Cylert recall demanded over safety concerns
After Adderall XR recall in Canada, and the refusal of the FDA to take similar action in the US, a lot of concern has been raised about other attention deficit hyperactivity disorder (ADHD) drugs like Prozac, Ritalin, Cylert, etc. Now Public Citizen, representing more than 150,000 consumers nationwide, is petitioning the FDA to recall pemoline (sold as CYLERT, made by Abbott Laboratories, and all its generic versions).
Several doctors, including Dr. Sidney Wolfe, who have written to the FDA, say that, "In addition to having no demonstrated unique therapeutic benefit over other ADHD drugs such as methylphenidate, pemoline is known to have caused at least 21 cases of liver failure, including 13 resulting in liver transplantation or death. The drug's unfavorable risk to benefit ratio has led to its withdrawal in the United Kingdom and Canada, while the FDA instead opted for two separate changes to the pemoline label, in 1996 and 1999. A 2002 FDA study has clearly demonstrated that these labeling changes failed to increase monitoring for liver toxicity or ensure only second-line use of pemoline. In light of this evidence of unique liver toxicity without evidence of unique therapeutic benefit, we contend that the only responsible course of action is to remove this dangerous drug from the market."
Pemoline, a central nervous system stimulant, was approved by the FDA for the treatment of ADHD on January 27, 1975. There were always concerns about its safety. A black box warning was added to the labeling for pemoline in the United States in December 1996, and a "Dear Doctor" letter was mailed out from Abbott to all U.S. physicians. The warning stressed pemoline's liver toxicity and recommended that it should no longer be considered a first-line therapy for ADHD. This decision to make pemoline a second-line therapy was made without any clinical trials showing that it actually worked in patients who had failed to respond to a first-line therapy. As liver failure cases continued to accumulate, the FDA addressed the issue with a stronger black box warning in June 1999. The 1999 warning label states that as of December 1998 there were 15 cases of acute liver failure due to pemoline reported to the FDA, 12 of which resulted in death or liver transplantation.
While the United States has allowed Abbott to continue marketing the drug, other countries have taken more decisive action based on patient liver toxicity data collected predominantly from the U.S. In September 1997, the United Kingdom removed pemoline from the market. The UK decision was based entirely on case reports of liver toxicity from the United States. In September 1999, the Canadian government reached a similar conclusion and removed pemoline from the market, reasoning that the drug's risks outweighed its benefits. (Related article: FDA reportedly pressured Health Canada not to recall Adderall XR)
In its usual attitude favoring drug companies over the health of American people, the FDA has not taken any decisive action so far and it is unlikely that much will happen this time either. A Crestor recall request was recently denied by the FDA, even though similar safety concerns remain.
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Several doctors, including Dr. Sidney Wolfe, who have written to the FDA, say that, "In addition to having no demonstrated unique therapeutic benefit over other ADHD drugs such as methylphenidate, pemoline is known to have caused at least 21 cases of liver failure, including 13 resulting in liver transplantation or death. The drug's unfavorable risk to benefit ratio has led to its withdrawal in the United Kingdom and Canada, while the FDA instead opted for two separate changes to the pemoline label, in 1996 and 1999. A 2002 FDA study has clearly demonstrated that these labeling changes failed to increase monitoring for liver toxicity or ensure only second-line use of pemoline. In light of this evidence of unique liver toxicity without evidence of unique therapeutic benefit, we contend that the only responsible course of action is to remove this dangerous drug from the market."
Pemoline, a central nervous system stimulant, was approved by the FDA for the treatment of ADHD on January 27, 1975. There were always concerns about its safety. A black box warning was added to the labeling for pemoline in the United States in December 1996, and a "Dear Doctor" letter was mailed out from Abbott to all U.S. physicians. The warning stressed pemoline's liver toxicity and recommended that it should no longer be considered a first-line therapy for ADHD. This decision to make pemoline a second-line therapy was made without any clinical trials showing that it actually worked in patients who had failed to respond to a first-line therapy. As liver failure cases continued to accumulate, the FDA addressed the issue with a stronger black box warning in June 1999. The 1999 warning label states that as of December 1998 there were 15 cases of acute liver failure due to pemoline reported to the FDA, 12 of which resulted in death or liver transplantation.
While the United States has allowed Abbott to continue marketing the drug, other countries have taken more decisive action based on patient liver toxicity data collected predominantly from the U.S. In September 1997, the United Kingdom removed pemoline from the market. The UK decision was based entirely on case reports of liver toxicity from the United States. In September 1999, the Canadian government reached a similar conclusion and removed pemoline from the market, reasoning that the drug's risks outweighed its benefits. (Related article: FDA reportedly pressured Health Canada not to recall Adderall XR)
In its usual attitude favoring drug companies over the health of American people, the FDA has not taken any decisive action so far and it is unlikely that much will happen this time either. A Crestor recall request was recently denied by the FDA, even though similar safety concerns remain.
Recommended articles
Shire expects that Health Canada will reverse its Adderall XR recall decision
American doctors support FDA decision on Adderall
Adderall XR to stay on the market in the US
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