoPlast human collagen products.
New Anti-Fungal Shampoo
M edicis received FDA approval for ciclopirox 1% (Loprox Shampoo) in early March. The first prescription anti-fungal shampoo to get approval for treating seborrheic dermatitis of the scalp, Loprox will be available in a 120-ml size within several months. Medicis will have a 3-year patent-pending period of exclusivity with Loprox, and longer if the patent is granted.
First Drug in a New Class of HIV Treatments
I n mid-March, the FDA approved enfuvirtide (Fuzeon), a drug that received accelerated approval as a treatment for patients with advanced HIV-1 infection in adults and children age 6 and older. The drug will be used in combination with other anti-HIV medications. Fuzeon is the first drug in a new class called fusion inhibitors. These drugs inhibit the fusion of viral and cellular membranes and therefore hinder the entry of HIV-1 into cells. Administered via subcutaneous injection, this drug offers hope to HIV sufferers who have previously used other anti-HIV treatments and have developed resistance to their effectiveness.
Warning for Lindane
T he FDA issued a health advisory regarding Lindane Lotion and Lindane Shampoo to significantly update the products’ labeling to include additional warnings and a Medication Guide that will be directly distributed to patients. The boxed warning on the products will highlight the following points:
• Lindane should be used as a second-line therapy for patients who found first-line therapy intolerable or ineffective.
• Because of reports of neurologic toxicity (seizures and deaths) with repeated or prolonged use of Lindane, the product shouldn’t be used with caution in infants, children, the elderly, and patients who have other skin conditions such as psoriasis or eczema. Patients who weigh under 110 pounds may be at risk for serious neurotoxicity.
• Lindane Lotion is contraindicated in premature infants and people who have uncontrolled seizure disorders.
• In addition to these warnings, product package sizes will be limited to 1 to 2 ounces to help avoid misuse or overuse.
Skin Lotion for Military Personnel
U .S. military personnel will now have a liquid decontamination lotion at their disposal for removing and treating chemical warfare agents and T-2 fungal toxins from the skin. The FDA approved the lotion, which is manufactured by O’Dell Engineering, on March 28. Reactive Skin Decontamination Lotion, the brand name of the product, is indicated for application as soon as possible after exposure to chemical agents. A sponge pad is soaked with the lotion and packaged in a heat-sealed foil pouch. The product was studied in more than 300 people for skin irritation, sensitization and photo irritation before approval.
Research Shorts
Study Finds No Correlation to BCG Vaccination and Reduced Risk of Atopy
I n a study published in the February issue of the Journal of the American Medical Association (JAMA), researchers tested the theory that the BCG vaccination given to infants reduced the risk of atopy. Conducted on the northwest coast of Greenland (Greenland infants were routinely given the BCG vaccination until 1990 when it was withdrawn from the vaccination program), 1,686 children between the ages of 8 and 16 participated in the study. The children had a blood sample drawn with atopy being defined as a positive test result in an assay that tests for IgE specific against common inhalant allergens in serum. The results indicated that atopy’s risk in BCG vaccinated children versus unvaccinated children was the same. The age of vaccination did not affect the risk of atopy in BCG-vaccinated children. Researchers indicated a BCG vaccination administered to infants did not reduce the risk of developing atopy.
— JAMA, February 2003
Researchers Say Adverse Drug Events Can Be Prevented Among Ambulatory Care Patients
N ew research is suggesting adverse drug events are potentially preventable among older patients in an ambulatory clinical setting. A study published in the March issue of the Journal of the American Medical Association (JAMA), followed all Medicare enrollees cared for by a multispecialty group practice between July 1, 1999, and June 30, 2000. During this 12-month period, 1,523 adverse drug events were identified, and 27.6% were considered preventable. Common medication categories associated with preventable adverse drug events included cardiovascular medications (24.5%), diuretics (22.1%), non-opioid analgesics (15.4%), hypoglycemics (10.9%) and anticoagulants (10.2%). The most common types of preventable adverse drug events included electrolyte/renal (26.6%), gastrointestinal tract (21.1%), hemorrhagic (15.9%), metabolic/ endocrine (13.8%) and neuropsychiatric (8.6%) events.
— JAMA, March 2003
FDA Aims to Improve Patient Safety
New proposals were unveiled to reduce medical errors and to more quickly identify potential errors before they occur.
L ast month, Health and Human Services Secretary Tommy G. Thompson announced two new proposals from the FDA to improve patient safety during the National Patient Safety Foundation’s (NPSF) 2003 Patient Safety Congress, “Let’s Get Results: Improving the Safety of Patients.”
