FDA APPROVALS & NEWS
FDA Approves Atralin (Tretinoin) Gel 0.05% for Acne
The U.S. Food and Drug Administration (FDA) has approved Coria Laboratories’ Atralin (tretinoin) Gel 0.05%, for topical treatment of acne vulgaris.
Formulated in a water-based, alcohol-free vehicle, Atralin Gel contains a patented combination of ingredients said to hydrate and moisturize the skin, reducing the potential for irritation and dryness in acne patients.
Two randomized, controlled clinical trials involving 674 patient ranging in age from 10 to 65 were conducted by the Ft. Worth, TX-based manufacturer. These studies showed no serious tretinoin-related adverse reactions by any patient in the treatment groups. The most common adverse reactions were mild to moderate irritation of the skin and occurred during the first weeks of treatment.
Boxed Warning about NSF Risk Added to Gadolinium-Based Contrast Agents
The manufacturers of several gadolinium-based contrast agents used for magnetic resonance imaging recently revised the prescribing information for these products after FDA received reports of over 250 cases of nephrogenic systemic fibrosis (NSF) after administration of gadolinium-based contrast agents.
Post-marketing reports showed that the use of these agents increases the risk of the development of NSF, in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73 m2) and patients with renal dysfunction due to the hepatorenal syndrome or in the perioperative liver transplantation period.
As a result of these NSF cases, the package inserts of all gadolinium-based contrast agents listed below in alphabetical order have been revised to include a boxed warning and update to the warnings section.
- Magnevist (gadopentetate dimeglumine) Injection
- MultiHance (gadobenate dimeglumine) injection,
- 529 mg/ml
- Omniscan (gadodiamide) Injection
- OptiMARK (gadoversetamide) Injection
- ProHanc (Gadoteridol) Injection, 279.3 mg/ml.
Serious Skin Reactions Associated with Wakefulness-Promoting Agent
The FDA has reported that modafinil, an oral wakefulness-promoting agent marketed as Provigil, has been found to be associated with some cases of severe cutaneous adverse reactions in the period between its initial marketing in December 1998 and January 30, 2007.
This controlled substance is prescribed for patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.
Findings
The reported adverse reactions, which occurred in six patients — four females and two males aged 49, 42, 17, 27, 15, and 7 years old, respectively — included erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms. There were no deaths, but five of the six patients required hospital admission for management, including one patient with TEN, who was admitted to the surgical burn unit 20 days after starting modafinil at recommended doses to treat a sleep disorder.
FDA Measures
The FDA has been monitoring cases of serious skin reactions, including EM, SJS, and TEN, in its post-marketing reviews of adverse event reports associated with the use of modafinil. The product labeling for modafinil has been recently updated to include a bolded warning for serious rash, including SJS.
Based on post-marketing data for modafinil, a recently approved drug with a similar chemical structure, armodafinil, includes a similar bolded warning in the product labeling.
S & A NEWS & TRENDS
Study Indicates Fewer FDA Warnings Despite Increased Drug Advertising to Consumers
A number of recent articles have noted the ever-increasing presence and impact of direct-to-consumer advertising — complete with celebrities and animation — since its introduction more than a decade ago. They include a New England Journal of Medicine editorial calling for a moratorium on the practice, which has been banned in Europe and Canada. (Donohue JM, Cevasco M, Rosenthal M. A Decade of Direct-to-Consumer Advertising of Prescription Drugs. N Engl J Med. 2007;357:673-81).
Study Method
The article was based on a study that examined industry-wide trends in spending by pharmaceutical companies on direct-to-consumer advertising and promotion to physicians since the practice was first allowed in 1996. At the same time, it examined trends in the FDA’s regulation of drug advertising. Advertising information was primarily gathered from three market-research firms that track advertising spending and specialize in forms of promotion for the pharmaceutical industry. FDA information was obtained from researchers and staff members at the FDA and other government agencies. These data have been widely used in studies of trends in and the effects of direct-to-consumer advertising. It characterized the drugs for which such advertising is used and assessed the timing of advertising after a drug is introduced.
Study Findings
Total spending on pharmaceutical promotion grew from $11.4 billion in 1996 to $29.9 billion in 2005. Although during that time spending on direct-to-consumer advertising increased by 330%, it made up only 14% of total promotional expenditures in 2005. Direct-to-consumer campaigns generally begin within a year after the approval of a product by the FDA. In the context of regulatory changes requiring legal review before issuing letters, the number of letters sent by the FDA to pharmaceutical manufacturers regarding violations of drug-advertising regulations fell from 142 in 1997 to only 21 in 2006.
