Israel drug company summoned to hearing over thyroid drug Eltroxin
Hearing could result in sanctions against drug manufacturer Perrigo, after hundreds of Israelis complained of suffering side effects from the drug since its formula was changed in February 2011.
The Health Ministry plans to summon executives from drug manufacturer Perrigo to a hearing as part of its ongoing investigation into problems caused by the thyroid drug Eltroxin. The hearing could result in sanctions against the company.
Hundreds of Israelis have complained of suffering side effects from the drug, which is marketed in Israel by Perrigo, after its formula was changed in February 2011. While Perrigo wasn't responsible for the new formula, it neglected to change the information on the drug's packaging until August 2011, and also failed to tell the ministry that the new formula had produced an exceptional number of side effects in New Zealand and Denmark, the ministry's investigation found.
Even after the upsurge in side effects had become clear, Perrigo did not include a clear warning in a letter it sent to doctors in June 2011. The letter said that "there might be a change in the clinical effect" of the drug, with no details on the kinds of side effects that had been reported.
At a meeting of the Knesset Labor, Welfare and Health Committee yesterday, attorney Nili Hayun Dickman of the ministry's legal department said that, while the ministry may impose sanctions on Perrigo after the hearing, it is not considering the most drastic measure - stripping the company of its license - because that would force it to stop importing Eltroxin, which would harm the 250,000 Israelis who use the drug.
Acting committee chairman MK Aryeh Eldad said his panel planned to introduce legislation that would allow the ministry to impose additional sanctions on errant drug companies, including fines.
Dr. Boaz Lev, the ministry's director general, said the ministry is now working to set up a special unit to monitor reports of drug side effects. The unit would collect reports from both doctors and patients, including material posted on online social networks, in an effort to identify problems at an early stage.
During the meeting, 25 patients demonstrated outside the Knesset against the ministry's slowness in arranging for Synthroid, an alternative to Eltroxin, to be readily obtainable by patients suffering from Eltroxin's side effects.
The ministry's deputy director general, Yoel Lipschitz, said the delay stemmed from the fact that the drug is not licensed in Israel, so no regular supplier exists, and suppliers that have offered the drug to date are not from countries that abide by OECD standards, meaning the drugs' quality must be carefully checked before they can be approved.
Two health maintenance organizations, Maccabi and Leumit, said they would have Synthroid available as of this week. Clalit, the largest HMO, said it is in advanced talks with the drug's manufacturer and would have it available soon.
Perrigo said it fully complies with all Health Ministry regulations and has always given the ministry all information in its possession promptly. It said it learned of the incidents in Denmark and New Zealand only after the new formula had been launched.
The ministry said that anyone prescribed an alternative to Eltroxin who is having trouble obtaining it should contact the ministry's information center or its ombudsman.