The two plans would require bar coding on medications and improved reporting requirements for safety problems involving medicines. The required bar code would contain the National Drug Code (NDC) number, which contains unique identifying information about the drug that is to be dispensed to the patient, in a linear bar code as part of the drug label. A design was proposed that would also allow manufacturers to include additional information about the drug. The hope for this program is that when the bar codes are used with scanner and computerized patient information systems, it will prevent many medication errors, including administering:
• the wrong drug
• a drug the patient has a known allergy to
• the wrong dose
• the drug at the wrong time
• the wrong route (such as injection instead of by mouth).
The second plan proposed revamping the safety reporting requirements, aimed at enhancing the FDA’s ability to effectively monitor and improve the safe use of medications, including drugs and biologics. The rule would:
• Improve the quality and usefulness of safety reports submitted to the agency, and facilitate the consistency of safety reporting worldwide.
• Require the submission of all suspected serious reactions for blood and blood products on the market.
• Require reports on important potential medication errors.
This plan would give the FDA more useful, timely and extensive information. It would also require all healthcare groups to submit to the FDA, within 15 days, all reports they receive of actual and potential medication errors in the United States.
The expected annual savings from preventing adverse events, due to medication errors, is $3.9 billion.
Cipro Ineffectiveness Against Gram-Negative Bacilli
Antibiotic overuse to blame.
R esults of a study published in the February 19 issue of the Journal of the American Medical Association (JAMA), showed an increasing incidence of ciprofloxacin (Cipro) resistance among Gram-negative bacilli in coincidence with increased use of fluoroquinolones.
Researchers studied data submitted by hospital institutions in Washington, D.C. and 43 other states showing antibiotic susceptibility results for 35,690 nonduplicate Gram-negative aerobic isolates recovered from intensive care unit (ICU) patients between 1994 and 2000. Susceptibility tests were performed and national fluoroquinolone consumption data were also studied. Researchers concluded that the susceptibility to ciprofloxacin decreased from 86% in 1994 to 76% in 2000, and that this decrease was significantly associated with increased national use of fluoroquinolones.
Bacteria that this study found to be increasingly resistant to ciprofloxacin included Escherechia coli, Pseudomonas aeruginosa and Klebsiella pneumoniae.
It was reported that the anthrax bacterium was not studied and that this study does not conclude that ciprofloxacin has become any less effective against anthrax.
In Brief…
Dermik Labs Acquires New-Fill…from Biotech Industry S.A. in Luxembourg. The non-animal, non-human source of New-Fill is poly-lactic acid, which as vicryl sutures, has been used in surgical procedures for more than 20 years and has a low allergenic potential, with no pre-test or waiting period required prior to treatment. It’s currently available in more than 25 countries and has been used in Europe, South America, Australia and other countries for more than 3 years to treat facial lines and wrinkles around the eyes, lips, and chin. A full development program is underway working towards an approval by the U.S. FDA.
Berlex Laboratories and Allergan Team Up…to promote Berlex’s new topical rosacea treatment, Finacea Gel 15% (azelaic acid). Berlex received marketing approval from the FDA in December 2002 for Finacea, making it the first new therapeutic class option to be approved for the treatment of rosacea in more than 10 years. The new drug was launched at last month’s American Academy of Dermatology meeting in San Francisco. Under the co-promotion agreement, both companies will call on dermatologists to provide information and product samples for Finacea.
SkinMedica Acquires NouriCel Product Line…The pharmacuetical company announced its purchase of this line of products and related assets from Advanced Tissue Sciences on March 21. NouriCel-MD, a part of the NouriCel product line, is the primary ingredient in the company’s TNS Recovery Complex, a topical skin care product only available through physicians.
New Wound Dressing Introduced that Absorbs into Skin…Researchers at the Virginia Commonwealth University in Richmond, VA, have introduced a new wound dressing that can be applied to the wound, gradually dissolving as new skin forms over the wound. The wound dressing, made from the blood protein fibrinogen, would be treated by the body as part of the normal healing process. The fibrinogen protein protects the wound from infection and stops bleeding. Researchers say the dressing should quicken healing.
AAD Honors Former Galderma President…Stephen W. Clark in a March 23 ceremony in San Francisco. The Academy recognized Mr. Clark as an honorary member — an honor bestowed only once before in the AAD’s history. The honorary membership recognizes Mr. Clark’s 32 years (16 as president) with Galderma and his help in advancing the practice of dermatology.