FDA APPROVALS & NEWS
FDA Approves Atralin (Tretinoin) Gel 0.05% for Acne
The U.S. Food and Drug Administration (FDA) has approved Coria Laboratories’ Atralin (tretinoin) Gel 0.05%, for topical treatment of acne vulgaris.
Formulated in a water-based, alcohol-free vehicle, Atralin Gel contains a patented combination of ingredients said to hydrate and moisturize the skin, reducing the potential for irritation and dryness in acne patients.
Two randomized, controlled clinical trials involving 674 patient ranging in age from 10 to 65 were conducted by the Ft. Worth, TX-based manufacturer. These studies showed no serious tretinoin-related adverse reactions by any patient in the treatment groups. The most common adverse reactions were mild to moderate irritation of the skin and occurred during the first weeks of treatment.
Boxed Warning about NSF Risk Added to Gadolinium-Based Contrast Agents
The manufacturers of several gadolinium-based contrast agents used for magnetic resonance imaging recently revised the prescribing information for these products after FDA received reports of over 250 cases of nephrogenic systemic fibrosis (NSF) after administration of gadolinium-based contrast agents.
Post-marketing reports showed that the use of these agents increases the risk of the development of NSF, in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73 m2) and patients with renal dysfunction due to the hepatorenal syndrome or in the perioperative liver transplantation period.
As a result of these NSF cases, the package inserts of all gadolinium-based contrast agents listed below in alphabetical order have been revised to include a boxed warning and update to the warnings section.
- Magnevist (gadopentetate dimeglumine) Injection
- MultiHance (gadobenate dimeglumine) injection,
- 529 mg/ml
- Omniscan (gadodiamide) Injection
- OptiMARK (gadoversetamide) Injection
- ProHanc (Gadoteridol) Injection, 279.3 mg/ml.
Serious Skin Reactions Associated with Wakefulness-Promoting Agent
The FDA has reported that modafinil, an oral wakefulness-promoting agent marketed as Provigil, has been found to be associated with some cases of severe cutaneous adverse reactions in the period between its initial marketing in December 1998 and January 30, 2007.
This controlled substance is prescribed for patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.
Findings
The reported adverse reactions, which occurred in six patients — four females and two males aged 49, 42, 17, 27, 15, and 7 years old, respectively — included erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms. There were no deaths, but five of the six patients required hospital admission for management, including one patient with TEN, who was admitted to the surgical burn unit 20 days after starting modafinil at recommended doses to treat a sleep disorder.
FDA Measures
The FDA has been monitoring cases of serious skin reactions, including EM, SJS, and TEN, in its post-marketing reviews of adverse event reports associated with the use of modafinil. The product labeling for modafinil has been recently updated to include a bolded warning for serious rash, including SJS.
Based on post-marketing data for modafinil, a recently approved drug with a similar chemical structure, armodafinil, includes a similar bolded warning in the product labeling.
S & A NEWS & TRENDS
Study Indicates Fewer FDA Warnings Despite Increased Drug Advertising to Consumers
A number of recent articles have noted the ever-increasing presence and impact of direct-to-consumer advertising — complete with celebrities and animation — since its introduction more than a decade ago. They include a New England Journal of Medicine editorial calling for a moratorium on the practice, which has been banned in Europe and Canada. (Donohue JM, Cevasco M, Rosenthal M. A Decade of Direct-to-Consumer Advertising of Prescription Drugs. N Engl J Med. 2007;357:673-81).
Study Method
The article was based on a study that examined industry-wide trends in spending by pharmaceutical companies on direct-to-consumer advertising and promotion to physicians since the practice was first allowed in 1996. At the same time, it examined trends in the FDA’s regulation of drug advertising. Advertising information was primarily gathered from three market-research firms that track advertising spending and specialize in forms of promotion for the pharmaceutical industry. FDA information was obtained from researchers and staff members at the FDA and other government agencies. These data have been widely used in studies of trends in and the effects of direct-to-consumer advertising. It characterized the drugs for which such advertising is used and assessed the timing of advertising after a drug is introduced.
Study Findings
Total spending on pharmaceutical promotion grew from $11.4 billion in 1996 to $29.9 billion in 2005. Although during that time spending on direct-to-consumer advertising increased by 330%, it made up only 14% of total promotional expenditures in 2005. Direct-to-consumer campaigns generally begin within a year after the approval of a product by the FDA. In the context of regulatory changes requiring legal review before issuing letters, the number of letters sent by the FDA to pharmaceutical manufacturers regarding violations of drug-advertising regulations fell from 142 in 1997 to only 21 in 2006.
