Israel's Health Ministry to Introduce Tougher Guidelines Over Drug Side Effects

The Health Ministry will require pharmaceutical companies to provide a detailed report on the side effects of drugs, including documentation from overseas. The new regulation, to be introduced next month, comes after hundreds of Israelis complained of side effects when using the thyroid drug Eltroxin after changes had been made to it.

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• Israel Drug Company Summoned to Hearing Over Thyroid Drug Eltroxin
• Israel's Health Ministry Probe Finds Officials Downplayed Eltroxin Side Effects
• Perrigo Acquires Eye-care Portfolio From Fera

The drug is marketed in Israel by Perrigo, but the company’s marketing neglected to change the information on the drug’s packaging until August 2011. It also failed to tell the ministry that the new formula had produced an exceptional number of side effects in New Zealand and Denmark, a ministry investigation found.

The new regulation will contain a list of side effects that all drug companies will be required to report within 15 days for a drug it markets in Israel, including any information it receives on the safety of the drug from the U.S. Food and Drug Administration or the European Medicines Agency, as well as information from published research in English with implications for safety.

According to Dr. Eyal Schwartzberg, head of the ministry’s pharmacy division which formulated the regulation: “A decision will not necessarily be made in every case attributed to a drug, but the ministry must have this information when decisions must subsequently be made about use of a drug or updating physicians and patients.”