AIDS Vaccine Trial Found Ineffective…A large clinical trial to test an AIDS vaccine has failed, according to a report issued by the vaccine’s manufacturer, VaxGen. The trial, conducted in California, was the first trial to be tested on a large group of people. The vaccine, known as Aidsvax, demonstrated virtually no effectiveness in protecting people with HIV from infection. The researchers were encouraged that the vaccine seemed to significantly lower the infection rate among African Americans and other non-Hispanic minorities. More research was called for in this area because minorities were a small fraction of people in the trial.
Phase II Results Announced for Potential New Psoriasis Therapy…Recent Phase II trial results have been announced by Canadian-based biotech company, Isotechnika, for an immunosuppressive therapy, ISA247, to treat patients with moderate to severe psoriasis. The therapy demonstrated ISA247 to be well tolerated and efficacious. ISA247 met or exceeded all of the primary and secondary efficacy and safety endpoints of the study. The trial consisted of 201 patients in a 12-week, double-blind, placebo-controlled, randomized study. Patients were studied at 12 centers throughout Canada. At the study’s conclusion, patients were monitored for an additional 6 weeks.
Common Gene Found in Lupus Patients…Researchers at the University of Minnesota and the North Shore Long Island Jewish Research Institute have discovered a genetic signature found in some patients with systemic lupus erythematosus (SLE). Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other parts of the National Institute of Health (NIH), gene expression profiling was used to analyze thousands of genes in peripheral blood cells of 48 lupus patients and 42 healthy couples. Of the genes studied, 161 showed different expression patterns in patients with SLE versus healthy controls.
The researchers noted that 14 of the thousands of genes studied were linked to a subset of SLE patients with severe disease. Known collectively as the interferon expression signature, the 14 genes are activated with the activity of interferon that regulates immune responses. Patients with severe SLE presented with higher expression levels of the interferon expression signature. Researchers suggest this data will help in developing new therapies to block interferon expression signature pathways in patients with severe lupus. Gene expression profiling will also helpful in identifying patients that would benefit from the new therapies, researchers conclude.
FDA Approvals
Two New Filler Substances Receive FDA Approval
T he FDA recently granted approval for the first time in more than 15 years for the first filler agents that contain human collagen. CosmoDerm and CosmoPlast contain human collagen purified from human dermal tissue. The fillers are approved for correction of facial wrinkles, acne scars and other soft tissue contour deficiencies. In addition, they’ve also been approved for restoration of the lip border. According to the company, the dermal fillers are the first commercially approved fillers in the United States that don’t require a skin test prior to use, so patients can be treated on their first visit. In addition, physicians don’t need to learn any new injection techniques.
Inamed Corp. will market and distribute CosmoDerm and CosmoPlast human collagen products.
New Anti-Fungal Shampoo
M edicis received FDA approval for ciclopirox 1% (Loprox Shampoo) in early March. The first prescription anti-fungal shampoo to get approval for treating seborrheic dermatitis of the scalp, Loprox will be available in a 120-ml size within several months. Medicis will have a 3-year patent-pending period of exclusivity with Loprox, and longer if the patent is granted.
First Drug in a New Class of HIV Treatments
I n mid-March, the FDA approved enfuvirtide (Fuzeon), a drug that received accelerated approval as a treatment for patients with advanced HIV-1 infection in adults and children age 6 and older. The drug will be used in combination with other anti-HIV medications. Fuzeon is the first drug in a new class called fusion inhibitors. These drugs inhibit the fusion of viral and cellular membranes and therefore hinder the entry of HIV-1 into cells. Administered via subcutaneous injection, this drug offers hope to HIV sufferers who have previously used other anti-HIV treatments and have developed resistance to their effectiveness.
Warning for Lindane
T he FDA issued a health advisory regarding Lindane Lotion and Lindane Shampoo to significantly update the products’ labeling to include additional warnings and a Medication Guide that will be directly distributed to patients. The boxed warning on the products will highlight the following points:
• Lindane should be used as a second-line therapy for patients who found first-line therapy intolerable or ineffective.
• Because of reports of neurologic toxicity (seizures and deaths) with repeated or prolonged use of Lindane, the product shouldn’t be used with caution in infants, children, the elderly, and patients who have other skin conditions such as psoriasis or eczema. Patients who weigh under 110 pounds may be at risk for serious neurotoxicity.
• Lindane Lotion is contraindicated in premature infants and people who have uncontrolled seizure disorders.
• In addition to these warnings, product package sizes will be limited to 1 to 2 ounces to help avoid misuse or overuse.
