Adcica (Cialis) letter from the FDA
Feb/04/2010 10:25 Filed in: FDA
Letters
According to the
FDA letter;
Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. Although the web page presents the most common side effects associated with Adcirca, it fails to include any of the Contraindications or Warnings and Precautions information for this drug product . Because the web page omits these important risks, it misleadingly suggests that Adcirca is safer than has been demonstrated by substantial evidence or substantial clinical experience. We further note that the web page fails to include any indication of where a viewer can get more risk information about the drug.
Overstatement of Efficacy – Patient Videos
Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience. The patient videos present statements made by Adcirca users, “Traci” and “Carolyn.” “Traci’s” statements (in pertinent part) include the following:
• “The first symptoms I had was breathlessness. Starting out with a little bit of breathlessness and turning into stairs being a problem for me. Getting up a flight of stairs and then coming very close to blacking out or blacking out and just complete breathlessness as if I ran a mile, really fast, as hard as I could. Just chest pounding, heart pounding, you know sweating, just complete exhaustion with just the smallest of things.”
• “I can walk, and stairs don’t bother me [after Adcirca treatment] Bending over used to make me breathless, picking up my cat used to make me breathless and it doesn’t affect me anymore.”
• “It went from walking five minutes and wanting to go home to walking one-half hour to one hour and not caring if I went home.”
• “From going to the mall and getting tired and wanting to go home in an hour to spending the night at the mall.”
• “Breathing, being able to get a full breath because before when I would breathe, it was almost like I had smog.”
• “Exercising and stairs and heat used to bother me and it didn’t bother me anymore
“Carolyn’s” statements (in pertinent part) include the following:
• “I couldn’t take a deep breath . . . I couldn’t breathe. At night, I just couldn’t catch my breath . . . I would wake up short of breath . . . .”
• “I can’t run along the beach with them [kids] or I can’t play with them . . . like I used to because I don’t have the wind to do it or the oxygen to do it.”
• “I could walk a block without stopping and having to take a deep breath [after taking Adcirca]. I don’t have to drag my oxygen tank with me as many places as I used to.”
• “[After taking Adcirca] Your breathing is better . . . your stamina is better . . . you could do a lot more and it takes you by surprise because I mean you couldn’t do it before. I went on this [Adcirca], I don’t have to use my oxygen tank, so that’s a great benefit.”
• “I have been able to put more things into my day because I don’t have to stop and rest as much as I used to and that to me is the biggest benefit of them all.”
• “I am exercising again . . . and I couldn’t exercise [before Adcirca], now I am walking on the treadmill. You know and I am walking along the beach, slowly I am beginning to do a lot more of the exercising that I used to be able to do”
• “As far as I am concerned, everyday I am beginning to do a lot more. I am moving more, I am breathing better.”
“Traci’s” and “Carolyn’s” statements seriously misrepresent what is known about the efficacy of Adcirca.
First, “Traci’s” and “Carolyn’s” statements misleadingly imply that patients treated with Adcirca will greatly increase their walking time and distance (e.g., “from . . . five minutes . . . to one hour,” “spending all night at the mall”, “now I am walking on the treadmill". These statements significantly exaggerate what was demonstrated in the clinical trials for Adcirca. As stated above, the placebo-adjusted mean change increase in 6-MWD was 33 meters. Thus, there is only data to support that study subjects can increase their walking distance by 33 meters in six minutes.
Second, “Traci’s” and “Carolyn’s” statements misleadingly imply that patients treated with Adcirca will experience an improvement in their symptoms of PAH (e.g., breathlessness), and an improvement in WHO functional class (e.g. walking, exercising more). According to the Adcirca clinical trials, secondary endpoints, such as the change in Borg dyspnea (or breathlessness) scale and WHO functional class, tended to show numerical improvement; however, these endpoints did not show a statistically significant improvement with the 40 mg dose of Adcirca compared to placebo. Furthermore, “Carolyn’s” statements misleadingly imply that Adcirca will reduce the need for an oxygen tank in patients who needed it prior to Adcirca therapy. FDA is not aware of any substantial evidence or substantial clinical experience to support these claims of improvement in PAH symptoms or daily functioning, or a reduction in the need for an oxygen tank. If you have data to support these claims, please submit them to FDA for review.
Furthermore, “Traci’s” statements include the following:
• “. . . I just couldn’t believe that I could have a short life . . . it was just too unbelievable to me to believe that I could just have years, a couple of years, no way.”
In addition, “Traci” and “Carolyn” make the following statements, respectively (emphasis added):
• “I got a phone call from Dr. Shapiro, who introduced me to Adcirca . . . I jumped at the idea that something could help me and I’ve been on it for three and a half years now.”
• “I started taking Adcirca . . . November 16, 2005. I am going on four years.”
These claims imply that Adcirca has demonstrated long-term benefits (i.e., up to four years), including a potential survival benefit, when this has not been demonstrated by substantial evidence or substantial clinical experience. According to clinical trials for Adcirca, patients from the placebo-controlled study entered a long-term extension study. However, the patients in the study were only treated with Adcirca for six months to one year. In addition, among other issues, this study did not have a control group, and according to Adcirca’s PI, “[w]ithout a control group, these data must be interpreted cautiously.” Furthermore, FDA is not aware of any substantial evidence or substantial clinical experience demonstrating the effect of treatment with Adcirca on survival. If you do, in fact, have data to support these claims, you should submit them to FDA for review.
