1. Alpha interferon products. Manufactured by Roche Products and marketed as Pegasys; by Schering-Plough as Viraferon-Peg; by Biogen as Avonex and by Serono as Rebif, the FDA is reviewing reports of pulmonary hypertension.
2. Comtan. Also known as entacapone and manufactured by Novartis, it is used in combination with other drugs to treat Parkinson’s Disease. The FDA is reviewing reports of colitis, which is an inflammatory bowel disease.
3. Flector. Also known as a diclofenac and manufactured by King Pharmaceuticals, it is an epolamine patch that is used to treat pain caused by minor sprains, strains or bruising. The FDA is reviewing reports concerning hypersensitivity reactions
4. Gadolinium-based contrast agents. Marketed by Bayer Health Corporation as Magnevist, by Bracco Diagnostics Products as Prohance and Multihance, by GE Healthcare as Omniscan and by Tyco Healthcare as Optimark, the products are used in MRIs and MRAs. Gadolinium has been linked to NSF/NFD. The FDA is currently reviewing reports of anaphylaxis – a life-threatening type of allergic reaction.
5. Mecasermin products. Marketed as Increlex by Tercica, Inc. and Iplex by Insmed, Inc, these are growth therapies for children. The FDA is reviewing reports of hypersensitivity reactions.
6. Promethazine injections. A generic version of the anti-nausea drug Phenergan, it is prescribed for a variety of post-surgical ailments, the FDA is reviewing reports of severe tissue injury including gangrene. The FDA recently required a black box warning on Phenergan – the same drug which was at the center of the U.S. Supreme Court's decision on drug preemption.
7. Reclast. Also known as zoledronic acid, it is a once-a-year treatment for postmenopausal osteoporosis. The FDA is reviewing reports of renal (kidney) impairment.
8. Relistor. Also known as methylnaltrexonem and manufactured by Wyeth and Prgenics, it is used to treat constipation side effects when patients are given opioid drugs. The FDA is reviewing reports of gastrointestinal perforation.
9. Rocephin. Also known as Ceftriaxone, it is used to treat bacterial infections, including severe or life-threatening forms such as meningitis. The FDA is reviewing reports of hemolytic anemia – a condition in which there are not enough red blood cells in the blood because they have been destroyed prematurely.
10. Solodyn. Also known as minocycline, it is a tetracycline antibiotic manufactured by Medicis used to treat acne. The FDA is reviewing reports of autoimmune disorders in pediatric patients.
11. Sutent. Also known as sunitinib and manufactured by Pfizer, it is used to treat a cancer of the digestive (gastrointestinal) system. The FDA is reviewing reports of liver failure.
12. Videx. Also known as didanosine, it is an anti-HIV treatment. The FDA has linked Videx to an increased risk of heart attacks. It is currently reviewing reports of portal hypertension.
13. Viread. Also known as tenofovir and manufactured by Bristol-Myers Squibb and Barr Laboratories, it is used in the treatment of HIV-1 infection in adults and in the treatment of chronic hepatitis B in adults. The FDA is reviewing reports of safety during pregnancy

The FDA's investigation may result in regulatory action including 1) requiring changes to the labeling of the drug, 2) requiring development of a Risk Evaluation and Mitigation Strategy (REMS) or 3) gathering additional data to better characterize the risk.