Skin Lotion for Military Personnel
U .S. military personnel will now have a liquid decontamination lotion at their disposal for removing and treating chemical warfare agents and T-2 fungal toxins from the skin. The FDA approved the lotion, which is manufactured by O’Dell Engineering, on March 28. Reactive Skin Decontamination Lotion, the brand name of the product, is indicated for application as soon as possible after exposure to chemical agents. A sponge pad is soaked with the lotion and packaged in a heat-sealed foil pouch. The product was studied in more than 300 people for skin irritation, sensitization and photo irritation before approval.
Research Shorts
Study Finds No Correlation to BCG Vaccination and Reduced Risk of Atopy
I n a study published in the February issue of the Journal of the American Medical Association (JAMA), researchers tested the theory that the BCG vaccination given to infants reduced the risk of atopy. Conducted on the northwest coast of Greenland (Greenland infants were routinely given the BCG vaccination until 1990 when it was withdrawn from the vaccination program), 1,686 children between the ages of 8 and 16 participated in the study. The children had a blood sample drawn with atopy being defined as a positive test result in an assay that tests for IgE specific against common inhalant allergens in serum. The results indicated that atopy’s risk in BCG vaccinated children versus unvaccinated children was the same. The age of vaccination did not affect the risk of atopy in BCG-vaccinated children. Researchers indicated a BCG vaccination administered to infants did not reduce the risk of developing atopy.
— JAMA, February 2003
Researchers Say Adverse Drug Events Can Be Prevented Among Ambulatory Care Patients
N ew research is suggesting adverse drug events are potentially preventable among older patients in an ambulatory clinical setting. A study published in the March issue of the Journal of the American Medical Association (JAMA), followed all Medicare enrollees cared for by a multispecialty group practice between July 1, 1999, and June 30, 2000. During this 12-month period, 1,523 adverse drug events were identified, and 27.6% were considered preventable. Common medication categories associated with preventable adverse drug events included cardiovascular medications (24.5%), diuretics (22.1%), non-opioid analgesics (15.4%), hypoglycemics (10.9%) and anticoagulants (10.2%). The most common types of preventable adverse drug events included electrolyte/renal (26.6%), gastrointestinal tract (21.1%), hemorrhagic (15.9%), metabolic/ endocrine (13.8%) and neuropsychiatric (8.6%) events.
— JAMA, March 2003
FDA Aims to Improve Patient Safety
New proposals were unveiled to reduce medical errors and to more quickly identify potential errors before they occur.
L ast month, Health and Human Services Secretary Tommy G. Thompson announced two new proposals from the FDA to improve patient safety during the National Patient Safety Foundation’s (NPSF) 2003 Patient Safety Congress, “Let’s Get Results: Improving the Safety of Patients.”
The two plans would require bar coding on medications and improved reporting requirements for safety problems involving medicines. The required bar code would contain the National Drug Code (NDC) number, which contains unique identifying information about the drug that is to be dispensed to the patient, in a linear bar code as part of the drug label. A design was proposed that would also allow manufacturers to include additional information about the drug. The hope for this program is that when the bar codes are used with scanner and computerized patient information systems, it will prevent many medication errors, including administering:
• the wrong drug
• a drug the patient has a known allergy to
• the wrong dose
• the drug at the wrong time
• the wrong route (such as injection instead of by mouth).
The second plan proposed revamping the safety reporting requirements, aimed at enhancing the FDA’s ability to effectively monitor and improve the safe use of medications, including drugs and biologics. The rule would:
• Improve the quality and usefulness of safety reports submitted to the agency, and facilitate the consistency of safety reporting worldwide.
• Require the submission of all suspected serious reactions for blood and blood products on the market.
• Require reports on important potential medication errors.
This plan would give the FDA more useful, timely and extensive information. It would also require all healthcare groups to submit to the FDA, within 15 days, all reports they receive of actual and potential medication errors in the United States.
The expected annual savings from preventing adverse events, due to medication errors, is $3.9 billion.
Cipro Ineffectiveness Against Gram-Negative Bacilli
Antibiotic overuse to blame.
R esults of a study published in the February 19 issue of the Journal of the American Medical Association (JAMA), showed an increasing incidence of ciprofloxacin (Cipro) resistance among Gram-negative bacilli in coincidence with increased use of fluoroquinolones.
Researchers studied data submitted by hospital institutions in Washington, D.C. and 43 other states showing antibiotic susceptibility results for 35,690 nonduplicate Gram-negative aerobic isolates recovered from intensive care unit (ICU) patients between 1994 and 2000. Susceptibility tests were performed and national fluoroquinolone consumption data were also studied. Researchers concluded that the susceptibility to ciprofloxacin decreased from 86% in 1994 to 76% in 2000, and that this decrease was significantly associated with increased national use of fluoroquinolones.
