The cold medicine does not alleviate congestion

The cold medicine does not alleviate congestion

The drug marketed in Israel since 1995 is intended to alleviate symptoms of colds, sinus congestion, and allergic rhinitis accompanied by fever and pain, according to the consumer leaflet. The promise to relieve nasal congestion is prominently displayed on the packaging. The leaflet also mentions a prohibition on taking medications with antihistamines or other decongestants while using the product. “Teva Cold” was temporarily taken off the shelves over a year ago for operational reasons, but its registration with the Ministry of Health’s Pharmacy Division is valid until 2031. It raises questions as to why consumers were not informed of this.

Attorneys Ohad Talraz and David Samuel submitted a request for a class action, claiming that Teva neglected to inform consumers about the ineffectiveness of the phenylephrine component of the drug despite findings dating back to 2009. They argue that Teva breached regulations, pharmacists’ standards, and consumer protection laws by not disclosing this information. The lawyers emphasize that drug owners have an obligation to inform the public and the Ministry of Health about any late disclosures regarding drug effectiveness.

A committee report confirmed concerns raised by researchers since the early 2000s about the original approval process for phenylephrine in 1994. The studies leading to approval were criticized for lack of control, bias, and possibly flawed efficacy results. However, the committee did not find any safety defects in phenylephrine, and the FDA has not yet made decisions on pulling products off the shelves. The report also highlighted the economic impact on consumers who may be purchasing ineffective medicines.

In response to the allegations, Teva stated that there was no flaw in their conduct and would provide a detailed position during court proceedings. The Ministry of Health noted that the FDA had not made any decisions regarding the regulatory status of phenylephrine and that safety concerns were not raised for oral use in accepted doses. They assured the public that they would continue monitoring safety information and make regulatory decisions accordingly.

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