FDA APPROVALS & NEWS
FDA Approves Atralin (Tretinoin) Gel 0.05% for Acne
The U.S. Food and Drug Administration (FDA) has approved Coria Laboratories’ Atralin (tretinoin) Gel 0.05%, for topical treatment of acne vulgaris.
Formulated in a water-based, alcohol-free vehicle, Atralin Gel contains a patented combination of ingredients said to hydrate and moisturize the skin, reducing the potential for irritation and dryness in acne patients.
Two randomized, controlled clinical trials involving 674 patient ranging in age from 10 to 65 were conducted by the Ft. Worth, TX-based manufacturer. These studies showed no serious tretinoin-related adverse reactions by any patient in the treatment groups. The most common adverse reactions were mild to moderate irritation of the skin and occurred during the first weeks of treatment.
Boxed Warning about NSF Risk Added to Gadolinium-Based Contrast Agents
The manufacturers of several gadolinium-based contrast agents used for magnetic resonance imaging recently revised the prescribing information for these products after FDA received reports of over 250 cases of nephrogenic systemic fibrosis (NSF) after administration of gadolinium-based contrast agents.
Post-marketing reports showed that the use of these agents increases the risk of the development of NSF, in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73 m2) and patients with renal dysfunction due to the hepatorenal syndrome or in the perioperative liver transplantation period.
As a result of these NSF cases, the package inserts of all gadolinium-based contrast agents listed below in alphabetical order have been revised to include a boxed warning and update to the warnings section.
- Magnevist (gadopentetate dimeglumine) Injection
- MultiHance (gadobenate dimeglumine) injection,
- 529 mg/ml
- Omniscan (gadodiamide) Injection
- OptiMARK (gadoversetamide) Injection
- ProHanc (Gadoteridol) Injection, 279.3 mg/ml.
Serious Skin Reactions Associated with Wakefulness-Promoting Agent
The FDA has reported that modafinil, an oral wakefulness-promoting agent marketed as Provigil, has been found to be associated with some cases of severe cutaneous adverse reactions in the period between its initial marketing in December 1998 and January 30, 2007.
This controlled substance is prescribed for patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.
Findings
The reported adverse reactions, which occurred in six patients — four females and two males aged 49, 42, 17, 27, 15, and 7 years old, respectively — included erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms. There were no deaths, but five of the six patients required hospital admission for management, including one patient with TEN, who was admitted to the surgical burn unit 20 days after starting modafinil at recommended doses to treat a sleep disorder.
FDA Measures
The FDA has been monitoring cases of serious skin reactions, including EM, SJS, and TEN, in its post-marketing reviews of adverse event reports associated with the use of modafinil. The product labeling for modafinil has been recently updated to include a bolded warning for serious rash, including SJS.
Based on post-marketing data for modafinil, a recently approved drug with a similar chemical structure, armodafinil, includes a similar bolded warning in the product labeling.
S & A NEWS & TRENDS
Study Indicates Fewer FDA Warnings Despite Increased Drug Advertising to Consumers
A number of recent articles have noted the ever-increasing presence and impact of direct-to-consumer advertising — complete with celebrities and animation — since its introduction more than a decade ago. They include a New England Journal of Medicine editorial calling for a moratorium on the practice, which has been banned in Europe and Canada. (Donohue JM, Cevasco M, Rosenthal M. A Decade of Direct-to-Consumer Advertising of Prescription Drugs. N Engl J Med. 2007;357:673-81).
Study Method
The article was based on a study that examined industry-wide trends in spending by pharmaceutical companies on direct-to-consumer advertising and promotion to physicians since the practice was first allowed in 1996. At the same time, it examined trends in the FDA’s regulation of drug advertising. Advertising information was primarily gathered from three market-research firms that track advertising spending and specialize in forms of promotion for the pharmaceutical industry. FDA information was obtained from researchers and staff members at the FDA and other government agencies. These data have been widely used in studies of trends in and the effects of direct-to-consumer advertising. It characterized the drugs for which such advertising is used and assessed the timing of advertising after a drug is introduced.
Study Findings
Total spending on pharmaceutical promotion grew from $11.4 billion in 1996 to $29.9 billion in 2005. Although during that time spending on direct-to-consumer advertising increased by 330%, it made up only 14% of total promotional expenditures in 2005. Direct-to-consumer campaigns generally begin within a year after the approval of a product by the FDA. In the context of regulatory changes requiring legal review before issuing letters, the number of letters sent by the FDA to pharmaceutical manufacturers regarding violations of drug-advertising regulations fell from 142 in 1997 to only 21 in 2006.
