WASHINGTON (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 saidin a letter sent last month and released 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 following medical practices in Tampa Bay were notified by the FDA:
- Bethel, Adrian
8146 Cerebellum Way Suite 102
- Florida Joint Replacement & Sports Medicine Center
3980 Tampa Rd. Ste. 202
- Golomb, Roger
1122 Druid Road East
- Matheson, Ian
800 West Martin Luther King Jr. Blvd. Ste. 4
- Said, Nader
8115 State Road 54
New Port Richey
- Sanchez, Rolando
4039 W. Kennedy Blvd.
- Sessa, Alberico
4143 Clark Rd.