Zicam Recalled!
Posted in Product Liability, Zicam on 17. Jun, 2009
The Food and Drug Administration told consumers to stop using certain Zicam cold and allergy products because they can cause permanent loss of smell, the latest crackdown under new FDA leaders.
The frequently advertised over-the-counter products contain zinc and have been the target of hundreds of lawsuits by consumers alleging that their sense of smell was damaged or destroyed.
Zicam’s maker, Matrixx Initiatives Inc., said it believes the products are safe and don’t cause loss of smell. It called the FDA’s move “unwarranted.” The action on Zicam is one of several high-profile moves under new FDA Commissioner Margaret “Peggy” Hamburg and her principal deputy, Joshua Sharfstein.
In an interview Tuesday before the Zicam announcement, Dr. Hamburg said public health is her top focus. Under Dr. Sharfstein, who came to the agency in March while Dr. Hamburg was awaiting confirmation, the FDA issued strong warning letters to some of the largest drug makers regarding Web-based marketing and announced recalls on California pistachios.
For example, Janet Trunzo of Advanced Medical Technology Association, the main medical-device trade group, said any regulatory changes should “ensure that patients continue to have access” to medical technologies “as quickly as possible.”
In a warning letter to Matrixx, the FDA said it “has concluded that these products may pose a serious risk to consumers who use them.”
The Zicam intranasal products affected by the FDA’s move account for about 40% of the company’s sales, which totaled about $112 million for its fiscal year ended March 31. Sales of over-the-counter cold and cough products total about $4 billion annually.
Zicam is sold primarily as a cold and allergy remedy. The FDA said consumers should stop using the nasal zinc-containing products, which are sold as Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs. The agency also warned against Zicam Cold Remedy Swabs, Kids Size, which the company no longer sells but says could remain in some medicine cabinets.
The FDA’s action doesn’t affect other Zicam products, such as tablets, “rapid melts” and liquid forms.
FDA officials said they have received more than 130 reports from consumers about the loss of smell, but believe there are more cases.
FDA spokeswoman Siobhan DeLancey said the agency inspected Matrixx in May and noticed it hadn’t reported “several hundred” adverse events related to Zicam, most of which involved a loss of sense of smell.
Agency officials said there is evidence that zinc could be toxic when delivered through the nose. The agency said the loss of smell can be long-lasting or permanent.
In 2006, Phoenix-based Matrixx settled more than 300 lawsuits brought by consumers who alleged that Zicam zinc nasal gel damaged or destroyed their sense of smell.
Matrixx wasn’t required to report adverse events to the FDA until the end of 2007 when a law went into effect requiring over-the-counter supplement makers to report side effects to the FDA, an agency spokeswoman said.
Over-the-counter products including the Zicam lineup generally don’t require preapproval from the FDA before going on the market.
