EPA Investigating Adverse Reactions to Flea and Tick Products

An increase in reports of adverse reactions among pets to topical flea and tick medicines has prompted the Environmental Protection Agency (EPA) to intensify its scrutiny of these products. The products have not been recalled, but the agency is warning pet owners that the treatments may have serious, even fatal, side effects.

This investigation, according to the EPA, is due to some 44,000 complaints over the past year that the EPA has received from consumers. This represents a 53% increase over the previous year. Approximately 1,200 of those reports accounted for animal deaths.

Spot-on flea and tick treatments are applied topically, usually between the animal’s shoulder blades or along the spine. A majority of products being investigated appear to be Over-the-Counter (OTC) products rather than those obtained through a veterinarian. A list of more than 200 brands of registered products appear on EPA’s website.

According to agency spokesman Dale Kemery, the adverse reactions included skin irritations, hair loss and tremors. The E.P.A.’s report on liquid flea and tick treatments is expected by October and will be published on the agency’s Web site.

The appearance of counterfeit pesticide products for dogs and cats has further complicated the picture. On April 28, the E.P.A. warned distributors and retailers to stop selling counterfeit products with the brand names Advantage and Frontline, and to recall those already sold.

Consumers may call the National Pesticide Information Center at (800) 858-7378 to report a problem with the products. The agency has also advised veterinarians to report adverse reactions at the center’s Veterinary Pesticide Adverse Effects reporting portal.

To view registered products list visit EPA website at: www.epa.gov

To view more information on counterfeit Advantage and Frontline, visit: www.epa.gov

For the Veterinary Pesticide Adverse Effects reporting portal visit: http://pi.ace.orst.edu/vetrep/

U.S. Marshal Seizes Drugs Manufactured by Caraco Pharmaceutical Laboratories

FDA acts to prevent repeated drug quality problems

Yesterday, U.S. Marshals, at the request of the Food and Drug Administration, seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities.

This action follows repeated violations of FDA’s current Good Manufacturing Practice (cGMP) requirements. Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

The FDA’s most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. FDA’s seizure is intended to lead to major changes at Caraco’s facilities.

The FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers.

"The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.

Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.

To View the entire FDA press release visit: www.fda.gov.
To view the listing of products affected by this recall visit: www.fda.gov.

Baltimore Pharmacist Charged with Fraud in Counterfeit Drug Case

1,700 pounds of suspected counterfeit drugs was found in two Medicine Shoppes in Maryland last year - In addition, the owner is being charged with Medicare and Medicaid fraud.

A year ago we wrote regarding two Medicine Shoppes in the Maryland area that had been cited for having expired drugs on their shelves. This, however, does not even begin to tell the true story of expired drugs, counterfeit drugs, Medicare and Medicaid fraud, and the exportation of these drugs to Africa.

Pamela Arrey, a Maryland pharmacist, has most recently been charged with Medicare and Medicaid fraud. She is accused of charging about $350,000 to the federal insurance programs for drugs she never dispensed. In fact in some cases she billed for prescriptions the patients did not even request.

Last July, she was charged with mislabeling and selling counterfeit drugs when nearly 1,700 pounds of suspected counterefeit drugs were found at one of Arrey’s two Medicine Shoppes in Maryland. The durgs valued at $749,000, were medications to help epilepsy patients control seizures. Mislabeled, expired and suspected counterfeit drugs, including those designed to help fight breast cancer, were also found at Arrey’s second Baltimore Medicine Shoppe.

In August of last year, the Food and Drug Administration(FDA) issued a press release warning to consumers who purchased prescriptions from Arrey’s pharmacies that the following drugs could be expired or counterfeit:

* Lisinopril (20 milligrams)
* Guaifenesin/Dextromethorphan (600 mg and 1000 mg)
* Gabapentin (100 mg, 300 mg and 400 mg)
* Metoprolol (50 mg)
* Nifedipine (30 mg)
* Diclofenac Sodium (30 mg)
* Glucophage (500 mg Extended Release)
* Glucovance (125 mg and 500 mg)
* Glipizide/Metformin (2.50 mg/250 mg)
* Furosemide (20 mg)
* Tamoxifen Citrate (10 mg)
* Metformin HCl ER (500 mg)
* Calcitrol (0.25 micrograms)

“The health and safety of Arrey’s pharmacy customers has been put in danger as Arrey, through her pharmacies, dispensed misbranded and expired drugs,” FDA Special Agent Matthew Rosenberg wrote in a sworn statement.

For more on this story....

Hi-Tech Pharmaceuticals Recalls Sexual Performance Supplement

The Food and Drug Administration (FDA) has ordered Hi Tech Pharmaceuticals to recall their sexual performance Supplement Stamina-Rx after it was discovered to contain an undeclared ingredient, benzamidenafil. The ingredient is in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED).

Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.

Since the recall is due to an undeclared ingredient and Hi-Tech Pharmaceuticals is under a Consent Decree of Permanent Injunction with FDA since September 23, 2003, FDA has ordered a recall of all lots to the consumer level. Stamina-Rx is sold predominantly in health food and drug stores nationwide. The product is sold in 10, 30, and 40-tablet bottles and in 2 and 6-tablet blister packs.

Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA’s MedWatch Adverse Event Reporting program online at [www.fda.gov/MedWatch/report.htm] or by phone [1-800-FDA-1088].

Stolen Insulin Vials Resurface in U.S. Market

Stolen vials of insulin have resurfaced at a Houston area medical center. The 10-mL vials of Levemir are from lots XZF0036, XZF0037, and XZF0038. The stolen insulin discovered was part of a shipment of 129,000 vials which was stolen in February this year in route from a Novo Nordisk facility in North Carolina.

The Food and Drug Administration (FDA) is warning the public that insulin from these lots may not have been stored and handled properly and therefore is not safe for use. Patients with Levemir vials from these lots should contact Nov Nordisk Customer Care Center at 800-727-6500 for instructions.

The agency said it had received one report of a patient who had an adverse event due to poor blood-glucose control after injecting insulin detemir from one of the three lots.

UK: Online Dealer of Fake Medicines is Jailed

The Medicines and Healthcare products Regulatory Agency (MHRA) reported that a 49-year-old unlicensed and counterfeit medicines dealer has been sentenced to two years imprisonment at Southwark Crown Court. Mr. Martin Simon Hickman pleaded guilty to six counts of selling and supplying fake and unlicensed medicines, and money laundering to the sum of £1.4m.

Mr. Hickman operated an illegal online pharmacy and sold over £6m worth of fake Viagra and unlicensed Kamagra and Lovegra (Indian erectile dysfunction drugs) in the United Kingdom and abroad between 2003 to 2007.

His illegal gains funded a lavish lifestyle - a £2.5million riverside apartment in Chelsea, West London, property in the Spanish millionaires’ resort of Marbella and a four-bedroom farmhouse.

MHRA Head of Enforcement, Mick Deats, said the man enjoyed a lavish lifestyle on the profits made by selling the unlicensed and fake drugs. "People dealing in these types of businesses are criminals, but at the much higher end of the pay scale," he said. "Mr Hickman has substantially benefitted financially from this unlawful trade."

"He is not a healthcare professional, in fact, he is not professional in any way shape or form. He is simply a money motivated criminal living a life of luxury at the expense of other people's health."

MHRA investigation began in 2005 and ran till his site was successfully closed in 2007. Because the website was hosted in Germany the MHRA had to take out an injunction to shut the website down. But Hickman still continued to trade and in 2007 was jailed for three months for ignoring the injunction.

Hickman also had prior dealings in illegal pharmaceuticals and in 1998 he was jailed for 10 months for conspiracy to trade in steroids.

NAFDAC Seizes N32Million in Fake Anti-Malaria Drugs

Nigeria officials seized a large cache of counterfeit drugs at Kirikiri Lighter Terminal in Lagos, on Wednesday May 20, 2009. The National Agency for Food and Drug Administration and Control (NAFDAC) acting on a tip, intercepted
the counterfeit anti-malarial drugs, Maloxine and Amalar tablets, which had an estimated street value of N31.1 Million.

Laboratory tests by the agency showed that the fake anti-malarials which were produced in China but labeled "Made in India," contained only sulfadioxine and no pyrimethamine.

Director General, NAFDAC, Dr. Paul Orhii, said the interception of the fake drugs may have saved hundreds of thousands of Nigerians from possible effects such as treatment failure, drug resistance, complications like anemia and death had the drugs been circulated into the open market.

"If these fake drugs were not intercepted by NAFDAC, 642,000 adults will be affected. This figure will go up if children are given half or quarter dose as some parents and guardians sometimes do that," he added.

FDA Warns 35 websites to stop Marketing Swine Flu Remedies

The FDA is monitoring websites claiming to have cures or prevention methods for swine flu.

Thirty five websites have been issued warning letters because the FDA has determined that their website offers products for sale that are intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people and these products have not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.

To see a listing of the warning letters issued, visit the FDA website at: www.fda.gov.

China Denies Branding as Fake Drug Center

China says it has been unfairly dubbed as the center of fake drugs. This branding has arisen out of the numerous problems with raw materials sourced from China. However, Chinese officials think it is the overseas companies that are to blame, stating that some companies are sourcing their raw material through illegal suppliers.

"The problem lies in the fact that some overseas companies have an implicit deal with underground factories or illegal manufacturers in China, so the product involved has problems," Bian Zhenjia, director of the drug safety supervision department under the State Food and Drug Administration, told a press conference.

In 2008, heparin was recalled after reports of deaths and hundreds of adverse reactions. The cause was linked to an adulterated substance found in the raw material traced to a dozen Chinese suppliers, some of whom were not even registered as pharmaceutical suppliers.

While China might deny the name, they have suffered the effects of counterfeiting domestically as well as abroad. Last year, they recalled several Chinese herbal medicines and recalled a diabetes drug in January that was linked to two deaths in Xinjiang. Samples showed the medicine contained six times the normal amount of a chemical ingredient used to lower blood sugar.

China's own regulatory authority, State Food and Drug Administration (SFDA) counted 329,613 cases of distribution of unlicensed drugs and medical products in 2007, according to the China Daily newspaper.