Parker Waichman LLP has called on the U.S. Food & Drug Administration (FDA) to compel Takeda Pharmaceuticals to issue its own notification to doctors regarding the association between long-term use of Actos and bladder cancer. The firm was prompted by Takeda Canada’s issuance of a “Dear Healthcare Professional” letter in Canada detailing Actos’ link to bladder cancer, and informing recipients of changes being made to the Actos label in that country.
The Actos letter was issued by Takeda Canada in collaboration with Health Canada, the country’s drug regulator. The document, dated April 16, states that: “Health Canada has recently completed a safety assessment of the available data and the Product Monograph (PM) was updated to reflect the potential risk of bladder cancer in treated patients.” Among other things, the modified label will acknowledge that findings from new studies reveal that there is a potential increased risk of bladder cancer in patients treated with pioglitazone-containing products. In addition to being sent to Canadian healthcare professionals, a copy of the letter was posted to Health Canada’s website.
the FDA issued a warning regarding long-term use of Actos and bladder cancer
When the FDA issued a warning regarding long-term use of Actos and bladder cancer last June, no such statement directed at U.S. healthcare providers was forthcoming from Takeda. Parker Waichman LLP believes the FDA should have required such a statement from the drug maker, and is pressing it to compel Takeda to release one now.
“We are hopeful that the FDA will take the strongest action possible to protect patients by requiring Takeda to directly notify the physicians of serious adverse events associated with taking Actos,” Daniel Burke, an attorney at Parker Waichman LLP, said in statement issued by the firm.