On May 5th 2009 the FDA issued a Safety Alert for Tarveca (erlotinib), a drug used to treat patients with unresectable cancer of the lung or of the pancreas that is either spreading locally or has metastasized. In most cases the patient has failed to respond to an initial chemotherapy treatment with another medication. For patients with pancreatic cancer the medication is used in combination with gemcitabine.
The drug is manufactured and distributed through a partnership of Genentech and OSI Pharmaceutical. Reports of adverse patient reaction have included occurrences of intestinal perforation that have on occasion been fatal. There have also been a series of reports of blistering and exfoliating skin conditions that have been associated with the use of Tarveca. Reports of eye problems that include ulcers and corneal perforations are also acknowledged and reported in the FDA alert.
Genentech will be including additional warning language in its packaging of the drug with regard to these developments. Since the medication was approved in 2005 it has been administered to about 350,000 patients worldwide. Sales in 2008 topped $1 billion. Genentech recently became a unit of Roche, when the Swiss company bought out the 49% of the firm that it had not already acquired.
The two pharmaceutical companies sent a warning to health professionals about these adverse affects in April of 2009. The FDA had not publicly acknowledged or acted on the problems with Tarveca until its announcement in early May.
Cancer patients who have experienced adverse reactions to Tarveca may report their experience to the FDA’s MedWatch reporting system by phone at 1-800-FDA-1088.
Impacted patients may also contact an attorney by using the filling out the brief Free Case Evaluation form. There is no charge for consultation with an attorney who is experienced in the field of damage from adverse reactions to medication.