WASHINGTON (CBSNewYork/AP) – Federal regulators have warned more than 350 medical practices that Botox they may have received from a Canadian supplier is unapproved and could be counterfeit or unsafe.
The Food and Drug Administration said in a letter sent last month, a letter released publicly last week, that batches of the wrinkle treatment shipped by suppliers owned by pharmacy Canada Drugs have not been approved by the FDA and that the agency cannot assure their effectiveness or their safety.
The FDA said Canada Drugs was previously tied to shipping unapproved and counterfeit cancer drugs.
The agency warned doctors about buying drugs from sources other than licensed U.S. pharmacies. It is the fifth warning the agency has made this year about foreign suppliers providing unapproved drugs.
In February, the agency warned 19 medical practices that they had received a counterfeit version of the cancer drug Avastin. On three more occasions the FDA issued similar warnings about counterfeit Avastin and Altuzan, another brand name for the same drug. The alerts were also primarily targeted at drugs distributed by Canada Drugs.
A request for comment from the drug distributor was not immediately returned.
Drug shortages increased the financial incentives for some pharmacies to provide counterfeit or illegally imported drugs. The drugs subject to warnings have all been injectable treatments typically distributed through medical practices and not directly to patients.
In October, the FDA ordered operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers. The vast majority of those sites were operated by Canada Drugs. The site was still operating Friday.
Genuine Botox is made by Allergan Inc., based in Irvine, Calif. Avastin is made by Roche Holding AG’s Genentech unit.
The FDA’s warning letter, plus a list of doctors who received it, can be found here.
The list of doctors and medical practices in New York and New Jersey that were sent letters is below:
Dr. Heller: 1424 Richmond Ave, Staten Island
Thomas Guttuso: 300 Essjay Rd., Williamsville
Ehab Kodsi: 5 Main St Ste 6, Queensbury
Amie Malihan: 5046 Amboy Rd., Staten Island
Thomas Militana: 1 Stone Pl. Ste. 307, Bronxville
Scott Newman: 1 Odell Plz., Yonkers
Guillermo Quetell: 4900 Broad Rd. Phys. Office Bldg. North Ste. 4L, Syracuse
Bijan Safai: 625 Park Avenue, New York
Patrick Scott: 4010 Southwestern Blvd., Orchard Park
George P Smith: 2066 Richmond Ave., Staten Island
Hubert Weinberg: 1050 Park Ave. New York
Perry M Herman: 18 Centre Dr Ste 207, Monroe Twp.
Anil Kapoor: 1680 Route 23 North Ste 160, Wayne
Andrew Li: 755 Memorial Pkwy Ste 204, Phillipsburg
George Logvinenko: 14-25 Plaza Rd Ste 3-1, Fair Lawn
Vincent Novelli: 1225 River Rd. Unit 6B, Edgewater
Michael Pecoraro: 450 Jack Martin Blvd., Brick
Joseph Pober: 144 East Ridgewood Ave., Ridgewood
Diana Trusky: 92 Half Mile Rd., Red Bank
Offer your thoughts and comments in the section below…