I wonder what women would really think if they knew they were taking Cialis ? Maybe they would have to hide their medication from their husbands !!
Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. Although the web page presents the most common side effects associated with Adcirca, it fails to include any of the Contraindications or Warnings and Precautions information for this drug product . Because the web page omits these important risks, it misleadingly suggests that Adcirca is safer than has been demonstrated by substantial evidence or substantial clinical experience. We further note that the web page fails to include any indication of where a viewer can get more risk information about the drug.
Overstatement of Efficacy – Patient Videos
Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience. The patient videos present statements made by Adcirca users, “Traci” and “Carolyn.” “Traci’s” statements (in pertinent part) include the following:
• “The first symptoms I had was breathlessness. Starting out with a little bit of breathlessness and turning into stairs being a problem for me. Getting up a flight of stairs and then coming very close to blacking out or blacking out and just complete breathlessness as if I ran a mile, really fast, as hard as I could. Just chest pounding, heart pounding, you know sweating, just complete exhaustion with just the smallest of things.”
• “I can walk, and stairs don’t bother me [after Adcirca treatment] Bending over used to make me breathless, picking up my cat used to make me breathless and it doesn’t affect me anymore.”
• “It went from walking five minutes and wanting to go home to walking one-half hour to one hour and not caring if I went home.”
• “From going to the mall and getting tired and wanting to go home in an hour to spending the night at the mall.”
• “Breathing, being able to get a full breath because before when I would breathe, it was almost like I had smog.”
• “Exercising and stairs and heat used to bother me and it didn’t bother me anymore
“Carolyn’s” statements (in pertinent part) include the following:
• “I couldn’t take a deep breath . . . I couldn’t breathe. At night, I just couldn’t catch my breath . . . I would wake up short of breath . . . .”
• “I can’t run along the beach with them [kids] or I can’t play with them . . . like I used to because I don’t have the wind to do it or the oxygen to do it.”
• “I could walk a block without stopping and having to take a deep breath [after taking Adcirca]. I don’t have to drag my oxygen tank with me as many places as I used to.”
• “[After taking Adcirca] Your breathing is better . . . your stamina is better . . . you could do a lot more and it takes you by surprise because I mean you couldn’t do it before. I went on this [Adcirca], I don’t have to use my oxygen tank, so that’s a great benefit.”
• “I have been able to put more things into my day because I don’t have to stop and rest as much as I used to and that to me is the biggest benefit of them all.”
• “I am exercising again . . . and I couldn’t exercise [before Adcirca], now I am walking on the treadmill. You know and I am walking along the beach, slowly I am beginning to do a lot more of the exercising that I used to be able to do”
• “As far as I am concerned, everyday I am beginning to do a lot more. I am moving more, I am breathing better.”
“Traci’s” and “Carolyn’s” statements seriously misrepresent what is known about the efficacy of Adcirca.
First, “Traci’s” and “Carolyn’s” statements misleadingly imply that patients treated with Adcirca will greatly increase their walking time and distance (e.g., “from . . . five minutes . . . to one hour,” “spending all night at the mall”, “now I am walking on the treadmill". These statements significantly exaggerate what was demonstrated in the clinical trials for Adcirca. As stated above, the placebo-adjusted mean change increase in 6-MWD was 33 meters. Thus, there is only data to support that study subjects can increase their walking distance by 33 meters in six minutes.
Second, “Traci’s” and “Carolyn’s” statements misleadingly imply that patients treated with Adcirca will experience an improvement in their symptoms of PAH (e.g., breathlessness), and an improvement in WHO functional class (e.g. walking, exercising more). According to the Adcirca clinical trials, secondary endpoints, such as the change in Borg dyspnea (or breathlessness) scale and WHO functional class, tended to show numerical improvement; however, these endpoints did not show a statistically significant improvement with the 40 mg dose of Adcirca compared to placebo. Furthermore, “Carolyn’s” statements misleadingly imply that Adcirca will reduce the need for an oxygen tank in patients who needed it prior to Adcirca therapy. FDA is not aware of any substantial evidence or substantial clinical experience to support these claims of improvement in PAH symptoms or daily functioning, or a reduction in the need for an oxygen tank. If you have data to support these claims, please submit them to FDA for review.
Furthermore, “Traci’s” statements include the following:
• “. . . I just couldn’t believe that I could have a short life . . . it was just too unbelievable to me to believe that I could just have years, a couple of years, no way.”
In addition, “Traci” and “Carolyn” make the following statements, respectively (emphasis added):
• “I got a phone call from Dr. Shapiro, who introduced me to Adcirca . . . I jumped at the idea that something could help me and I’ve been on it for three and a half years now.”
• “I started taking Adcirca . . . November 16, 2005. I am going on four years.”
These claims imply that Adcirca has demonstrated long-term benefits (i.e., up to four years), including a potential survival benefit, when this has not been demonstrated by substantial evidence or substantial clinical experience. According to clinical trials for Adcirca, patients from the placebo-controlled study entered a long-term extension study. However, the patients in the study were only treated with Adcirca for six months to one year. In addition, among other issues, this study did not have a control group, and according to Adcirca’s PI, “[w]ithout a control group, these data must be interpreted cautiously.” Furthermore, FDA is not aware of any substantial evidence or substantial clinical experience demonstrating the effect of treatment with Adcirca on survival. If you do, in fact, have data to support these claims, you should submit them to FDA for review.
I wonder what women would really think if they knew they were taking Cialis ? Maybe they would have to hide their medication from their husbands !!
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