Bacteria that this study found to be increasingly resistant to ciprofloxacin included Escherechia coli, Pseudomonas aeruginosa and Klebsiella pneumoniae.
It was reported that the anthrax bacterium was not studied and that this study does not conclude that ciprofloxacin has become any less effective against anthrax.
In Brief…
Dermik Labs Acquires New-Fill…from Biotech Industry S.A. in Luxembourg. The non-animal, non-human source of New-Fill is poly-lactic acid, which as vicryl sutures, has been used in surgical procedures for more than 20 years and has a low allergenic potential, with no pre-test or waiting period required prior to treatment. It’s currently available in more than 25 countries and has been used in Europe, South America, Australia and other countries for more than 3 years to treat facial lines and wrinkles around the eyes, lips, and chin. A full development program is underway working towards an approval by the U.S. FDA.
Berlex Laboratories and Allergan Team Up…to promote Berlex’s new topical rosacea treatment, Finacea Gel 15% (azelaic acid). Berlex received marketing approval from the FDA in December 2002 for Finacea, making it the first new therapeutic class option to be approved for the treatment of rosacea in more than 10 years. The new drug was launched at last month’s American Academy of Dermatology meeting in San Francisco. Under the co-promotion agreement, both companies will call on dermatologists to provide information and product samples for Finacea.
SkinMedica Acquires NouriCel Product Line…The pharmacuetical company announced its purchase of this line of products and related assets from Advanced Tissue Sciences on March 21. NouriCel-MD, a part of the NouriCel product line, is the primary ingredient in the company’s TNS Recovery Complex, a topical skin care product only available through physicians.
New Wound Dressing Introduced that Absorbs into Skin…Researchers at the Virginia Commonwealth University in Richmond, VA, have introduced a new wound dressing that can be applied to the wound, gradually dissolving as new skin forms over the wound. The wound dressing, made from the blood protein fibrinogen, would be treated by the body as part of the normal healing process. The fibrinogen protein protects the wound from infection and stops bleeding. Researchers say the dressing should quicken healing.
AAD Honors Former Galderma President…Stephen W. Clark in a March 23 ceremony in San Francisco. The Academy recognized Mr. Clark as an honorary member — an honor bestowed only once before in the AAD’s history. The honorary membership recognizes Mr. Clark’s 32 years (16 as president) with Galderma and his help in advancing the practice of dermatology.
AIDS Vaccine Trial Found Ineffective…A large clinical trial to test an AIDS vaccine has failed, according to a report issued by the vaccine’s manufacturer, VaxGen. The trial, conducted in California, was the first trial to be tested on a large group of people. The vaccine, known as Aidsvax, demonstrated virtually no effectiveness in protecting people with HIV from infection. The researchers were encouraged that the vaccine seemed to significantly lower the infection rate among African Americans and other non-Hispanic minorities. More research was called for in this area because minorities were a small fraction of people in the trial.
Phase II Results Announced for Potential New Psoriasis Therapy…Recent Phase II trial results have been announced by Canadian-based biotech company, Isotechnika, for an immunosuppressive therapy, ISA247, to treat patients with moderate to severe psoriasis. The therapy demonstrated ISA247 to be well tolerated and efficacious. ISA247 met or exceeded all of the primary and secondary efficacy and safety endpoints of the study. The trial consisted of 201 patients in a 12-week, double-blind, placebo-controlled, randomized study. Patients were studied at 12 centers throughout Canada. At the study’s conclusion, patients were monitored for an additional 6 weeks.
Common Gene Found in Lupus Patients…Researchers at the University of Minnesota and the North Shore Long Island Jewish Research Institute have discovered a genetic signature found in some patients with systemic lupus erythematosus (SLE). Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other parts of the National Institute of Health (NIH), gene expression profiling was used to analyze thousands of genes in peripheral blood cells of 48 lupus patients and 42 healthy couples. Of the genes studied, 161 showed different expression patterns in patients with SLE versus healthy controls.
The researchers noted that 14 of the thousands of genes studied were linked to a subset of SLE patients with severe disease. Known collectively as the interferon expression signature, the 14 genes are activated with the activity of interferon that regulates immune responses. Patients with severe SLE presented with higher expression levels of the interferon expression signature. Researchers suggest this data will help in developing new therapies to block interferon expression signature pathways in patients with severe lupus. Gene expression profiling will also helpful in identifying patients that would benefit from the new therapies, researchers conclude.
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October 2024
Volume 32
Issue 7
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