Showing posts with label Unapproved Drugs. Show all posts
Showing posts with label Unapproved Drugs. Show all posts

Saturday, December 22, 2012

FDA Warns Against Unapproved Drugs From Foreign Suppliers

Dec 21, 2012

More than 350 medical practices in the United States may have received unapproved medications, including unapproved versions of Botox, from a foreign supplier, the US Food and Drug Administration (FDA) warned on its Web site this week.
"These medications may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Medical practices that purchase and administer illegal and unapproved medications from foreign sources are placing patients at risk and potentially depriving them of proper treatment," the agency said.
The FDA has sent a letter to the physicians or medical practices involved informing them of the situation.
A list of the doctors and clinics that received the letter is available here.
Products Not FDA Approved
To reduce the chance of patients receiving an unapproved, counterfeit, unsafe, or ineffective medication, the FDA is asking that medical practices stop administering the unapproved versions of Botox and any other products they have received from foreign suppliers owned and operated by Canada Drugs and known under the following names: Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care.
"Many, if not all, of the products sold and distributed by these suppliers have not been approved by FDA. Therefore, FDA cannot confirm that the manufacture and handling of these products follow U.S. regulations or that these medications are safe and effective for their intended uses," the FDA said. Medications not approved by the FDA may also lack the necessary and required labels that ensure their appropriate and safe use, the agency reminds clinicians.
So far in 2012, the FDA has issued letters to medical practices in the United States that purchased unapproved medications from foreign suppliers 5 times: on February 10, April 5, April 23, June 28, and September 10.
The FDA is asking healthcare providers to examine their purchasing practices to ensure that products are purchased directly from the manufacturer or from state-licensed wholesale drug distributors in the United States.
"Health care professionals, pharmacies, and wholesalers/distributors are valuable partners in efforts to protect consumers from the risks of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported. The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering them," the FDA said.
Healthcare providers are asked to report suspected criminal activity to FDA's Office of Criminal Investigations (OCI) by calling 1-800-551-3989 or visiting the OCI Web site.
The FDA has provided information on its Web site on how to verify that a wholesale drug distributor is licensed in the state(s) where it is conducting business.
Adverse events related to the use of suspect medications may be reported to MedWatch, the FDA's safety information and adverse event reporting program, either online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Source found here

Thursday, July 5, 2012

FDA prompts companies to remove certain unapproved oxycodone products from market

For Immediate Release: July 5, 2012 
Media Inquiries: Sarah Clark-Lynn 301-796-9110, sarah.clark-lynn@fda.hhs.gov 
Consumer Inquiries: 888-INFO-FDA 
The U.S. Food and Drug Administration today issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone. The notice is part of the FDA’s Unapproved Drugs Initiative to remove unapproved new drugs from the market. The FDA action affects companies that manufacture and distribute unapproved single-ingredient, immediate-release oxycodone drug products in oral dosage forms, including tablets, capsules and oral solutions. These products have not been evaluated by the FDA for safety, effectiveness, manufacturing quality, or appropriate labeling, including dosing information and warnings, and cannot be legally marketed in the United States. Oxycodone is an opioid analgesic, a class of powerful pain medications. Oxycodone is listed under Schedule II of the Controlled Substances Act with an abuse liability similar to other opioid agonists. Improper labeling and use of oxycodone can lead to overdose and death. FDA recognizes that opioid medications are associated with prescription drug misuse, abuse, and addiction, which have resulted in an increase in injuries and deaths across the United States over the last 10 years. “It’s a high public health priority for FDA to remove these unapproved products from the market to minimize consumer exposure to drugs that may be unsafe, ineffective, and of poor quality,” said Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Since FDA-approved versions of these oral dosage forms are available by prescription, there should be no negative impact on consumers as a result of this action and no disruptions to the drug supply.” The FDA’s Unapproved Drugs Initiative, which began in June 2006, is the agency’s risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process. One of the goals of the initiative is to reduce consumer exposure to drugs that are not proven safe, effective, and of high quality. Companies with certain products that are subject to this action are expected to stop manufacturing the products within 45 days and stop shipping the products within 90 days. Products that are subject to these timeframes are products that: were introduced onto the market before Sept. 19, 2011, were listed in the FDA’s Drug Registration and Listing System before July 6, 2012, and were being commercially used or sold before July 6, 2012. Companies that continue to market products that fall within this scope of this Federal Register notice are subject to enforcement action including seizure, injunction, or other judicial or administrative proceeding. Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of prescription drug products to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. For more information: Questions and Answers for Consumers about FDA's Action Involving Unapproved Oxycodone Single-Ingredient, Immediate Release Drug Products for Oral Administration

Tuesday, June 26, 2012

What are unapproved drugs and why are they on the market?

From FDA website:

What are unapproved drugs and why are they on the market?

The original Federal Food and Drugs Act of 1906 brought drug regulation under federal law. That Act prohibited the sale of adulterated or misbranded drugs, but did not require that drugs be approved by FDA. In 1938, Congress required that new drugs be approved for safety.  In 1962, Congress amended the 1938 law to require manufacturers to show that their drug products were effective, as well as safe. As a result, all drugs approved between 1938 and 1962 had to be reviewed again for effectiveness.  To be consistent with current regulations and to ensure that all drugs have been shown to be safe and effective, all new drugs are required to have an approved application for continued marketing.
Many healthcare providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.   In addition, since many unapproved drugs are marketed without brand names and have been available for many years, it is often assumed that these unapproved drugs are generic drugs.  This is not correct. Generic drugs have been evaluated and approved by FDA to demonstrate bioequivalence to a brand name reference drug.  Healthcare professionals and consumers can be assured that FDA-approved generic drug products have met the same quality, strength, purity and stability as brand name drugs. Additionally, the generic manufacturing, packaging, and testing sites must meet the same quality standards as those of brand name drugs. Unapproved drug products have not been evaluated and approved by FDA. Unapproved drugs are not generic medications, and neither their safety nor their efficacy can be assured.
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The FDA website also contain the following:

All the above can be found here.